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Ovarian Cancer Publications

Title Authors Presented at / Published in Cancer Type Patient Count Primary Endpoint
Clinical Activity of the Poly(ADP-Ribose) Polymerase (PARP) Inhibitor Rucaparib in Patients with High-Grade Ovarian Carcinoma and a BRCA Mutation: Analysis of Pooled Data from Study 10 (Parts 1, 2a, and 3) and ARIEL2 (Parts 1 and 2) Rebecca S. Kristeleit, Ronnie Shapira-Frommer, Ana Oaknin, Judith Balmaña, Isabelle Ray-Coquard, Susan Domchek, Anna V. Tinker, Cesar Castro,
Stephen Welch, Andres Poveda, Kathy Bell-McGuinn, Gottfried Konecny,
Heidi Giordano, Lara Maloney, Sandra Goble, Lindsey Rolfe, Amit M. Oza
European Society for Medical Oncology Congress 2016 (Abstract 8560) High-grade ovarian cancer 106 patients Progression-free survival
Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer Mansoor R. Mirza, Bradley J. Monk, Jørn Herrstedt, Amit M. Oza, Sven Mahner, Andrés Redondo, Michel Fabbro, Jonathan A. Ledermann, Domenica Lorusso, Ignace Vergote, Noa E. Ben-Baruch, Christian Marth, Radosław Mądry, René D. Christensen, , Jonathan S. Berek, Anne Dørum, Anna V. Tinker, Andreas du Bois, Antonio González-Martín, Philippe Follana, Benedict Benigno, Per Rosenberg, Lucy Gilbert,, Bobbie J. Rimel, Joseph Buscema, John P. Balser, Shefali Agarwal, and Ursula A. Matulonis N Engl J Med 2016; 375:2154-2164 Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with predominantly high-grade serous histologic features 109 patients Progression-free survival
Olaparib maintenance therapy in patients with platinum sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomized phase 2 trial Jonathan Ledermann, Philipp Harter, Charlie Gourley, Michael Friedlander, Ignace Vergote, Gordon Rustin, Clare L Scott, Werner Meier, Ronnie Shapira-Frommer, Tamar Safra, Daniela Matei, Anitra Fielding, Stuart Spencer, Brian Dougherty, Maria Orr, Darren Hodgson, J Carl Barrett, Ursula Matulonis Lancet Oncol 2014; 15: 852–61 Ovarian Cancer 136 patients were assigned to olaparib and 129 to placebo. Progression-free survival
Characterization of long-term responders to olaparib from study D0810C000019 Stephanie Lheureux, Jonathan Ledermann, Sarah Runswick, Darren Hodgson, Kirsten Timms, Jerry Lanchbury, Stanley Kaye, Charlie Gourley, David Bowtell, Elise Kohn, Clare Scott, Ursula Matulonis, Tony Panzarella, Brian Dougherty, Carl Barrett, Zhongwu Lai, Mark O’Connor, Jane Robertson, Tony Ho, Amit M. Oza 2015 American Society of Clinical Oncology (Abstract 5566) Serous Ovarian Cancer 32 long-term responders (>2 years), 21 short-term responders (<3 months) Predictive markers of long-term and short-term response to olaparib
3-Biomarker HRD Score versus Individual Biomarker (LOH, TAI, LST) Scores in Platinum Treated Serous Ovarian Cancer (SOC) Jerry S. Lanchbury, Kirsten M. Timms, Julia Reid, Euan A. Stronach, Alexander Gutin, Thomas Krivak, Bryan Hennessy, James Paul, Rebecca Nix, Zaina Sangale, Elisha Hughes, Victor Abkevich, Gordon B. Mills 2016 European Society of Medical Oncology (Abstract 112P) Serous Ovarian Cancer 859 patients False Positive Rate, False Negative Rate
Homologous Recombination Deficiency (HRD) Score Shows Superior Association with Outcome Compared to its Individual Score Components (LOH, TAI, and LST Scores) in Platinum Treated Serous Ovarian Cancer Gordon Mills, Kirsten M. Timms, Julia Reid, Alexander Gutin, Thomas Krivak, Bryan Hennessy, James Paul, Robert Brown, Jerry S. Lanchbury, Euan A. Stronach 2016 Annual Meeting on Women’s Cancer (Abstract 2) Serous Ovarian Cancer 859 patients Progression-free Survival, Overall Survival
Characteristics of homologous recombination deficiency (HRD) in paired primary and recurrent high-grade serous ovarian cancer (HGSOC) specimens Jai N. Patel, Jalid Sehouli, Kirsten M. Timms, Cara Solimeno, Julia E. Reid, Jerry S. Lanchbury, Ioana Braicu, Silvia Darb-Esfahani, Mahrukh K. Ganapathi, Ram N. Ganapathi 2015 American Society of Clinical Oncology (Abstract 5534) High Grade Serous Ovarian Cancer 25 patients Correlation of myChoice HRD results between paired primary and recurrent specimens
Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial Eric Pujade-Lauraine, Jonathan A Ledermann, Frédéric Selle, Val Gebski, Richard T Penson, Amit M Oza, Jacob Korach, Tomasz Huzarski, Andrés Poveda, Sandro Pignata, Michael Friedlander, Nicoletta Colombo, Philipp Harter, Keiichi Fujiwara, Isabelle Ray-Coquard, Susana Banerjee, Joyce Liu, Elizabeth S Lowe, Ralph Bloomfield, Patricia Pautier Lancet Oncol 2017; S1470-2045(17)30469-2 high-grade serous ovarian cancer 196 patients were assigned to olaparib and 99 to placebo. Progression-free survival
Homologous recombination deficiency (HRD) of high grade serous ovarian tumors from the NOVA Phase III clinical study Keith Wilcoxen, Christopher Neff, Victor Abkevich, Joshua Timothy Jones, Kathryn Kolquist, Michael Mirza, Jerry Lanchbury, Keith Mikule, Shefali Agarwal, Anne-Renee Hartman, Alexander Gutin, Kirsten Timms 2015 European Organisation for Research and Treatment (Abstract C53) High Grade Serous Ovarian Cancer 347 patients HRD Score Distribution
Homologous recombination deficiency (HRD) score enriches for niraparib sensitive high grade ovarian tumors. Keith Wilcoxen, Marc Becker, Christopher Neff, Victor Abkevich, Joshua Timothy Jones, Xiaonan Hou, Yan Wang, Anne-Renee Hartman, Mariam M. Al Hilli, Alexander Gutin, Shefali Agarwal, Kirsten Timms, and Paul Haluska 2015 American Society of Clinical Oncology (Abstract 5532) High Grade Ovarian Tumors 174 patients PDx Tumor Burden
Patterns of genomic loss of heterozygosity predict homologous recombination repair defects in epithelial ovarian cancer Victor Abkevich, Kirsten M. Timms, Bryan T. Hennessy, Jennifer Potter, Mark S. Carey, Larissa A. Meyer, Karen Smith-McCune, Russell Broaddus, Karen H. Lu, Jian Chen, Thanh V. Tran, Deborah Williams, Diana Iliev, Srikanth Jammulapati, Lisa M. FitzGerald, Thomas C. Krivak, Julie A. DeLoia, Alexander Gutin, Gordon B. Mills, and Jerry S. Lanchbury British Journal of Cancer (2012). 107(10):1776-82. Ovarian Cancer 640 patients Association between HRD score and HR deficiency
Evaluation of BRCA1/2 and homologous recombination defects in ovarian cancer and impact on clinical outcomes Melinda S. Yates, Kirsten Timms, Molly S Daniels, Holly D. Oakley, Mark F. Munsell, Jerry S. Lanchbury, Karen H. Lu 2017 American Society of Clinical Oncology (Abstract 5511) Ovarian Cancer 299 patients Event-Free Survival, Overall Survival
Homologous Recombination (HR) Deficiency, Tumor BRCA1/2 Mutations (tmBRCA) and Association with Response and Outcome Following Platinum Monotherapy in High Grade Serous Ovarian Cancer (HGSOC) Robert Brown, Kirsten Timms, James Paul, Elisha Hughes, Mona El-Bahrawy, Jennifer H. Steel, Saritha Kalva, Xinxue Liu, Yuepeng Wang, Nona Rama, Charlotte Wilhelm-Benartzi, Alexander Gutin, Liz-Anne Lewsley, Nadeem Siddiqui, Naina Patel, Jerry Lanchbury, Hani Gabra, Euan A. Stronach 2015 American Society of Clinical Oncology (Abstract 5576) High Grade Serous Ovarian Cancer 165 patients Progression-Free Survival, Overall Survival
Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicenter, open-label, phase 2 trial Dr Prof Elizabeth M Swisher, Kevin K Lin, Prof Amit M Oza, Clare L Scott, Heidi Giordano, James Sun, Gottfried E Konecny, Prof Robert L Coleman, Anna V Tinker, David M O’Malley, Rebecca S Kristeleit, Ling, Katherine M Bell-McGuinn, Prof James D Brenton, Janiel M Cragun, Ana Oaknin, Prof Isabelle Ray-Coquard, Maria I Harrell, Elaina Mann, Prof Scott H Kaufmann, Anne Floquet, Alexandra Leary, Thomas C Harding, Sandra Goble, Lara Maloney, Jeff Isaacson, Andrew R Allen, Lindsey Rolfe, Roman Yelensky, Mitch Raponi, Prof Iain A McNeish Lancet Oncol 2017; 18: 75-87 Ovarian cancer 206 patients Progression-free survival

Breast Cancer Publications

Title Authors Presented at / Published in Cancer Type Patient Count Primary Endpoint
Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation Mark Robson, Seock-Ah Im, Elżbieta Senkus, Binghe Xu, Susan M. Domchek, Norikazu Masuda, Suzette Delaloge, Wei Li, Nadine Tung, Anne Armstrong, Wenting Wu, Carsten Goessl, Sarah Runswick, and Pierfranco Conte New England Journal of Medicine 2017; Jun 4 doi: 10.1056/NEJMoa1706450. HER2-negative metastatic breast cancer 205 patients were assigned to olaparib and 97 to standard therapy (physician choice chemotherapy) Progression-free survival
Prediction of pathological complete response (pCR) by Homologous Recombination Deficiency (HRD) after carboplatin-containing neoadjuvant chemotherapy in patients with TNBC – Results from GeparSixto Gunter von Minckwitz, Kirsten Timms, Michael Untch, Eric P. Elkin, Eric Hahnen, Peter A. Fasching, Andreas Schneeweiss, Christoph T. Salat, Mahdi Rezai, Jens U. Blohmer, Dirk M. Zahm, Christian Jackisch, Bernd Gerber, Peter Klare, Sherko Kümmel, Holger Eidtmann, Stefan Paepke, Rita Schmutzler, Julia Reid, Valentina Nekljudova, Karsten Weber, Anne-Renee Hartman, Sibylle Loibl 2015 American Society of Clinical Oncology (Abstract 1004) Triple Negative Breast Cancer 193 patients Pathologic Complete Response
Homologous Recombination Deficiency (HRD) Score Predicts Response to Cisplatin Neoadjuvant Chemotherapy in Patients with Triple Negative Breast Cancer Andrea L. Richardson, Daniel P. Silver, Zoltan Szallasi, Erica L. Mayer, Nicolai J. Birkbak, Zhigang C. Wang, J. Dirk Iglehart, Eric P. Winer, Nadine M. Tung, Paula D. Ryan, Steven J. Isakoff, William T. Barry, April Greene-Colozzi, Alexander Gutin, Julia Reid, Chris Neff, Joshua Jones, Kirsten Timms, Anne-Renee Hartman, and Judy E. Garber 2014 San Antonio Breast Conference Symposium (P3-06-11) Triple Negative Breast Cancer 53 patients Pathologic Partial Response, Pathologic Complete Response
TBCRC030: A randomized phase II study of preoperative cisplatin versus paclitaxel in patients (pts) with BRCA1/2-proficient triple negative breast cancer (TNBC): Evaluating the Homologous Recombination Deficiency (HRD) Biomarker Erica L. Mayer, Ines Vaz-Luis, Andrea Richardson, Charles Perou, Nadine Tung, Vandana Abramson, Carey Anders, Andres Forero, P. Kelly Marcom, Kathy Miller, Shannon Puhalla, Mothaffar Rimawi, Vered Stearns, Tiffany Traina, William Barry, Kirsten Timms, Anne-Renee Hartman, Antonio Wolff, Eric Winer 2014 American Society of Clinical Oncology (Abstract TPS1145) BRCA1/2- Proficient Triple Negative Breast Cancer Target accrual 160 patients Pathologic Complete Response
Reproducibility of homologous recombination deficiency (HRD) scores in biopsies of triple negative breast cancer (TNBC) tumors Kirsten Timms, Anees Chagpar, Vikram Wali, Veerle Bossuyt, Julia Reid, Alexander Gutin, Chris Neff, Erin Hofstatter, Jerry Lanchbury, Lajos Pusztai 2015 American Society of Clinical Oncology (Abstract 1091) Triple Negative Breast Cancer 32 patients Standard deviation of HRD scores between samples
Role of Germline BRCA Status and Tumor Homologous Recombination (HR) Deficiency in Response to Neoadjuvant Weekly Paclitaxel Followed by Anthracycline-Based Chemotherapy Judy C. Boughey, Krishna R. Kalari, Vera J. Suman, Sarah A. McLaughlin, Alvaro Moreno-Aspitia, Ann M. Moyer, Donald W. Northfelt, Richard J. Gray, Peter Vedell, Xiaojia Tang, Travis Dockter, Sara J. Felten, Katie Hunt, Amy Conners, Steven N. Hart, Daniel W. Visscher, Eric D. Wieben, James N. Ingle, Anne-Renee Hartman, Kirsten Timms, Brent Evans, Joshua Jones, Liewei Wang, Richard W. Weinshilboum, Matthew P. Goetz 2015 San Antonio Breast Cancer Symposium (P3-07-29 ) Stage I-III Breast Cancer 93 patients MRI Response Rate, Pathologic Complete Response
Phase II neoadjuvant clinical trial of carboplatin and eribulin in women with triple negative early stage breast cancer (NCT01372579) Virginia G. Kaklamani, Elisha Hughes, Kalliopi Siziopikou, Kirsten M. Timms, Victor Abkevich, Cara Solimeno, Anne-Renee Hartman, Jacqueline S. Jeruss, Caitlin Meservey, Borko Jovanovic, Irene Helenowski, Seema A. Khan, Kevin P. Bethke, Nora Hansen, Regina Uthe, Steven Rosen, Kent Hoskins, Jamie Von Roenn, Sarika Jain, William Gradishar 2015 American Society of Clinical Oncology (Abstract 1017) Triple Negative Early Stage Breast Cancer 30 patients Pathologic Complete Response
Association of BRCA1/2 defects with genomic scores predictive of DNA damage repair deficiency among breast cancer subtypes Kirsten Timms, Victor Abkevich, Elisha Hughes, Chris Neff, Julia Reid, Brian Morris, Saritha Kalva, Jennifer Potter, Thanh V Tran, Jian Chen, Diana Iliev, Zaina Sangale, Eliso Tikishvili, Michael Perry, Andrey Zharkikh, Alexander Gutin and Jerry S Lanchbury Breast Cancer Research (2014). 16:475 Breast Cancer (ER/HER2 subtypes) 197 patients Correlation between BRCA mutation status and LOH, TAI, and LST
Combined Homologous Recombination Deficiency (HRD) Scores and Response to Neoadjuvant Platinum-Based Chemotherapy in Triple Negative and/or BRCA1/2 Mutation-Associated Breast Cancer Melinda L. Telli, Kirsten Timms, Julia Reid, Chris Neff, Victor Abkevich, Alexander Gutin, Zaina Sangale, Diana Iliev, Joshua T. Jones, Bryan Hennessy, Jerry Lanchbury, Gordon Mills, Anne-Renee Hartman, James M. Ford 2015 American Society of Clinical Oncology (Abstract 1018) Triple Negative and/or BRCA1/2 Mutation-Associated Breast Cancer 68 patients Residual Cancer Burden
Homologous Recombination Deficiency (HRD) as a predictive biomarker of response to neoadjuvant platinum-based therapy in patients with triple-negative breast cancer (TNBC): A pooled analysis Melinda L. Telli, Alex McMillan, James M. Ford, Andrea L. Richardson, Daniel P. Silver, Steven J. Isakoff, Virginia G. Kaklamani, William Gradishar, Vered Stearns, Roisin M. Connolly, Sibylle Loibl, Karsten Weber, Eric Elkin, Brent Evans, Kirsten Timms, Anne-Renee Hartman, Gunter von Minckwitz 2015 San Antonio Breast Cancer Symposium (P3-07-12) Triple Negative Breast Cancer 267 patients Pathologic Complete Response
TNT: A randomized phase III trial of carboplatin (C) compared with docetaxel (D) for patients with metastatic or recurrent locally advanced triple negative or BRCA1/2 breast cancer Andrew Tutt, Paul Ellis, Lucy Kilburn, Cheryl Gilett, Sarah Pinder, Jacinta Abraham, Sophie Barrett, Peter Barrett-Lee, Stephen Chan, Maggie Cheang, Mitch Dowsett, Lisa Fox, Patrycja Gazinska, Anita Grigoriadis, Alexander Gutin, Catherine Harper-Wynne, Matthew Hatton, Sarah Kernaghan, Jerry Lanchbury, James Morden, Julie Owen, Jyoti Parikh, Peter Parker, Nazneen Rahman, Rebecca Roylance, Adam Shaw, Ian Smith, Rose Thompson, Kirsten Timms, Holly Tovey, Andrew Wardley, Gregory Wilson, Mark Harries and Judith Bliss 2014 San Antonio Breast Conference Symposium (S3-01) Triple Negative Breast Cancer 376 patients Objective Response Rate

HRD and PARP Inhibitors

Title Authors Presented at / Published in Cancer Type Patient Count Primary Endpoint
Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer Mansoor R. Mirza, Bradley J. Monk, Jørn Herrstedt, Amit M. Oza, Sven Mahner, Andrés Redondo, Michel Fabbro, Jonathan A. Ledermann, Domenica Lorusso, Ignace Vergote, Noa E. Ben-Baruch, Christian Marth, Radosław Mądry, René D. Christensen, , Jonathan S. Berek, Anne Dørum, Anna V. Tinker, Andreas du Bois, Antonio González-Martín, Philippe Follana, Benedict Benigno, Per Rosenberg, Lucy Gilbert,, Bobbie J. Rimel, Joseph Buscema, John P. Balser, Shefali Agarwal, and Ursula A. Matulonis N Engl J Med 2016; 375:2154-2164 Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with predominantly high-grade serous histologic features 109 patients Progression-free survival
Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial Dr Prof Elizabeth M Swisher, Kevin K Lin, Prof Amit M Oza, Clare L Scott, Heidi Giordano, James Sun, Gottfried E Konecny, Prof Robert L Coleman, Anna V Tinker, David M O’Malley, Rebecca S Kristeleit, Ling, Katherine M Bell-McGuinn, Prof James D Brenton, Janiel M Cragun, Ana Oaknin, Prof Isabelle Ray-Coquard, Maria I Harrell, Elaina Mann, Prof Scott H Kaufmann, Anne Floquet, Alexandra Leary, Thomas C Harding, Sandra Goble, Lara Maloney, Jeff Isaacson, Andrew R Allen, Lindsey Rolfe, Roman Yelensky, Mitch Raponi, Prof Iain A McNeish Lancet Oncol 2017; 18: 75-87 Ovarian cancer 206 patients Progression-free survival
Clinical Activity of the Poly(ADP-Ribose) Polymerase (PARP) Inhibitor Rucaparib in Patients with High-Grade Ovarian Carcinoma and a BRCA Mutation: Analysis of Pooled Data from Study 10 (Parts 1, 2a, and 3) and ARIEL2 (Parts 1 and 2) Rebecca S. Kristeleit, Ronnie Shapira-Frommer, Ana Oaknin, Judith Balmaña, Isabelle Ray-Coquard, Susan Domchek, Anna V. Tinker, Cesar Castro,
Stephen Welch, Andres Poveda, Kathy Bell-McGuinn, Gottfried Konecny,
Heidi Giordano, Lara Maloney, Sandra Goble, Lindsey Rolfe, Amit M. Oza
European Society for Medical Oncology Congress 2016 (Abstract 8560) High-grade ovarian cancer 106 patients Progression-free survival
Olaparib maintenance therapy in patients with platinum sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomized phase 2 trial Jonathan Ledermann, Philipp Harter, Charlie Gourley, Michael Friedlander, Ignace Vergote, Gordon Rustin, Clare L Scott, Werner Meier, Ronnie Shapira-Frommer, Tamar Safra, Daniela Matei, Anitra Fielding, Stuart Spencer, Brian Dougherty, Maria Orr, Darren Hodgson, J Carl Barrett, Ursula Matulonis Lancet Oncol 2014; 15: 852–61 Ovarian Cancer 136 patients were assigned to olaparib and 129 to placebo. Progression-free survival
Characterization of long-term responders to olaparib from study D0810C000019 Stephanie Lheureux, Jonathan Ledermann, Sarah Runswick, Darren Hodgson, Kirsten Timms, Jerry Lanchbury, Stanley Kaye, Charlie Gourley, David Bowtell, Elise Kohn, Clare Scott, Ursula Matulonis, Tony Panzarella, Brian Dougherty, Carl Barrett, Zhongwu Lai, Mark O’Connor, Jane Robertson, Tony Ho, Amit M. Oza 2015 American Society of Clinical Oncology (Abstract 5566) Serous Ovarian Cancer 32 long-term responders (>2 years), 21 short-term responders (<3 months) Predictive markers of long-term and short-term response to olaparib

BRCA1/2 Mutations and PARP Inhibitors

Title Authors Presented at / Published in Cancer Type Patient Count Primary Endpoint
BRACAnalysis CDx as a companion diagnostic tool for Lynparza Camille C Gunderson, Kathleen N Moore Taylor & Francis (2015); 1473-7159 Ovarian Cancer n/a n/a
Inhibition of Poly(ADP-Ribose) Polymerase in Tumors from BRCA Mutation Carriers Peter C. Fong, David S. Boss, Timothy A. Yap, Andrew Tutt, Peijun Wu, Marja Mergui-Roelvink, Peter Mortimer, Helen Swaisland, Alan Lau, Mark J. O’Connor, Alan Ashworth, James Carmichael, Stan B. Kaye, Jan H.M. Schellens, and Johann S. de Bono N Engl J Med 2009; 361:123-134 patients be carriers of BRCA1 or BRCA2 mutations 60 patients Adverse Events
Applying Synthetic Lethality for the Selective Targeting of Cancer Donal P. McLornan, Alan List, and Ghulam J. Mufti N Engl J Med 2014; 371:1725-1735
Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation Mark Robson, Seock-Ah Im, Elżbieta Senkus, Binghe Xu, Susan M. Domchek, Norikazu Masuda, Suzette Delaloge, Wei Li, Nadine Tung, Anne Armstrong, Wenting Wu, Carsten Goessl, Sarah Runswick, and Pierfranco Conte New England Journal of Medicine 2017; Jun 4 doi: 10.1056/NEJMoa1706450. HER2-negative metastatic breast cancer 205 patients were assigned to olaparib and 97 to standard therapy (physician choice chemotherapy) Progression-free survival
Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer Mansoor R. Mirza, Bradley J. Monk, Jørn Herrstedt, Amit M. Oza, Sven Mahner, Andrés Redondo, Michel Fabbro, Jonathan A. Ledermann, Domenica Lorusso, Ignace Vergote,  Noa E. Ben-Baruch,  Christian Marth, Radosław Mądry, René D. Christensen, Jonathan S. Berek, Anne Dørum, Anna V. Tinker, M.D., Andreas du Bois, Antonio González-Martín, Philippe Follana, Benedict Benigno, Per Rosenberg, Lucy Gilbert, Bobbie J. Rimel, Joseph Buscema, John P. Balser, Shefali Agarwal, and Ursula A. Matulonis N Engl J Med 2016; 375:2154-2164 ovarian cancer 203 were in the gBRCA cohort (with 138 assigned to niraparib and 65 to placebo), and 350 patients were in the non-gBRCA cohort (with 234 assigned to niraparib and 116 to placebo) progression-free survival

BRCA1/2 Mutations, HRD and DNA damaging Agents

Title Authors Presented at / Published in Cancer Type Patient Count Primary Endpoint
Homologous Recombination (HR) Deficiency, Tumor BRCA1/2 Mutations (tmBRCA) and Association with Response and Outcome Following Platinum Monotherapy in High Grade Serous Ovarian Cancer (HGSOC) Robert Brown, Kirsten Timms, James Paul, Elisha Hughes, Mona El-Bahrawy, Jennifer H. Steel, Saritha Kalva, Xinxue Liu, Yuepeng Wang, Nona Rama, Charlotte Wilhelm-Benartzi, Alexander Gutin, Liz-Anne Lewsley, Nadeem Siddiqui, Naina Patel, Jerry Lanchbury, Hani Gabra, Euan A. Stronach 2015 American Society of Clinical Oncology (Abstract 5576) High Grade Serous Ovarian Cancer 165 patients Progression-free Survival, Overall Survival
BCRC030: A randomized phase II study of preoperative cisplatin versus paclitaxel in patients (pts) with BRCA1/2-proficient triple negative breast cancer (TNBC): Evaluating the Homologous Recombination Deficiency (HRD) Biomarker Erica L. Mayer, Ines Vaz-Luis, Andrea Richardson, Charles Perou, Nadine Tung, Vandana Abramson, Carey Anders, Andres Forero, P. Kelly Marcom, Kathy Miller, Shannon Puhalla, Mothaffar Rimawi, Vered Stearns, Tiffany Traina, William Barry, Kirsten Timms, Anne-Renee Hartman, Antonio Wolff, Eric Winer 2014 American Society of Clinical Oncology (Abstract TPS1145) BRCA1/2- Proficient Triple Negative Breast Cancer Target accrual 160 patients Pathologic Complete Response
Phase II neoadjuvant clinical trial of carboplatin and eribulin in women with triple negative early stage breast cancer (NCT01372579) Virginia G. Kaklamani, Elisha Hughes, Kalliopi Siziopikou, Kirsten M. Timms, Victor Abkevich, Cara Solimeno, Anne-Renee Hartman, Jacqueline S. Jeruss, Caitlin Meservey, Borko Jovanovic, Irene Helenowski, Seema A. Khan, Kevin P. Bethke, Nora Hansen, Regina Uthe, Steven Rosen, Kent Hoskins, Jamie Von Roenn, Sarika Jain, William Gradishar 2015 American Society of Clinical Oncology (Abstract 1017) Triple Negative Early Stage Breast Cancer 30 patients Pathologic Complete Response
Combined Homologous Recombination Deficiency (HRD) Scores and Response to Neoadjuvant Platinum-Based Chemotherapy in Triple Negative and/or BRCA1/2 Mutation-Associated Breast Cancer Melinda L. Telli, Kirsten Timms, Julia Reid, Chris Neff, Victor Abkevich, Alexander Gutin, Zaina Sangale, Diana Iliev, Joshua T. Jones, Bryan Hennessy, Jerry Lanchbury, Gordon Mills, Anne-Renee Hartman, James M. Ford 2015 American Society of Clinical Oncology (Abstract 1018) Triple Negative and/or BRCA1/2 Mutation-Associated Breast Cancer 68 patients Residual Cancer Burden
TNT: A randomized phase III trial of carboplatin (C) compared with docetaxel (D) for patients with metastatic or recurrent locally advanced triple negative or BRCA1/2 breast cancer Andrew Tutt, Paul Ellis, Lucy Kilburn, Cheryl Gilett, Sarah Pinder, Jacinta Abraham, Sophie Barrett, Peter Barrett-Lee, Stephen Chan, Maggie Cheang, Mitch Dowsett, Lisa Fox, Patrycja Gazinska, Anita Grigoriadis, Alexander Gutin, Catherine Harper-Wynne7, Matthew Hatton, Sarah Kernaghan, Jerry Lanchbury, James Morden, Julie Owen, Jyoti Parikh, Peter Parker, Nazneen Rahman, Rebecca Roylance, Adam Shaw, Ian Smith, Rose Thompson, Kirsten Timms, Holly Tovey, Andrew Wardley, Gregory Wilson, Mark Harries and Judith Bliss 2014 San Antonio Breast Conference Symposium (S3-01) Triple Negative Breast Cancer 376 patients Overall Response Rate
Prediction of pathological complete response (pCR) by Homologous Recombination Deficiency (HRD) after carboplatin-containing neoadjuvant chemotherapy in patients with TNBC – Results from GeparSixto Gunter von Minckwitz, Kirsten Timms, Michael Untch, Eric P. Elkin, Eric Hahnen, Peter A. Fasching, Andreas Schneeweiss, Christoph T. Salat, Mahdi Rezai, Jens U. Blohmer, Dirk M. Zahm, Christian Jackisch, Bernd Gerber, Peter Klare, Sherko Kümmel, Holger Eidtmann, Stefan Paepke, Rita Schmutzler, Julia Reid, Valentina Nekljudova, Karsten Weber, Anne-Renee Hartman, Sibylle Loibl 2015 American Society of Clinical Oncology (Abstract 1004) Triple Negative Breast Cancer 193 patients Pathologic Complete Response
Homologous Recombination Deficiency (HRD) Score Predicts Response to Cisplatin Neoadjuvant Chemotherapy in Patients with Triple Negative Breast Cancer Andrea L. Richardson, Daniel P. Silver, Zoltan Szallasi, Erica L. Mayer, Nicolai J. Birkbak, Zhigang C. Wang, J. Dirk Iglehart, Eric P. Winer, Nadine M. Tung, Paula D. Ryan, Steven J. Isakoff, William T. Barry, April Greene-Colozzi, Alexander Gutin, Julia Reid, Chris Neff, Joshua Jones, Kirsten Timms, Anne-Renee Hartman, and Judy E. Garber 2014 San Antonio Breast Conference Symposium (P3-06-11) Triple Negative Breast Cancer 53 patients Pathologic Partial Response, Pathologic Complete Response
Role of Germline BRCA Status and Tumor Homologous Recombination (HR) Deficiency in Response to Neoadjuvant Weekly Paclitaxel Followed by Anthracycline-Based Chemotherapy Judy C. Boughey, Krishna R. Kalari, Vera J. Suman, Sarah A. McLaughlin, Alvaro Moreno-Aspitia, Ann M. Moyer, Donald W. Northfelt, Richard J. Gray, Peter Vedell, Xiaojia Tang, Travis Dockter, Sara J. Felten, Katie Hunt, Amy Conners, Steven N. Hart, Daniel W. Visscher, Eric D. Wieben, James N. Ingle, Anne-Renee Hartman, Kirsten Timms, Brent Evans, Joshua Jones, Liewei Wang, Richard W. Weinshilboum, Matthew P. Goetz 2015 San Antonio Breast Cancer Symposium (P3-07-29 ) Stage I-III Breast Cancer 93 patients MRI Response Rate, Pathologic Complete Response
Homologous recombination deficiency (HRD) as a predictive biomarker of response to preoperative systemic therapy (PST) in TBCRC008 comprising a platinum in HER2-negative primary operable breast cancer Roisin M. Connolly, Eric P. Elkin, Kirsten Timms, Matthew P. Goetz, Judy C. Boughey, Zhe Zhang, Bridget Walsh, John Carpenter, Anna Maria Storniolo, Stanley Watkins, Edward Gabrielson, Anne-Renee Hartman, Vered Stearns 2015 San Antonio Breast Cancer Symposium (P3-07-13) HER2-Negative Breast Cancer 48 patients Pathologic Complete Response

Ovarian Cancer Publications

Title Authors Presented at / Published in Cancer Type Patient Count Primary Endpoint
Clinical Activity of the Poly(ADP-Ribose) Polymerase (PARP) Inhibitor Rucaparib in Patients with High-Grade Ovarian Carcinoma and a BRCA Mutation: Analysis of Pooled Data from Study 10 (Parts 1, 2a, and 3) and ARIEL2 (Parts 1 and 2) Rebecca S. Kristeleit, Ronnie Shapira-Frommer, Ana Oaknin, Judith Balmaña, Isabelle Ray-Coquard, Susan Domchek, Anna V. Tinker, Cesar Castro,
Stephen Welch, Andres Poveda, Kathy Bell-McGuinn, Gottfried Konecny,
Heidi Giordano, Lara Maloney, Sandra Goble, Lindsey Rolfe, Amit M. Oza
European Society for Medical Oncology Congress 2016 (Abstract 8560) High-grade ovarian cancer 106 patients Progression-free survival
Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer Mansoor R. Mirza, Bradley J. Monk, Jørn Herrstedt, Amit M. Oza, Sven Mahner, Andrés Redondo, Michel Fabbro, Jonathan A. Ledermann, Domenica Lorusso, Ignace Vergote, Noa E. Ben-Baruch, Christian Marth, Radosław Mądry, René D. Christensen, , Jonathan S. Berek, Anne Dørum, Anna V. Tinker, Andreas du Bois, Antonio González-Martín, Philippe Follana, Benedict Benigno, Per Rosenberg, Lucy Gilbert,, Bobbie J. Rimel, Joseph Buscema, John P. Balser, Shefali Agarwal, and Ursula A. Matulonis N Engl J Med 2016; 375:2154-2164 Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with predominantly high-grade serous histologic features 109 patients Progression-free survival
Olaparib maintenance therapy in patients with platinum sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomized phase 2 trial Jonathan Ledermann, Philipp Harter, Charlie Gourley, Michael Friedlander, Ignace Vergote, Gordon Rustin, Clare L Scott, Werner Meier, Ronnie Shapira-Frommer, Tamar Safra, Daniela Matei, Anitra Fielding, Stuart Spencer, Brian Dougherty, Maria Orr, Darren Hodgson, J Carl Barrett, Ursula Matulonis Lancet Oncol 2014; 15: 852–61 Ovarian Cancer 136 patients were assigned to olaparib and 129 to placebo. Progression-free survival
Characterization of long-term responders to olaparib from study D0810C000019 Stephanie Lheureux, Jonathan Ledermann, Sarah Runswick, Darren Hodgson, Kirsten Timms, Jerry Lanchbury, Stanley Kaye, Charlie Gourley, David Bowtell, Elise Kohn, Clare Scott, Ursula Matulonis, Tony Panzarella, Brian Dougherty, Carl Barrett, Zhongwu Lai, Mark O’Connor, Jane Robertson, Tony Ho, Amit M. Oza 2015 American Society of Clinical Oncology (Abstract 5566) Serous Ovarian Cancer 32 long-term responders (>2 years), 21 short-term responders (<3 months) Predictive markers of long-term and short-term response to olaparib
3-Biomarker HRD Score versus Individual Biomarker (LOH, TAI, LST) Scores in Platinum Treated Serous Ovarian Cancer (SOC) Jerry S. Lanchbury, Kirsten M. Timms, Julia Reid, Euan A. Stronach, Alexander Gutin, Thomas Krivak, Bryan Hennessy, James Paul, Rebecca Nix, Zaina Sangale, Elisha Hughes, Victor Abkevich, Gordon B. Mills 2016 European Society of Medical Oncology (Abstract 112P) Serous Ovarian Cancer 859 patients False Positive Rate, False Negative Rate
Homologous Recombination Deficiency (HRD) Score Shows Superior Association with Outcome Compared to its Individual Score Components (LOH, TAI, and LST Scores) in Platinum Treated Serous Ovarian Cancer Gordon Mills, Kirsten M. Timms, Julia Reid, Alexander Gutin, Thomas Krivak, Bryan Hennessy, James Paul, Robert Brown, Jerry S. Lanchbury, Euan A. Stronach 2016 Annual Meeting on Women’s Cancer (Abstract 2) Serous Ovarian Cancer 859 patients Progression-free Survival, Overall Survival
Characteristics of homologous recombination deficiency (HRD) in paired primary and recurrent high-grade serous ovarian cancer (HGSOC) specimens Jai N. Patel, Jalid Sehouli, Kirsten M. Timms, Cara Solimeno, Julia E. Reid, Jerry S. Lanchbury, Ioana Braicu, Silvia Darb-Esfahani, Mahrukh K. Ganapathi, Ram N. Ganapathi 2015 American Society of Clinical Oncology (Abstract 5534) High Grade Serous Ovarian Cancer 25 patients Correlation of myChoice HRD results between paired primary and recurrent specimens
Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial Eric Pujade-Lauraine, Jonathan A Ledermann, Frédéric Selle, Val Gebski, Richard T Penson, Amit M Oza, Jacob Korach, Tomasz Huzarski, Andrés Poveda, Sandro Pignata, Michael Friedlander, Nicoletta Colombo, Philipp Harter, Keiichi Fujiwara, Isabelle Ray-Coquard, Susana Banerjee, Joyce Liu, Elizabeth S Lowe, Ralph Bloomfield, Patricia Pautier Lancet Oncol 2017; S1470-2045(17)30469-2 high-grade serous ovarian cancer 196 patients were assigned to olaparib and 99 to placebo. Progression-free survival
Homologous recombination deficiency (HRD) of high grade serous ovarian tumors from the NOVA Phase III clinical study Keith Wilcoxen, Christopher Neff, Victor Abkevich, Joshua Timothy Jones, Kathryn Kolquist, Michael Mirza, Jerry Lanchbury, Keith Mikule, Shefali Agarwal, Anne-Renee Hartman, Alexander Gutin, Kirsten Timms 2015 European Organisation for Research and Treatment (Abstract C53) High Grade Serous Ovarian Cancer 347 patients HRD Score Distribution
Homologous recombination deficiency (HRD) score enriches for niraparib sensitive high grade ovarian tumors. Keith Wilcoxen, Marc Becker, Christopher Neff, Victor Abkevich, Joshua Timothy Jones, Xiaonan Hou, Yan Wang, Anne-Renee Hartman, Mariam M. Al Hilli, Alexander Gutin, Shefali Agarwal, Kirsten Timms, and Paul Haluska 2015 American Society of Clinical Oncology (Abstract 5532) High Grade Ovarian Tumors 174 patients PDx Tumor Burden
Patterns of genomic loss of heterozygosity predict homologous recombination repair defects in epithelial ovarian cancer Victor Abkevich, Kirsten M. Timms, Bryan T. Hennessy, Jennifer Potter, Mark S. Carey, Larissa A. Meyer, Karen Smith-McCune, Russell Broaddus, Karen H. Lu, Jian Chen, Thanh V. Tran, Deborah Williams, Diana Iliev, Srikanth Jammulapati, Lisa M. FitzGerald, Thomas C. Krivak, Julie A. DeLoia, Alexander Gutin, Gordon B. Mills, and Jerry S. Lanchbury British Journal of Cancer (2012). 107(10):1776-82. Ovarian Cancer 640 patients Association between HRD score and HR deficiency
Evaluation of BRCA1/2 and homologous recombination defects in ovarian cancer and impact on clinical outcomes Melinda S. Yates, Kirsten Timms, Molly S Daniels, Holly D. Oakley, Mark F. Munsell, Jerry S. Lanchbury, Karen H. Lu 2017 American Society of Clinical Oncology (Abstract 5511) Ovarian Cancer 299 patients Event-Free Survival, Overall Survival
Homologous Recombination (HR) Deficiency, Tumor BRCA1/2 Mutations (tmBRCA) and Association with Response and Outcome Following Platinum Monotherapy in High Grade Serous Ovarian Cancer (HGSOC) Robert Brown, Kirsten Timms, James Paul, Elisha Hughes, Mona El-Bahrawy, Jennifer H. Steel, Saritha Kalva, Xinxue Liu, Yuepeng Wang, Nona Rama, Charlotte Wilhelm-Benartzi, Alexander Gutin, Liz-Anne Lewsley, Nadeem Siddiqui, Naina Patel, Jerry Lanchbury, Hani Gabra, Euan A. Stronach 2015 American Society of Clinical Oncology (Abstract 5576) High Grade Serous Ovarian Cancer 165 patients Progression-Free Survival, Overall Survival
Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicenter, open-label, phase 2 trial Dr Prof Elizabeth M Swisher, Kevin K Lin, Prof Amit M Oza, Clare L Scott, Heidi Giordano, James Sun, Gottfried E Konecny, Prof Robert L Coleman, Anna V Tinker, David M O’Malley, Rebecca S Kristeleit, Ling, Katherine M Bell-McGuinn, Prof James D Brenton, Janiel M Cragun, Ana Oaknin, Prof Isabelle Ray-Coquard, Maria I Harrell, Elaina Mann, Prof Scott H Kaufmann, Anne Floquet, Alexandra Leary, Thomas C Harding, Sandra Goble, Lara Maloney, Jeff Isaacson, Andrew R Allen, Lindsey Rolfe, Roman Yelensky, Mitch Raponi, Prof Iain A McNeish Lancet Oncol 2017; 18: 75-87 Ovarian cancer 206 patients Progression-free survival

Breast Cancer Publications

Title Authors Presented at / Published in Cancer Type Patient Count Primary Endpoint
Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation Mark Robson, Seock-Ah Im, Elżbieta Senkus, Binghe Xu, Susan M. Domchek, Norikazu Masuda, Suzette Delaloge, Wei Li, Nadine Tung, Anne Armstrong, Wenting Wu, Carsten Goessl, Sarah Runswick, and Pierfranco Conte New England Journal of Medicine 2017; Jun 4 doi: 10.1056/NEJMoa1706450. HER2-negative metastatic breast cancer 205 patients were assigned to olaparib and 97 to standard therapy (physician choice chemotherapy) Progression-free survival
Prediction of pathological complete response (pCR) by Homologous Recombination Deficiency (HRD) after carboplatin-containing neoadjuvant chemotherapy in patients with TNBC – Results from GeparSixto Gunter von Minckwitz, Kirsten Timms, Michael Untch, Eric P. Elkin, Eric Hahnen, Peter A. Fasching, Andreas Schneeweiss, Christoph T. Salat, Mahdi Rezai, Jens U. Blohmer, Dirk M. Zahm, Christian Jackisch, Bernd Gerber, Peter Klare, Sherko Kümmel, Holger Eidtmann, Stefan Paepke, Rita Schmutzler, Julia Reid, Valentina Nekljudova, Karsten Weber, Anne-Renee Hartman, Sibylle Loibl 2015 American Society of Clinical Oncology (Abstract 1004) Triple Negative Breast Cancer 193 patients Pathologic Complete Response
Homologous Recombination Deficiency (HRD) Score Predicts Response to Cisplatin Neoadjuvant Chemotherapy in Patients with Triple Negative Breast Cancer Andrea L. Richardson, Daniel P. Silver, Zoltan Szallasi, Erica L. Mayer, Nicolai J. Birkbak, Zhigang C. Wang, J. Dirk Iglehart, Eric P. Winer, Nadine M. Tung, Paula D. Ryan, Steven J. Isakoff, William T. Barry, April Greene-Colozzi, Alexander Gutin, Julia Reid, Chris Neff, Joshua Jones, Kirsten Timms, Anne-Renee Hartman, and Judy E. Garber 2014 San Antonio Breast Conference Symposium (P3-06-11) Triple Negative Breast Cancer 53 patients Pathologic Partial Response, Pathologic Complete Response
TBCRC030: A randomized phase II study of preoperative cisplatin versus paclitaxel in patients (pts) with BRCA1/2-proficient triple negative breast cancer (TNBC): Evaluating the Homologous Recombination Deficiency (HRD) Biomarker Erica L. Mayer, Ines Vaz-Luis, Andrea Richardson, Charles Perou, Nadine Tung, Vandana Abramson, Carey Anders, Andres Forero, P. Kelly Marcom, Kathy Miller, Shannon Puhalla, Mothaffar Rimawi, Vered Stearns, Tiffany Traina, William Barry, Kirsten Timms, Anne-Renee Hartman, Antonio Wolff, Eric Winer 2014 American Society of Clinical Oncology (Abstract TPS1145) BRCA1/2- Proficient Triple Negative Breast Cancer Target accrual 160 patients Pathologic Complete Response
Reproducibility of homologous recombination deficiency (HRD) scores in biopsies of triple negative breast cancer (TNBC) tumors Kirsten Timms, Anees Chagpar, Vikram Wali, Veerle Bossuyt, Julia Reid, Alexander Gutin, Chris Neff, Erin Hofstatter, Jerry Lanchbury, Lajos Pusztai 2015 American Society of Clinical Oncology (Abstract 1091) Triple Negative Breast Cancer 32 patients Standard deviation of HRD scores between samples
Role of Germline BRCA Status and Tumor Homologous Recombination (HR) Deficiency in Response to Neoadjuvant Weekly Paclitaxel Followed by Anthracycline-Based Chemotherapy Judy C. Boughey, Krishna R. Kalari, Vera J. Suman, Sarah A. McLaughlin, Alvaro Moreno-Aspitia, Ann M. Moyer, Donald W. Northfelt, Richard J. Gray, Peter Vedell, Xiaojia Tang, Travis Dockter, Sara J. Felten, Katie Hunt, Amy Conners, Steven N. Hart, Daniel W. Visscher, Eric D. Wieben, James N. Ingle, Anne-Renee Hartman, Kirsten Timms, Brent Evans, Joshua Jones, Liewei Wang, Richard W. Weinshilboum, Matthew P. Goetz 2015 San Antonio Breast Cancer Symposium (P3-07-29 ) Stage I-III Breast Cancer 93 patients MRI Response Rate, Pathologic Complete Response
Phase II neoadjuvant clinical trial of carboplatin and eribulin in women with triple negative early stage breast cancer (NCT01372579) Virginia G. Kaklamani, Elisha Hughes, Kalliopi Siziopikou, Kirsten M. Timms, Victor Abkevich, Cara Solimeno, Anne-Renee Hartman, Jacqueline S. Jeruss, Caitlin Meservey, Borko Jovanovic, Irene Helenowski, Seema A. Khan, Kevin P. Bethke, Nora Hansen, Regina Uthe, Steven Rosen, Kent Hoskins, Jamie Von Roenn, Sarika Jain, William Gradishar 2015 American Society of Clinical Oncology (Abstract 1017) Triple Negative Early Stage Breast Cancer 30 patients Pathologic Complete Response
Association of BRCA1/2 defects with genomic scores predictive of DNA damage repair deficiency among breast cancer subtypes Kirsten Timms, Victor Abkevich, Elisha Hughes, Chris Neff, Julia Reid, Brian Morris, Saritha Kalva, Jennifer Potter, Thanh V Tran, Jian Chen, Diana Iliev, Zaina Sangale, Eliso Tikishvili, Michael Perry, Andrey Zharkikh, Alexander Gutin and Jerry S Lanchbury Breast Cancer Research (2014). 16:475 Breast Cancer (ER/HER2 subtypes) 197 patients Correlation between BRCA mutation status and LOH, TAI, and LST
Combined Homologous Recombination Deficiency (HRD) Scores and Response to Neoadjuvant Platinum-Based Chemotherapy in Triple Negative and/or BRCA1/2 Mutation-Associated Breast Cancer Melinda L. Telli, Kirsten Timms, Julia Reid, Chris Neff, Victor Abkevich, Alexander Gutin, Zaina Sangale, Diana Iliev, Joshua T. Jones, Bryan Hennessy, Jerry Lanchbury, Gordon Mills, Anne-Renee Hartman, James M. Ford 2015 American Society of Clinical Oncology (Abstract 1018) Triple Negative and/or BRCA1/2 Mutation-Associated Breast Cancer 68 patients Residual Cancer Burden
Homologous Recombination Deficiency (HRD) as a predictive biomarker of response to neoadjuvant platinum-based therapy in patients with triple-negative breast cancer (TNBC): A pooled analysis Melinda L. Telli, Alex McMillan, James M. Ford, Andrea L. Richardson, Daniel P. Silver, Steven J. Isakoff, Virginia G. Kaklamani, William Gradishar, Vered Stearns, Roisin M. Connolly, Sibylle Loibl, Karsten Weber, Eric Elkin, Brent Evans, Kirsten Timms, Anne-Renee Hartman, Gunter von Minckwitz 2015 San Antonio Breast Cancer Symposium (P3-07-12) Triple Negative Breast Cancer 267 patients Pathologic Complete Response
TNT: A randomized phase III trial of carboplatin (C) compared with docetaxel (D) for patients with metastatic or recurrent locally advanced triple negative or BRCA1/2 breast cancer Andrew Tutt, Paul Ellis, Lucy Kilburn, Cheryl Gilett, Sarah Pinder, Jacinta Abraham, Sophie Barrett, Peter Barrett-Lee, Stephen Chan, Maggie Cheang, Mitch Dowsett, Lisa Fox, Patrycja Gazinska, Anita Grigoriadis, Alexander Gutin, Catherine Harper-Wynne, Matthew Hatton, Sarah Kernaghan, Jerry Lanchbury, James Morden, Julie Owen, Jyoti Parikh, Peter Parker, Nazneen Rahman, Rebecca Roylance, Adam Shaw, Ian Smith, Rose Thompson, Kirsten Timms, Holly Tovey, Andrew Wardley, Gregory Wilson, Mark Harries and Judith Bliss 2014 San Antonio Breast Conference Symposium (S3-01) Triple Negative Breast Cancer 376 patients Objective Response Rate

HRD and PARP Inhibitors

Title Authors Presented at / Published in Cancer Type Patient Count Primary Endpoint
Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer Mansoor R. Mirza, Bradley J. Monk, Jørn Herrstedt, Amit M. Oza, Sven Mahner, Andrés Redondo, Michel Fabbro, Jonathan A. Ledermann, Domenica Lorusso, Ignace Vergote, Noa E. Ben-Baruch, Christian Marth, Radosław Mądry, René D. Christensen, , Jonathan S. Berek, Anne Dørum, Anna V. Tinker, Andreas du Bois, Antonio González-Martín, Philippe Follana, Benedict Benigno, Per Rosenberg, Lucy Gilbert,, Bobbie J. Rimel, Joseph Buscema, John P. Balser, Shefali Agarwal, and Ursula A. Matulonis N Engl J Med 2016; 375:2154-2164 Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with predominantly high-grade serous histologic features 109 patients Progression-free survival
Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial Dr Prof Elizabeth M Swisher, Kevin K Lin, Prof Amit M Oza, Clare L Scott, Heidi Giordano, James Sun, Gottfried E Konecny, Prof Robert L Coleman, Anna V Tinker, David M O’Malley, Rebecca S Kristeleit, Ling, Katherine M Bell-McGuinn, Prof James D Brenton, Janiel M Cragun, Ana Oaknin, Prof Isabelle Ray-Coquard, Maria I Harrell, Elaina Mann, Prof Scott H Kaufmann, Anne Floquet, Alexandra Leary, Thomas C Harding, Sandra Goble, Lara Maloney, Jeff Isaacson, Andrew R Allen, Lindsey Rolfe, Roman Yelensky, Mitch Raponi, Prof Iain A McNeish Lancet Oncol 2017; 18: 75-87 Ovarian cancer 206 patients Progression-free survival
Clinical Activity of the Poly(ADP-Ribose) Polymerase (PARP) Inhibitor Rucaparib in Patients with High-Grade Ovarian Carcinoma and a BRCA Mutation: Analysis of Pooled Data from Study 10 (Parts 1, 2a, and 3) and ARIEL2 (Parts 1 and 2) Rebecca S. Kristeleit, Ronnie Shapira-Frommer, Ana Oaknin, Judith Balmaña, Isabelle Ray-Coquard, Susan Domchek, Anna V. Tinker, Cesar Castro,
Stephen Welch, Andres Poveda, Kathy Bell-McGuinn, Gottfried Konecny,
Heidi Giordano, Lara Maloney, Sandra Goble, Lindsey Rolfe, Amit M. Oza
European Society for Medical Oncology Congress 2016 (Abstract 8560) High-grade ovarian cancer 106 patients Progression-free survival
Olaparib maintenance therapy in patients with platinum sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomized phase 2 trial Jonathan Ledermann, Philipp Harter, Charlie Gourley, Michael Friedlander, Ignace Vergote, Gordon Rustin, Clare L Scott, Werner Meier, Ronnie Shapira-Frommer, Tamar Safra, Daniela Matei, Anitra Fielding, Stuart Spencer, Brian Dougherty, Maria Orr, Darren Hodgson, J Carl Barrett, Ursula Matulonis Lancet Oncol 2014; 15: 852–61 Ovarian Cancer 136 patients were assigned to olaparib and 129 to placebo. Progression-free survival
Characterization of long-term responders to olaparib from study D0810C000019 Stephanie Lheureux, Jonathan Ledermann, Sarah Runswick, Darren Hodgson, Kirsten Timms, Jerry Lanchbury, Stanley Kaye, Charlie Gourley, David Bowtell, Elise Kohn, Clare Scott, Ursula Matulonis, Tony Panzarella, Brian Dougherty, Carl Barrett, Zhongwu Lai, Mark O’Connor, Jane Robertson, Tony Ho, Amit M. Oza 2015 American Society of Clinical Oncology (Abstract 5566) Serous Ovarian Cancer 32 long-term responders (>2 years), 21 short-term responders (<3 months) Predictive markers of long-term and short-term response to olaparib

BRCA1/2 Mutations and PARP Inhibitors

Title Authors Presented at / Published in Cancer Type Patient Count Primary Endpoint
BRACAnalysis CDx as a companion diagnostic tool for Lynparza Camille C Gunderson, Kathleen N Moore Taylor & Francis (2015); 1473-7159 Ovarian Cancer n/a n/a
Inhibition of Poly(ADP-Ribose) Polymerase in Tumors from BRCA Mutation Carriers Peter C. Fong, David S. Boss, Timothy A. Yap, Andrew Tutt, Peijun Wu, Marja Mergui-Roelvink, Peter Mortimer, Helen Swaisland, Alan Lau, Mark J. O’Connor, Alan Ashworth, James Carmichael, Stan B. Kaye, Jan H.M. Schellens, and Johann S. de Bono N Engl J Med 2009; 361:123-134 patients be carriers of BRCA1 or BRCA2 mutations 60 patients Adverse Events
Applying Synthetic Lethality for the Selective Targeting of Cancer Donal P. McLornan, Alan List, and Ghulam J. Mufti N Engl J Med 2014; 371:1725-1735
Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation Mark Robson, Seock-Ah Im, Elżbieta Senkus, Binghe Xu, Susan M. Domchek, Norikazu Masuda, Suzette Delaloge, Wei Li, Nadine Tung, Anne Armstrong, Wenting Wu, Carsten Goessl, Sarah Runswick, and Pierfranco Conte New England Journal of Medicine 2017; Jun 4 doi: 10.1056/NEJMoa1706450. HER2-negative metastatic breast cancer 205 patients were assigned to olaparib and 97 to standard therapy (physician choice chemotherapy) Progression-free survival
Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer Mansoor R. Mirza, Bradley J. Monk, Jørn Herrstedt, Amit M. Oza, Sven Mahner, Andrés Redondo, Michel Fabbro, Jonathan A. Ledermann, Domenica Lorusso, Ignace Vergote,  Noa E. Ben-Baruch,  Christian Marth, Radosław Mądry, René D. Christensen, Jonathan S. Berek, Anne Dørum, Anna V. Tinker, M.D., Andreas du Bois, Antonio González-Martín, Philippe Follana, Benedict Benigno, Per Rosenberg, Lucy Gilbert, Bobbie J. Rimel, Joseph Buscema, John P. Balser, Shefali Agarwal, and Ursula A. Matulonis N Engl J Med 2016; 375:2154-2164 ovarian cancer 203 were in the gBRCA cohort (with 138 assigned to niraparib and 65 to placebo), and 350 patients were in the non-gBRCA cohort (with 234 assigned to niraparib and 116 to placebo) progression-free survival

BRCA1/2 Mutations, HRD and DNA damaging Agents

Title Authors Presented at / Published in Cancer Type Patient Count Primary Endpoint
Homologous Recombination (HR) Deficiency, Tumor BRCA1/2 Mutations (tmBRCA) and Association with Response and Outcome Following Platinum Monotherapy in High Grade Serous Ovarian Cancer (HGSOC) Robert Brown, Kirsten Timms, James Paul, Elisha Hughes, Mona El-Bahrawy, Jennifer H. Steel, Saritha Kalva, Xinxue Liu, Yuepeng Wang, Nona Rama, Charlotte Wilhelm-Benartzi, Alexander Gutin, Liz-Anne Lewsley, Nadeem Siddiqui, Naina Patel, Jerry Lanchbury, Hani Gabra, Euan A. Stronach 2015 American Society of Clinical Oncology (Abstract 5576) High Grade Serous Ovarian Cancer 165 patients Progression-free Survival, Overall Survival
BCRC030: A randomized phase II study of preoperative cisplatin versus paclitaxel in patients (pts) with BRCA1/2-proficient triple negative breast cancer (TNBC): Evaluating the Homologous Recombination Deficiency (HRD) Biomarker Erica L. Mayer, Ines Vaz-Luis, Andrea Richardson, Charles Perou, Nadine Tung, Vandana Abramson, Carey Anders, Andres Forero, P. Kelly Marcom, Kathy Miller, Shannon Puhalla, Mothaffar Rimawi, Vered Stearns, Tiffany Traina, William Barry, Kirsten Timms, Anne-Renee Hartman, Antonio Wolff, Eric Winer 2014 American Society of Clinical Oncology (Abstract TPS1145) BRCA1/2- Proficient Triple Negative Breast Cancer Target accrual 160 patients Pathologic Complete Response
Phase II neoadjuvant clinical trial of carboplatin and eribulin in women with triple negative early stage breast cancer (NCT01372579) Virginia G. Kaklamani, Elisha Hughes, Kalliopi Siziopikou, Kirsten M. Timms, Victor Abkevich, Cara Solimeno, Anne-Renee Hartman, Jacqueline S. Jeruss, Caitlin Meservey, Borko Jovanovic, Irene Helenowski, Seema A. Khan, Kevin P. Bethke, Nora Hansen, Regina Uthe, Steven Rosen, Kent Hoskins, Jamie Von Roenn, Sarika Jain, William Gradishar 2015 American Society of Clinical Oncology (Abstract 1017) Triple Negative Early Stage Breast Cancer 30 patients Pathologic Complete Response
Combined Homologous Recombination Deficiency (HRD) Scores and Response to Neoadjuvant Platinum-Based Chemotherapy in Triple Negative and/or BRCA1/2 Mutation-Associated Breast Cancer Melinda L. Telli, Kirsten Timms, Julia Reid, Chris Neff, Victor Abkevich, Alexander Gutin, Zaina Sangale, Diana Iliev, Joshua T. Jones, Bryan Hennessy, Jerry Lanchbury, Gordon Mills, Anne-Renee Hartman, James M. Ford 2015 American Society of Clinical Oncology (Abstract 1018) Triple Negative and/or BRCA1/2 Mutation-Associated Breast Cancer 68 patients Residual Cancer Burden
TNT: A randomized phase III trial of carboplatin (C) compared with docetaxel (D) for patients with metastatic or recurrent locally advanced triple negative or BRCA1/2 breast cancer Andrew Tutt, Paul Ellis, Lucy Kilburn, Cheryl Gilett, Sarah Pinder, Jacinta Abraham, Sophie Barrett, Peter Barrett-Lee, Stephen Chan, Maggie Cheang, Mitch Dowsett, Lisa Fox, Patrycja Gazinska, Anita Grigoriadis, Alexander Gutin, Catherine Harper-Wynne7, Matthew Hatton, Sarah Kernaghan, Jerry Lanchbury, James Morden, Julie Owen, Jyoti Parikh, Peter Parker, Nazneen Rahman, Rebecca Roylance, Adam Shaw, Ian Smith, Rose Thompson, Kirsten Timms, Holly Tovey, Andrew Wardley, Gregory Wilson, Mark Harries and Judith Bliss 2014 San Antonio Breast Conference Symposium (S3-01) Triple Negative Breast Cancer 376 patients Overall Response Rate
Prediction of pathological complete response (pCR) by Homologous Recombination Deficiency (HRD) after carboplatin-containing neoadjuvant chemotherapy in patients with TNBC – Results from GeparSixto Gunter von Minckwitz, Kirsten Timms, Michael Untch, Eric P. Elkin, Eric Hahnen, Peter A. Fasching, Andreas Schneeweiss, Christoph T. Salat, Mahdi Rezai, Jens U. Blohmer, Dirk M. Zahm, Christian Jackisch, Bernd Gerber, Peter Klare, Sherko Kümmel, Holger Eidtmann, Stefan Paepke, Rita Schmutzler, Julia Reid, Valentina Nekljudova, Karsten Weber, Anne-Renee Hartman, Sibylle Loibl 2015 American Society of Clinical Oncology (Abstract 1004) Triple Negative Breast Cancer 193 patients Pathologic Complete Response
Homologous Recombination Deficiency (HRD) Score Predicts Response to Cisplatin Neoadjuvant Chemotherapy in Patients with Triple Negative Breast Cancer Andrea L. Richardson, Daniel P. Silver, Zoltan Szallasi, Erica L. Mayer, Nicolai J. Birkbak, Zhigang C. Wang, J. Dirk Iglehart, Eric P. Winer, Nadine M. Tung, Paula D. Ryan, Steven J. Isakoff, William T. Barry, April Greene-Colozzi, Alexander Gutin, Julia Reid, Chris Neff, Joshua Jones, Kirsten Timms, Anne-Renee Hartman, and Judy E. Garber 2014 San Antonio Breast Conference Symposium (P3-06-11) Triple Negative Breast Cancer 53 patients Pathologic Partial Response, Pathologic Complete Response
Role of Germline BRCA Status and Tumor Homologous Recombination (HR) Deficiency in Response to Neoadjuvant Weekly Paclitaxel Followed by Anthracycline-Based Chemotherapy Judy C. Boughey, Krishna R. Kalari, Vera J. Suman, Sarah A. McLaughlin, Alvaro Moreno-Aspitia, Ann M. Moyer, Donald W. Northfelt, Richard J. Gray, Peter Vedell, Xiaojia Tang, Travis Dockter, Sara J. Felten, Katie Hunt, Amy Conners, Steven N. Hart, Daniel W. Visscher, Eric D. Wieben, James N. Ingle, Anne-Renee Hartman, Kirsten Timms, Brent Evans, Joshua Jones, Liewei Wang, Richard W. Weinshilboum, Matthew P. Goetz 2015 San Antonio Breast Cancer Symposium (P3-07-29 ) Stage I-III Breast Cancer 93 patients MRI Response Rate, Pathologic Complete Response
Homologous recombination deficiency (HRD) as a predictive biomarker of response to preoperative systemic therapy (PST) in TBCRC008 comprising a platinum in HER2-negative primary operable breast cancer Roisin M. Connolly, Eric P. Elkin, Kirsten Timms, Matthew P. Goetz, Judy C. Boughey, Zhe Zhang, Bridget Walsh, John Carpenter, Anna Maria Storniolo, Stanley Watkins, Edward Gabrielson, Anne-Renee Hartman, Vered Stearns 2015 San Antonio Breast Cancer Symposium (P3-07-13) HER2-Negative Breast Cancer 48 patients Pathologic Complete Response