Kevin Punie (Leuven, Belgium)
University Hospitals LeuvenAuthor Of 3 Presentations
Closing remarks (ID 20)
161O - VIOLETTE: Randomised Phase 2 Study of Olaparib (ola) + Ceralasertib (cer) or Adavosertib (ada) vs Ola Alone in Patients (pts) With Metastatic Triple-Negative Breast Cancer (mTNBC) (ID 278)
- Andrew Tutt (London, United Kingdom)
- Zbigniew Nowecki (Warsaw, Poland)
- Renata Szoszkiewicz (Skorzewo, Poland)
- Seock-Ah Im (Seoul, Korea, Republic of)
- Hendrik-Tobias Arkenau (London, United Kingdom)
- Anne Armstrong (Manchester, United Kingdom)
- William Jacot (Montpellier, France)
- Jee Hyun Kim (Seongnam, Korea, Republic of)
- Marc Webster (Calgary, Canada)
- Judith Balmaña (Barcelona, Spain)
- Suzette Delaloge (Villejuif, France)
- Natasha Lukashchuk (Cambridge, United Kingdom)
- Ronny Odegbami (Cambridge, United Kingdom)
- Ed Casson (Cambridge, United Kingdom)
- Arsene B. Loembe (Oss, Netherlands)
- Moritz W. Drachsler (Cambridge, United Kingdom)
- Emma J. Dean (Cambridge, United Kingdom)
- Kevin Punie (Leuven, Belgium)
Abstract
Background
Combining DNA damage response (DDR) inhibitors to inhibit multiple DDR pathways may enhance tumour cell death. Preclinical models show synergistic antitumour effects of ola (PARP1 inhibitor) + cer (ATR inhibitor) or ada (WEE1 inhibitor). VIOLETTE (NCT03330847), a phase 2 open-label study, evaluated ola ± cer or ada as 2nd–3rd line in pts with mTNBC.
Methods
Randomisation was stratified within each arm by mutation status (BRCAm, non-BRCAm homologous recombination repair pathway mutations [HRRm], or no HRRm [non-HRRm]) based on a prospective central tumour test and prior platinum therapy. Pts received ola 300 mg BID, 28-d cycle; cer 160 mg d 1–7 + ola 300 mg BID (cer+ola), 28-d cycle; or ada 150 mg BID d 1–3, 8–10 + ola 200 mg BID (ada+ola), 21-d cycle. Primary study endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), safety, and tolerability. Ada+ola was discontinued early due to higher than expected grade ≥3 haematologic toxicity, which limited its interpretation. We focus on cer+ola vs ola. The sponsor stopped VIOLETTE after reviewing BRCAm stratum efficacy data.
Results
Of 273 pts (450 planned; median age: 53 y), 114 received ola, 112 cer+ola, and 47 ada+ola. Primary analyses showed no statistically significant difference in PFS for cer+ola vs ola (BRCAm: n=83; HR 1.02 [90% CI 0.63–1.66, P=0.94], HRRm: n=40; 0.54 [0.28–1.03, 0.13], non-HRRm: n=103; 0.76 [0.50–1.14, 0.30]). No statistically significant difference in ORR was seen for cer+ola vs ola in BRCAm (50% vs 44%) or HRRm (20% vs 15%). ORR was higher in non-HRRm for cer+ola (15%, n=8) vs ola (4%, n=2) (odds ratio 4.45; 90% CI 1.30–21.20, P=0.04). In all pts, nausea and anaemia were the most common adverse events (AEs). Grade ≥3 AEs: 36% ola, 47% cer+ola, 78% ada+ola. Details of exploratory and subgroup analyses will be presented.
Conclusions
Cer+ola did not improve PFS vs ola as 2nd–3rd line for mTNBC. Clinical significance of higher ORR with cer+ola in non-HRRm pts is unclear. Cer+ola had a manageable safety profile consistent with known profiles of each. Further analyses may identify pts likely to benefit from each treatment.
Clinical trial identification
NCT03330847.
Editorial acknowledgement
Medical writing assistance, funded by AstraZeneca, was provided by Anna Frangou, PhD, and Stephan Lindsey, PhD, of Peloton Advantage, LLC, an OPEN Health company, under the direction of the authors.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
A. Tutt: Financial Interests, Personal, Advisory Board, Personal fees /Advisory Board related to targeted therapies in DNA repair deficient: Pfizer; Financial Interests, Personal, Advisory Board, Personal fees from /Advisory Board related to targeted therapies in DNA repair deficient: Vertex; Financial Interests, Personal, Advisory Board, Personal fees/Advisory Board related to targeted therapies in DNA repair deficient: Artios; Financial Interests, Personal, Advisory Board, Personal fees/Advisory Board related to targeted therapies in DNA repair deficient: prIME Oncology; Financial Interests, Personal, Advisory Board, Personal Fees/Moon Shot Breast Cancer Scientific Advisory Board Honoraria: MD Anderson; Financial Interests, Personal, Advisory Board, Personal fees/Scientific Ad Board function and stock options: Inbiomotion; Financial Interests, Personal, Invited Speaker, Speaking role at mini symposium: SABCS 2020; Financial Interests, Personal, Advisory Board, Personal fees relating to advisory board: Gilead 21.05.21; Financial Interests, Institutional, Expert Testimony, CRUK expert panel monies going to my research account at the Institute of Cancer Research/Honoraria associated with Deputy Chair also going into research account: CRUK; Financial Interests, Institutional, Invited Speaker, Paid into research account at the Institute of Cancer Research: AZ Symposium ESMO 2021; Financial Interests, Personal, Advisory Board, Personal fees from Advisory Boards: MERCK Serano; Financial Interests, Institutional, Expert Testimony, Paid into research institute account: GE Healthcare 17.06.21; Financial Interests, Personal, Expert Testimony, Personal fees paid for expert testimony: EM Partners 16.06.21; Financial Interests, Institutional, Invited Speaker, Speaker at round table and monies went into research account: VJ Oncology 11.06.21; Financial Interests, Personal, Expert Testimony, Personal fees for an educational video: Medscape Education; Financial Interests, Personal, Advisory Board, Personal and institution fees for Ad Board: Gilead; Financial Interests, Personal, Full or part-time Employment, Head of Division for Breast Research, Director Breast Cancer Now Research Centre, Honorary Consultant Clinical Oncologist, Royal Marsden Hospital, joint leadership appointment with KCL that is processed through ICR payroll: Institute of Cancer Research; Financial Interests, Personal, Full or part-time Employment, Director of Breast Cancer Now Research Unit, King's College London, Honorary Consultant Clinical Oncologist, Breast Unit, Guy’s and St Thomas’ NHS Foundation Trust, joint leadership appointment with ICR that is processed through ICR payroll: King's College London; Financial Interests, Personal, Stocks/Shares: Inbiomotion; Financial Interests, Personal, Royalties, AstraZeneca with royalties paid to The Institute of Cancer Research (ICr) for the use of PARP inhibitors in DNA deficient cancers, licensee - AstraZeneca. ICR rewards to inventor's payments paid to Andrew Tutt's research accounts at The Institute of Cancer Research and to personal accounts: AstraZeneca; Financial Interests, Institutional, Research Grant, Received research support for TNT trial: Myriad genetics; Financial Interests, Personal and Institutional, Invited Speaker, Financial support to my academic and hospital institutions for costs associated with global academic study chair and local site costs for OlympiA trial/Travel expenses related to any trial related travel. Payments through Breast International Group for trial conduct in Olympic trial and through CRO's for commercial PARP inhibitor trial: AstraZeneca; Financial Interests, Institutional, Research Grant, Local site trial associated with clinical trial DNA: MERCK KGAA; Financial Interests, Institutional, Research Grant, Financial support for research at ICR: Medivation; Non-Financial Interests, Other, Member of Strategy Group: NCRI Strategy Group; Non-Financial Interests, Other, Member of the Committee: ESMO Guidelines Committee; Non-Financial Interests, Officer, Committee Member: ESMO 2023 Scientific Committee; Non-Financial Interests, Institutional, Product Samples, Responsible for care of patients receiving Olaparib on named patient programme in Breast Cancer @ Guy's London: Guy's Hospital; Other, Grant funded to study homologous recombination deficient breast and other cancers, BCN receive payments through AstraZeneca related to PARP inhibitor patents: Breast Cancer Now; Other, Grant funded to study homologous recombination deficient breast and other cancers, CRUK receive payments through AstraZeneca related to PARP inhibitor patents: CRUK. Z. Nowecki: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Sanofi Aventis; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Other, Traveler Grant: Roche. R. Szoszkiewicz: Financial Interests, Personal, Principal Investigator: Centrum Medyczne Pratia Poznan. S. Im: Non-Financial Interests, Personal, Advisory Role: AstraZeneca; Non-Financial Interests, Personal, Advisory Role: Daiichi Sankyo; Non-Financial Interests, Personal, Advisory Role: Eisai; Non-Financial Interests, Personal, Advisory Role: GSK; Non-Financial Interests, Personal, Advisory Role: Hanmi; Non-Financial Interests, Personal, Advisory Role: Idience; Non-Financial Interests, Personal, Advisory Role: Lilly; Non-Financial Interests, Personal, Advisory Role: MSD; Non-Financial Interests, Personal, Advisory Role: Pfizer; Non-Financial Interests, Personal, Advisory Role: Novartis; Non-Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Daewoong Pharm; Financial Interests, Institutional, Research Grant: Boryung Pharm; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Roche. H. Arkenau: Financial Interests, Personal, Invited Speaker: Servier; Financial Interests, Personal, Invited Speaker: Guardant; Financial Interests, Personal, Advisory Board: iOnctura; Financial Interests, Personal, Advisory Board: Beigene; Financial Interests, Institutional, Invited Speaker: multiple small and large Pharma/Biotechs. A. Armstrong: Financial Interests, Personal, Advisory Board: Gilead; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Other, Conference Fees: Gilead; Financial Interests, Personal, Other, Conference Fees: MSD; Financial Interests, Institutional, Other, Research Funding: AstraZeneca; Financial Interests, Personal, Other, Spousal Shares: AstraZeneca. W. Jacot: Financial Interests, Institutional, Other, Research Funding: AstraZeneca; Financial Interests, Personal, Advisory Board: AstraZeneca; Other, Personal, Other, Congress Travel Support: AstraZeneca; Other, Personal, Other, Congress Travel Support: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Lilly France; Other, Personal, Other, Congress Travel Support: Lilly France; Financial Interests, Personal, Advisory Board: Eisai; Other, Personal, Invited Speaker, Congress Travel Support: Eisai; Financial Interests, Personal, Advisory Board: BMS; Other, Personal, Other, Congress Travel Support: Chugai Pharma; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Other, Personal, Other, Congress Travel Support: Glaxo Smith Kline; Financial Interests, Personal, Advisory Board: Novartis; Other, Personal, Other, Congress Travel Support: Novartis; Financial Interests, Personal, Advisory Board: MSD; Other, Personal, Other, Congress Travel Support: Pierre Fabre; Financial Interests, Personal, Advisory Board: Roche; Other, Personal, Other, Congress Travel Support: Roche; Financial Interests, Personal, Advisory Board: Rain Pharmaceuticals; Other, Personal, Other, Congress Travel Support: Sanofi Aventis; Financial Interests, Personal, Advisory Board: Seagen. J.H. Kim: Financial Interests, Institutional, Other, Research Funding: Ono Pharma Korea Co., Ltd. M. Webster: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Seagen; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: Knight; Financial Interests, Personal, Advisory Role: Gilead; Financial Interests, Personal, Advisory Role: Genomic Health. J. Balmana: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Pfizer. S. Delaloge: Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Exact Sciences; Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: Pierre fabre; Financial Interests, Institutional, Advisory Board: Orion; Financial Interests, Institutional, Advisory Board: Sanofi; Financial Interests, Institutional, Advisory Board: Rappta; Financial Interests, Institutional, Advisory Board: Cellectis; Financial Interests, Institutional, Advisory Board: Isis/servier; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: Seagen; Financial Interests, Institutional, Invited Speaker: Lilly; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: MSD; Financial Interests, Institutional, Advisory Board, ad board: Besins Healthcare; Financial Interests, Institutional, Invited Speaker: Roche Genentech; Financial Interests, Institutional, Invited Speaker: BMS; Financial Interests, Institutional, Invited Speaker: Puma; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Orion; Financial Interests, Institutional, Invited Speaker: Sanofi; Financial Interests, Institutional, Funding: GE; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker, clinical research funding to my institution: Taiho; Non-Financial Interests, Invited Speaker, Société Française de Sénologie et Pathologie Mammaire: SFSPM. N. Lukashchuk: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. R. Odegbami, A.B. Loembe, M.W. Drachsler: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. E. Casson: Financial Interests, Personal, Full or part-time Employment, Independent contractor: AstraZeneca. E.J. Dean: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. K. Punie: Financial Interests, Personal, Other, Travel Support: AstraZeneca; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Eli Lilly; Financial Interests, Institutional, Advisory Board: Gilead Sciences; Financial Interests, Institutional, Invited Speaker: Medscape; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Institutional, Invited Speaker: MundiPharma; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Institutional, Advisory Role: Novartis; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Personal, Other, Travel Support: Pfizer; Financial Interests, Institutional, Advisory Role: Pfizer; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Advisory Role: Pierre Fabre; Financial Interests, Personal, Other, Travel Support: Roche; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Institutional, Advisory Role: Roche; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Personal, Advisory Role: Seagen; Financial Interests, Institutional, Invited Speaker: Seagen; Financial Interests, Institutional, Advisory Role: Teva; Financial Interests, Institutional, Research Grant: Sanofi; Financial Interests, Institutional, Advisory Role: Vifor Pharma; Financial Interests, Personal, Other, Travel Support: PharmaMar.
168P - Sacituzumab govitecan (SG) efficacy in patients with metastatic triple-negative breast cancer (mTNBC) by HER2 immunohistochemistry (IHC) status: Findings from the Phase 3 ASCENT study (ID 176)
- Sara A. Hurvitz (Los Angeles, United States of America)
- Aditya Bardia (Boston, United States of America)
- Kevin Punie (Leuven, Belgium)
- Kevin Kalinsky (Atlanta, United States of America)
- Javier Cortes (Madrid and Barcelona, Spain)
- Joyce O'Shaughnessy (Dallas, United States of America)
- Lisa A. Carey (Chapel Hill, United States of America)
- Hope S. Rugo (San Francisco, United States of America)
- Oh Kyu Yoon (Foster City, United States of America)
- Yang Pan (Foster City, United States of America)
- Rosemary J. Delaney (Foster City, United States of America)
- Scott Hofsess (Foster City, United States of America)
- Paul Hodgkins (Foster City, United States of America)
- See-Chun Phan (Foster City, United States of America)
- Veronique Dieras (Rennes, France)
Abstract
Background
HER2 IHC1+ or IHC2+ and in situ hybridization (ISH)-negative results are sometimes referred to as HER2-Low. SG is a novel antibody-drug conjugate composed of an anti–Trop-2 antibody coupled to SN-38 via a proprietary, hydrolyzable linker. SG is approved in mTNBC for the second line (2L) onwards. In the ASCENT study, SG had significant progression-free survival (PFS) and overall survival (OS) benefit vs chemotherapy of physician’s choice (TPC). This ASCENT post hoc subgroup analysis evaluates SG efficacy in HER2 IHC0 and HER2-Low mTNBC.
Methods
Patients (pts) with mTNBC refractory/relapsing after ≥2 prior chemotherapies (≥1 in the metastatic setting) were randomized 1:1 to receive SG (10 mg/kg IV on d 1 and 8, every 21 d) or TPC (capecitabine, eribulin, vinorelbine, or gemcitabine) until unacceptable toxicity/progression. Primary endpoint was PFS per RECIST 1.1 by central review. Pts with known HER2-positive disease were ineligible, but HER2 status was not assessed centrally in ASCENT. Local HER2 IHC results were analyzed retrospectively.
Results
In the intent-to-treat (ITT) population (SG vs TPC), 149 vs 144, 63 vs 60, and 55 vs 58 pts had HER2 IHC0, HER2-Low, and missing HER2 IHC results, respectively; 79% of the ITT population was HER2-evaluable. Baseline characteristics between HER2 IHC0 vs HER2-Low were comparable and similar to the ITT population. Median PFS and OS were significantly improved, and objective response rate was numerically higher with SG vs TPC in the HER2 IHC0 and HER2-Low groups (Table). HER2-Low had numerically better outcomes vs HER2 ICH0 in both the SG and TPC arms.
Conclusions
Clinical benefit with SG in HER2 IHC0 and HER2-Low mTNBC was consistent with that of the ASCENT ITT population, regardless of HER2 status. SG should be considered an effective treatment option for pts with mTNBC eligible for 2L or later therapy. ISH, in situ hybridization; HR, hazard ratio; IHC, immunohistochemistry; mPFS, median progression-free survival; mOS, median overall survival, ORR, objective response rate; SG, sacituzumab govitecan; TPC, treatment of physician’s choice ∗HER2-Low defined as IHC1+ or ICH2+ and ISH-neg
HER2 IHC0 HER2-Low∗ SG (n=149) TPC (n=144) SG (n=63) TPC (n=60) mPFS, mo 4.3 1.6 6.2 2.9 HR (95% CI) 0.38 (0.28-0.50) 0.44 (0.27-0.72) mOS, mo 11.3 5.9 14.0 8.7 HR (95% CI) 0.51 (0.39-0.66) 0.43 (0.28-0.67) ORR, n (%) 46 (31) 5 (3) 20 (32) 5 (8)
Clinical trial identification
NCT02574455.
Editorial acknowledgement
Editorial support was provided by Yao Bian, PhD, of Team 9 Science and funded by Gilead Sciences, Inc.
Legal entity responsible for the study
Gilead Sciences, Inc.
Funding
Gilead Sciences, Inc.
Disclosure
S.A. Hurvitz: Financial Interests, Personal, Invited Speaker: Clinical Care Options; Financial Interests, Personal, Invited Speaker: aptitude health; Financial Interests, Personal, Invited Speaker: axis medical; Financial Interests, Personal, Invited Speaker: cancer expert now; Financial Interests, Personal, Invited Speaker: ICHE; Financial Interests, Personal, Invited Speaker: MJH Associates; Financial Interests, Personal, Invited Speaker: PER; Financial Interests, Personal, Invited Speaker: Primo; Financial Interests, Personal, Invited Speaker: Projects in Knowledge; Financial Interests, Personal, Invited Speaker: Prova Education; Financial Interests, Personal, Invited Speaker: Research to Practice; Financial Interests, Personal, Invited Speaker: Ultimate Medical Academy; Financial Interests, Personal, Invited Speaker: Vaniam; Financial Interests, Personal, Invited Speaker: WebMD; Financial Interests, Personal, Invited Speaker: Rockpointe; Financial Interests, Personal, Invited Speaker: OBR; Financial Interests, Personal, Invited Speaker: Peer Education; Financial Interests, Personal, Invited Speaker: Spire Learning; Financial Interests, Personal, Invited Speaker: PrecisCA; Financial Interests, Personal, Stocks/Shares, stock options: NK Max; Financial Interests, Personal, Stocks/Shares, spouse owns: ROM Tech; Financial Interests, Personal, Ownership Interest, spouse: Ideal Implant; Financial Interests, Personal, Royalties, author medical book: McGraw; Financial Interests, Personal, Royalties: Elsevier; Financial Interests, Personal, Royalties: Springer; Financial Interests, Personal, Royalties: Sage; Financial Interests, Personal, Royalties: Wolters Kluwer; Financial Interests, Personal, Royalties: Wiley; Financial Interests, Institutional, Invited Speaker: Ambrx; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Arvinas; Financial Interests, Institutional, Invited Speaker: Bayer; Financial Interests, Institutional, Invited Speaker: Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: Genentech/Roche; Financial Interests, Institutional, Invited Speaker: Gilead; Financial Interests, Institutional, Invited Speaker: GSK; Financial Interests, Institutional, Invited Speaker: Immunomedics; Financial Interests, Institutional, Invited Speaker: Lilly; Financial Interests, Institutional, Invited Speaker: Macrogenics; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: OBI Pharma; Financial Interests, Institutional, Invited Speaker: Pieris; Financial Interests, Institutional, Invited Speaker: Puma; Financial Interests, Institutional, Invited Speaker: Radius; Financial Interests, Institutional, Invited Speaker: sanofi; Financial Interests, Institutional, Invited Speaker: Seattle Genetics; Financial Interests, Institutional, Invited Speaker: Dignitana; Financial Interests, Institutional, Invited Speaker: Zymeworks; Financial Interests, Institutional, Invited Speaker: Phoenix Molecular Designs, Ltd.; Financial Interests, Institutional, Research Grant: Samumed; Financial Interests, Institutional, Research Grant: Ambrx; Non-Financial Interests, Advisory Role: Daiichi Sankyo; Non-Financial Interests, Principal Investigator: Daiichi Sankyo; Non-Financial Interests, Advisory Role: Novartis; Non-Financial Interests, Principal Investigator: Genentech; Non-Financial Interests, Principal Investigator: Seattle Genetics; Non-Financial Interests, Advisory Role: Ambrx; Non-Financial Interests, Advisory Role: 4DPharma; Non-Financial Interests, Advisory Role: Dantari; Non-Financial Interests, Advisory Role: Macrogenics; Non-Financial Interests, Advisory Role: Lilly; Non-Financial Interests, Advisory Role: Artios; Non-Financial Interests, Advisory Role: Roche; Non-Financial Interests, Advisory Role: Pyxis; Non-Financial Interests, Advisory Role: Amgen; Non-Financial Interests, Advisory Role: Pieris; Non-Financial Interests, Advisory Role: Arvinas; Non-Financial Interests, Advisory Role: Immunomedics/Gilead; Non-Financial Interests, Member: ASCO; Non-Financial Interests, Member: AACR; Non-Financial Interests, Other, speaker: National Breast Cancer Coalition; Non-Financial Interests, Member, site representative for breast cancer guidelines: National Comprehensive Cancer Network. A. Bardia: Financial Interests, Institutional, Financial Interests, grants: Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health/Menarini, Immunomedics/Gilead, Daiichi Pharma/AstraZeneca, Eli Lilly; Financial Interests, Personal, Financial Interests, consulting fees: Pfizer, Novartis, Genentech, Merck, Radius Health/Menarini, Immunomedics/Gilead, Sanofi, Daiichi Pharma/AstraZeneca, Phillips, Eli Lilly, Foundation Medicine. K. Punie: Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Advisory Board: Roche; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Advisory Board: Vifor Pharma; Financial Interests, Institutional, Advisory Board: Eli Lilly; Financial Interests, Institutional, Invited Speaker: Eli Lilly; Financial Interests, Institutional, Invited Speaker: Mundi Pharma; Financial Interests, Institutional, Advisory Board: Pierre Fabre; Financial Interests, Institutional, Advisory Board: McCann Health; Financial Interests, Institutional, Advisory Board: Roularta; Financial Interests, Institutional, Advisory Board: Teva; Financial Interests, Institutional, Invited Speaker: MSD; Financial Interests, Institutional, Advisory Board: Gilead Sciences; Financial Interests, Institutional, Advisory Board: Pfizer; Financial Interests, Institutional, Other, Consultancy: Roche; Financial Interests, Institutional, Funding: Sanofi; Non-Financial Interests, Principal Investigator: EORTC 1745-ETF-BCG trial; Non-Financial Interests, Other, Committee member: ESMO Young Oncologists Committee; Non-Financial Interests, Invited Speaker: BSMO; Non-Financial Interests, Other, Committee Member: ESMO Resilience Task Force; Non-Financial Interests, Advisory Role: Commission personalized medecine Federal Government Belgium. K. Kalinsky: Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Immunomedics; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Seattle Genetics; Financial Interests, Personal, Advisory Board: Cyclacel; Financial Interests, Personal, Advisory Board: Oncosec; Financial Interests, Personal, Advisory Board: 4D Pharma; Financial Interests, Personal, Advisory Board: Puma; Financial Interests, Personal, Stocks/Shares, Employment + Stock = spouse: Grail; Financial Interests, Institutional, Invited Speaker: Incyte; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Invited Speaker: Genentech; Financial Interests, Institutional, Invited Speaker: Eli Lilly; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: Calithera; Financial Interests, Institutional, Invited Speaker: Immunomedics; Financial Interests, Institutional, Invited Speaker: Acetylon; Financial Interests, Institutional, Invited Speaker: Seattle Genetics; Financial Interests, Institutional, Invited Speaker: Amgen; Financial Interests, Institutional, Invited Speaker: Zentalis; Financial Interests, Institutional, Invited Speaker: CytomX Therapeutics; Other, Support for attending meetings and/or travel: Eli Lilly; Other, Support for attending meetings and/or travel: AstraZeneca; Other, Support for attending meetings and/or travel: Pfizer; Other, Steering Committee: Immunomedics; Other, Steering Committee: AstraZeneca; Other, Steering Committee: Ambryx; Other, Steering Committee: Genentech. J. Cortés: Financial Interests, Personal, Financial Interests, stock: Leuko, MedSIR, Nektar; Financial Interests, Personal, Financial Interests, honoraria: Novartis, Eisai, Celgene, Pfizer, Roche, Samsung, Lilly, Merck Sharp & Dohme, Daachi Sankyo; Financial Interests, Personal, Financial Interests, consulting or advisory role: Celgene, Cellestia Biotech, AstraZeneca, Roche, Seattle Genetics, Daachi Sankyo, ERYTECH Pharma, Polyphor, Athenex, Lilly, Servier, Merck Sharp & Dohme, GlaxoSmithKline, Leuko, Clovis Oncology, Bioasis, Boehringer, Ingelheim, Ellipses Pharma, HiberCell; Financial Interests, Institutional, Financial Interests, research funding: Ariad, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer, Eisai Farmaceutica, Guardaanth Health, Merck Sharp & Dohme, Pfizer, Puma Co, Queen Mary University of London, Roche, Piqur; Financial Interests, Personal, Financial Interests, travel, accomodations, expenses: Roche, Pfizer, Eisai, Novartis, Daiichi Sankyo. J. O'Shaughnessy: Financial Interests, Personal, Advisory Board: AbbVie; Financial Interests, Personal, Advisory Board: Agendia; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Aptitude Health; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: G1 Therapeutics; Financial Interests, Personal, Advisory Board: Genentech; Financial Interests, Personal, Advisory Board: Immunomedics; Financial Interests, Personal, Advisory Board: Ipsen Biopharmaceuticals; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Myriad; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Ondonate; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Puma; Financial Interests, Personal, Advisory Board: prIME Oncology; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Seattle Genetics; Financial Interests, Personal, Advisory Board: Syndax. H.S. Rugo: Financial Interests, Personal, Invited Speaker: Puma; Financial Interests, Personal, Advisory Board: samsung; Financial Interests, Personal, Invited Speaker: mylan; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Invited Speaker: Lilly; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: OBI Pharma; Financial Interests, Institutional, Invited Speaker: Immunomedics; Financial Interests, Institutional, Invited Speaker: Macrogenics; Financial Interests, Institutional, Invited Speaker: Daiichi; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Invited Speaker: Merck; Financial Interests, Institutional, Invited Speaker: Odonate; Financial Interests, Institutional, Invited Speaker: sermonix; Financial Interests, Institutional, Invited Speaker: seattle genetics; Financial Interests, Institutional, Invited Speaker: polyphor; Financial Interests, Institutional, Invited Speaker: Boehringer Ingelheim; Non-Financial Interests, Advisory Role, I advise a number of companies without compensation: various. O.K. Yoon: Financial Interests, Personal, Financial Interests, employee, stock options: Gilead. Y. Pan: Financial Interests, Personal, Financial Interests, employee: Gilead. R.J. Delaney: Financial Interests, Personal, Financial Interests, employee, stock or stock options: Gilead. S. Hofsess: Financial Interests, Personal, Financial Interests, employee, meeting attendance, stock options: Gilead; Non-Financial Interests, Personal, Non-Financial Interests, unpaid: Chair of the William Paterson University Professional Science Master’s External Advisory Board. P. Hodgkins: Financial Interests, Personal, Financial Interests, employee, stock options: Gilead Sciences. S. Phan: Financial Interests, Personal, Financial Interests, employee, grants or contracts, meeting attendance, stock or stock options, receipt of materials: Gilead. V. Dieras: Financial Interests, Personal, Financial Interests, consulting fees: Roche Genentech, Novartis, Pfizer, Lilly, AbbVie, Eisai, AstraZeneca, Daiichi Sankyo, Seagen, Gilead, MSD, Pierre Fabre Oncologie; Financial Interests, Personal, Financial Interests, honoraria: Novartis, Pfizer, Lilly, AstraZeneca, Seagen, Daiichi Sankyo, Gilead, MSD; Financial Interests, Personal, Financial Interests, meeting attendance and/or travel: Roche, Novartis, Pfizer, Seagen, Lilly, AstraZeneca, Daiichi Sankyo, Gilead; Financial Interests, Personal, Financial Interests, data safety monitoring board or advisory board: Roche Genentech, Novartis, Pfizer, Lilly, AbbVie, Eisai, AstraZeneca, Daiichi Sankyo, Seagen, Gilead, MSD, Pierre Fabre Oncologie. All other authors have declared no conflicts of interest.