527MO - Rucaparib maintenance treatment in patients (pts) with newly diagnosed ovarian cancer (OC): Defining benefit according to disease risk subgroups within the phase 3 ATHENA–MONO study

Background

In ATHENA–MONO (GOG-3020/ENGOT-ov45), progression-free survival (PFS) improvement was observed with first-line (1L) rucaparib maintenance treatment vs placebo in pts with advanced OC, regardless of molecular characteristics (median PFS, 20.2 vs 9.2 months, log-rank P<.0001; HR, 0.52; 95% CI, 0.40–0.68). Pts with or without high-risk clinical characteristics for disease progression were enrolled in ATHENA–MONO. In the subgroup analyses presented here, we sought to evaluate if all patients benefited from rucaparib 1L maintenance treatment, including those with more favourable prognostic factors at baseline.

Methods

Pts with high-grade, FIGO stage III–IV OC who had completed cytoreductive surgery and 4–8 cycles of 1L platinum-doublet chemotherapy with a response (partial [PR] or complete [CR]) were randomized 4:1 to oral rucaparib 600 mg BID or placebo. Investigator-assessed PFS was evaluated in pt subgroups based on FIGO stage, timing of surgery, and disease status post-chemotherapy.

Results

As of March 23, 2022 (data cutoff), 427 and 111 pts were randomized to rucaparib monotherapy vs placebo. The majority of patients had FIGO stage III disease (75%); approximately half underwent primary surgery (49%); and most patients had no residual disease post-chemotherapy (75%). In the intent-to-treat (ITT) population, investigator-assessed PFS was improved with rucaparib vs placebo across all subgroups based on FIGO stage, timing of surgery, and residual disease (Table). Table: 527MO

*P values are nominal, not adjusted for multiplicity No difference in treatment effect across subgroups based on Cox proportional model including interaction between subgroup and treatment effect.

Conclusions

In the ITT population, 1L rucaparib maintenance treatment improved PFS vs placebo across subgroups regardless of timing of surgery or prognostic disease characteristics, including FIGO stage or residual disease. These results confirm a new maintenance treatment option for OC pts with or without high risk factors for progression at baseline irrespective of molecular characteristics.

Clinical trial identification

NCT03522246 May 11, 2018.

Editorial acknowledgement

Medical writing support and editorial support funded by Clovis Oncology, Inc. were provided by Sachi Yim and Frederique Evans of Ashfield MedComms, an Ashfield Health company.

Legal entity responsible for the study

Clovis Oncology, Inc.

Funding

Clovis Oncology, Inc.

Disclosure

R. Kristeleit: Financial Interests, Personal, Advisory Board: GSK, Eisai, Basilea Pharmaceutica, iTEOS, Clovis Oncology, Shattuck Labs, AstraZeneca, Regeneron; Financial Interests, Personal, Invited Speaker: GSK, Zydus Cadila, Clovis Oncology, AstraZeneca, GSK; Financial Interests, Personal, Expert Testimony: Amgen; Financial Interests, Personal, Other, Membert of Oncology and Haematology Expert Advisory Group: Commission on Human Medicines; Financial Interests, Institutional, Invited Speaker: GSK, Clovis Oncology, Clovis Oncology, Eisai, InCyte, AstraZeneca, MSD, Roche, BerGenBio, Allarity, IoVance, Artios, Regeneron; Financial Interests, Institutional, Research Grant: MSD. M. Lim: Financial Interests, Personal, Advisory Board: AstraZeneca, Boryung, GI Innovation, Takeda; Financial Interests, Personal and Institutional, Research Grant: AstraZeneca, CKD Pharm, Clovis Oncology, OncoQuest. A. Oaknin: Financial Interests, Personal, Advisory Board: AstraZeneca, Clovis Oncology, Deciphera Pharmaceuticals, Genmab, GSK, Immunogen, Mersana Therapeutics, PharmaMar, Roche, Tesaro, Merck Sharps & Dohme de España, SA, Agenus, Sutro, Corcept Therapeutics, EMD Serono, Novocure, prIME Oncology, Sattucklabs, Itheos, Eisai, F. Hoffmann-La Roche,; Financial Interests, Personal, Other, Travel and accomodation: AstraZeneca, PharmaMar, Roche; Financial Interests, Institutional, Funding: Abbvie Deutschland, Advaxis Inc., Aeterna Zentaris, Amgen, Aprea Therapeutics AB, Clovis Oncology Inc, EISAI limited LTD, F. Hoffmann –La Roche LTD, Regeneron Pharmaceuticals, Immunogen Inc, Merck, Sharp & Dohme de España SA, Millennium Pharmaceuticals Inc, PharmaMar SA, Tesaro Inc., Bristol Myers Squibb; Non-Financial Interests, Leadership Role, Executive Board member as a Co-Chair: GEICO; Non-Financial Interests, Leadership Role, Phase II Committee and Cervix Cancer Committee Representative on behalf of GEICO: GCIG; Non-Financial Interests, Officer, Chair of Gynaecological Track ESMO 2019. Scientific Track Member Gynaecological Cancers ESMO 2018, ESMO 2020, ESMO 2022. Member of Gynaecological Cancers Faculty and Subject Editor Gyn ESMO Guidelines: ESMO; Non-Financial Interests, Member: ESMO, ASCO, GCIG, SEOM, GOG. J. Buscema: Financial Interests, Personal, Leadership Role: Arizona Oncology Associates; Financial Interests, Personal, Advisory Board: Caris Life Science; Financial Interests, Personal, Stocks/Shares: McKesson. P. Bessette: Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca, Canadian Cancer Trials Group, Clovis Oncology, Inc., Merck, Tesaro. D. Lorusso: Financial Interests, Personal, Advisory Board, Participation in Advisory Boards and Invited Speaker: GSK, Clovis Oncology, PharmaMar; Financial Interests, Personal, Advisory Board, Participation in Advisory Boards and Invited Speakers: AstraZeneca, MSD; Financial Interests, Personal, Other, Consultancy: PharmaMar, Amgen, AstraZeneca, Clovis Oncology, GSK, MSD, Immunogen, Genmab, Seagen; Financial Interests, Personal, Advisory Board, Participation in Advisory Boards: Merck Serono; Financial Interests, Personal, Advisory Board, Invited member of advisory board: Seagen, Immunogen, Genmab, Oncoinvest, Corcept, Sutro; Financial Interests, Institutional, Funding, Grant for founding accdemic trial: MSD, Clovis Oncology, PharmaMar; Financial Interests, Institutional, Funding, Grant for founding acamemic trial: GSK; Financial Interests, Institutional, Invited Speaker, ENGOT trial with institutional support for coordination: Clovis Oncology; Financial Interests, Institutional, Invited Speaker, ENGOT trial with insitutional support for coordination: Genmab, MSD; Financial Interests, Institutional, Funding, Clnical trial/contracted research: AstraZeneca, Clovis Oncology, GSK, MSD, Seagen; Financial Interests, Institutional, Funding, Clinical trials/contracted research: Genmab, Immunogen, Incyte, Novartis, Roche; Non-Financial Interests, Principal Investigator, PI of several trials, no compensation received: GSK; Non-Financial Interests, Principal Investigator, PI of several trials. No personal compensation received: AstraZeneca, genmab; Non-Financial Interests, Principal Investigator, PI in several trials. No personal compensation received: MSD; Non-Financial Interests, Principal Investigator, PI of clinical trial. No personal compensation received: immunogen, clovis, Incyte; Non-Financial Interests, Principal Investigator, PI of clinical trial. No personal compensation receive: roche; Non-Financial Interests, Member, Board of Directors: GCIG. F. Marmé: Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK/Tesaro, Clovis, Pfizer, Lilly; Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Novartis, Roche, Gilead/immunomedics, Eisai, PharmaMar, GenomicHealth, Myriad, Seagen; Financial Interests, Institutional, Invited Speaker: Roche, AstraZeneca, Novartis, Roche, Eisai, Gilead/Immunomedics, MSD, German Breast Group, AGO Research GmbH, Vaccibody, GSK; Financial Interests, Institutional, Funding: AstraZeneca. T.J. Herzog: Financial Interests, Personal, Advisory Board: AstraZeneca, Caris, Clovis Oncology, Inc., Johnson & Johnson, Roche, Tesaro. I. McNeish: Financial Interests, Personal, Advisory Board, Advisory Boards: Clovis Oncology; Financial Interests, Personal, Advisory Board, Advisory Boards and travel: AstraZeneca, GSK; Financial Interests, Personal, Advisory Board: Roche, Alkermes, OncoC4, Theolytics; Financial Interests, Institutional, Funding: AstraZeneca; Non-Financial Interests, Invited Speaker, Trustee of this charity: Worldwide Cancer Research. S. Goble: Financial Interests, Personal, Stocks/Shares: Clovis Oncology; Financial Interests, Personal, Full or part-time Employment: Clovis Oncology. S. Hume: Financial Interests, Personal, Full or part-time Employment: Clovis Oncology, Inc.; Financial Interests, Personal, Stocks/Shares: Clovis Oncology, Inc. K. Fujiwara: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Takeda, Regenerone, Zeria; Financial Interests, Personal, Advisory Board: MSD, Eisai, Genmab, Nano Carrier, Daiichi Sankyo; Financial Interests, Institutional, Funding: Regenerone; Financial Interests, Institutional, Research Grant: MSD, Ono, Zeria, Genmab; Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca; Non-Financial Interests, Leadership Role: GOTIC. B.J. Monk: Financial Interests, Personal, Advisory Role: Agenus, Akeso Biopharma, Amgen, Aravive, AstraZeneca, Bayer, Clovis Oncology, Inc., Eisai, Genmab/Seattle Genetics, Elevar Therapeutics, EMD Merck, GOG Foundation, Gradalis, ImmunoGen, Iovance Biotherapeutics, Karyopharm Therapeutics, Merck, Mersana, Myriad Pharmaceuticals, Novocure, Pfizer, Puma Biotechnology, Regeneron, Roche/Genentech, Sorrento Therapeutics, Tesaro/GSK, US Oncology, Vascular Biogenics; Financial Interests, Personal, Leadership Role: US Oncology; Financial Interests, Personal, Advisory Board: AstraZeneca, Clovis Oncology, Inc., Eisai, GSK, Merck, Roche/Genentech, Tesaro; Financial Interests, Other, Honoraria: Agenus, Akeso Biopharma, Aravive, AstraZeneca, Bayer, Clovis Oncology, Inc., Eisai, Elevar Therapeutics, EMD Merck, Genmab/Seattle Genetics, GOG Foundation, Gradalis, ImmunoGen, Lovance Biotherapeutics, Karyopharm Therapeutics, Macrogenics, Merck, Mersana, Myriad Pharmaceuticals, Novocure, Pfizer, Puma Biotechnology, Regeneron, Roche/Genentech, Sorrento Therapeutics, Tesaro/GSK, US Oncology, Vascular Biogenics; Financial Interests, Invited Speaker: Advaxis, Amgen, Array BioPharma, AstraZeneca, Genentech, Immunogen, Janssen, Lilly, Morphotek, Novartis, Nucana, Pfizer, Regeneron, Tesaro. All other authors have declared no conflicts of interest.