Abstract 737P
Background
In the phase 3 ENGOT-en9/LEAP-001 study, first-line LEN + pembro did not meet the prespecified statistical criteria for PFS or OS vs chemotherapy (chemo) in mismatch repair-proficient (pMMR) advanced/recurrent endometrial cancer (aEC). We report tumor response analyses in the LEN + pembro arm.
Methods
ORR per RECIST v1.1 by blinded independent central review was assessed in the pMMR pop and all-comers. Responders were patients (pts) with a confirmed complete or partial response (CR/PR; ≥30% reduction in sum of target lesion diameters from baseline). This exploratory analysis evaluated duration of response (DOR), treatment duration, and efficacy in responders.
Results
420 pts were randomized to LEN + pembro (320 pts in pMMR pop). As of data cutoff (Oct 2, 2023), 162 pts (50.6%) in the pMMR pop and 234 (55.7%) among all-comers achieved an objective response; median (range) DOR was 16.1 (1.0+–48.7+) and 23.2 (1.0+–49.0+) mo. Median (range) duration of treatment for responders was 17.1 (1.5–48.4) and 19.8 (1.5–51.5) mo. ORRs by baseline characteristics are shown in the table. Among responders, median (95% CI) PFS was 18.4 (15.1–26.8) mo in the pMMR pop and 27.3 (20.9–36.8) mo in all-comers, NR (29.1–NR) and NR (NR–NR) in pts with CR, and 13.9 (12.3–15.6) and 15.1 (12.9–19.4) mo in pts with PR. Median PFS was 5.2 (4.3–6.1) and 5.7 (4.4–6.1) mo in pts with stable disease (SD), respectively. Among responders, median OS was 43.6 (37.9–NR) mo in the pMMR pop and NR (47.0–NR) mo in all-comers, NR (39.6–NR) and NR (NR–NR) in pts with CR, and 37.6 (30.9–NR) and 43.5 (32.7–NR) mo in pts with PR. Median OS was 19.2 (14.5–22.3) and 20.6 (17.2–24.8) mo in pts with SD, respectively. Table: 737P
| Baseline characteristic | pMMR Pop | All-Comers | ||
| n a | ORR, % | n a | ORR, % | |
Age, y ConclusionsAs in a prior analysis of Study 309/KEYNOTE-775, responses were deep, durable, and translated into extended PFS and OS in the ENGOT-en9/LEAP-001 LEN + pembro arm, in both the pMMR pop and all-comers, thus supporting LEN + pembro as an important treatment option for aEC after PD on prior systemic therapy. Clinical trial identificationNCT03884101; EudraCT 2018-003009-24. Editorial acknowledgementMedical writing assistance was provided by Christabel Wilson, MSc, of ICON plc (Blue Bell, PA, USA). This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Legal entity responsible for the studyMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. FundingMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. DisclosureA. Danska-Bidzinska: Financial Interests, Institutional, Other, Honoraria for lectures: Eli Lilly, MSD, AstraZeneca, and GSK; Financial Interests, Institutional, Other, Support for attending meetings and/or travel: Roche, MSD, AstraZeneca; Financial Interests, Institutional, Advisory Board, Participation on Data Safety Monitoring Boards or Advisory Boards: MSD, AstraZeneca, GSK. V. Makker: Financial Interests, Institutional, Funding, Study funding: Merck, Eisai, Clovis, Karyopharm, AstraZeneca; Financial Interests, Institutional, Funding, Study support: Zymeworks; Financial Interests, Institutional, Funding, Study Support: BMS, Duality, Faeth, Takeda; Financial Interests, Institutional, Local PI: Cullinan; Non-Financial Interests, Principal Investigator: Merck; Non-Financial Interests, Advisory Role: Eisai, Clovis, Novartis, Lilly, GSK, Karyopharm, Iteos, Faeth, Duality, ZYmeworks, Morphosys, Moreo; Other, Travel to Scientific Congress-SGO2024: AstraZeneca. V. Salutari: Financial Interests, Personal, Advisory Board: Astazeneca, Eisai; Financial Interests, Personal, Invited Speaker: MSD, GSK; Financial Interests, Institutional, Local PI: MSD, Astazeneca; Financial Interests, Personal and Institutional, Steering Committee Member: MSD. I. Romero: Financial Interests, Personal, Advisory Board: Roche, PharmaMar, Clovis, GSK, AstraZeneca, Pharma&; Financial Interests, Personal, Invited Speaker: Roche, PharmaMar, AstraZeneca, Clovis, GSK; Financial Interests, Institutional, Funding: AstraZeneca; Financial Interests, Institutional, Research Grant: GSK; Non-Financial Interests, Member of Board of Directors: GEICO; Non-Financial Interests, Advisory Role: GEICO; Non-Financial Interests, Member: SEOM. M. McCormack: Financial Interests, Institutional, Advisory Board, Consultancy/advisory board: AstraZeneca, Eisai, GSK; Financial Interests, Institutional, Other, Honoraria/meeting expenses: Daiichi Sankyo, Roche, Medscape; Financial Interests, Institutional, Funding, Institutional funding: Roche, MSD, GSK. J. Baurain: Financial Interests, Institutional, Invited Speaker, educational lecture: MSD; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Advisory Board: Sanofi, GSK, Pierre Fabre, AstraZeneca. P. Mach: Financial Interests, Institutional, Advisory Board: MSD, AstraZeneca and Eisai. K.A. Cadoo: Financial Interests, Institutional, Other, Fees for grants or contracts paid to institution: The Irish Cancer Society Clinician Research Leadership Award 2021, MSD Ireland, ImmunoGen, Karyopharm Therapeutics, NRG Oncology; Financial Interests, Personal, Speaker, Consultant, Advisor, Consulting fees: NextCure and GSK Ireland; Financial Interests, Personal, Other, Payment or Honoraria to self: GSK Ireland, MJH Life Sciences, AstraZeneca, MSD Ireland; Financial Interests, Personal, Other, Payment for expert testimony to self: St Vincent’s Health; Financial Interests, Institutional, Other, Support to attend meeting: Roche Ireland, MSD Ireland, Pfizer; Financial Interests, Personal, Advisory Board, Data Safety Monitoring Board or Advisory Board to self: AstraZeneca, Eisai, GSK Ireland; Non-Financial Interests, Institutional, Other, Merck Scientific Advisory Board (no reimbursement): Merck; Non-Financial Interests, Personal, Other, Board Member (voluntary): Arc Cancer Support Centers; Non-Financial Interests, Personal, Advisory Board, Advisory role (voluntary): National Cancer Control Programme Ireland and National Center for Pharmacoeconomics Ireland. H. Mackay: Financial Interests, Personal, Advisory Board: Eisai, GAK; Financial Interests, Personal, Other, Associate Editor: British Journal of Cancer. M.L. Friedlander: Financial Interests, Institutional, Advisory Board: AstraZeneca, GSK, MSD, Limbic, Takeda; Financial Interests, Institutional, Other, Fees paid to institution: AstraZeneca, Novartis, Beigene; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca, Beigene. A.D. Santin: Financial Interests, Personal, Advisory Board: Merck, Eisai, Daiichi Sankyo, R-PHARM-US; Financial Interests, Institutional, Local PI: Merck, Verastem; Non-Financial Interests, Advisory Role: Merck, Eisai, Daiichi Sankyo, R-Pharm-USA. B.M. Slomovitz: Financial Interests, Personal, Advisory Board: AstraZeneca, Eisai, GSK, Genentech, Merck, ImmunoGen, Novocure, Aadi, Seagen, Incyte; Non-Financial Interests, Member of Board of Directors: GOG Foundation. D.S. Miller: Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme, Eisai Europe Limited; Financial Interests, Institutional, Member of Board of Directors: NRG Oncology; Financial Interests, Institutional, Coordinating PI: Advenchen Laboratories, Aeterna Zentaris; Financial Interests, Institutional, Local PI: Merck Sharp & Dohme, NVision, Novartis, Syros Pharmaceuticals, Karyopharm Therapeutics, Agenus, Akesobio, Leap Therapeutics. J. McKenzie: Financial Interests, Personal, Full or part-time Employment, Full time employee of Eisai Inc.: Eisai Inc. L. Yao: Financial Interests, Personal, Full or part-time Employment: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA; Financial Interests, Personal, Stocks/Shares: Merck & Co., Inc., Rahway, NJ, USA. V. Khemka: Financial Interests, Personal, Full or part-time Employment: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA; Financial Interests, Personal, Stocks/Shares: Merck & Co., Inc., Rahway, NJ, USA. A. Nogueira-Rodrigues: Financial Interests, Personal, Advisory Board, Personal honoraria for advisory boards: AstraZeneca, Daiichi Sankyo, Eisai, Gilead, GSK, ImmunoGen, MSD, Novartis, Pfizer, Roche; Non-Financial Interests, Personal, Other, President elect: Brazilian Society of Medical Oncology; Non-Financial Interests, Personal, Other, Chair: LACOG; Non-Financial Interests, Personal, Other, Director of strategic planning: Brazilian Group of Gynecologic Cancer. C. Marth: Financial Interests, Personal, Advisory Board: AstraZeneca, Roche Austria, Novartis, MSD, PharmaMar, GSK, Pfizer, ImmunoGen, Daiichi Sankyo, Biontech, Novocure, Eisai; Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche, GSK, Novartis, MSD, PharmaMar, Roche, AstraZeneca, GSK; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche. All other authors have declared no conflicts of interest. 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