Abstract 20MO
Background
In study 309/KEYNOTE-775, L+P showed significant OS and PFS benefits and improved ORR vs TPC in pts with aEC following prior platinum-based therapy. There were no substantial differences in health-related quality of life (HRQoL) scores between the 2 arms at 12 weeks. We describe a post-hoc analysis of time to first (TTfD) and time to definitive (TTdD) deterioration (by 10 points) of patient-reported outcomes (PROs).
Methods
Pts were randomized 1:1 to lenvatinib 20 mg QD PO + pembrolizumab 200 mg IV Q3W (n=411) or TPC (n=416; doxorubicin 60 mg/m2 IV Q3W or paclitaxel 80 mg/m2 IV QW, 3 wks on/1 wk off). PROs were assessed on day 1 of each treatment cycle (L+P and doxorubicin, 21 days; paclitaxel, 28 days) until the end of treatment visit using EORTC QLQ-C30, QLQ-EN24, and EQ-5D-5L in pts with ≥1 study dose and ≥1 postbaseline PRO. TTfD for the EORTC QLQ-C30 and QLQ-EN24 was defined as the time from treatment start to first onset of a ≥10-point increase (symptom score) or decrease (functional/global health status [GHS] score) from baseline. TTdD was defined as the time from treatment start to first onset of an increase (symptom score) or decrease (functional/GHS score) of ≥10 points from baseline without subsequent recovery.
Results
The mean observation period for PRO measures was longer for L+P vs TPC (eg, EORTC QLQ-C30: L+P, 9.3 mos; TPC, 4.3 mos). TTfD was generally similar between the 2 arms for most functional scales. Among the symptom scales, TTfD for dyspnea, poor body image, tingling/numbness, and hair loss favored L+P over TPC, whereas pain, appetite loss, diarrhea, and muscular pain favored TPC. TTdD favored L+P for most of the assessed scales.
Conclusions
Although TTfD did not demonstrably favor either arm, L+P was favored over TPC for almost all scales in the TTdD analysis. This may be due to longer follow-up and/or overall greater efficacy with L+P vs TPC. These data along with previously reported positive efficacy, safety, and overall HRQoL scores from Study 309/KEYNOTE-775 further support L+P for use in pts with aEC following prior platinum-based therapy.
Clinical trial identification
NCT03517449.
Editorial acknowledgement
Medical writing support was provided by Oxford PharmaGenesis Inc., Newtown, PA, USA, and was funded by Eisai Inc., Nutley, NJ, USA, and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Legal entity responsible for the study
Eisai Inc., Nutley, NJ, USA, and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Funding
Eisai Inc., Nutley, NJ, USA, and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Disclosure
D. Lorusso: Financial Interests, Personal, Advisory Board, Participation in Advisory Boards and Invited Speaker: GSK; Financial Interests, Personal, Advisory Board, Participation in Advisory Boards and Invited Speakers: AstraZeneca; Financial Interests, Personal, Advisory Board, Participation in Advisory Boards and Invited Speakers: MSD; Financial Interests, Personal, Advisory Board, Participation in Advisory Boards and Invited Speaker: Clovis Oncology; Financial Interests, Personal, Other, Consultancy: PharmaMar; Financial Interests, Personal, Other, Consultancy: Amgen; Financial Interests, Personal, Other, Consultancy: AstraZeneca; Financial Interests, Personal, Other, Consultancy: Clovis Oncology; Financial Interests, Personal, Other, Consultancy: GSK; Financial Interests, Personal, Other, Consultancy: MSD; Financial Interests, Personal, Advisory Board, Participation in Advisory Boards and Invited Speaker: PharmaMar; Financial Interests, Personal, Advisory Board, Participation in Advisory Boards: Merck Serono; Financial Interests, Personal, Other, Consultancy: Immunogen; Financial Interests, Personal, Other, Consultancy: Genmab; Financial Interests, Personal, Other, Consultancy: Seagen; Financial Interests, Personal, Advisory Board, Invited Member of Advisory Board: Seagen; Financial Interests, Personal, Advisory Board, Invited Member of Advisory Board: Immunogen; Financial Interests, Personal, Advisory Board, Invited Member of Advisory Board: Genmab; Financial Interests, Personal, Advisory Board, Invited Member of Advisory Board: Oncoinvest; Financial Interests, Personal, Advisory Board, Invited Member of Advisory Board: Corcept; Financial Interests, Personal, Advisory Board, Invited Member of Advisory Board: Sutro; Financial Interests, Institutional, Funding, Grant for Founding Academic Trial: MSD; Financial Interests, Institutional, Funding, Grant for Founding Academic Trial: Clovis Oncology; Financial Interests, Institutional, Funding, Grant for Founding Academic Trial: GSK; Financial Interests, Institutional, Invited Speaker, ENGOT Trial with Institutional Support for Coordination: Clovis Oncology; Financial Interests, Institutional, Invited Speaker, ENGOT Trial with Institutional Support for Coordination: Genmab; Financial Interests, Institutional, Funding, Grant for founding academic trial: PharmaMar; Financial Interests, Institutional, Funding, Clinical trial/contracted research: AstraZeneca; Financial Interests, Institutional, Funding, Clinical trial/contracted research: Clovis Oncology; Financial Interests, Institutional, Funding, Clinical trial/contracted research: GSK; Financial Interests, Institutional, Funding, Clinical trial/contracted research: MSD; Financial Interests, Institutional, Funding, Clinical trial/contracted research: Seagen; Financial Interests, Institutional, Funding, Clinical trials/contracted research: Genmab; Financial Interests, Institutional, Funding, Clinical trials/contracted research: Immunogen; Financial Interests, Institutional, Funding, Clinical trials/contracted research: Incyte; Financial Interests, Institutional, Funding, Clinical trials/contracted research: Novartis; Financial Interests, Institutional, Funding, Clinical trials/contracted research: Roche; Financial Interests, Institutional, Invited Speaker, ENGOT Trial with Institutional Support for Coordination: MSD; Non-Financial Interests, Personal, Principal Investigator, PI of several trials, no compensation received: GSK; Non-Financial Interests, Personal, Principal Investigator, PI of several trials. No personal compensation received: AstraZeneca; Non-Financial Interests, Personal, Principal Investigator, PI in several trials. No personal compensation received: MSD; Non-Financial Interests, Personal, Principal Investigator, PI of several trials. No personal compensation received: Genmab; Non-Financial Interests, Personal, Principal Investigator, PI of clinical trial. No personal compensation received: Immunogen; Non-Financial Interests, Personal, Principal Investigator, PI of clinical trial. No personal compensation received: Clovis; Non-Financial Interests, Personal, Principal Investigator, PI of clinical trial. No personal compensation receive: Roche; Non-Financial Interests, Personal, Principal Investigator, PI of clinical trial. No personal compensation received: Incyte; Non-Financial Interests, Personal, Member, Board of Directors: GCIG. N. Colombo: Financial Interests, Personal, Advisory Board, Various: Roche; Financial Interests, Personal, Advisory Board, Various: PharmaMar; Financial Interests, Personal, Invited Speaker, Congress, Symposia, Lectures: AstraZeneca; Financial Interests, Personal, Advisory Board, Various: AstraZeneca; Financial Interests, Personal, Advisory Board, Various: MSD/Merck; Financial Interests, Personal, Advisory Board, Various: Clovis Oncology; Financial Interests, Personal, Invited Speaker, Congress, Symposia, Lectures: Tesaro; Financial Interests, Personal, Advisory Board, Various: Tesaro; Financial Interests, Personal, Advisory Board, Various: GSK; Financial Interests, Personal, Invited Speaker, Lectures: Novartis; Financial Interests, Personal, Advisory Board, Various: Pfizer; Financial Interests, Personal, Advisory Board, Various: Takeda; Financial Interests, Personal, Advisory Board, Various: BIOCAD; Financial Interests, Personal, Advisory Board, Various: Immunogen; Financial Interests, Personal, Advisory Board, Various: Mersana; Financial Interests, Personal, Advisory Board, Lectures: Eisai; Financial Interests, Personal, Advisory Board, Advisory role: Nuvation Bio; Financial Interests, Personal, Advisory Board, Advisory Role: Onxerna; Financial Interests, Personal, Advisory Board, Advisory role: Pieris; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: PharmaMar; Financial Interests, Institutional, Research Grant: Roche; Non-Financial Interests, Personal, Other, Steering Committee Member Clinical Guidelines: ESMO; Non-Financial Interests, Personal, Leadership Role, Chair, Scientific Committee: ACTO (Alleanza Contro il Tumore Ovarico). A. Casado Herraez: Financial Interests, Personal, Other, Honoraria: AstraZeneca; Financial Interests, Personal, Other, Honoraria: Eisai; Financial Interests, Personal, Other, Honoraria: Lilly; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Other, Honoraria: PharmaMar; Financial Interests, Personal, Other, Honoraria: Roche; Financial Interests, Personal, Other, Honoraria: Tesaro; Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Institutional, Research Grant: PharmaMar; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Lilly; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: PharmaMar; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Roche. A.D. Santin: Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: Tesaro; Financial Interests, Institutional, Funding: Tesaro; Financial Interests, Institutional, Funding: Merck; Financial Interests, Institutional, Funding: Boehringer Ingelheim; Financial Interests, Institutional, Funding: Gilead Sciences; Financial Interests, Institutional, Funding: Puma Biotechnology; Financial Interests, Institutional, Funding: Genentech/Roche; Financial Interests, Institutional, Funding: R-Pharm; Financial Interests, Institutional, Funding: Immunomedics. E. Colomba: Financial Interests, Personal, Other, Honoraria: Bristol Myers Squibb; Financial Interests, Personal, Other, Honoraria: GlaxoSmithKline; Financial Interests, Personal, Other, Honoraria: Ipsen; Financial Interests, Personal, Other, Honoraria: Merck; Financial Interests, Personal, Other, Travel. Accommodations, Expenses: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Ipsen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Pfizer. D.S. Miller: Financial Interests, Personal, Advisory Role: Incyte; Financial Interests, Personal, Other, Honoraria: Clovis Oncology; Financial Interests, Personal, Member, Honoraria: Genentech; Financial Interests, Personal, Research Grant: EMD Serono Research & Development Institute; Financial Interests, Institutional, Research Grant: US Biotest; Financial Interests, Institutional, Research Grant: Advenchen Laboratories; Financial Interests, Institutional, Research Grant: Tesaro; Financial Interests, Institutional, Research Grant: Xenetic Biosciences; Financial Interests, Institutional, Research Grant: Advaxis; Financial Interests, Institutional, Research Grant: Janssen; Financial Interests, Institutional, Research Grant: Aeterna Zentaris; Financial Interests, Institutional, Research Grant: TRACON Pharma; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Immunogen; Financial Interests, Institutional, Research Grant: Mateon Therapeutics; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Millennium Pharmaceuticas; Financial Interests, Institutional, Research Grant: Aprea AB; Financial Interests, Institutional, Research Grant: Regeneron; Financial Interests, Institutional, Research Grant: NVision; Financial Interests, Institutional, Research Grant: Leap Therapeutics; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Syros Pharmaceuticals; Financial Interests, Institutional, Research Grant: Karyopharm Therapeutics; Financial Interests, Institutional, Research Grant: Agenus and Akesobio; Financial Interests, Institutional, Research Grant: Merck Sharpe & Dohme; Financial Interests, Personal, Other, Consulting Fees: Genentech; Financial Interests, Personal, Other, Consulting Fees: Tesaro; Financial Interests, Personal, Other, Consulting Fees: Eisai; Financial Interests, Personal, Other, Consulting Fees: AstraZeneca; Financial Interests, Personal, Other, Consulting Fees: Guardant Health; Financial Interests, Personal, Other, Consulting Fees: Janssen Oncology; Financial Interests, Personal, Other, Consulting Fees: Alexion Pharmaceuticals; Financial Interests, Personal, Other, Consulting Fees: Karyopharm Therapeutics; Financial Interests, Personal, Other, Consulting Fees: Incyte; Financial Interests, Personal, Other, Consulting Fees: Guardant Health; Financial Interests, Personal, Other, Consulting Fees: Janssen; Financial Interests, Personal, Other, Consulting Fees: Clovis Oncology; Financial Interests, Personal, Other, Consulting Fees: Asymmetrics Therapeutics LLC; Financial Interests, Personal, Other, Consulting Fees: Boston Biomedical Research Institute; Financial Interests, Personal, Other, Consulting Fees: Tarveda Therapeutics; Financial Interests, Personal, Other, Consulting Fees: Myriad Genetic Laboratories Inc.; Financial Interests, Personal, Other, Consulting Fees: GlaxoSmithKline LLC; Financial Interests, Personal, Other, Consulting Fees: AbbVie Inc.; Financial Interests, Personal, Other, Consulting Fees: EMD Serono Inc.; Financial Interests, Personal, Other, Consulting Fees: Seager Inc.; Financial Interests, Institutional, Other, Consulting Fees: Merck Sharpe & Dohme. K. Fujiwara: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Genmab; Financial Interests, Personal, Advisory Board: Nano Carrier; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Institutional, Funding: Regenerone; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Research Grant: Ono; Financial Interests, Institutional, Research Grant: Zeria; Financial Interests, Institutional, Research Grant: Genmab; Financial Interests, Personal, Invited Speaker: Regenerone; Financial Interests, Personal, Invited Speaker: Zeria; Non-Financial Interests, Personal, Leadership Role: GOTIC. S. Pignata: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AZ; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: PPharmaMar; Financial Interests, Institutional, Funding: Roche; Financial Interests, Institutional, Funding: MSD; Financial Interests, Institutional, Funding: Pfizer; Financial Interests, Institutional, Funding: Az. S.E. Baron-Hay: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Merck Sharpe & Dohme; Financial Interests, Personal, Advisory Role: Novartis. I.L. Ray-Coquard: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Mersana; Financial Interests, Personal, Advisory Board: Deciphera; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Institutional, Other, COLIBRI Translational Research: BMS; Financial Interests, Personal, Advisory Board: Oxnea; Financial Interests, Personal, Advisory Board: Merck Sereno; Financial Interests, Personal, Advisory Board: Agenus; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Macrogenics; Financial Interests, Institutional, Advisory Board, translational research NEOPREMBROV trial: MSD; Financial Interests, Personal, Advisory Board: Clovis; Non-Financial Interests, Personal, Principal Investigator: PAOLA1. R. Shapira-Frommer: Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Medison; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Neopharm; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Other, consultation: Msdison; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: MSD. R. Massaad: Financial Interests, Personal and Institutional, Full or part-time Employment: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. A. Martin Nguyen: Financial Interests, Personal and Institutional, Stocks/Shares: Merck & Co., Inc.; Financial Interests, Personal and Institutional, Full or part-time Employment: Merck & Co., Inc. Q. Zhao: Financial Interests, Personal and Institutional, Full or part-time Employment: Eisai Inc. J. McKenzie: Financial Interests, Personal and Institutional, Full or part-time Employment: Eisai Inc. V.S. Prabhu: Financial Interests, Personal and Institutional, Full or part-time Employment: Merck & Co., Inc.; Financial Interests, Personal and Institutional, Stocks/Shares: Merck & Co., Inc.; Financial Interests, Personal and Institutional, Other, Travel, Accommodations, Expenses: Merck & Co., Inc. V. Makker: Financial Interests, Institutional, Funding, Study funding: Merck; Financial Interests, Institutional, Funding, Study funding: Eisai; Financial Interests, Institutional, Funding, Study funding: Clovis; Financial Interests, Institutional, Funding, Study funding: Karyopharm; Financial Interests, Institutional, Funding, Study funding: AstraZeneca; Financial Interests, Institutional, Funding, Study support: Zymeworks; Non-Financial Interests, Personal, Principal Investigator: Merck; Non-Financial Interests, Personal, Advisory Role: Eisai; Non-Financial Interests, Personal, Advisory Role: Clovis; Non-Financial Interests, Personal, Advisory Role: Novartis; Non-Financial Interests, Personal, Advisory Role: Lilly; Non-Financial Interests, Personal, Advisory Role: GSK; Non-Financial Interests, Personal, Advisory Role: Karyopharm; Non-Financial Interests, Personal, Advisory Role: Iteos; Non-Financial Interests, Personal, Advisory Role: Faeth. All other authors have declared no conflicts of interest.
Resources from the same session
Invited Discussant of abstract 20MO
Presenter: Jean Emmanuel Kurtz
Session: Mini Oral session
Resources:
Slides
Webcast
21MO - Limited benefit of molecular profiling in patients with low-grade endometrial cancer
Presenter: Stephanie Vrede
Session: Mini Oral session
Resources:
Abstract
Slides
Webcast
27MO - Integrated digital pathology and single-cell analysis identify the spatial and temporal evolution of immune cells networks in epithelial ovarian cancer
Presenter: Eleonora Ghisoni
Session: Mini Oral session
Resources:
Abstract
Slides
Webcast
Invited Discussant of abstracts 21MO and 27MO
Presenter: Iain McNeish
Session: Mini Oral session
Resources:
Slides
Webcast
28MO - Real-world whole sequencing data of ovarian cancer patients
Presenter: James Brenton
Session: Mini Oral session
Resources:
Abstract
Slides
Webcast
Invited Discussant of abstract 28MO
Presenter: Liselore Loverix
Session: Mini Oral session
Resources:
Slides
Webcast
Q&A and discussion
Presenter: Jean Emmanuel Kurtz
Session: Mini Oral session
Resources:
Webcast