Abstract 25P
Background
In the multicohort phase 2 KEYVIBE-005 study (NCT05007106), first-line vibo/pembro (n = 85) showed antitumor activity similar to pembro (n = 84; ORR, 20.0% vs 15.5%) with a manageable safety profile in patients (pts) with metastatic CC with PD-L1 CPS ≥1. We report prespecified PRO end points.
Methods
Pts ≥18 y with previously untreated locally recurrent or metastatic CC with PD-L1 CPS ≥1 were randomly assigned 1:1 to vibo 200 mg/pembro 200 mg or pembro 200 mg IV Q3W for ≤35 cycles. Prespecified PRO end points were least squares mean (LSM) change from baseline (BL) to wk 12 in EORTC QLQ-C30 global health status/quality of life (GHS/QoL) and physical functioning (PF) subscales, EORTC QLQ-CX24 symptom experience subscale, and EQ-5D-5L VAS health status score; within-pt changes of 10 points were considered clinically meaningful for QLQ-C30 and QLQ-CX24 measures. PRO assessments were performed at every cycle before treatment and evaluated in pts who received ≥1 dose of study treatment and completed ≥1 postbaseline PRO assessment.
Results
The PRO population comprised 166 pts (n = 85; vibo/pembro; n = 81; pembro). At wk 12, completion and compliance rates for both treatment groups were ≥64% and ≥86%, respectively, for all assessments. LSM change and 95% CIs from BL to wk 12 for all scales are reported in the table. Pts in both groups experienced small changes in EORTC QLQ-C30 GHS/QoL and PF, EORTC QLQ-CX24 symptom experience, and EQ-5D-5L scores, with overlapping CIs. None of the group differences were clinically meaningful. Table: 25P
Least squares mean change from baseline to week 12
| PRO Scale | Vibo/pembron = 85LSM (95% CI) | Pembron = 81LSM (95% CI) | Difference (95% CI) |
| EORTC QLQ-C30 | |||
| Global health status/quality of lifea | 0.77 (–3.84 to 5.38) | 3.53 (–1.13 to 8.20) | –2.76 (–8.81 to 3.29) |
| Physical functioninga | –3.58 (–8.29 to 1.14) | –3.14 (–7.96 to 1.68) | –0.44 (–7.07 to 6.19) |
| EORTC QLQ-CX24 | |||
| Symptom experienceb | 0.27 (–2.74 to 3.27) | –2.99 (–6.04 to 0.05) | 3.26 (–0.61 to 7.13) |
| EuroQol 5D-5L VASa | 1.86 (–2.52 to 6.24) | 2.23 (–2.18 to 6.64) | –0.37 (–6.20 to 5.46) |
aHigher values indicate improvement. bHigher values indicate worsening.
Conclusions
These are the first PRO results from the KEYVIBE-005 study in which pts with previously untreated metastatic CC with PD-L1 CPS ≥1 were randomly assigned to vibo/pembro vs pembro. For all PRO assessments, the change from BL to wk 12 with vibo/pembro was similar to pembro alone; thus, vibo/pembro did not negatively impact health-related QoL in this pt population.
Clinical trial identification
NCT05007106 (study start date: 2021-09-16).
Editorial acknowledgment
Medical writing and/or editorial assistance was provided by Shanel Dhani, PhD, Mehak Aggarwal, PharmD, and Holly C. Cappelli, PhD, CMPP, of ApotheCom (Yardley, 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 study
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Funding
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Disclosure
K. Yonemori: Financial Interests, Personal, Advisory Board: Eisai, AstraZeneca, Sanofi, Genmab, Gilead, OncoXerna, Takeda, Novartis, MSD; Financial Interests, Personal, Invited Speaker: Pfizer, Eisai, AstraZeneca, Eli Lilly, Takeda, Chugai, Fuji Film Pharma, PDR Pharma, MSD, Ono, BMS, Boehringer Ingelheim, Daiichi Sankyo, Bayer, Janssen, Sanofi; Financial Interests, Institutional, Invited Speaker: MSD, Daiichi Sankyo, AstraZeneca, Taiho, Pfizer, Novartis, Takeda, Chugai, Ono, Sanofi, Seagen, Eisai, Eli Lilly, Genmab, Boehringer Ingelheim, Kyowa Hakko Kirrin, Nihon Kayaku, Haihe. C.I. Rojas: Financial Interests, Personal, Advisory Board: BMS, Roche, MSD, Pfizer, Sanofi; Financial Interests, Personal, Invited Speaker: BMS, MSD, AstraZeneca, Knight, Pfizer; Financial Interests, Personal, Member of Board of Directors: Bradford Hill. A. Leary: Financial Interests, Personal, Advisory Board: Zentalis; Financial Interests, Personal, Invited Speaker, Educational: GSK, Medscape, Onko+; Financial Interests, Institutional, Other, Steering committee: MSD; Financial Interests, Institutional, Advisory Board: GSK, AstraZeneca, Clovis, Ability Pharma, MSD, Merck Serono, Apmonia, Blueprint; Financial Interests, Institutional, Invited Speaker, Educational: Kephren publishing; Financial Interests, Institutional, Other, Consultancy: Orion; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Clovis; Financial Interests, Personal, Other, Consultancy: GLG; Financial Interests, Institutional, Other, consultancy: OWKIN; Financial Interests, Institutional, Research Grant, PI translational research: ARCAGY-GINECO, Sanofi, AstraZeneca; Financial Interests, Institutional, Funding, CI clinical trial: AstraZeneca; Financial Interests, Institutional, Research Grant, Int CI clinical trial: OSE immuno; Financial Interests, Institutional, Funding, PI clinical trial: Agenus, BMS, Iovance, GSK; Financial Interests, Institutional, Funding, PI 5 clinical trials: Roche; Financial Interests, Institutional, Funding, PI 2 clinical trials: AstraZeneca; Financial Interests, Institutional, Funding, PI 3 clinical trials and steering committee: MSD; Non-Financial Interests, Institutional, Other, Academic research project: Owkin, LXRepair; Non-Financial Interests, Personal, Proprietary Information, IDMC member: Clovis; Non-Financial Interests, Personal, Proprietary Information, IDMC chair: Pfizer; Non-Financial Interests, Personal, Member: GCIG. C. Le Tourneau: Financial Interests, Personal, Advisory Board: BMS, MSD, Merck Serono, Nanobiotix, Roche, Rakuten, Seattle Genetics, GSK, Celgene, ALX Oncology, Exscientia. I. Lugowska: Financial Interests, Personal, Invited Speaker: Roche, ESMO; Financial Interests, Institutional, Other, Research grants: Roche; Financial Interests, Institutional, Other, Research grant: Agenus; Financial Interests, Personal and Institutional, Invited Speaker: MSD, Roche, BMS, Janssen, AstraZeneca, Amgen, RyVu, Incyte, Siropa, Mennarini, Celon, Pfizer, Agenus, Rhizen; Non-Financial Interests, Personal, Project Lead: MSCI; Non-Financial Interests, Personal, Other, Board Member: OECI; Other, Personal, Other, Robert Lugowski (my husband) co-ownership: Clininote. C. Caglevic: Financial Interests, Personal, Advisory Role: Gilead Sciences; Financial Interests, Personal, Research Grant: Principal/ Sub investigator for: MSD, AstraZeneca, Roche, Astellas Pharma, BMS, GSK, Athenex, Sanofi, AbbVie, Amgen, Bayer Healthcare Pharmaceuticals, Biontech, Daiichi Sankyo INC, Exelixis, Novartis, F. Hoffmann LaRoche, PharmaMar, Zymeworks, Cogent Biosciences, . F. Ghiringhelli: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Amgen, Merck Serono, MSD. R. Perets: Financial Interests, Personal, Other, Consultant: Galmed Therapeutics, Gilboa Therapeutics, 1E Therapuetics; Financial Interests, Institutional, Invited Speaker: Janssen, MSD, BMS, Genentech, Biomica, Amgen, AbbVie, Ammune; Non-Financial Interests, Institutional, Product Samples, Antibody for research: AbbVie. M. Kwiatkowski: Financial Interests, Personal, Invited Speaker: Janssen Cilag, Novartis, Roche; Non-Financial Interests, Personal, Principal Investigator, Clinical Trials: MSD, BMS; Non-Financial Interests, Personal, Principal Investigator, Clinical trials: AstraZeneca, Roche, Hengrui, JanssenCilag, BeiGene, Shanghai Jinshu, Bayer. S.Y. Rha: Financial Interests, Personal, Advisory Board: Indivumed, Amgen, LG biochemical, Astellas; Financial Interests, Personal, Invited Speaker: MSD, Eli Lilly, Daiichi Sankyo, Amgen; Financial Interests, Institutional, Funding: MSD, Eli Lilly; Financial Interests, Institutional, Research Grant: BMS, Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: Indivumed, AstraZeneca; Financial Interests, Personal, Other, Drug supply for clinical trial: Merck; Financial Interests, Institutional, Invited Speaker, Drug supply for clinical trial: MSD; Financial Interests, Institutional, Invited Speaker, Drug supply for clinical trial: zy, Meworks; Financial Interests, Institutional, Invited Speaker, drug supply for clinical trial: BeiGene; Financial Interests, Personal, Invited Speaker, Drug supply for clinical trial: Incyte. Q. Liu, T. Keenan, A.M. Nguyen: Financial Interests, Personal, Full or part-time Employment: Merck & Co., Inc.; Financial Interests, Personal, Stocks/Shares: Merck & Co., Inc.. P. Singhal: Financial Interests, Personal, Stocks/Shares: Merck & Co., Inc.; Financial Interests, Personal, Full or part-time Employment: Merck & Co., Inc.. D. Tosi: Financial Interests, Institutional, Advisory Board: Mabqi, Vertical; Financial Interests, Institutional, Invited Speaker, preclinical research grant: Ipsen, Bayer; Financial Interests, Institutional, Invited Speaker, Compensations for local PI role in clinical trials: Several pharmaceutical companies; Non-Financial Interests, Personal, Leadership Role: Fondazione Gianni Bonadonna; Non-Financial Interests, Personal, Advisory Role: CyteaBio, Phost'in, Revolution Medicines, Brenus Pharma, Italian Ministry of health, Cancéropôle PACA, Qu Biologics; Non-Financial Interests, Institutional, Product Samples, drug for research purposes: Ipsen, Bayer; Non-Financial Interests, Personal, Other, support for participation to scientific meetings: Several pharmaceuticals companies. All other authors have declared no conflicts of interest.