121P - MK-7684A (Vibostolimab [Vibo] Plus Pembrolizumab [Pembro] Coformulation) With/Without Docetaxel in Metastatic NSCLC After Platinum-Chemotherapy (Chemo) and Immunotherapy

Background

Patients (pts) with metastatic non–small-cell lung cancer (mNSCLC) who progress on anti–PD-(L)1 therapy in combination with or after chemo often have poor prognosis resulting in high unmet need. The anti–T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT) antibody vibo has shown antitumor activity alone and in combination with pembro (anti–PD-1). The phase 2 KEYVIBE-002 study (NCT04725188) evaluated MK-7684A, a coformulation of vibo + pembro, with/without docetaxel vs docetaxel alone for previously treated mNSCLC.

Methods

Eligible pts aged ≥18 y had pathologically confirmed mNSCLC without EGFR/ALK/ROS1 alterations, PD after 1 prior anti–PD-(L)1 therapy (PD ≤12 wks from last dose) and platinum-doublet chemo, measurable disease per RECIST v1.1, ECOG PS 0 or 1, and tumor sample for PD-L1 assessment. Pts were randomized 1:1:1 to MK-7684A (vibo 200 mg + pembro 200 mg) + docetaxel 75 mg/m² Q3W (Arm 1; blinded), MK-7684A (Arm 2; open label), or placebo + docetaxel (Arm 3; blinded). Treatment continued for ≤35 cycles (∼2 y) for MK-7684A/placebo, per local guidelines for docetaxel, or until PD, unacceptable AEs, or pt/physician decision. Primary endpoint was PFS per RECIST v1.1 by BICR. Safety was a secondary endpoint.

Results

87 pts were randomized to Arm 1, 83 to Arm 2, and 85 to Arm 3. Median follow-up at data cutoff (Jan 26, 2023) was 12.3 (range, 6.2–19.8) mo. Median PFS (95% CI) was 5.6 (3.9–6.8) mo in Arm 1, 2.7 (1.8–4.0) mo in Arm 2, and 3.2 (2.8–5.7) mo in Arm 3. HR (95% CI) for PFS for Arm 1 vs Arm 3 was 0.77 (0.53–1.13), P = 0.0910; and for Arm 2 vs Arm 3 was 1.40 (0.96–2.02), P = 0.9622. Treatment-related AEs occurred in 82 pts (96.5%) in Arm 1, 50 (60.2%) in Arm 2, and 74 (89.2%) in Arm 3; these were fatal in 4 (4.7%), 1 (1.2%), and 1 (1.2%), respectively. Immune-mediated AEs and infusion reactions occurred in 25 pts (29.4%), 17 (20.5%), and 10 (12.0%), respectively. Additional data will be presented.

Conclusions

In pts with mNSCLC previously treated with anti-PD-(L)1 therapy and platinum-doublet chemo, MK-7684A and MK-7684A + docetaxel vs docetaxel alone did not show statistically significant differences in PFS, and no new safety signals. Follow-up is ongoing.

Clinical trial identification

NCT04725188.

Editorial acknowledgement

Medical writing assistance was provided by Kathleen Estes, PhD, of ICON plc (Blue Bell, PA, 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

N. Peled: Financial Interests, Personal, Other, Advisor, honorarium, Research: AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Foundation Medicine, Guardant360, Imagene, Merck KGaA, MSD, Novartis, Novocure, Pfizer, Roche, Renium, Takeda. J. Mazieres: Financial Interests, Personal, Other, Personal fees: Roche, AstraZeneca, Pierre Fabre, Takeda, BMS, MSD, Pfizer, Jiangsu, Hengruii, Blueprint, Daiichi, Novartis, Amgen; Financial Interests, Personal, Research Grant: Roche, AstraZeneca, Pierre Fabre, BMS. D.M. Kowalski: Financial Interests, Personal, Other, Advisory Board & Honorarium: Roche, Takeda, AstraZeneca, MSD, BMS, Merck KGaA, Pfizer, Amgen, Johnson & Johnson, Sanofi-Aventis, Boehringer Ingelheim, Novartis. W. Lam: Financial Interests, Personal, Other, Honorarium & Education Support: BMS, MSD, Roche, Prifer, Novartis, AstraZeneca, Sanofi, Merck Healthcare Pty. Ltd. M.J. Hochmair: Financial Interests, Personal, Other, Lectures and advisory boards: MSD, Roche, Lilly, AstraZeneca, Takeda. M. Majem: Financial Interests, Personal, Advisory Board: Amgen, Roche, AstraZeneca, Takeda, Janssen, Cassen Recordati, BMS; Financial Interests, Personal, Invited Speaker: Amgen, Roche, AstraZeneca, Pfizer, Takeda, Helsinn; Financial Interests, Institutional, Funding: BMS, AstraZeneca, Roche. A. Calles Blanco: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Pfizer, Roche, Lilly, Merck Sharp & Dohme, Novartis, Bristol Myers Squibb, Takeda, Sanofi, Janssen; Financial Interests, Personal, Other, Speaker honoraria: Bayer; Financial Interests, Institutional, Research Grant, Drug-only for Investigator-initiated trial: Merck Sharp & Dohme. K. Cuppens: Financial Interests, Personal, Advisory Board: F. Hoffmann-La Roche, AstraZeneca, Merck Sharp Dohme, Merck Sharp Dohme, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Bayer; Financial Interests, Personal, Invited Speaker: Pfizer, Bristol Myers Squibb, Merck Sharp & Dohme, F. Hoffmann-La Roche. I.A. Casarini: Financial Interests, Institutional, Research Funding: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. O. Bylicki: Financial Interests, Personal, Advisory Board, Expert Board: BMS, Roche, Takeda; Financial Interests, Personal, Advisory Board, Annuel contrat: MSD; Financial Interests, Personal, Advisory Board, expert board: AstraZeneca, Janssen. B. Shim: Financial Interests, Personal, Advisory Role: Gadent, Takeda, Roche, Bion, Chogendang, J INST Bio; Financial Interests, Personal, Research Funding: Yohan. J.B. Sørensen: Financial Interests, Personal, Other, Advisor and Honorarium: MSD, BMS, AstraZeneca, Roche, Sanofi. M. Gilli: Financial Interests, Institutional, Research Funding: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. S.H. How: Financial Interests, Personal, Other, Advisor & Honorarium & Research grant: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, MSD, Novartis, Roche, Takeda. C. Schumann: Financial Interests, Personal, Other, Honoraria for Advisory and Research: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, Takeda. C. Gonzalez Arenas: Financial Interests, Personal, Full or part-time Employment: MSD, Spain; Financial Interests, Personal, Stocks/Shares: Merck & Co., Inc., Rahway, NJ, USA. T. He: Financial Interests, Personal, Full or part-time Employment: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. A. Samkari: 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. S. Novello: Financial Interests, Personal, Other, Advisor/Speaker Bureau: AZ, AMG, MSD, Eli Lilly, Sanofi, Roche, Takeda, Pfizer, Thermofisher, Janssen. All other authors have declared no conflicts of interest.