TPS9160

A Randomized, Double-Blind, Phase 3

M.C. Garassino;1 E. Felip;2 W. Wang;3 S.J. Kim;3
M.C. Pietanza;3 D. Rodríguez-Abreu4

Trial of MK-7684A Plus Chemotherapy vs

1University
of Chicago Medicine & Biological Sciences, Chicago, IL, USA; 2Vall
d’Hebron University and Vall d’Hebron Institute of Oncology, Barcelona, Spain;
3Merck & Co., Inc., Rahway, NJ, USA; 4Complejo Hospitalario Universitario Insular

Pembrolizumab Plus Chemotherapy as

Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las
Palmas de Gran Canaria, Spain

First-Line Therapy for Metastatic

Non‒Small-Cell Lung Cancer: KEYVIBE-007
Assessments
Background • PD-L1 expression will be centrally assessed using PD-L1 IHC 22C3 pharmDx (Investigational Use
• Pembrolizumab, an anti‒PD-1 antibody, plus chemotherapy is a standard of care first-line treatment Only) diagnostic kit (Agilent Technologies, Carpinteria, CA, USA)
for metastatic non–small-cell lung cancer (NSCLC) without EGFR or ALK alterations regardless of
• Tumor imaging will be performed at baseline, every 6 weeks from date of randomization through
PD-L1 status1
week 18, every 9 weeks until week 63, and every 12 weeks thereafter
• Vibostolimab (MK-7684) is a humanized monoclonal antibody against T-cell immunoreceptor with
immunoglobulin and immunoreceptor tyrosine-based inhibitor motif (ITIM) domains (TIGIT) that • PROs will be assessed before dosing at every cycle through cycle 17, every other cycle through
functions as an inhibitory immune checkpoint in innate and adaptive immunity2 cycle 35, at treatment discontinuation, and at the 30-day safety follow-up visit using the European
• Vibostolimab plus pembrolizumab demonstrated a manageable safety profile and promising Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-
antitumor activity in a phase 1 study in advanced NSCLC, suggesting that combining these Core 30, EORTC Quality of Life Questionnaire-Lung Cancer Module 13, NSCLC Symptom
immunotherapies may further improve outcomes3 Assessment Questionnaire, and EuroQol EQ-5D-5L
• Here, we present the study design of the phase 3, randomized, double-blind KEYVIBE-007
• AEs will be assessed throughout the study and for 30 days following cessation of treatment
study (NCT05226598) evaluating MK-7684A (co-formulation of vibostolimab and pembrolizumab)
plus chemotherapy vs pembrolizumab plus chemotherapy as first-line treatment in patients with (90 days for serious AEs) and graded in severity using the National Cancer Institute Common
metastatic NSCLC Terminology Criteria for Adverse Events, version 5.0
Analyses
Objectives • Efficacy will be evaluated in all randomized patients (intent-to-treat population); safety will be
Primary evaluated in all randomized patients who receive ≥1 dose of study drug according to the treatment
• Dual primary endpoints are overall survival (OS) and progression-free survival (PFS) per RECIST actually received (all patients as treated population); and PROs will be analyzed in all randomized
version 1.1 by blinded independent central review (BICR) patients who have ≥1 postbaseline PRO assessment and receive ≥1 dose of study drug
Secondary • OS and PFS treatment differences will be evaluated using a stratified log-rank test
• ORR and duration of response per RECIST version 1.1 by BICR – Hazard ratios will be estimated using a stratified Cox regression model
• Safety
– OS and PFS rates over time will be estimated using the Kaplan-Meier method
• Patient-reported outcomes (PROs)
• ORR treatment differences will be analyzed using the stratified Miettinen and Nurminen method,
with randomization stratification factors applied and strata weighted by sample size
Methods
Study design, patients, and treatment Current Status
Figure. KEYVIBE-007 study design • Enrollment is ongoing at 153 sites around the world
Key Eligibility Criteria MK-7684A Second Courseb
(co-formulation of vibostolimab 200 mg
• Aged ≥18 years
and pembrolizumab 200 mg) IV
• Histologically/cytologically confirmed +
MK-7684A PD MK-7684A
untreated stage IV squamous or Carboplatin AUC 6 mg/mL/min and Q3W for up to 31 cycles Q3W for up to
nonsquamous NSCLC (+ pemetrexeda) 17 cycles
Paclitaxel 200 mg/m2 or Nab-paclitaxel 100 mg/m2 IV
• Measureable disease per RECIST v1.1 ORa
R (1:1)
• Provision of tumor tissue for PD-L1 Pemetrexed 500 mg/m2 and
N = ~700 Cisplatin 75 mg/m2 or Carboplatin AUC 5 mg/mL/min IV
assessment
• No EGFR, ALK, or ROS1 alterations
Q3W for 4 cycles
• ECOG PS 0 or 1

Pembrolizumab 200 mg IV
+
Stratification Factors Carboplatin AUC 6 mg/mL/min and
Pembrolizumab PD Pembrolizumab
• ECOG PS (0 vs 1) Paclitaxel 200 mg/m2 or Nab-paclitaxel 100 mg/m2 IV
ORa Q3W for up to 31 cycles Q3W for up to
• Histology (squamous vs nonsquamous)
Pemetrexed 500 mg/m2 and (+ pemetrexed )
a
17 cycles
• PD-L1 TPS (<50% vs ≥50%) Cisplatin 75 mg/m2 or Carboplatin AUC 5 mg/mL/min IV
• Geographic region (East Asia vs North
America/Western Europe vs rest of world) Q3W for 4 cycles

AE, adverse event; AUC, area under the curve; ECOG PS, Eastern Cooperative Oncology Group performance status; IV, intravenous; Q3W, every 3 weeks;
PD, progressive disease; TPS, tumor proportion score.
aPatients with squamous histology will receive carboplatin with investigator’s choice of paclitaxel or nab-paclitaxel. Patients with nonsquamous histology will receive
pemetrexed with investigator’s choice of cisplatin or carboplatin followed by pemetrexed maintenance until PD, intolerable AE, or patient or investigator decision.
bPatients who complete the first course of treatment with MK-7684A or pembrolizumab with SD or better and then experience PD per RECIST version 1.1
verified by BICR, meet eligibility criteria, and do not receive subsequent anticancer therapy after last dose of study treatment are eligible for a second course of
MK-7684A or pembrolizumab (per initial randomization).

Table. Key eligibility criteria

Inclusion criteria Exclusion criteria

References
• Aged ≥18 y • Prior systemic treatment for metastatic NSCLC 1. National Comprehensive Cancer Network (NCCN). NCCN 2. Chauvin JM and Zarour HM. J Immunother Cancer.
• Histologically or cytologically confirmed • Prior treatment with anti–TIGIT, anti–PD-(L)1/2, or agent directed to Clinical Practice Guidelines in Oncology (NCCN Guidelines). 2020;8(2):e000957.
Non-Small Cell Lung Cancer. Version 3.2022
stage IV squamous or nonsquamous another stimulatory or coinhibitory T-cell receptor 3. Niu J, et al. Ann Oncol. 2022;33(2):169-180.
https://www.nccn.org.
NSCLC with measurable disease per • Prior radiotherapy ≤2 wk before study treatment, or radiation therapy to
RECIST version 1.1 the lung >30 Gy ≤6 mo before study treatment Acknowledgements
• EGFR–, ALK–, or ROS1–directed • Known active CNS metastases and/or carcinomatous meningitisa The authors thank the patients and their families and all investigators and site personnel who participated in this study. This
therapy not indicated as primary therapy • Diagnosis of immunodeficiency or receiving chronic systemic steroid study was sponsored by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Medical writing
• Tumor tissue sample provided for therapy assistance was provided by Kathleen Estes, PhD of ICON
determination of PD-L1 status • Active autoimmune disease that has required systemic therapy in the
plc (Blue Bell, PA, USA). This assistance was funded
by Merck Sharp & Dohme LLC, a subsidiary of Merck Poster presented Poster slides
• ECOG PS 0 or 1 past 2 y
& Co., Inc., Rahway, NJ, USA.
• Adequate organ function • History of noninfectious pneumonitis/ILD requiring steroids or current Copies of this poster obtained through

pneumonitis/ILD Contact Information Quick Response (QR) Code are for

personal use only and may not be
reproduced without permission from
CNS, central nervous system; ILD, interstitial lung disease. Contact Marina C. Garassino at ASCO® or the author of this poster.
aPatients with treated brain metastases are eligible if they have no evidence of progression for ≥4 wk as confirmed by repeat imaging during screening and
mgarassino@medicine.bsd.uchicago.edu
are clinically stable with no requirement for steroid therapy ≤14 d before study treatment. Patients with asymptomatic brain metastases (ie, no neurological
symptoms, no requirement for steroid therapy, no or minimal surrounding edema, and no lesion measuring ≥1.5 cm) may participate in the study. for questions or comments. https://bit.ly/3L1dFkO https://bit.ly/3LXeE71

Presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting; Chicago, IL, USA and Online; June 3–7, 2022. Copyright © 2022 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.