Merck Provides Update from Open-Label Arm of Phase 2 KeyVibe-002 Trial Evaluating MK-7684A, a Coformulation of Vibostolimab and Pembrolizumab, in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)21 March 2023
RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided an update on the open-label arm of the non-registrational Phase 2 KeyVibe-002 trial. KeyVibe-002 is evaluating MK-7684A, a coformulation of vibostolimab, an anti-TIGIT therapy, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, with or without docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progressive disease after treatment with immunotherapy and platinum-doublet chemotherapy. KeyVibe-002, a partially blinded study, was designed with two primary objectives: 1) to evaluate the efficacy of MK-7684A alone compared with docetaxel, a standard of care; and 2) in a blinded assessment, evaluate the efficacy of adding MK-7684A to docetaxel compared with docetaxel alone.
Results from the open-label arm of the study evaluating MK-7684A alone showed that the coformulation did not reach statistical significance for the primary endpoint of progression-free survival (PFS) and was numerically less effective compared with docetaxel. Merck is notifying study investigators that patients in this arm of the study should be switched to a standard of care, unless their physician considers the patient is benefitting from MK-7684A alone.
The blinded arms of the study will continue to further evaluate MK-7684A with docetaxel versus docetaxel alone. The safety profile of MK-7684A was consistent with that observed for vibostolimab and pembrolizumab in previously reported studies, with no new safety signals observed. Results will be presented at an upcoming medical meeting once further data from the blinded study arms are available.
Merck has an extensive clinical development program evaluating the safety and efficacy of MK-7684A alone and in combination with other agents in over 4,000 patients. Ongoing Phase 3 studies in lung cancer include KeyVibe-003, KeyVibe-006, KeyVibe-007 and KeyVibe-008, as well as KeyVibe-010 in melanoma.
“Through different approaches, such as novel combinations and coformulations, we hope to build on the foundation of KEYTRUDA to help even more patients with cancer,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We are grateful to the patients and investigators for their participation in this study evaluating MK-7684A in a heavily pre-treated group of patients, and look forward to additional data from the continuation of the blinded arms of KeyVibe-002. Based on responses we have seen in the signal-finding Phase 1/2 program to date, we are moving forward with our comprehensive research program evaluating MK-7684A across a wide range of cancers, including lung, other solid tumors and blood cancers.”
KeyVibe-002 is a randomized, partially blind Phase 2 trial (ClinicalTrials.gov, NCT04725188) evaluating MK-7684A, a coformulation of vibostolimab and pembrolizumab, with or without docetaxel versus placebo plus docetaxel in patients with metastatic NSCLC with progressive disease after treatment with immunotherapy and platinum-doublet chemotherapy. The trial’s primary endpoint is PFS, as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors Version (RECIST) v1.1. Key secondary endpoints include overall survival (OS) and objective response (OR), as assessed by BICR per RECIST v1.1. The study enrolled 255 patients who were randomly assigned in three separate study arms (1:1:1) to receive either:
Arm 1 (Open-label): MK-7684A (pembrolizumab 200 mg plus vibostolimab 200mg/20 mL intravenously [IV] every three weeks [Q3W] until a discontinuation criterion is met or completion of 35 cycles), or;
Arm 2 (Blinded): MK-7684A (pembrolizumab 200 mg plus vibostolimab 200mg/20 mL IV Q3W until a discontinuation criterion is met or completion of 35 cycles) plus docetaxel (75 mg/m^2, IV Q3W until a discontinuation criterion is met or as per approved local label), or;
Arm 3 (Placebo-blinded): Placebo (saline IV Q3W) plus docetaxel (75 mg/m^2, IV Q3W until a discontinuation criterion is met or as per approved local label).
KeyVibe-002, a non-registrational study, was designed with two primary objectives: 1) to evaluate the efficacy of MK-7684A alone compared with docetaxel, a standard of care; and 2) in a blinded assessment, evaluate the efficacy of adding MK-7684A to docetaxel, compared with docetaxel alone.