Blinded arms of the study will continue to evaluate the combination therapy with docetaxel vs docetaxel alone, Merck says.
Results from the KeyVibe-002 (NCT04725188) trial showed that MK-7684A (Merck), a coformulation of vibostolimab, an anti-TIGIT therapy, and pembrolizumab (Keytruda) also from Merck, did not reach statistical significance for the primary endpoint of progression-free survival.
Additionally, investigators found that the coformulation was numerically less effective compared with docetaxel.
“Through different approaches, such as novel combinations and coformulations, we hope to build on the foundation of [pembrolizumab] to help even more patients with cancer,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said in a statement.
“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 ½ 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,” Barr said.
Merck notified the study investigators that the individuals in this arm of the study should switch to the standard of care, unless the physician determines that the investigator is benefiting from MK-7684A alone.
The blinded arms of the study will continue to evaluate MK-7684A with docetaxel compared with docetaxel alone.
Investigators reported that the drug’s safety profile was consistent with that observed for vibostolimab and pembrolizumab in previous studies, with no new safety signals.
The study results will be presented at an upcoming medical meeting, once there is further data form the blinded portions of the study.
The open-label arm of the study evaluated MK-7684A, with or without docetaxel, for the treatment of individuals with metastatic non–small cell lung cancer with progressive disease after treatment with immunotherapy and platinum-doublet chemotherapy. There were 2 primary objectives: to evaluate the efficacy of MK-7684A alone compared with docetaxel, the standard of care and to evaluate the efficacy of adding MK-7684A to docetaxel compared with docetaxel alone.
There were 255 individuals who were randomly assigned to the 3 separate study arms at 1:1:1.
The blinded portions of the study included administering MK-7684A until a discontinuation criterion is met or the completion of 35 cycles plus docetaxel until a discontinuation criterion is met or as per approved local label and placebo plus docetaxel until a discontinuation criterion is met or as per approved local label.
Key secondary endpoints of the trial included objective response and overall survival.
The primary and secondary endpoints were assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors Version v1.1.
Merck has other clinical development programs that will evaluate MK-7684A alone and in combination with other agents for lung cancer and melanoma.
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). News release. Merck. March 16, 2023. Accessed March 17, 2023. https://www.merck.com/news/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/