Quavonlimab Plus KEYTRUDA Demonstrates Promising Phase I/II Results in First-Line NSCLC, Paving the Way for Phase III Trial

Recently, Merck & Co., Inc. (MSD) announced the Phase I/II clinical data of its Quavonlimab (Q drug) combined with Keytruda (K drug) therapy ("Q+K") at the IASLC 2020 North American Lung Cancer Conference. Quavonlimab (MK-1308) is an anti-CTLA-4 antibody that MSD acquired from Akeso Biopharma in 2015, granting MSD exclusive global development and sales rights for a total consideration of up to $200 million.

The aforementioned Q+K treatment regimen was evaluated in a first-in-human, open-label, multi-arm Phase I/II clinical trial, primarily assessing the safety and tolerability of Quavonlimab in combination with Keytruda as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC), with secondary endpoints including objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and duration of response (DOR).

With a median follow-up of 16.9 months (range: 7–21.3 months), the study results demonstrated the efficacy of the Q+K combination therapy on primary and secondary endpoints in clinical trials, including ORR, PFS, and OS. The safety and efficacy data presented support the recommendation of Q drug 25 mg Q6W + K drug as the recommended dose for the expansion cohort.

In terms of safety, 85% of patients experienced treatment-related adverse events (TRAEs), with grade ≥3 TRAEs occurring in 36% across all treatment groups. Furthermore, the objective response rates (ORRs) for the various dose cohorts of the Q+K regimen in patients with NSCLC were 40.0% (95% CI, 24.9–56.7), 37.5% (95% CI, 22.7–54.2), 27.5% (95% CI, 14.6–43.9), and 35.7% (95% CI, 12.8–64.9), respectively.

The study results indicate that the Q+K combination therapy demonstrates a favorable safety and efficacy profile, with no unexpected toxicities, and shows promising antitumor activity. Dr. Vicki Goodman, Vice President of Oncology Clinical Research at Merck Research Laboratories, stated, “The latest data on the combination of our anti-CTLA-4 antibody, quavonlimab, with KEYTRUDA support the continued development of this novel regimen. A Phase III clinical trial evaluating quavonlimab in combination with KEYTRUDA for the treatment of advanced non-small cell lung cancer is already in the planning stages.”

References

Merck Presents Three-Year Survival Data for KEYTRUDA(pembrolizumab) in Combination With Chemotherapy and Updated Phase 1/2 Data for Investigational Quavonlimab (MK-1308)