Merck announced positive data regarding 2 studies, one examining pembrolizumab in combination with chemotherapy and another in combination with quavonlimab in combination to treat advanced non-small cell lung cancer.
Merck recently announced positive results from 2 separate studies examining pembrolizumab (Keytruda) combination treatments for patients with advanced nonsquamous non-small cell lung cancer (NSCLC).
The first study, KEYNOTE-021, examined pembrolizumab in combination with chemotherapy to treat patients with advanced nonsquamous NSCLC. The second is a first-in-human, open-label, multi-arm phase 1/2 study designed to evaluate pembrolizumab in combination with quavonlimab to treat patients with advanced NSCLC.
“Over the last 5 years, Keytruda has become foundational in the treatment of metastatic lung cancer. The long-term data from KEYNOTE-021 (Cohort G) reinforce the use of Keytruda in combination with chemotherapy in certain advanced lung cancer patients, while data from our oncology pipeline reflect our commitment to exploring a number of new combinations with Keytruda that we believe could have a meaningful impact for more lung cancer patients,” Dr. Vicki Goodman, vice president of oncology clinical research at Merck Research Laboratories, said in a press release.
The data from KEYNOTE-021 showed a significant improvement in objective response rates (ORR) and progression-free survival (PFS) for patients with advanced NSCLC. Overall, 50% of patients treated with pembrolizumab in combination with chemotherapy were alive at 3 years compared to 37% of patients receiving chemotherapy alone.
More, the pembrolizumab combination also reduced the risk of death by 29% (HR, 0.71; 95% CI, 0.45-1.12) for patients compared to chemotherapy treatment alone. Median overall survival (OS) was 34.5 months for patients on the pembrolizumab combination versus 21.1 months for chemotherapy alone.
ORR for patients on the pembrolizumab combination was 58% compared to 33% for patients taking chemotherapy alone. The combination also reduced the risk of disease progression or death by 46% (HR, 0.54; 95% CI, 0.35-0.83) versus chemotherapy, with a median PFS of 24.5 months (range, 9.7-36.3) versus 9.9 months (range, 6.2-15.2).
The researchers found that 92% of patients completing 2 years of treatment with the pembrolizumab combination were alive at 3 years, with all 12 patients experiencing an objective response. The estimated 3-year duration of response (DOR) rate was 100% (median DOR not reached; range, 11.7+ to 49.3+ months).
As for the study examining quavonlimab in combination with pembrolizumab, the primary end point was safety and tolerability, with the data showing an acceptable safety profile and no unexpected toxicities. Any-grade adverse events (AEs) occurred in 98% of patients, treatment-related AEs occurred in 85% of patients, and grade 3 or worse AEs occurred in 36% of patients.
The data regarding safety and efficacy for this phase 1/2 study suggest that the 25 mg dose of quavonlimab administered every 6 weeks is the recommended phase 2 dose.
“Updated data from our anti-CTLA-4 antibody quavonlimab in combination with Keytruda support the continued development of this new combination and a Phase 3 study of quavonlimab co-formulated with KEYTRUDA in advanced non-small cell lung cancer is planned,” said Goodman.
Merck Presents Three-Year Survival Data for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy and Updated Phase 1/2 Data for Investigational Quavonlimab (MK-1308) in Combination With KEYTRUDA in Advanced Non‑Small Cell Lung Cancer [news release]. Kenilworth, New Jersey. Published October 16, 2020. https://www.merck.com/news/merck-presents-three-year-survival-data-for-keytruda-pembrolizumab-in-combination-with-chemotherapy-and-updated-phase-1-2-data-for-investigational-quavonlimab-mk-1308-in-combination-with-key/. Accessed October 19, 2020.