Merck Reports 92% Three-Year Survival Rate in Advanced NSCLC Patients Completing Two Years of KEYTRUDA Plus Chemotherapy in Long-Term Follow-Up

October 19, 2020 /BioValleyBIOON/ -- Merck & Co. recently announced positive results from two clinical studies within the lung cancer clinical development program for its anti-PD-1 therapy Keytruda (pembrolizumab): Keytruda in combination with chemotherapy (KEYNOTE-021 [Cohort G]) and Keytruda in combination with the anti-CTLA-4 antibody quavonlimab (MK-1308).

In KEYNOTE-021 (cohort G), patients with advanced non-squamous non-small cell lung cancer (NSCLC) receiving first-line treatment were evaluated, regardless of PD-L1 expression level; patients in cohort G did not have EGFR or ALK gene alterations.TumorAbnormal.

With a median follow-up of 4 years (49.4 months), the results demonstrated that first-line treatment with Keytruda in combination with chemotherapy (n=60) yielded significantly superior efficacy compared to chemotherapy alone (n=63): (1) The objective response rate (ORR) was significantly higher (58% vs. 33%), and the median duration of response (DOR) was prolonged by more than one year (36.3 months vs. 22.8 months); (2) Progression-free survival (median PFS: 24.5 months vs. 9.9 months) was significantly extended, with a 46% significant reduction in the risk of disease progression or death (HR=0.54 [95% CI: 0.35–0.83]).

Furthermore, Keytruda in combination with chemotherapy demonstrated sustained long-term survival benefits. At 3 years, 50% of patients in the Keytruda plus chemotherapy group remained alive, compared with 37% in the chemotherapy group. Additionally, Keytruda plus chemotherapy reduced the risk of death by 29% compared with chemotherapy alone (HR=0.71 [95% CI, 0.45–1.12]) and significantly prolonged overall survival (median OS: 34.5 months vs. 21.1 months). An OS benefit was observed despite a 70% effective crossover rate from chemotherapy to anti-PD-1/PD-L1 therapy (n=43/61), including 28 patients who received Keytruda as part of study-mandated crossover treatment.

These findings represent the longest follow-up data for anti-PD-1/PD-L1 combined with chemotherapy in the treatment of NSCLC. Notably, among patients who completed 2 years of Keytruda treatment, 92% were alive at 3 years (n=11/12). All 12 patients achieved an objective response, with an estimated 3-year duration of response (DOR) rate of 100% (median DOR not reached [NR]; range: 11.7+ to 49.3+ months).

Long-term follow-up did not reveal any new safety signals for Keytruda in combination with chemotherapy. Among all treated patients, 39% in the Keytruda plus chemotherapy group and 31% in the chemotherapy group experienced Grade 3–5 treatment-related adverse events (TRAEs). The incidence of Grade 3–5 TRAEs leading to discontinuation was 17% in the Keytruda plus chemotherapy group and 16% in the chemotherapy group. The incidence of Grade 3–5 TRAEs leading to death was 2% (n=1) in the Keytruda plus chemotherapy group and 3% (n=2) in the chemotherapy group.

Furthermore, the latest follow-up data from the Phase 1/2 study demonstrated that quavonlimab in combination with Keytruda as first-line treatment for patients with advanced NSCLC showed anti-Tumoractivity, and demonstrated acceptable safety.

Dr. Vicki Goodman, Vice President of Oncology Clinical Research at MSD Research Laboratories, stated: “Over the past five years, Keytruda has become a cornerstone therapy for the treatment of metastatic lung cancer. Long-term data from KEYNOTE-021 (Cohort G) reinforce the role of Keytruda in combination with chemotherapy in certain patients with advanced lung cancer, while data from ourTumor"The data from our research pipeline reflects our commitment to exploring a range of new Keytruda combinations that we believe could have a meaningful impact on more lung cancer patients. The latest data supporting the combination of our anti-CTLA-4 antibody quavonlimab with Keytruda reinforces the continued development of this novel combination, and we plan to conduct a Phase 3 study evaluating quavonlimab in combination with Keytruda for the treatment of advanced non-small cell lung cancer."(Bioon.com)

Original Source: 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