Merck's Keytruda combo fails Phase 3 ovarian cancer survival test

Merck recently announced that a regimen involving Keytruda met its primary endpoint of progression-free survival in a Phase 3 study involving certain ovarian cancer patients. Nevertheless, the study did not achieve its secondary goal of overall survival.

The Phase 3 KEYLYNK-001 trial evaluated a combination of Keytruda and chemotherapy, followed by maintenance therapy with AstraZeneca and Merck's Lynparza, with or without bevacizumab. This combination was tested on patients with advanced epithelial ovarian cancer who do not have BRCA mutations. The study showed a statistically significant improvement in progression-free survival compared to chemotherapy alone. Despite this, the overall survival endpoint was not met, leading Merck to state that the role of Keytruda in the broader patient population remains uncertain at this time.

Merck has indicated plans to present detailed findings at an upcoming medical conference and to discuss the results with regulatory authorities. The safety profiles for both Keytruda and Lynparza were consistent with results seen in previous clinical trials.

The collaboration between Merck and AstraZeneca on Lynparza, a PARP inhibitor, dates back to 2017. Lynparza was initially approved for the treatment of ovarian cancer in 2014, the same year Keytruda received its first FDA approval.

In addition to the Keytruda and Lynparza combination, Merck has various other ovarian cancer treatments in development. Among these are a Keytruda and vibostolimab combination, currently in Phase 2 trials. Vibostolimab is a TIGIT inhibitor. Moreover, Merck is testing three antibody-drug conjugates: ifinatamab deruxtecan, raludotatug deruxtecan, and patritumab deruxtecan, all of which are also in Phase 2 clinical trials.

These developments highlight Merck's ongoing efforts and commitment to expanding the treatment options available for ovarian cancer, despite the mixed results from the KEYLYNK-001 trial. The continued research and collaboration with AstraZeneca signify a strategic effort to improve outcomes for patients dealing with this challenging disease.