Merck hits primary endpoint in ovarian cancer trial, but what does it mean for patients?

In the United States, Merck & Co Inc revealed significant findings on December 9, 2024, from the Phase 3 KEYLYNK-001 trial aimed at treating BRCA non-mutated advanced epithelial ovarian cancer. The trial assessed the effectiveness of a combination regimen of Keytruda (pembrolizumab) and chemotherapy, followed by maintenance therapy with Lynparza (olaparib), with or without bevacizumab. Notably, the trial met its primary endpoint, indicating that the combination therapy displayed a statistically significant and clinically meaningful enhancement in progression-free survival when compared to chemotherapy alone. This development is crucial as it demonstrates a new potential approach to treatment for a challenging form of ovarian cancer, addressing a critical need for effective therapies in this population. However, the trial did not successfully achieve its secondary endpoint of overall survival, raising questions regarding the long-term efficacy of the treatment. The results have sparked discussions within the medical community about the place of Keytruda in the treatment regimen, especially since it currently lacks approval for the treatment of ovarian cancer in the U.S. The uncertainty surrounding Keytruda’s role necessitates further research to clarify its impact and effectiveness in various patient populations. Additionally, on the same day, Merck disclosed preliminary findings from the Phase 2 waveLINE-007 trial assessing zilovertamab vedotin in combination with the R-CHP regimen, which includes cyclophosphamide, doxorubicin, and prednisone, for previously untreated diffuse large B-cell lymphoma (DLBCL). The data revealed that a substantial number of patients achieved a complete response, with results suggesting that 100% of participants receiving the 1.75 mg/kg dosage attained a complete response. The recommended Phase 3 dosage was confirmed to be 1.75 mg/kg based on these findings, marking a potential advancement in lymphoma treatment options. Overall, Merck’s announcements highlight significant progress in oncology, particularly with the new insights into both ovarian cancer and diffuse large B-cell lymphoma treatment. As the company continues to develop its therapies, these results could pave the way for more robust treatment strategies in the field, benefiting patients with difficult-to-treat cancers.