Merck reports positive phase 3 results for Keytruda/Lynparza in ovarian cancer

Merck & Co, known as MSD outside the US and Canada, has announced promising results from a significant phase 3 clinical trial involving Keytruda (pembrolizumab) and Lynparza (olaparib) as a first-line treatment for advanced ovarian cancer. This study, named KEYLYNK-001, was conducted to assess the effectiveness of Keytruda, an anti-PD-1 therapy, when combined with chemotherapy, followed by maintenance treatment with Lynparza, a PARP inhibitor developed in partnership with AstraZeneca. The trial also explored the addition of bevacizumab in certain patients.

KEYLYNK-001 focused on patients with advanced epithelial ovarian cancer who do not possess BRCA mutations. The trial achieved its primary goal, demonstrating that the combination of Keytruda and Lynparza led to a statistically significant and clinically meaningful improvement in progression-free survival compared to the use of chemotherapy alone. However, the secondary endpoint of overall survival was not reached. Merck acknowledged that the impact of Keytruda on the intention-to-treat population remains unclear at this stage.

Ovarian cancer, often originating in the fallopian tubes or on the outer surfaces of the ovaries, ranks as the second most prevalent gynecological cancer and the seventh most common cancer affecting women worldwide. In the United States alone, nearly 19,680 new cases are anticipated by the end of 2024. Keytruda works by enhancing the immune system's ability to detect and combat cancer cells, while Lynparza inhibits the repair of cancer cell DNA, hindering their growth and spread.

While Keytruda is already approved for a variety of cancers, including specific types of breast, cervical, and bladder cancers, it has not yet been approved for ovarian cancer treatment. Conversely, Lynparza has been approved for three different indications in ovarian cancer in the United States.

Merck plans to present the findings from the KEYLYNK-001 trial at an upcoming medical conference and engage with regulatory authorities regarding the results. Gursel Aktan, Vice President of Global Clinical Development at Merck Research Laboratories, emphasized the significance of the study, stating that there remains a critical need for new treatment options that can potentially improve outcomes for ovarian cancer patients. Aktan highlighted that KEYLYNK-001 marks the first successful phase 3 trial for the Keytruda and Lynparza combination.

The announcement of these results follows Merck's earlier release of positive findings from the phase 3 KEYNOTE-689 trial. This trial evaluated Keytruda as a perioperative treatment for patients newly diagnosed with stage 3 or 4A resected, locally advanced head and neck squamous cell carcinoma. These successive positive results underscore Merck's ongoing commitment to developing innovative treatment options for various types of cancer.