Merck's Phase 3 KEYLYNK-001 Trial Achieves PFS Goal in Advanced Ovarian Cancer

Merck, known as MSD outside the US and Canada, has announced the results of the Phase 3 KEYLYNK-001 trial, which studied the combination of KEYTRUDA® (pembrolizumab) and chemotherapy followed by maintenance with LYNPARZA® (olaparib), with or without bevacizumab, as a first-line treatment for patients with BRCA non-mutated advanced epithelial ovarian cancer. The trial met its primary goal, showing significant and meaningful improvement in progression-free survival (PFS) compared to chemotherapy alone. However, it did not meet the secondary endpoint of overall survival (OS).

KEYLYNK-001 is the first successful Phase 3 trial combining KEYTRUDA with LYNPARZA, highlighting Merck’s dedication to research aimed at addressing the impact of cancers in women. The safety profiles for both KEYTRUDA and LYNPARZA were consistent with previous studies. Detailed results will be shared at an upcoming medical meeting and with regulatory authorities.

Dr. Gursel Aktan, Vice President of Global Clinical Development at Merck Research Laboratories, emphasized the ongoing need for effective treatment options in ovarian cancer, noting the commitment to research that can improve patient outcomes. In the US, LYNPARZA has three approved uses in ovarian cancer for maintenance treatment in patients with BRCA mutations and homologous recombination deficiency (HRD)-positive status, making it a significant treatment option.

KEYLYNK-001 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT03740165) evaluating the efficacy of KEYTRUDA combined with chemotherapy (paclitaxel and carboplatin) followed by KEYTRUDA with maintenance LYNPARZA, with or without bevacizumab, in patients with BRCA non-mutated advanced epithelial ovarian cancer. Primary endpoints included PFS in patients whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10) and in the intention-to-treat population, with secondary endpoints including OS and safety. The trial enrolled 1,367 patients who were randomized to receive treatment, allowing for adjustments in cases of severe hypersensitivity reactions or adverse events.

Ovarian cancer, which often begins in the fallopian tubes or on the ovaries' surface, is the second most common gynecologic malignancy and the seventh most common cancer in women globally. In 2022, approximately 324,603 women were diagnosed with ovarian cancer worldwide, with about 206,956 deaths. In the US, it is estimated that around 19,680 women will be diagnosed with ovarian cancer and about 12,740 will die from the disease in 2024. The primary goal of first-line treatment is to delay disease progression to achieve long-term remission.

Merck is committed to improving treatment options for breast and gynecologic cancers. Their research includes over 20 clinical trials involving more than 18,000 patients globally. These trials focus on evaluating Merck’s medicines in earlier stages and exploring new combinations and mechanisms. Merck aims to provide better treatment options for patients and reduce the overall impact of women's cancers.

KEYTRUDA is an anti-PD-1 therapy that enhances the immune system's ability to detect and combat tumor cells. It is currently being studied in more than 1,600 trials across various cancers and treatment settings. LYNPARZA is a first-in-class PARP inhibitor that targets DNA damage response pathway deficiencies, such as BRCA mutations, to kill cancer cells. It is being developed and commercialized by AstraZeneca and Merck, with ongoing studies to assess its effectiveness as a monotherapy and in combination with other treatments across multiple cancer types.

Merck’s continued efforts in oncology research aim to bring innovative treatment options to patients, addressing barriers to clinical trial participation and ensuring high-quality cancer care is accessible to all. Their commitment to research and development reflects their mission to improve the lives of patients globally through scientific advancements.