Merck & Co – known as MSD outside of the US and Canada – has shared positive results from a late-stage trial of a Keytruda (pembrolizumab)/Lynparza (olaparib) regimen as a first-line treatment for advanced ovarian cancer.
The phase 3 KEYLYNK-001 trial has been evaluating Merck’s anti-PD-1 therapy Keytruda in combination with chemotherapy followed by maintenance with the company’s AstraZeneca-partnered PARP inhibitor Lynparza, with or without bevacizumab, in patients with advanced epithelial ovarian cancer without BRCA mutations.
The study met its primary endpoint, with the Keytruda/Lynparza regimen demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy alone.
The study did not reach its secondary endpoint of overall survival, however, with Merck noting that the role of Keytruda in the intention-to-treat population “remains uncertain at this time”.
Ovarian cancer, which usually begins in the fallopian tubes or on the outer surface of the ovaries, is the second most common gynaecological malignancy and seventh most common cancer in women globally. Approximately 19,680 cases of the disease are expected to have been diagnosed in the US by the end of 2024.
Keytruda is designed to increase the ability of the body’s immune system to help detect and fight tumour cells, while Lynparza prevents the DNA of cancer cells from being repaired, preventing them from growing and spreading.
Keytruda already holds approvals to treat a wide range of cancers, including specific cases of breast, cervical and bladder cancer, but is not approved for use in ovarian cancer. Lynparza, however, has three approved indications in ovarian cancer in the US.
Merck said the results from KEYLYNK-001 will be presented at an upcoming medical meeting and discussed with regulatory authorities.
“For people living with ovarian cancer, there remains an unmet need for new treatment options that have the potential to improve outcomes,” said Gursel Aktan, vice president, global clinical development, Merck Research Laboratories, adding that KEYLYNK-001 is the first positive phase 3 trial for Keytruda plus Lynparza.
The results come two months after Merck shared positive results from the phase 3 KEYNOTE-689 trial of Keytruda as a perioperative treatment for patients newly diagnosed with stage 3 or 4A, resected, locally advanced head and neck squamous cell carcinoma.