Merck & Co – known as MSD outside the US and Canada – has shared promising results from a late-stage study of its anti-PD-1 therapy Keytruda (pembrolizumab) in ovarian cancer.
The phase 3 KEYNOTE-B96 trial has been evaluating the drug in combination with paclitaxel chemotherapy, with or without Roche’s Avastin (bevacizumab), in patients with platinum-resistant recurrent ovarian cancer.
The study met its primary endpoint, with the Keytruda-based regimen demonstrating a statistically significant and clinically meaningful improvement in progression-free survival regardless of PD-L1 status compared to placebo plus chemotherapy with or Avastin.
The Keytruda regimen was also associated with a statistically significant and clinically meaningful improvement in overall survival, a secondary endpoint, in patients whose tumours express PD-L1 compared to the placebo cohort.
Ovarian cancer, which usually begins in the fallopian tubes or on the outer surface of the ovaries, is the seventh most common cancer in women globally. Approximately 20,890 cases of the disease are expected to be diagnosed in the US this year.
Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumour cells. The drug already holds approvals to treat a wide range of cancers, including specific cases of breast cancer, cervical cancer, bladder cancer, biliary tract cancer, non-small cell lung cancer and renal cell carcinoma, but is not currently approved to treat ovarian cancer.
Gursel Aktan, vice president, global clinical development, Merck Research Laboratories, outlined that this is the “first time a Keytruda-based regimen has shown the ability to help certain patients with platinum-resistant ovarian cancer live longer, and the first time an immune checkpoint inhibitor-based regimen has demonstrated an overall survival benefit in ovarian cancer”.
“The positive results from this trial add to the growing body of evidence supporting the potential benefit of Keytruda across gynaecological cancers, including this difficult-to-treat form of ovarian cancer for which patients are in need of new options,” he added.
Results from KEYNOTE-B96, which is being conducted in collaboration with the European Network for Gynecologic Oncology Trial groups, will be presented at an upcoming medical meeting and shared with regulatory authorities globally, Merck said.