Merck reveals promising phase 3 results for Keytruda in ovarian cancer

Merck & Co, also known as MSD outside of the US and Canada, has announced encouraging findings from a pivotal phase 3 trial involving their anti-PD-1 treatment, Keytruda (pembrolizumab), for ovarian cancer. This latest study, called KEYNOTE-B96, examined the efficacy of Keytruda in combination with the chemotherapy drug paclitaxel, with or without the addition of Roche’s drug Avastin (bevacizumab), in patients suffering from platinum-resistant recurrent ovarian cancer.

The trial successfully reached its main goal, revealing that the regimen featuring Keytruda provided a statistically significant and clinically relevant enhancement in progression-free survival. This improvement was observed regardless of the PD-L1 status of the patients, in comparison to the placebo group that received chemotherapy with or without Avastin. Additionally, the Keytruda-based treatment showed a significant and meaningful boost in overall survival rates, a crucial secondary measure, for patients whose tumors expressed PD-L1, compared to those given the placebo.

Ovarian cancer primarily originates in the fallopian tubes or the outer surface of the ovaries, making it the seventh most prevalent cancer among women globally. In the United States alone, an estimated 20,890 new cases are projected to be diagnosed this year. Keytruda functions by enhancing the immune system's capacity to identify and combat tumor cells. It is already approved for treating a diverse array of cancers, such as specific types of breast, cervical, bladder, biliary tract, non-small cell lung, and renal cell carcinomas, although it has not yet received approval for use against ovarian cancer.

Gursel Aktan, Vice President of Global Clinical Development at Merck Research Laboratories, emphasized that this trial marks the first instance in which a Keytruda-based treatment has shown the potential to prolong the lives of certain patients with platinum-resistant ovarian cancer. It is also the first time an immune checkpoint inhibitor regimen has demonstrated a survival benefit for ovarian cancer. Aktan highlighted the significance of these positive outcomes, noting that they contribute to a growing body of evidence supporting Keytruda's potential benefits across various gynecological cancers, including this challenging form of ovarian cancer where patients are desperate for new treatment options.

The findings from the KEYNOTE-B96 trial, which is conducted in collaboration with the European Network for Gynecologic Oncology Trial groups, will soon be presented at a forthcoming medical conference. Merck plans to share these results with regulatory authorities worldwide.