New Keytruda regimen OK’d in EU for hard-to-treat gynecological cancers
Combo with chemo approved for use in platinum-resistant ovarian cancer
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A new regimen using the immunotherapy Keytruda (pembrolizumab) has been approved in the European Union for use by certain people with hard-to-treat gynecological cancer.
The new approval, by the European Commission, specifically covers the use of Keytruda in combination with the chemotherapy paclitaxel, with or without bevacizumab (sold as Avastin, among others), as a treatment for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, a type of cancer that starts in tissue. The combination is approved for use in adults whose tumors express a protein called PD-L1 and who have received one or two prior systemic treatment regimens.
The approval in the EU covers both the original formulation of Keytruda, which is administered by infusion into the bloodstream, and a subcutaneous, or under-the-skin, injection formulation called Keytruda SC, known in the U.S. as Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph). Both therapies are sold by Merck (known as MSD outside of the U.S. and Canada).
“This milestone marks real progress for patients and advances our broader mission of expanding access to effective options for women’s cancers globally,” Gursel Aktan, PhD, vice president of global clinical development at Merck Research Laboratories, said in a company press release announcing the new approval.
Keytruda works by blocking PD-1, a protein expressed by immune cells, which normally helps prevent immune attacks against the body’s own healthy tissue. Many cancers avoid immune destruction by expressing a related protein called PD-L1, which binds to PD-1 and stops immune cells from attacking. By blocking PD-1, Keytruda is designed to unleash immune cells to more effectively attack cancer cells.
Approval in EU follows similar decision in US
Keytruda is widely approved as a treatment for various cancer types. Merck noted that this new approval makes it the first and only PD-1 inhibitor-based treatment option that’s approved in the EU for eligible patients with ovarian cancer that’s resistant to standard platinum-based chemotherapies.
“We’re proud to bring this Keytruda-based regimen to appropriate patients in Europe with PD-L1-positive platinum-resistant ovarian cancer – giving this community access to the region’s first PD-1 inhibitor treatment approach for this disease,” Aktan said.
Despite recent advances, patients with ovarian cancer face a significant unmet need when their disease progresses and becomes resistant to standard platinum-based therapy. … The approval of this [Keytruda]-based regimen … provides a crucial new treatment option.
The approval in the EU approval comes on the heels of a similar approval in the U.S. less than two months ago. Both decisions were based on data from KEYNOTE-B96 (NCT05116189), a Phase 3 clinical trial that enrolled hundreds of people with platinum-resistant gynecological cancers. Participants were randomly assigned to receive Keytruda or a placebo, in addition to paclitaxel, with or without bevacizumab.
According to Merck, results from KEYNOTE-B96 showed that in patients whose tumors express PD-L1, Keytruda reduced the risk of disease progression or death by 28% relative to the placebo. Data also showed the overall risk of death was reduced by 24% with Keytruda versus the placebo.
Nicoletta Colombo, MD, director of the gynecologic oncology program at the European Institute of Oncology in Milan, Italy, called the approval “an important advance” for individuals in the EU with hard-to-treat cancer.
“Despite recent advances, patients with ovarian cancer face a significant unmet need when their disease progresses and becomes resistant to standard platinum-based therapy,” Colombo said. “The approval of this [Keytruda]-based regimen … provides a crucial new treatment option and represents a welcome addition to the treatment landscape for appropriate patients with PD-L1-positive platinum-resistant ovarian cancer across Europe.”
