For three years, Merck & Co.’s Keytruda has been the onlyimmuno-oncology drug allowed to treat cervical cancer. Now, thanks to a new clinical win, Merck aims to move Keytruda up the treatment line and beat out upcoming competition.
Adding Keytruda to chemotherapy with or without Roche’s Avastin for the first-line treatment of cervical cancer significantly extended patients’ lives in a phase 3 trial, Merck said Tuesday. The Keytruda regimen also performed better at staving off cancer progression in the study, dubbed Keynote-826, the company said.
The new win builds on Keytruda’s existing accelerated approval as a second-line treatment for cervical cancer, coming after chemotherapy, in patients whose tumors express the PD-L1 biomarker, where PD-1 inhibitors like Keytruda often work better.
The first-line results cover patients regardless of their tumors’ PD-L1 status, and the Keynote-826 trial serves as the confirmatory trial that could convert that conditional nod into a full one.
Keytruda’s new win comes as Sanofi and Regeneron’s PD-1 rival Libtayo looks on track to challenge its dominance in the second-line setting. In its phase 3 trial, Libtayo monotherapy significantly pared down the risk of death by 31% over chemotherapy in chemo-pretreated cervical cancer patients regardless of their PD-L1 status.
Besides Keytruda and Libtayo, AstraZeneca is testing its PD-L1 inhibitor Imfinzi alongside chemoradiotherapy in the phase 3 Calla trial for earlier, locally advanced cervical cancer that has not undergone surgery.
The results Merck announced today marks the first time an immunotherapy has shown a survival benefit for patients with persistent, recurrent or metastatic cervical cancer who haven’t been treated with systemic chemotherapy, Roy Baynes, M.D., Ph.D., chief medical officer of Merck Research Laboratories, noted in a statement.
Merck will discuss the data with regulatory authorities and will share the findings at an upcoming medical meeting, Baynes added. If approved, it would tap into a U.S. market, which had nearly 14,500 new diagnoses of invasive cervical cancer in 2021, according to Merck.
Front-line cervical cancer represents the latest gynecologic cancer win for Keytruda. The PD-1 inhibitor is also getting help from Eisai-partnered small-molecule drug Lenvima. In March, Merck and partner Eisai unveiled data showing that in endometrial cancer, the combination cut the risk of death by 38% over chemotherapy in patients with previously treated disease.
Merck also highlighted a potential role for Keytruda and Lenvima in ovarian cancer, after a phase 2 trial showed the combo triggered a response in 32.3% of patients who had tried three other treatment options.