On October 13, 2021, the FDA approved Keytruda (pembrolizumab; from Merck), an immunotherapy, in combination with chemotherapy, with or without Avastin (bevacizumab), for the treatment of patients with persistent, recurrent, or metastatic cervical cancer and PD-L1 expression ≥1%, as determined by an FDA-approved test.
The approval of first-line Keytruda plus chemotherapy was based on the KEYNOTE-826 study, a multicenter, randomized, double-blind, placebo-controlled clinical trial. The study included 617 patients with persistent, recurrent, or first-line metastatic cervical cancer who had not received chemotherapy. Patients were enrolled regardless of a PD-L1 expression status. Patients received either Keytruda plus chemotherapy (paclitaxel and cisplatin or paclitaxel and carboplatin), with or without Avastin or placebo plus chemotherapy, with or without Avastin. Keytruda therapy continued until disease progression, unacceptable side effects, or completion of 24-month treatment.
For the 548 patients with tumors expressing PD-L1 ≥1%, the average overall survival was not reached (meaning patients were still responding) in the Keytruda group versus 16.3 months in the placebo group. The average time without disease progression was 10.4 months in the Keytruda arm versus 8.2 months in the placebo arm. The objective response rate was 68% with Keytruda and 50% with placebo, and the average duration of response was 18 months with Keytruda versus 10.4 months with placebo.
The most common side effects in the Keytruda arm were peripheral neuropathy, alopecia, anemia, fatigue/asthenia, nausea, neutropenia, diarrhea, hypertension, thrombocytopenia, constipation, arthralgia, vomiting, urinary tract infection, rash, leukopenia, hypothyroidism, and decreased appetite.
