“Today’s news is a meaningful step forward, as it offers a new therapeutic option for these patients and reinforces the role of Keytruda in treating certain types of cervical cancers, with a second indication for the disease,” said Roy Baynes, MD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a press release. Among patients with tumors with a PD-L1 CPS of 1 or higher (n = 548), the median OS was not yet reached (95% CI, 19.8–not reached) in the pembrolizumab cohort compared with 16.3 months (95% CI, 14.5-19.4) in the placebo cohort (HR 0.64 95% CI, 0.50-0.81 1-sided P = .0001).įurther, median PFS was 10.4 months (95% CI, 9.70-12.3) in the pembrolizumab cohort compared with 8.2 months (95% CI, 6.3-8.5) in the placebo cohort (HR 0.62 95% CI, 0.50-0.77 1-sided P < .0001). The ORRs were 68% (95% CI, 62%-74%) and 50% (95% CI, 44%-56%), respectively, with a median DOR of 18.0 and 10.4 months, respectively.Īdverse events that occurred in 20% or more of patients administered pembrolizumab, chemotherapy, and bevacizumab included peripheral neuropathy, alopecia, anemia, fatigue/asthenia, nausea, neutropenia, diarrhea, hypertension, thrombocytopenia, constipation, arthralgia, vomiting, urinary tract infection, rash, leukopenia, hypothyroidism, and decreased appetite. The primary efficacy outcome measures were investigator-assessed overall survival (OS) and progression-free survival (PFS) per RECIST v1.1 criteria, which was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Additional outcome measures of interest included ORR and DOR. Pembrolizumab was continued until disease progression, intolerable toxicity, or 24 months of treatment. Study participants were randomized 1:1 to receive either pembrolizumab 200 mg plus paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab or placebo, plus chemotherapy with or without bevacizumab. A total of 617 patients with persistent, recurrent, or first-line metastatic cervical cancer who had not received chemotherapy were enrolled irrespective of PD-L1 expression status. The multicenter, randomized, double-blind, placebo-controlled, phase 3 KEYNOTE-826 trial was used as the confirmatory trial for the approval. 3Ĭontinued approval for this indication was contingent upon verification and description of clinical benefit in confirmatory trials. Ninety-one percent of responders experienced a response that lasted for 6 months or longer. ![]() The median duration of response (DOR) was not reached. 2 The approved was based on data from 98 patients with recurrent or metastatic cervical cancer enrolled to a single cohort in the phase 2 KEYNOTE-158 trial.Īt a median follow-up of 11.7 months, pembrolizumab produced an overall response rate (ORR) of 14.3% (95% CI, 7.4-24.1) in 77 patients with PD-L1 positivity who were previously treated with at least 1 line of chemotherapy in the metastatic setting. In June 2018, the FDA granted accelerated approval to pembrolizumab in the second-line treatment of patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy and whose tumors express PD-L1. I am excited for today’s approval of a new combination with Keytruda, which offers a new treatment option for appropriate patients.” ![]() ![]() “There have been no first-line approvals for women with persistent, recurrent or metastatic cervical cancer in the past 7 years. “Cervical cancer more commonly affects younger women and certain women of color in the US, and unfortunately, women diagnosed with persistent, recurrent or metastatic cervical cancer often have a low survival rate,” said Bradley Monk, MD, medical director of US Oncology Research Gynecology Program, in a press release. 1įurther, the FDA granted regular approval to pembrolizumab monotherapy for patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy with tumors that have a PD-L1 CPS of 1 or greater as determined by an FDA-approved test. The FDA has approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab (Avastin), in patients with persistent, recurrent, or metastatic cervical cancer whose tumors have a programmed death-ligand 1 (PD-L1) combined positive score (CPS) of 1 or higher determined by an FDA-approved test.
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