ORR was 12.2% (95% CI, 6.5% to 20.4%), with three complete and nine partial responses. Median follow-up was 10.2 months (range, 0.6 to 22.7 months). Eighty-two patients (83.7%) had programmed death-ligand 1 (PD-L1)–positive tumors (combined positive score $ 1), 77 having previously received one or more lines of chemotherapy for recurrent or metastatic disease. Median age was 46.0 years (range, 24 to 75 years), and 65.3% of patients had Eastern Cooperative Oncology Group performance status of 1. RESULTS Ninety-eight patients were treated. The primary end point was objective response rate (ORR), assessed per Response Evaluation Criteria in Solid Tumors (version 1.1) by independent central radiologic review. Tumor imaging was performed every 9 weeks for the first 12 months and every 12 weeks thereafter. PATIENTS AND METHODS Patients received pembrolizumab 200 mg every 3 weeks for 2 years or until progression, intolerable toxicity, or physician or patient decision. We present interim results from patients with previously treated advanced cervical cancer. Ĭheck out recent approvals at the OCE’s podcast, Drug Information Soundcast in Clinical Oncology.PURPOSE KEYNOTE-158 ( identifier: NCT02628067) is a phase II basket study investigating the antitumor activity and safety of pembrolizumab in multiple cancer types. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-80.įollow the Oncology Center of Excellence on Twitter. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This indication is approved under accelerated approval based on tumor response rate and durability of response. View full prescribing information for Keytruda.įDA granted this application priority review. The recommended pembrolizumab dose for treatment of cervical cancer is 200 mg every 3 weeks. The FDA also concurrently approved PD-L1 IHC 22C3 pharmDx (Dako North America Inc.) as a companion diagnostic. The most frequent serious adverse reactions reported included anemia (7%), fistula (4.1%), hemorrhage (4.1%), and infections (except UTIs) (4.1%). Serious adverse reactions occurred in 39% of patients. Pembrolizumab was discontinued due to adverse reactions in 8% of patients. The most common adverse reactions in at least 10% of patients with cervical cancer enrolled in KEYNOTE-158 were fatigue, pain, pyrexia, peripheral edema, musculoskeletal pain, diarrhea/colitis, abdominal pain, nausea, vomiting, constipation, decreased appetite, hemorrhage, UTI, infections, rash, hypothyroidism, headache, and dyspnea. No responses were observed in patients whose tumors did not have PD-L1 expression (CPS ˂1). The estimated median response duration based on 11 patients with a response by independent review was not reached (range 4.1, 18.6+ months) 91% had a response duration of greater than or equal to 6 months. With a median follow-up time of 11.7 months, the ORR in 77 patients was 14.3% (95% CI: 7.4, 24.1), including 2.6% complete responses and 11.7% partial responses. The major efficacy outcomes were objective response rate (ORR) according to RECIST 1.1 as assessed by blinded independent central review, and response duration. ![]() PD-L1 status was determined using the PD-L1 IHC 22C3 pharmDx Kit. Among the 98 patients, approval was based on 77 (79%) patients who had tumors that expressed PD-L1 with a CPS ≥1 and who had received at least one line of chemotherapy for metastatic disease. Patients were treated with pembrolizumab intravenously at a dose of 200 mg every 3 weeks until unacceptable toxicity or documented disease progression. Pembrolizumab was investigated in 98 patients with recurrent or metastatic cervical cancer enrolled in a single cohort of KEYNOTE 158 (NCT02628067), a multicenter, non-randomized, open-label, multi-cohort trial. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck and Co.
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