Keytruda Gains First Gynecologic Cancer Indication

The approval was based on a trial of 98 individuals with recurrent or metastatic cervical cancer.
The approval was based on a trial of 98 individuals with recurrent or metastatic cervical cancer.

Merck announced that the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (combined positive score [CPS] ≥1) as determined by an FDA-approved test. 

The new indication is approved under the Agency's accelerated approval pathway based on tumor response rate and durability of response. Continued approval may be based on verification and description of clinical benefit in confirmatory trials. The approval marks Keytruda as the first anti-programmed death receptor-1 (PD-1) therapy approved for advanced cervical cancer.

Keytruda was evaluated in patients with recurrent or metastatic cervical cancer who were a part of a single cohort (Cohort E; n=98) in the multicenter, non-randomized, open-label, KEYNOTE-158 study. Study patients received Keytruda 200mg every 3 weeks until acceptable toxicity or confirmed disease progression and their tumor status was performed every 9 weeks for the first year and then every 12 weeks thereafter. 

The major efficacy outcome measures were objective response rate (ORR) according to RECIST 1.1, as assessed by blinded independent central review, and duration of response (DOR). Median follow-up was 11.7 months.

Among Cohort E, 79% had PD-L1 expressing tumors with a CPS ≥1  and patients received ≥1 line of chemotherapy in the metastatic setting. Data showed ORR was 14.3% (95% CI, 7.4-24.1) with 2.6% achieving complete response and 11.7% achieving partial response. Of the 11 responders, median DOR was not yet reached at the time of analysis; 91% of patients, however, had a DOR of ≥6 months. 

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Adverse reactions led to study discontinuation in 8% of patients in Cohort E. The most common adverse reactions included fatigue, musculoskeletal pain, diarrhea, pain, abdominal pain, and decreased appetite. 

Keytruda, a human PD-1-blocking antibody, is already indicated to treat various cancers, including melanoma, lung cancer, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancer, and gastric cancer.

Keytruda for injection is available as a single-dose vial containing 50mg lyophilized powder. Keytruda injection is available as a 100mg/4mL solution in single-dose vials.

For more information call (877) 888-4231 or visit Keytruda.com.