FDA approves Keytruda for advanced endometrial carcinoma subset
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The FDA approved pembrolizumab for certain women with microsatellite instability-high or mismatch repair-deficient advanced endometrial cancer.
The latest approval of pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, applies to women who experience disease progression after previous systemic therapy in any setting and do not qualify for curative surgery or radiation, according to a press release from the manufacturer.
New data from Cohorts D and K of the KEYNOTE-158 trial served as the basis for approval. The cohorts enrolled 90 women with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient advanced endometrial cancer who received at least one dose of pembrolizumab, administered at 200 mg via IV every 3 weeks until disease progression or unacceptable toxicity.
Objective response rate and duration of response as assessed by blinded independent central review served as major efficacy outcome measures.
Median duration of pembrolizumab exposure was 8.3 months (range, 1 day to 26.9 months).
Results at median follow-up of 16 months (range, 0.5-62.1) showed an objective response rate of 46% (95% CI, 35-56), including a 12% complete response rate and 33% partial response rate. Among the 41 women who responded to treatment, 68% had responses that lasted at least 12 months and 44% had responses that lasted at least 24 months.
Median duration of response had not yet been reached (range, 2.9-55.7+ months).
“The objective response rate and duration of response observed in this trial solidify the role of Keytruda as a treatment option for these patients,” David M. O’Malley, MD, director of the division of gynecologic oncology at The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center, said in the press release.
Adverse reactions among women with endometrial carcinoma appeared similar to those observed among 2,799 patients with melanoma or non-small cell lung cancer who received single-agent pembrolizumab, according to the release. Immune-mediate adverse reactions that can occur during or after pembrolizumab treatment include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection and complications of allogeneic hematopoietic stem cell transplantation.
“This FDA approval is great news for women facing advanced endometrial cancer,” Scot Ebbinghaus, MD, vice president for clinical research at Merck Research Laboratories, said in the release. “We have seen substantial progress in delivering treatment options for patients with advanced endometrial cancer with Keytruda, as monotherapy and in combination, with two approved indications in this area.”
Pembrolizumab also is approved in combination with lenvatinib (Lenvima, Eisai), a multiple receptor tyrosine kinase inhibitor, for women with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair-deficient whose disease progressed after systemic therapy in any setting and who are not candidates for curative surgery or radiation.
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