FDA Approves Keytruda Combination for Advanced Endometrial Cancer

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WASHINGTON, D.C. — On Monday, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) in combination with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma. This approval provides a new treatment option for a challenging type of cancer.

Clinical Trial Findings

The approval stems from the KEYNOTE-868/NRG-GY018 clinical trial. This large-scale study enrolled 810 patients with advanced or recurrent endometrial carcinoma. The trial evaluated the efficacy of pembrolizumab combined with standard chemotherapy against a placebo plus chemotherapy. Patients were divided based on their mismatch repair (MMR) status: 222 were mismatch repair deficient (dMMR) and 588 were mismatch repair proficient (pMMR).

Patients in the trial received either pembrolizumab or a placebo, along with carboplatin and paclitaxel every three weeks for six cycles, followed by pembrolizumab or placebo alone every six weeks for up to 14 cycles.

Key Results

The primary measure of efficacy was progression-free survival (PFS), which assesses how long patients live without their disease worsening. In the dMMR group, median PFS was not reached in the pembrolizumab arm, indicating that many patients had not experienced disease progression during the study period. By contrast, median PFS in the placebo group was 6.5 months. This significant difference highlights pembrolizumab’s effectiveness in extending the time patients remain progression-free.

In the pMMR group, median PFS was 11.1 months for those receiving pembrolizumab and chemotherapy, compared to 8.5 months for those receiving the placebo and chemotherapy. Both cohorts showed statistically significant improvements with pembrolizumab, underscoring its potential benefits.

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Safety and Dosage

Adverse reactions to pembrolizumab combined with chemotherapy were generally similar to those previously reported for each treatment individually. However, there was a higher incidence of rash. Other common side effects included fatigue, nausea, and loss of appetite.

The recommended pembrolizumab dose is 200 mg every three weeks or 400 mg every six weeks. Treatment continues until disease progression, unacceptable toxicity, or up to 24 months.

FDA Approves Pembrolizumab: A Breakthrough in Endometrial Cancer Treatment

This approval marks a significant step forward in treating advanced endometrial cancer, offering hope to patients with limited options. Endometrial cancer, which affects the lining of the uterus, can be particularly aggressive when advanced or recurrent. Pembrolizumab, an immunotherapy drug, works by helping the immune system recognize and attack cancer cells, providing a new avenue for treatment.

In summary, the FDA’s approval of pembrolizumab combined with chemotherapy offers a promising new treatment for patients with advanced endometrial carcinoma, potentially improving survival rates and quality of life for many.

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