April 22, 2024

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FDA Prioritizes Pembrolizumab for Advanced Endometrial Cancer

FDA Prioritizes Pembrolizumab for Advanced Endometrial Cancer



FDA Prioritizes Pembrolizumab for Advanced Endometrial Cancer

Merck announced that the US Food and Drug Administration (FDA) has granted priority review to the supplemental Biologics License Application (sBLA) for pembrolizumab in combination with chemotherapy for the treatment of patients with advanced or recurrent endometrial cancer. A decision on approval is expected by June 21 this year.

Priority review is a mechanism by which the FDA accelerates the review of certain drug, biologic, or medical device applications. It is typically granted to drugs that provide significant clinical advantages in treating diseases or offer significant improvements over current treatment options. Obtaining priority review means that the approval process timeline is usually shorter, allowing new treatment options to enter the market more quickly to meet patient needs.

The sBLA is a submission made by a pharmaceutical company or research institution to the FDA for modifying or supplementing an approved biologic product.

Key points include:

  1. There are limited first-line treatment options for patients with advanced or recurrent endometrial cancer, and there is an urgent need for effective new therapies. If approved, pembrolizumab will be the first approved immunotherapy for first-line treatment of advanced endometrial cancer.

  2. In clinical trials, pembrolizumab in combination with chemotherapy showed significant advantages over current standard chemotherapy, significantly improving patients’ progression-free survival and significantly reducing the risk of disease progression or death.

  3. In patients with advanced or recurrent endometrial cancer, there are two types: mismatch repair-deficient (dMMR) and mismatch repair-proficient (pMMR) patients. pMMR patients are typically insensitive to immunotherapy drugs and are more difficult to treat. The trial showed that pembrolizumab in combination with chemotherapy had good efficacy in both types of patients.

FDA Prioritizes Pembrolizumab for Advanced Endometrial Cancer.

Research details:

On February 20, the FDA granted priority review to Merck’s sBLA for pembrolizumab in combination with chemotherapy for the treatment of patients with advanced or recurrent endometrial cancer. A decision on approval is expected by June 21, 2024.

Specifically, pembrolizumab is used in combination with standard chemotherapy (carboplatin and paclitaxel), followed by monotherapy with pembrolizumab, for the treatment of patients with primary advanced or recurrent endometrial cancer.

Application basis:

This sBLA was supported by the results of the NRG-GY018 trial (NCT03914612). The trial results were presented at the 2023 Society of Gynecologic Oncology Annual Meeting and simultaneously published in the New England Journal of Medicine.

About the NRG-GY018 trial:

NRG-GY018 is a randomized, double-blind, placebo-controlled Phase 3 trial that primarily evaluated the efficacy of pembrolizumab in combination with chemotherapy (carboplatin + paclitaxel) compared with placebo in patients with stage III, IVA, IVB, or recurrent endometrial cancer.

The trial included 816 patients who were randomized 1:1 to receive either pembrolizumab in combination with chemotherapy (carboplatin + paclitaxel) or placebo in combination with chemotherapy (carboplatin + paclitaxel).

Before randomization, patients underwent specific tests, with 225 patients being mismatch repair-deficient (dMMR) and 591 patients being mismatch repair-proficient (pMMR).

The response to drug treatment in these two types of patients may differ. pMMR patients are typically insensitive to immunotherapy drugs and are more difficult to treat.

The primary endpoint of the study was progression-free survival (PFS), and secondary endpoints included overall survival, objective response rate, duration of response, safety, and health-related quality of life.

Research results:

Compared with chemotherapy alone, pembrolizumab in combination with chemotherapy significantly improved progression-free survival (PFS) and significantly reduced the risk of disease progression or death in patients with advanced or recurrent endometrial cancer, regardless of their mismatch repair status.

Specifically:

  • In the pembrolizumab in combination with chemotherapy group, the average PFS for the mismatch repair-deficient (dMMR) patient cohort did not reach the median during the 12-month average follow-up period, meaning that some patients did not experience disease progression or death during the observation period. The median PFS in the placebo group was 7.6 months. The hazard ratio was 0.30, indicating that pembrolizumab in combination with chemotherapy reduced the risk of disease progression or death by 70%.
  • In the pembrolizumab in combination with chemotherapy group, the average PFS for the mismatch repair-proficient (pMMR) patient cohort was 13.1 months during the 7.9-month average follow-up period, compared to 8.7 months in the placebo group. The hazard ratio was 0.54, indicating that pembrolizumab in combination with chemotherapy reduced the risk of disease progression or death by 46%.

Safety:

In terms of safety, the incidence of any grade adverse events (AEs) in the pembrolizumab combination therapy group was 98.2% for the mismatch repair-deficient (dMMR) patient cohort and 93.5% for the mismatch repair-proficient (pMMR) patient cohort. The incidence of grade 3 or higher AEs was 63.3% and 55.1%, respectively.

In the placebo group, the incidence of any grade AEs was 99.1% for the dMMR cohort and 93.4% for the pMMR cohort. The incidence of grade 3 or higher AEs was 47.2% and 45.3%, respectively.

“Endometrial cancer is a common type of gynecologic cancer, and for patients with advanced or recurrent disease, first-line treatment options are very limited. In this situation, the use of pembrolizumab may address the significant unmet medical needs of these patients,” said Ramez N. Eskander, Assistant Professor of Obstetrics, Gynecology, and Reproductive Sciences at the Moores Cancer Center, University of California, San Diego, in a press release.

“If approved, pembrolizumab will be the first approved immunotherapy for first-line treatment of advanced endometrial cancer, regardless of the patient’s mismatch repair status,” said Dr. Gursel Aktan, Vice President of Global Clinical Development at Merck Research Laboratories, in a press release.

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FDA Prioritizes Pembrolizumab for Advanced Endometrial Cancer


References:

[1]https://www.onclive.com/view/fda-grants-priority-review-to-pembrolizumab-plus-chemotherapy-in-endometrial-cancer
[2]https://www.merck.com/news/fda-grants-priority-review-to-mercks-application-for-keytruda-pembrolizumab-plus-chemotherapy-as-treatment-for-primary-advanced-or-recurrent-endometrial-carcinoma/

(source:internet, reference only)

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