Tuesday, July 16, 2024

Endometrial Carcinoma Treatment Advances with FDA Approval of Keytruda Combo

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The U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) in combination with carboplatin and paclitaxel for treating adult patients with primary advanced or recurrent endometrial carcinoma. This significant approval marks the third indication for Keytruda in endometrial carcinoma and the 40th indication overall for Keytruda in the United States, highlighting its expanding role in cancer treatment.

The FDA’s approval is based on data from the Phase 3 NRG-GY018 trial, also known as Keynote-868. The study demonstrated that Keytruda, when combined with carboplatin and paclitaxel and followed by Keytruda alone, significantly reduced the risk of disease progression or death. Specifically, there was a 40% reduction in patients with mismatch repair proficient (pMMR) cancer and a 70% reduction in patients with mismatch repair deficient (dMMR) cancer compared to the placebo group receiving chemotherapy alone. These compelling results underscore the potential of Keytruda as an effective treatment for this patient population.

Keytruda Enhances Survival in Advanced Endometrial Carcinoma

Principal investigator Dr. Ramez N. Eskander emphasized the trial’s success, stating, “The addition of pembrolizumab to chemotherapy represents a new frontline therapeutic option for patients with primary advanced or recurrent endometrial carcinoma.” In the trial, patients with pMMR cancer treated with Keytruda had a median progression-free survival (PFS) of 11.1 months, compared to 8.5 months in the placebo group. For patients with dMMR cancer, the median PFS was not reached in the Keytruda group versus 6.5 months in the placebo group, indicating a substantial improvement in disease management.

Keytruda’s safety profile includes potential immune-mediated adverse reactions, which can be severe or even fatal. These adverse reactions may affect any organ system and include conditions such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of hematopoietic stem cell transplantation. Healthcare providers must identify and manage these adverse reactions early to ensure patient safety. Depending on the severity, Keytruda treatment may need to be withheld or permanently discontinued, with corticosteroids administered as appropriate.

Endometrial Carcinoma

Phase 3 NRG-GY018 Trial Validates Keytruda Combo for Advanced Endometrial Carcinoma

The NRG-GY018 trial was a multicenter, randomized, double-blind, placebo-controlled Phase 3 study that enrolled 810 patients with advanced or recurrent endometrial carcinoma. The study design included two cohorts based on mismatch repair (MMR) status: 222 patients were in the dMMR cohort, and 588 were in the pMMR cohort. Eligible patients had measurable Stage III, IVA, IVB, or recurrent endometrial cancer and had not received prior systemic therapy or had a chemotherapy-free interval of at least 12 months if they had previously received adjuvant chemotherapy. The trial’s rigorous design and broad patient inclusion criteria enhance the reliability and applicability of the findings.

Dr. Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, highlighted the broader implications of this approval. “Endometrial cancer is now the most common gynecologic cancer in the U.S., and deaths from the disease are projected to surpass deaths from ovarian cancer in 2024. This approval represents the first and only anti-PD-1-based option for adult patients with primary advanced or recurrent endometrial carcinoma, regardless of mismatch repair status.” The combination of Keytruda with chemotherapy offers a new treatment paradigm, potentially improving outcomes for many patients with advanced or recurrent endometrial carcinoma.

 

Resource: Merck, June 17, 2024

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