The Food and Drug Administration (FDA) has approved a new treatment regimen for adult patients with primary advanced or recurrent endometrial cancer (EC). This approval includes the combination of dostarlimab-gxly (Jemperli, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly. This regimen was previously approved for patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) EC.
Image Source: Vinoth Khandelwal
Dostarlimab-gxly is an anti-PD-1 monoclonal antibody that works by blocking the PD-1 receptor, thereby enhancing the body’s immune response against cancer cells. The recommended dosage is 500 mg every three weeks for six cycles with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every six weeks until disease progression or unacceptable toxicity, for up to three years. It is crucial to administer dostarlimab-gxly before chemotherapy on the same day.
The efficacy and safety of this combination were evaluated in the RUBY trial (NCT03981796), a randomized, multicenter, double-blind, placebo-controlled study involving 494 patients with primary advanced or recurrent EC. Participants were randomized (1:1) to receive either dostarlimab-gxly with carboplatin and paclitaxel, followed by dostarlimab-gxly, or a placebo regimen. The trial stratified patients by MMR/MSI status, prior external pelvic radiotherapy, and disease status (recurrent, primary Stage III, or primary Stage IV).
The major efficacy outcome measures were progression-free survival (PFS) and overall survival (OS). In the overall population, dostarlimab-gxly demonstrated a statistically significant improvement in OS, with a median of 44.6 months compared to 28.2 months in the placebo group (Hazard Ratio=0.69). Median PFS was 11.8 months for the dostarlimab-gxly group, compared to 7.9 months for the placebo group (Hazard Ratio=0.64).
This application benefited from the FDA’s expedited programs, receiving priority review and approval three weeks ahead of the goal date. The review utilized the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s evaluation process.
The expanded indication for dostarlimab-gxly in combination with carboplatin and paclitaxel, followed by monotherapy, marks a significant advancement in the treatment options for patients with primary advanced or recurrent endometrial cancer. This approval provides a new therapeutic approach that improves both progression-free and overall survival for patients facing this challenging condition.
Dr. Vinoth Khandelwal, Ph.D.
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