FDA Expands Label for GSK's Jemperli in First-Line Endometrial Cancer

GSK has announced that the FDA has extended the approval of Jemperli (dostarlimab-gxly) to include patients with mismatch repair proficient (MMRp) or microsatellite stable (MSS) tumors in the front-line treatment of endometrial cancer. This anti-PD-1 antibody, previously approved in the US and Europe for patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) advanced or recurrent endometrial cancer, is now positioned to compete with Merck's Keytruda (pembrolizumab) for first-line treatment of endometrial cancer, irrespective of mismatch repair status.

The expanded approval of Jemperli is supported by promising results from the Phase III RUBY trial, which included 787 participants. The trial consisted of two parts: the first evaluated the combination of Jemperli with carboplatin-paclitaxel followed by Jemperli against chemotherapy alone. The dual endpoints assessed were progression-free survival (PFS) and overall survival (OS). Data released in March last year showed a substantial reduction in disease progression or death risk by 72% in the dMMR/MSI-H patient group and by 36% in the overall patient population, which led to Jemperli's earlier approval for patients with dMMR/MSI-H.

New overall survival data from the RUBY trial indicated a 31% reduction in the risk of death in the overall population treated with Jemperli compared to those receiving chemotherapy alone. At the 2.5-year checkpoint, 61% of patients treated with Jemperli were still alive compared to 49% in the chemotherapy-only group. Moreover, the combination of Jemperli and chemotherapy resulted in a median overall survival improvement of 16.4 months over chemotherapy alone.

Hesham Abdullah, global head of oncology R&D at GSK, emphasized the significance of this new treatment option for patients with MMRp/MSS tumors, who represent 70% to 75% of all endometrial cancer cases. “Jemperli plus chemotherapy is the first and only immuno-oncology regimen to show significant and meaningful improvement in overall survival, regardless of biomarker status,” said Abdullah.

Jemperli was developed in collaboration with AnaptysBio and received its first FDA approval in 2021 for patients with advanced or recurrent dMMR endometrial cancer unresponsive to platinum-based treatments. Along with Zejula (niraparib) and Ojjaara/Omjjara (momelotinib), Jemperli continues to be a key growth driver for GSK's oncology portfolio, generating £108 million ($137.5 million) in global sales in the latest quarter.

This expanded approval of Jemperli represents a significant advancement in the treatment of endometrial cancer, particularly for the majority of patients whose tumors are MMRp/MSS. It also solidifies Jemperli's position as a formidable competitor in the immuno-oncology landscape, offering hope for improved survival outcomes in a broader patient population.

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