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Dostarlimab shows promise in improving endometrial cancer treatment outcomes

By Brian Buntz | March 28, 2023

Jemperli

[Image courtesy of GSK]

Endometrial cancer, a common gynecological malignancy, leaves considerable unmet needs for patients with advanced or recurrent disease. GSK‘s (NYSE:GSK) Jemperli (dostarlimab), a PD-1 receptor antagonist, brings hope to the numerous women diagnosed with this cancer each year. As the first immunotherapy approved for patients with deficient mismatch repair (dMMR) endometrial cancer, dostarlimab has the potential to shift the treatment landscape.

The addition of dostarlimab to chemotherapy has shown promising results, with a 72% and 36% reduction in the risk of disease progression or death observed in the dMMR/MSI-H population and overall patient population, respectively, compared to placebo plus chemotherapy.

The phase 3 RUBY clinical trial demonstrated the safety and tolerability of dostarlimab combined with the chemotherapy drugs carboplatin and paclitaxel. This combination may enhance endometrial cancer treatment by generating synergistic effects. Although the first interim analysis showed a meaningful overall survival (OS) trend, statistical significance was not achieved. GSK plans further analysis.

In the RUBY trial, the placebo group received chemotherapy plus a placebo. The trial revealed a significant improvement in progression-free survival (PFS) for both the dMMR/microsatellite instability-high (MSI-H) population and the overall population. Severe and serious treatment-emergent adverse events (TEAEs) increased by 10% with dostarlimab plus carboplatin-paclitaxel compared to placebo. However, immune-related adverse events (irAEs) were consistent with dostarlimab’s mechanism of action and similar to those reported for other PD-(L)1 inhibitors. These results were presented at the SGO annual meeting’s virtual plenary. The New England Journal of Medicine also published the results.

Patients in the study had either primary advanced stage III or IV or first recurrent endometrial cancer. Dr. Mansoor Raza Mirza, the RUBY trial’s principal investigator, stated that the RUBY clinical trial results represent a significant breakthrough in endometrial cancer treatment after decades of stagnation. GSK seeks to make dostarlimab the cornerstone of their immuno-oncology research and development program, both as a standalone treatment and in combination with standard and novel cancer therapies.

GSK is also investigating dostarlimab in registrational-enabling studies for patients with primary advanced or recurrent endometrial cancer, stage III or IV non-mucinous epithelial ovarian cancer, and other advanced solid tumors or metastatic cancers. The RUBY trial’s positive outcomes emphasize the potential of dostarlimab and other pipeline therapies in transforming endometrial cancer treatment. Ongoing research and development of new treatment options are essential to address the challenges and unmet needs in this field.

In addition to the promising potential of dostarlimab, several other treatments are under development for endometrial cancer. Investigational therapies such as the lenvatinib-pembrolizumab combination, developed by Eisai (TYO:4523) and Merck (NYSE:MRK), and the PARP inhibitor niraparib, developed also from GSK, show potential in addressing unmet needs in endometrial cancer treatment. These therapies, combined with continued advancements in immunotherapy and targeted therapy, could lead to an evolving landscape of treatment options for patients.


Filed Under: clinical trials, Drug Discovery, Oncology
Tagged With: deficient mismatch repair (dMMR), dostarlimab, Eisai, Endometrial cancer, GSK, Jemperli, lenvatinib-pembrolizumab combination, Merck, metastatic cancers, RUBY clinical trial
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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