FDA Approval Insights: Dostarlimab Plus Chemotherapy in dMMR/MSI-H Advanced Endometrial Cancer


Dr Mirza discusses the FDA approval of dostarlimab plus chemotherapy in patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer; key efficacy and safety findings from the RUBY trial, and ongoing research investigating the role of frontline immune checkpoint inhibitors in patients with endometrial cancer.

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Mansoor Raza Mirza, MD, about the FDA approval of dostarlimab-gxly (Jemperli) in combination with chemotherapy in patients with mismatch repair–deficient (dMMR) or microsatellite instability–high (MSI-H) primary advanced or recurrent endometrial cancer. Dr Mirza is a chief oncologist in the Department of Oncology at Copenhagen University Hospital in Denmark.

On July 31, 2023, the FDA granted approval to dostarlimab plus carboplatin and paclitaxel, followed by dostarlimab monotherapy, for adult patients with primary advanced or recurrent dMMR or MSI-H endometrial cancer. This regulatory decision was backed by findings from an interim analysis of part 1 of the phase 3 RUBY trial (NCT03981796), in which the estimated 24-month progression-free survival rate with dostarlimab in the dMMR/MSI-H population was 61.4% (95% CI, 46.3%-73.4%) vs 15.7% (95% CI, 7.2%-27.0%) with placebo.

In our exclusive interview, Dr Mirza discussed the significance of this approval, key efficacy and safety findings from RUBY, and ongoing research investigating the role of frontline immune checkpoint inhibitors in patients with endometrial cancer.


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