On April 24, the FDA granted Priority Review to the supplemental Biologics License Application (sBLA) for GSK’s Jemperli (dostarlimab) in combination with standard of care (SOC) chemotherapy for the treatment of adult patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient (MMRp)/microsatellite stable (MSS) status, which is a severely underserved patient population. The sBLA approval is based on the success of the Phase III RUBY Part I trial and places Jemperli in direct competition with Merck & Co’s Keytruda (pembrolizumab), the blockbuster agent of the same immune checkpoint inhibitor (ICI) class.

Jemperli is a monoclonal antibody targeting PD-1, an inhibitory immunological checkpoint receptor, which activates an anti-tumor immune response during cancer treatment. Jemperli has already been approved in combination with SOC chemotherapy, followed by Jemperli as monotherapy, for the treatment of recurrent or advanced endometrial cancer adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) status.

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In the Phase III RUBY Part I trial, the combination of Jemperli with SOC chemotherapy versus chemotherapy alone demonstrated a significant reduction in the risk of death by 31% and an extended median overall survival (mOS) by 16.4 months (44.6 months versus 28.2 months) in the overall population. A similar trend was observed in the MMRp/MSS population with a clinically meaningful reduced risk of death by 21% and improved mOS by seven months (34.0 months versus 27.0 months). Based on these results, Jemperli’s current approval could expand from exclusively the dMMR-MSI-H population to all primary advanced or recurrent endometrial cancer patients as another first-line treatment option, and will exceed the projected total global sales of $727m by 2030, according to GlobalData’s analyst consensus forecast.

Currently, Keytruda is approved for use as monotherapy in the same patient population of advanced dMMR or MSI-H endometrial cancer patients and in combination with Eisai’s Lenvima (Lenvatinib) for the second-line treatment of patients with MMRp advanced endometrial cancer. Despite Jemperli’s potential encroachment in the first-line MMRp/MSS patient population, Keytruda in combination with chemotherapy may soon follow. After Jemperli with SOC chemotherapy was approved as the first PD-1 inhibitor in the first-line dMMR-MSI-H setting, Keytruda quickly followed with a positive readout and approval in the same setting with the Phase III NRG-GY018 trial. The results showed a significantly improved progression-free survival (PFS) regardless of MMR status in advanced or recurrent metastatic endometrial cancer patients with a PFS of 74% in the dMMR cohort and a median PFS of 13.1 months in the MMRp cohort. However, the interim analysis revealed a mOS of 28.0 months with Keytruda versus 27.4 months with placebo for the MMRp cohort, where the mOS was not reached in either arm for the dMMR cohort. No unexpected new side effects were observed for either ICI. These studies highlight the clear benefit of adding an ICI to the SOC in the treatment of endometrial cancer and a significant improvement over the current SOC. Jemperli may be able to drive a longer OS in the overall population, but a head-to-head comparison of the checkpoint inhibitors would be required to support this conclusion.

Jemperli currently presents as a looming threat to Keytruda in endometrial cancer. However, Keytruda’s sales, which GlobalData forecasts to reach $22.7bn by 2030, are not likely to be affected by this impingement given the fact that Keytruda is currently approved for use in 39 indications.

Note: The last paragraph has been updated to reflect the correct number of indications in which Keytruda is approved.

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