GSK Reveals New Phase 3 Data For Jemperli Combo Therapy To Support Expanded Use Approval For Wider Endometrial Cancer

Saturday, GSK plc GSK announced overall survival (OS) results from Part 1 and progression-free survival (PFS) results from Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial of Jemperli (dostarlimab) for primary advanced or recurrent endometrial cancer, paving the way for a potential label expansion beyond its current indication.

In 2023, the FDA approved Jemperli in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H). 

Part 1 tested Jemperli plus carboplatin-paclitaxel followed by Jemperli versus carboplatin-paclitaxel plus placebo followed by placebo.

• In part one, Jemperli met the overall survival (OS) co-primary endpoint in the overall population, achieving a median 16.4-month improvement versus control, with a 31% reduction in risk of death.
• The drug reached a median seven-month OS improvement in the subset of mismatch repair proficient and microsatellite stable patients and reduced the risk of death by 21%.

Part 2 tested Jemperli plus carboplatin-paclitaxel followed by Jemperli plus Zejula (niraparib) versus placebo plus carboplatin-paclitaxel followed by placebo. 

• Jemperli plus Zejula met the progression-free survival (PFS) co-primary endpoint in part two, achieving a median 6.2-month improvement versus control in the overall population. 
• The treatment regimen reached a median six-month PFS improvement in the subset of mismatch repair proficient and microsatellite stable patients.

GSK expects FDA regulatory submission acceptance based on RUBY Part 1 data for an expanded indication in the overall population in the first half of this year.

In its fiscal year 2023 earnings release, GSK said the oncology segment demonstrated strong growth driven by Jemperli and Zejula’s performance.

Jemperli generated 2023 sales of £141 million.

Price Action: GSK shares are up 0.24% at $42.298 on the last check Monday.

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