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Saturday, GSK plc (NYSE: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.
Part 2 tested Jemperli plus carboplatin-paclitaxel followed by Jemperli plus Zejula (niraparib) versus placebo plus carboplatin-paclitaxel followed by placebo.
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.
Photo via Shutterstock
Posted In: GSK