GSK Will Seek Expanded Use for Jemperli

GSK says it plans to submit a BLA supplement by 7/1 after reporting interim results from its RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 trial investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer. Trial data, according to the company, showed a “statistically significant and clinically meaningful improvement in progression-free survival…”

After first obtaining accelerated approval, GSK earlier this year was granted full approval for Jemperli and its use in adult patients with dMMR recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation (see earlier story).