GSK Phase 3 Trial for Jemperli Endometrial Cancer Treatment Met Primary Endpoint
December 02 2022 - 1:47AM
Dow Jones News
By Joe Hoppe
GSK PLC said Friday that a Phase 3 trial for its Jemperli
treatment for advanced or recurrent endometrial cancer met its
primary endpoint, showing meaningful improvement in
progression-free survival.
The pharmaceutical giant said Jemperli was investigated together
with standard-of-care chemotherapy. The trial also assessed the
performance of Jemperli when compared to chemotherapy with a
placebo, and a placebo, in patients with the cancer.
The trial showed a statistically significant and clinically
meaningful improvement in investigator-assessed progression-free
survival. The trial was the only first-line trial to show such an
improvement for an immuno-oncology therapy combined with
chemotherapy in endometrial cancer, GSK said.
While the overall survival data is immature at the time of
analysis, a favorable trend was observed in the overall population.
The safety and tolerability of Jemperli was consistent with
clinical trials of similar regimens, the company said.
Regulatory submissions based on the trial results are expected
in the first half of 2023.
The company separately said the European Medicines Agency has
validated the marketing authorization application for momelotinib,
its potential new oral treatment for myelofibrosis, based on
results from key Phase 3 trials. A Committee for Medicinal Products
for Human Use regulatory action is expected by the end of 2023.
Write to Joe Hoppe at joseph.hoppe@wsj.com
(END) Dow Jones Newswires
December 02, 2022 02:32 ET (07:32 GMT)
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