20th Jan 2025 08:40
(Alliance News) - GSK PLC on Monday said the European Commission has expanded approval for its drug Jemperli, in combination with chemotherapy, to include all adult patients with primary advanced or recurrent endometrial cancer eligible for systemic therapy.
The Brentford, England-based pharmaceutical and biotechnology firm said that the expanded indication includes patients with mismatch repair proficient or microsatellite stable tumours, which account for approximately 75% of endometrial cancer cases.
The approval is based on results from the Ruby phase III trial, which showed that Jemperli plus chemotherapy extended median overall survival to 44.6 months, compared to 28.2 months with chemotherapy alone. The trial demonstrated a 31% reduction in the risk of death for patients receiving the combination therapy.
"For the first time, all patients with primary advanced or recurrent endometrial cancer in the EU have an approved immuno-oncology-based treatment that has shown a statistically significant and clinically meaningful overall survival benefit. We are proud Jemperli continues to redefine the treatment landscape for patients," said Hesham Abdullah, GSK's global head of Oncology.
Endometrial cancer, the most common gynecologic cancer in developed countries, affects over 121,000 people in Europe annually. Approximately 15% to 20% of cases are diagnosed at an advanced stage.
Jemperli, a PD-1 blocking antibody, is also approved in the US for a similar indication. GSK said the drug forms the backbone of its ongoing immuno-oncology research, which includes investigations in gynaecologic, colorectal, and lung cancers.
Shares in GSK were 0.8% up at 1,369.32pence each in London on Monday morning.
By Eva Castanedo, Alliance News reporter
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