GSK plc (LSE/NYSE: LON:GSK), a prominent global pharmaceutical company with a market capitalization of $67.94 billion and currently trading below its InvestingPro Fair Value, received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the expansion of Jemperli (dostarlimab) usage combined with chemotherapy for treating endometrial cancer, the company announced today.
The CHMP's recommendation could potentially broaden the treatment to include a larger patient group suffering from primary advanced or recurrent endometrial cancer.
The favorable opinion is based on the phase III RUBY trial, which showed statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for patients receiving the combination of dostarlimab and chemotherapy, compared to chemotherapy alone.
This opinion is one of the final steps before the European Commission makes a marketing authorization decision, expected in the first quarter of 2025.
The RUBY trial's results were significant because they included patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, which account for 70-75% of endometrial cancer cases and typically have limited treatment options. The safety profile of the combined treatment was consistent with the known profiles of the individual agents.
In the United States, Jemperli's label was already expanded in August 2024 to include all adult patients with primary advanced or recurrent endometrial cancer. Endometrial cancer is the most common gynecologic cancer in developed countries, and its incidence is expected to rise by approximately 40% between 2020 and 2040.
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody and forms the backbone of GSK's immuno-oncology research and development program. The drug is currently being studied in various cancers, including gynecologic, colorectal, and lung cancers.
The RUBY trial is a part of an international collaboration between the European Network of Gynaecological Oncological Trial groups and the GOG Foundation, which aims to improve the standard of care in gynecologic oncology through cooperative clinical trials.
GSK is a global biopharma company focused on uniting science, technology, and talent to combat diseases. With a robust gross profit margin of 72.39% and revenue growth of 5.59% over the last twelve months, the company maintains a strong financial position. According to InvestingPro, GSK demonstrates GREAT overall financial health with a score of 3.15, and offers a compelling dividend yield of 4.5%. This news is based on a press release statement and the company's SEC filing.
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In other recent news, GSK has announced strategic developments, including an extended vaccine partnership in China until 2034 with Chongqing Zhifei Biological Products Co., Ltd.
This collaboration focuses on the commercialization of GSK's shingles vaccine, Shingrix. The deal could potentially be worth up to £2.3 billion to GSK from 2024 to 2029.
In Japan, GSK's respiratory syncytial virus (RSV) vaccine, Arexvy, has been approved for adults aged 50-59. The company also reported positive results from its phase III GLISTEN trial of linerixibat, a drug aimed at treating cholestatic pruritus in patients with primary biliary cholangitis. However, financial analysts from Jefferies and Guggenheim have downgraded GSK's stock due to expectations of subdued growth in 2025.
In addition, HUTCHMED has announced the appointment of a new independent non-executive director to enhance the company's governance and strategic planning.
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