PHILADELPHIA - GSK plc (LSE/NYSE: GSK) has announced the FDA approval of Jemperli (dostarlimab-gxly) in combination with chemotherapy for the treatment of adult patients with primary advanced or recurrent endometrial cancer. This expanded approval includes patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, which account for the majority of endometrial cancer cases and have historically had limited treatment options.
The decision by the FDA was based on results from the RUBY phase III trial, which demonstrated a 31% reduction in the risk of death when Jemperli plus chemotherapy was used, compared to chemotherapy alone. At the 2.5-year landmark, the survival rate was higher for patients treated with the Jemperli regimen (61%) versus those who received chemotherapy only (49%). The median overall survival improved by 16.4 months with the Jemperli combination therapy, indicating significant benefits for patients.
The safety profile of Jemperli combined with carboplatin and paclitaxel was generally consistent with the known safety profiles of the individual agents. The most common adverse events included nausea, fatigue, and anemia, among others.
Hesham Abdullah of GSK highlighted that Jemperli plus chemotherapy is the first immuno-oncology regimen to show a significant improvement in overall survival for endometrial cancer patients regardless of biomarker status. Dr. Matthew Powell, the US principal investigator of the RUBY trial, noted the expanded approval as a meaningful step forward in treating this challenging cancer.
Adrienne Moore, a survivor and president of the Endometrial Cancer Action Network for African-Americans (ECANA), expressed hope for patients and families with this new treatment option now available to a broader patient group in the US.
Endometrial cancer is the most common gynecologic cancer in developed countries, with rising incidence rates expected. The RUBY trial is part of an international collaboration aimed at improving clinical outcomes for patients with this condition.
Jemperli, a PD-1-blocking antibody, is at the forefront of GSK's research and development program in immuno-oncology. The drug was discovered by AnaptysBio (NASDAQ:ANAB), Inc. and licensed to TESARO, Inc., with GSK now responsible for its ongoing development and manufacturing.
Today's news reflects GSK's commitment to advancing treatments in oncology, focusing on delivering breakthroughs in immuno-oncology and tumor-cell targeting therapies. This information is based on a press release statement.
In other recent news, GlaxoSmithKline PLC (NYSE:GSK) reported a strong second-quarter performance, with a 13% increase in sales to £7.9 billion and a 21% rise in core operating profit to £2.5 billion. This led to an upgraded full-year guidance due to robust performance across all product areas, particularly in specialty medicines and vaccines.
InvestingPro Insights
The FDA's approval of GSK's Jemperli for the treatment of endometrial cancer represents a significant step forward for the pharmaceutical giant and could potentially impact its financial performance. Reflecting on GSK's recent financial metrics, the company boasts a robust market capitalization of $78.64 billion USD, underscoring its stature in the pharmaceutical industry. Furthermore, GSK's P/E ratio stands at a favorable 15.37, with an adjusted P/E ratio of 9.39 for the last twelve months as of Q2 2024, which may signal an attractive valuation for investors.
From a profitability standpoint, GSK's revenue growth has been positive, with a 7.2% increase over the last twelve months as of Q2 2024 and a quarterly revenue growth of 9.84% in Q2 2024. This top-line growth is complemented by a strong gross profit margin of 72.78%, indicating the company's efficiency in managing its cost of goods sold.
InvestingPro Tips highlight that GSK has maintained dividend payments for 24 consecutive years, which could be an important consideration for income-focused investors. Additionally, analysts have revised their earnings upwards for the upcoming period, suggesting confidence in GSK's future performance. For investors seeking more detailed analysis and additional insights, there are 9 more InvestingPro Tips available on GSK at https://www.investing.com/pro/GSK.
These financial insights and expert analyses could provide valuable context for investors considering GSK's stock, particularly as the company continues to make strides in its immuno-oncology research and development program.
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