GSK plc (LSE/NYSE: LON:GSK) announced today that the European Medicines Agency (EMA) has accepted its application to extend the use of Jemperli (dostarlimab) in combination with chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer. The EMA's review process is underway, with potential approval anticipated in the first half of 2025.
The current EU approval for Jemperli, in combination with carboplatin and paclitaxel, is limited to patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer. The proposed expansion would include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, a group for which no frontline immuno-therapy-based treatments are approved in the EU.
This regulatory submission is backed by data from Part 1 of the phase III RUBY trial, which met its primary endpoints of progression-free survival (PFS) and overall survival (OS). The trial showed statistically significant and clinically meaningful outcomes in patients treated with dostarlimab plus carboplatin-paclitaxel compared to chemotherapy alone.
Notably, RUBY Part 1 is the only clinical trial to demonstrate a statistically significant OS benefit in this broader patient demographic. The safety profile of the combined treatment was consistent with the known profiles of the individual medications.
Endometrial cancer is the most common gynecologic malignancy in developed countries, with a rising incidence expected. In Europe, approximately 121,000 individuals are diagnosed annually with primary advanced or recurrent endometrial cancer, with 70-75% of these tumors being MMRp/MSS.
Jemperli is a PD-1-blocking antibody and forms the foundation of GSK's immuno-oncology research and development efforts. It is the first immuno-oncology treatment approved in combination with chemotherapy for dMMR/MSI-H endometrial cancer in the frontline setting.
In the US, Jemperli is approved for use in combination with chemotherapy for dMMR primary advanced or recurrent endometrial cancer and as a monotherapy for dMMR recurrent or advanced endometrial cancer following a platinum-containing regimen. Additionally, Jemperli is approved for dMMR recurrent or advanced solid tumors that have progressed following prior treatment with no satisfactory alternative options.
This news is based on a press release statement.
In other recent news, GlaxoSmithKline (NYSE:GSK) has been making headlines with a series of noteworthy developments.
GSK reported a 13% increase in sales to £7.4 billion in the first quarter, along with significant growth in core operating profit and earnings per share. The company's diverse product portfolio, particularly in vaccines and specialty medicines, contributed to this performance. GSK also upgraded its full-year guidance, expecting another year of substantial growth for shareholders.
In a significant scientific breakthrough, GSK reported a 100% clinical complete response rate in patients treated with Jemperli (dostarlimab-gxly) as part of a phase II study conducted in collaboration with Memorial Sloan Kettering Cancer Center.
Goldman Sachs (NYSE:GS) recently initiated coverage on GSK, issuing a neutral rating with a price target of £18.50. The firm acknowledged GSK's successful shift from a conglomerate to a company focused on specialty medicines and vaccines, but noted that the current market valuation already reflects this progress.
The company is also facing legal action from Valisure, an independent laboratory based in Connecticut, over allegations that GSK concealed cancer risks associated with its heartburn medication, Zantac. The lawsuit, which seeks billions of dollars in damages, accuses GSK of defrauding U.S. government health programs by hiding the risks for nearly four decades. The future of related litigation remains uncertain, with more than 70,000 private lawsuits still pending in U.S. courts.
InvestingPro Insights
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The company's next earnings date is slated for July 31, 2024, which will be a key event for investors monitoring GSK's performance and future outlook. As the market anticipates these results, the insights provided by InvestingPro could be instrumental in shaping investment strategies.
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