The GSK plc (LON: GSK) share price traded sideways after the global pharmaceuticals company announced that it had received marketing authorisation from the European Commission (EC) for Jemperli (dostarlimab) in combination with carboplatin-paclitaxel (chemotherapy).
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The two drugs have been approved to treat adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.
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The approval of Jemperli by the European Commission (EC) is based on a thorough analysis of interim data derived from the dMMR/MSI-H (mismatch repair-deficient/microsatellite instability-high) population in Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III clinical trial.
This analysis encompassed a robust median follow-up duration of at least 25 months. The trial successfully met its primary endpoint: the evaluation of progression-free survival (PFS) as assessed by investigators.
The trial results showcased a statistically significant and clinically significant advantage in patients treated with Jemperli in conjunction with carboplatin and paclitaxel within the dMMR/MSI-H population.
Notably, there was a remarkable 72% reduction in the risk of disease progression or mortality compared to patients receiving chemotherapy alone (Hazard Ratio: 0.28 [95% Confidence Interval: 0.16-0.50]).
Furthermore, pre-planned exploratory analysis of overall survival (OS) within the dMMR/MSI-H population demonstrated a 70% reduction in the risk of death when Jemperli was added to the chemotherapy regimen compared to chemotherapy alone (Hazard Ratio: 0.30 [95% Confidence Interval: 0.13-0.70]).
These compelling findings were presented at the European Society for Medical Oncology (ESMO) Virtual Plenary and the Society of Gynecologic Oncology (SGO) Annual Meeting on March 27, 2023. Simultaneously, they were published in The New England Journal of Medicine.
Hesham Abdullah, Senior VP, Global Head Oncology, R&D, GSK, said: “People living with this type of endometrial cancer typically experience disease progression and poor long-term outcomes with the current standard of care. With this approval, we can expand the number of patients who can potentially benefit from treatment with Jemperli in Europe, including patients who are earlier in their journey. We are proud of the recent approvals for Jemperli as we believe that it continues to transform the frontline endometrial cancer treatment landscape and shows promise as a foundational immuno-oncology therapy.”
GSK share price.
The GSK share price traded sideways after receiving EU approval for its Jemperli cancer drug.
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