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Positive phase III RUBY results for Jemperli
Positive phase III RUBY results for Jemperli.
About this update from Gsk Plc
[{"type":"text","content":"\n \n \n Issued: 27 March 2023, London UK\n \n \n \n \n \n \n \n \n Phase III RUBY clinical trial demonstrates potential of Jemperli (dostarlimab) plus chemotherapy to redefine the treatment of primary advanced or recurrent endometrial cancer versus chemotherapy alone\n \n \n \n ·\n 72% and 36% reduction in the risk of disease progression or death observed in the dMMR/MSI-H population and overall patient population, respectively\n \n \n ·\n Clinically meaningful overall survival trend observed at interim analysis\n \n \n ·\n Results presented in same-day presentations at ESMO Virtual Plenary and SGO Annual Meeting and simultaneously published in TheNew England Journal of Medicine\n \n \n ·\n Regulatory submissions planned for the first half of 2023\n \n \n \n \n \n \n \n \n \n GSK plc (LSE/NYSE: GSK) today announced interim results from Part 1 of the RUBY\n /\n ENGOT-EN6/GOG3031/NSGO phase III trial investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer.\n \n \n \n \n \n \n Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK\n \n said: \"These positive results from the RUBY trial bring us one step closer to addressing the significant unmet needs of endometrial cancer patients and add to the growing body of evidence on dostarlimab, strengthening our belief in its potential to transform cancer treatment as a backbone immuno-oncology therapy.\" \n \n \n \n \n \n A statistically significant and clinically meaningful improvement in progression free survival (PFS) was observed for dostarlimab plus carboplatin-paclitaxel in the mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) population (n=118) and in the overall population (n=494) versus placebo plus chemotherapy.\n The separation of the lines in the Kaplan-Meier curve below illustrates the significant reduction in risk of disease progression or death in patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in the dostarlimab plus chemotherapy treatment arm compared to the placebo plus chemotherapy treatment arm.\n \n \n \n \n \n \n \n \n \n Dr Mansoor Raza Mirza, Chief Oncologist, Copenhagen...