HS-20093

Endometrial cancer originates in the endometrium, which is the inner lining of the uterus. Credit: megaflopp/Shutterstock. The European Commission (EC) has approved GSK’s Jemperli (dostarlimab) combined with chemotherapy that includes carboplatin and paclitaxel for the first-line treatment of primary advanced or recurrent endometrial cancer in adults. The decision extends the use of the combination in the European Union (EU) for individuals with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours. Such tumours account for 75% of individuals with endometrial cancer, and present limited treatment alternatives. The expanded approval is based on the outcomes from Part I of the RUBY Phase III trial – the only study in this setting to demonstrate statistically significant overall survival (OS) benefit across the complete subject population with this cancer type. A 31% decrease in the mortality risk is observed in the trial versus chemotherapy alone. GSK oncology, research and development global head and senior vice-president Hesham Abdullah stated: “For the first time, all patients with primary advanced or recurrent endometrial cancer in the EU have an approved immuno-oncology-based treatment that has shown a statistically significant and clinically meaningful overall survival benefit.” The dual-primary endpoints in Part I were investigator-assessed progression-free survival based on the Response Evaluation Criteria in Solid Tumours v1.1 and OS. At the two-and-a-half-year mark, the probability of survival was 61% for subjects who received the combination, as opposed to 49% for those receiving chemotherapy alone. A median OS improvement of 16.4 months was observed in the combination group compared to the chemotherapy group alone. The tolerability and safety profile for Jemperli combined with carboplatin-paclitaxel was consistent with the known safety profiles of the individual agents. Endometrial cancer originates in the endometrium, which is the inner lining of the uterus. In early January 2025, the company received the US Food and Drug Administration (FDA) breakthrough therapy designation (BTD) for its B7-H3-targeted antibody-drug conjugate, GSK’227, for treating adults with relapsed or refractory osteosarcoma after a minimum of two lines of previous therapy.

London: In a strategic move to enhance its cancer drug portfolio, GlaxoSmithKline (GSK) has entered into an agreement to acquire Boston-based clinical-stage biopharmaceutical company IDRx. The acquisition, valued at up to $1.15 billion, includes an upfront payment of $1 billion and the potential for an additional $150 million contingent on regulatory success. IDRx specialises in developing precision therapeutics for gastrointestinal stromal tumors (GIST), a type of soft tissue cancer. The acquisition will also involve GSK assuming responsibility for success-based milestone payments and tiered royalties related to IDRX-42, a selective KIT TKI, which is owed to Merck KGaA, Darmstadt, Germany. Tony Wood, Chief Scientific Officer, GSK, expressed excitement about IDRX-42, noting its potential to target all clinically relevant KIT mutations in GIST, filling a significant gap in current treatment options. Luke Miels, Chief Commercial Officer, GSK added that this acquisition aligns with GSK's strategy of acquiring assets that target validated therapeutic areas with clear unmet needs. GIST primarily affects the GI tract, with 80 per cent of cases driven by mutations in the KIT gene. Despite current treatments, patients often develop resistance mutations, leading to relapse and limited therapeutic options. The deal reflects GSK’s ambition to address these unmet needs and accelerate the development of innovative cancer treatments . Founded in 2022, IDRx has attracted investment from major backers such as Andreessen Horowitz, Blackstone, RA Capital, and Merck KGaA. Beyond this acquisition, GSK is advancing other promising cancer therapies, including dostarlimab and GSK5764227, which recently received breakthrough designations from the FDA for small-cell lung cancer and bone cancer. The acquisition of IDRx is expected to play a key role in GSK’s cancer strategy, which aims for significant growth through 2031 and beyond. By Online Bureau ,