2024-12-16 18:19:00
The European and American drug agencies have given a favorable opinion on 3 new therapies developed by GSK for the treatment of endometrial, rectal and lung cancers.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) – informs the pharmaceutical company – has expressed a favorable opinion on the first-line indication of dostarlimab in combination with chemotherapy (carboplatin and paclitaxel) for the treatment of all adult patients with advanced or recurrent primary endometrial cancer who are candidates for systemic therapy. This would include patients with mismatch repair proficient (Mmrp)/microsatellite stable (Mss) tumors, which account for 70-75% of endometrial cancer diagnoses and who have limited treatment options. Marketing authorization from the European Commission is expected in the first quarter of 2025. The application to expand the use of dostarlimab is based on results from Part 1 of the phase III Ruby study, which met 2 endpoints primary progression-free survival (Pfs) and overall survival (OS), demonstrating a statistically and clinically significant benefit in the entire population of patients treated with dostarlimab plus carboplatin-paclitaxel compared to chemotherapy alone. Dostarlimab in combination with chemotherapy is the only immuno-oncology-based regimen to show a statistically significant OS benefit in this patient population. Safety and tolerability analyzes in the Ruby trial showed a safety profile for dostarlimab plus carboplatin-paclitaxel that was consistent with known safety profiles of the individual agents.
The EMA has also granted ‘Priority medicines’ (Prime) designation for Gsk5764227 (Gsk’227), the antibody-drug conjugate (ADC) targeting B7-H3 being evaluated for the treatment of patients with advanced lung cancer. small cells in extensive relapsing stage (Es-Sclc). Prime designation supports the development of medicines that potentially offer an important therapeutic benefit to patients. This designation, in this case, is supported by preliminary clinical data from the Artemis-001 study. This is a phase I, open-label, multicenter study of more than 200 patients evaluating safety, tolerability, and preliminary antitumor activity in locally advanced or metastatic solid tumors, including relapsed Es-Sclc, led by Hansoh Pharma. Efficacy and safety results from this study were presented at the 2024 World Lung Cancer Conference earlier this year. GSK recently initiated a global Phase I study to support a registration pathway for GSK’227.
Finally, the US Food and Drug Administration (FDA) granted breakthrough therapy designation to dostarlimab for the treatment of patients with locally advanced rectal cancer with mismatch repair (dMmr) deficiency/microsatellite instability-high (Msi-H). The Breakthrough Therapy Designation aims to accelerate the development and review of drugs with the potential to treat a serious condition and where preliminary clinical evidence indicates a substantial improvement over currently available therapy.
#Tumors #approval #therapies #endometrial #rectal #lung #cancers