GSK PLC - GSK STOCK NEWS

GSK announced that the US FDA has expanded the approval of Jemperli (dostarlimab-gxly) in combination with chemotherapy for treating adult patients with primary advanced or recurrent endometrial cancer. This approval now includes MMRp/MSS tumors, representing 70-75% of endometrial cancer cases. The decision is based on the RUBY phase III trial results, which showed a 31% reduction in the risk of death compared to chemotherapy alone. At the 2.5-year mark, 61% of patients in the Jemperli plus chemotherapy group were alive compared to 49% in the chemotherapy-only group. The median overall survival improved by 16.4 months with Jemperli plus chemotherapy. This makes Jemperli the first and only immuno-oncology-based treatment to demonstrate an overall survival benefit in this patient population.

GSK has initiated the shipment of its trivalent influenza vaccines, FLULAVAL and FLUARIX, for the 2024-25 flu season across the US. This follows the FDA's licensing and lot-release approval, aligning with WHO's recommendation for the removal of the B/Yamagata strain. The vaccines will contain strains A/Victoria/4897/2022 (H1N1)pdm09-like virus, A/Thailand/8/2022 (H3N2)-like virus, and B/Austria/1359417/2021 (B/Victoria lineage)-like virus. GSK anticipates distributing over 36 million doses and the vaccines are suitable for individuals aged six months and older. The CDC underscores annual flu vaccination as the optimal protection against influenza, with vaccination ideally completed by the end of October.

The US FDA has approved GSK's AREXVY for preventing RSV lower respiratory tract disease (LRTD) in adults aged 50-59 at increased risk. Previously, the vaccine was only approved for those 60+. Over 13 million US adults aged 50-59 have medical conditions that heighten their risk of severe RSV outcomes, such as COPD, asthma, heart failure, and diabetes. A phase III trial supported this approval, showing positive immune responses and safety in the targeted age group. GSK has also submitted regulatory filings in Europe, Japan, and other regions. Data from ongoing trials in adults 18+ are expected in H2 2024.

GSK announced updated results from a phase II study evaluating Jemperli (dostarlimab-gxly) for treating mismatch repair deficient (dMMR) locally advanced rectal cancer. The trial, conducted with Memorial Sloan Kettering Cancer Center, showed a 100% clinical complete response (cCR) in 42 patients. The results, presented at the 2024 ASCO Annual Meeting, indicate no evidence of disease with a median follow-up of 26.3 months for the first 24 evaluated patients. The study highlights the potential of Jemperli as a non-surgical, first-line treatment option, addressing the negative impacts of current standard treatments. GSK is also advancing further studies, including AZUR-1 and AZUR-2 clinical trials, to evaluate Jemperli in various colorectal cancers.

GSK announced positive interim results from the DREAMM-8 phase III trial, showing that the combination of belantamab mafodotin, pomalidomide, and dexamethasone (PomDex) significantly reduced the risk of disease progression or death by nearly 50% compared to a standard of care combination in relapsed/refractory multiple myeloma. The median progression-free survival (PFS) was not yet reached at a 21.8-month median follow-up for the belantamab mafodotin combination versus 12.7 months for the bortezomib combination. Additionally, the PFS benefit was observed across all pre-specified subgroups, including high-risk patients. Although a positive trend in overall survival (OS) was noted, it was not statistically significant at this interim analysis. Safety profiles were consistent with known profiles of the individual agents, and common adverse events included neutropenia and ocular symptoms. These findings, presented at the 2024 ASCO Annual Meeting and published in the NEJM, support the potential of belantamab mafodotin in redefining treatment for multiple myeloma at or after first relapse.

GSK announces positive results from the RUBY phase III trial for dostarlimab-gxly in combination with chemotherapy and niraparib for endometrial cancer. The trial shows significant improvements in overall survival and progression-free survival in the overall population and MMRp/MSS population.

GSK announces $2 million commitment in 2024 to boost adult immunization rates and health equity under COiMMUNITY Initiative. New resources and data show adult vaccination rates returning to pre-pandemic levels.

Elsie Biotechnologies, Inc. announces GSK's licensing of their discovery platform after a successful research collaboration, potentially leading to development and commercial milestones. The agreement allows GSK to utilize Elsie's platform for oligonucleotide drug discovery, showcasing the platform's potential for next-generation RNA medicines.

GSK plc has announced that the US FDA has accepted an application to extend the indication of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. If approved, this would be the first vaccine available to help protect this population. The application is supported by positive results from a phase III trial evaluating the immune response and safety of the RSV vaccine in adults aged 50-59. The US FDA has set a Prescription Drug User Fee Act action date of June 7, 2024.