GSK plc American Depositary Shares (Each representing two Ordinary Shares) - GSK STOCK NEWS

GSK announced new data from the AReSVi-006 phase III trial evaluating the efficacy and safety of AREXVY, its Respiratory Syncytial Virus (RSV) vaccine, in adults aged 60 years and older over three full RSV seasons. The results show:

- Cumulative efficacy over three seasons: 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD

- Third season efficacy: 48.0% against RSV-LRTD

- Safety and reactogenicity data consistent with previous results

The vaccine demonstrated efficacy against different RSV subtypes, in adults aged 70-79, and those with certain underlying medical conditions. GSK will continue to share data with recommending bodies to inform decisions on immunization schedules and future revaccination.

GSK announced positive topline data from a phase 3 trial evaluating the co-administration of AREXVY (RSV vaccine) and SHINGRIX (shingles vaccine) in adults 50 years and older. The study met its primary endpoint, showing a non-inferior immune response when the vaccines were given together compared to separate administration. Co-administration was well-tolerated with acceptable safety profiles.

Key findings include:

• Comparable immune responses in co-administration and separate administration groups
• Most common adverse events: injection site pain, fatigue, and myalgia
• Similar duration of adverse events across groups

GSK plans to submit these results to support regulatory submissions to the FDA, EMA, and other regulators. The company aims to reduce barriers to adult immunization by potentially decreasing the number of healthcare visits required for vaccination.

GSK plc (LSE/NYSE: GSK) has partnered with Brooke Shields for its THRIVE@50+ campaign, aiming to educate adults 50 and older about their shingles risk and the importance of vaccination. Shields, at 59, directs a short film featuring other celebrities and influencers over 50, discussing the power of aging and health protection. The campaign highlights that 99% of people over 50 are at risk for shingles, with about 1 million cases annually in the US.

The initiative seeks to create a cultural movement around healthy aging, emphasizing that age brings both power and new health considerations. Shields and other participants share their experiences of thriving in their 50s and beyond, while also addressing the importance of protecting one's health from vulnerabilities like shingles.

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.