GSK PLC Stock Price, News & Analysis

GSK has announced the acquisition of IDRx, a clinical-stage biopharmaceutical company, for $1 billion upfront plus a potential $150 million regulatory milestone payment. The acquisition centers on IDRX-42, a selective KIT tyrosine kinase inhibitor designed to treat gastrointestinal stromal tumours (GIST).

IDRX-42 has shown promising results in clinical trials, demonstrating activity against all key primary and secondary KIT mutations in GIST. In the StrateGIST 1 phase I/Ib trial, the drug achieved a 29% objective response rate across all patients (n=87) and 53% in second-line patients (n=15), with manageable safety profiles.

The acquisition strengthens GSK's portfolio in gastrointestinal cancers and supports its growth ambitions through 2031. The deal is subject to regulatory clearances under the Hart-Scott-Rodino Act in the US.

GSK announced significant overall survival (OS) results from the DREAMM-7 trial evaluating belantamab mafodotin combination therapy for multiple myeloma. The study showed a 42% reduction in death risk compared to the daratumumab-based treatment.

Key findings include:

• Median follow-up of 39.4 months
• Projected median OS of 84 months for belantamab mafodotin combination vs 51 months for daratumumab combination
• Three-year OS rate of 74% vs 60%
• 2.5-fold improvement in minimal residual disease negativity

The therapy is currently under regulatory review in seven major markets, with priority review status in several countries.

GSK announced new preliminary data for AREXVY, its RSV vaccine, showing promising results in two key populations: adults aged 18-49 with risk factors and immunocompromised adults. A single dose demonstrated robust immune response in at-risk adults 18-49, while immunocompromised adults showed positive results with two doses. The vaccine's potential expansion could benefit over 21 million at-risk adults aged 18-49 in the US alone. Currently approved for adults 60+ in over 50 countries and at-risk adults 50-59 in select regions, these new data support potential broader application. The safety profile remained consistent with previous trials, showing mainly mild, transient effects.

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.