GSK plc reports developments across its global biopharma business, including vaccines, respiratory medicines, infectious disease, immunology and oncology programs. Recurring updates include regulatory decisions and clinical evidence for products such as AREXVY, GSK's RSV vaccine, and Exdensur for severe asthma, along with data presentations, product indications and therapeutic-area access initiatives.
GSK news also covers manufacturing and supply agreements, commercial collaborations, public-health grant programs and product partnerships tied to its medicine and vaccine portfolio. As an American Depositary Share issuer, company updates may reflect both parent-company announcements and ADR-related market disclosures.
GSK announced promising interim results from the RUBY phase III trial, which evaluates dostarlimab-gxly combined with standard chemotherapy for advanced endometrial cancer. Notably, a 72% reduction in disease progression risk was observed in the dMMR/MSI-H subgroup, while an overall reduction of 36% was reported across all participants. The trial showcased clinically meaningful trends in overall survival and was presented at prestigious medical forums, with regulatory submissions anticipated by mid-2023. These advancements underscore GSK’s commitment to improving treatment options for endometrial cancer.
GSK has launched a national health education campaign called Sideline RSV in partnership with Earvin “Magic” Johnson to raise awareness about the risks of Respiratory Syncytial Virus (RSV) among older adults. The campaign aims to educate this demographic, particularly those with chronic health issues, about RSV's severity, given that approximately 177,000 adults aged 65+ are hospitalized annually in the US due to RSV, leading to an estimated 14,000 deaths. The campaign will include a dedicated website, social media initiatives, and community events to enhance understanding and encourage discussions about RSV and its risks.
GSK plc (LSE/NYSE: GSK) announced that the US FDA granted full approval for Jemperli (dostarlimab-gxly) as a treatment for adult patients with mismatch repair-deficient recurrent or advanced endometrial cancer. This decision is based on long-term data from the GARNET phase I trial, showing an overall response rate of 45.4%. Additionally, 85.9% of patients experienced a response duration of at least 12 months. GSK aims for Jemperli to serve as a core element in its immuno-oncology development programs.
WuXi Biologics has signed a license agreement with GSK granting exclusive rights to one preclinical bi-specific T cell engaging antibody and options for three more. WuXi Biologics will receive an upfront payment of $40 million and could earn up to $1.46 billion from milestone payments. The agreement highlights GSK’s expansion into novel cancer therapies and validates WuXi's proprietary technology platforms. The CEO of WuXi emphasized the significance of this partnership in facilitating GSK's ability to develop potentially life-saving treatments for patients worldwide.
GSK plc (LSE/NYSE:GSK) announced 48-week data from the MOMENTUM phase III clinical trial for momelotinib, showing significant efficacy in myelofibrosis patients previously treated with JAK inhibitors. Key findings include a 97% Total Symptom Score (TSS) response and 90% transfusion independence at week 24, with an associated improvement in overall survival. These results underscore momelotinib's potential as a treatment option to alleviate symptoms of myelofibrosis and reduce transfusion needs. A New Drug Application is currently under FDA and EMA review.
GSK and IQVIA have launched Vaccine Track, a new platform to enhance data transparency regarding adult vaccinations in the US. This resource aims to address the decline in adult immunization rates, particularly among minority populations, which saw an 18% drop in overall claims for recommended vaccinations from 2019 to 2021. The platform provides quarterly updates and diverse trend analyses, supporting public health efforts to improve vaccination rates post-pandemic. The initiative emphasizes the importance of vaccination data and could significantly impact public health policy.
GSK has received FDA approval for Benlysta (belimumab), making it the first biologic treatment for children aged 5 to 17 with active lupus nephritis (LN). This approval expands Benlysta's indications in the U.S. to include both lupus and active LN in pediatric patients. Lupus nephritis can lead to severe kidney complications. The treatment focuses on preserving renal function while reducing toxicities associated with traditional therapies. GSK aims to enhance treatment options and outcomes for children facing this serious condition.
GSK has initiated shipping of its FLULAVAL QUADRIVALENT and FLUARIX QUADRIVALENT influenza vaccines to US healthcare providers for the 2022-23 season, following FDA approval. The company aims to distribute over 50 million doses to support annual immunization efforts. Despite extensive public health campaigns, vaccination rates in the US remain consistent with previous seasons. GSK emphasizes the need for increased awareness, particularly in underserved communities. Both vaccines are approved for patients aged six months and older, aligning with CDC recommendations.
GSK has awarded the inaugural £70,000 grant (about $100,000) to the HealthTree Foundation for its "HealthTree Equity and Diversity for Multiple Myeloma Program." This initiative aims to address disparities in care for underserved communities and minority patients. The funding will support digital tools for education and outreach, including programs like "Black Myeloma Health" and "HealthTree for Mieloma Multiple" to enhance information access and community engagement. GSK emphasizes its commitment to innovation in the multiple myeloma community through this initiative.
GSK has received FDA approval for PRIORIX, a measles, mumps, and rubella (MMR) vaccine, aimed at individuals aged 12 months and older. This marks the vaccine's debut in the US market, where it adds to GSK's pediatric vaccine offerings, currently distributed in over 100 countries with more than 800 million doses. The FDA's approval comes in response to recent measles outbreaks and declining vaccination rates in children, emphasizing the need for additional vaccine options to protect against these highly-contagious diseases.