02 September 2024 | Analysis
Lenacapavir’s Historic HIV Prevention Success and CAR T-Cell Therapy Breakthroughs Propel Gilead’s Leadership in Biopharmaceutical Innovation
Between January and June 2024, Gilead Sciences made substantial progress across multiple therapeutic areas, reinforcing its leadership in the biopharmaceutical industry. The company focused on breakthrough advancements in HIV prevention, oncology, and liver diseases, marking a period of significant clinical achievements and strategic growth.
Revolutionizing HIV Prevention
A major highlight of the first half of 2024 was the success of Gilead’s twice-yearly injectable HIV prevention drug, lenacapavir. In a Phase 3 trial, lenacapavir demonstrated 100% efficacy, outperforming the daily oral regimen of Truvada, particularly in cisgender women. This outstanding result led to a recommendation to offer lenacapavir openly to all trial participants, marking a historic milestone in HIV prevention. The drug’s success underscores Gilead’s ongoing commitment to combating HIV and offering more effective and convenient prevention options to those at risk.
Oncology Breakthroughs with CAR T-Cell Therapies
Gilead’s subsidiary, Kite, continued to push the boundaries in oncology, particularly with its CAR T-cell therapies, Yescarta® and Tecartus®. Yescarta showed improved patient outcomes when used earlier in the treatment of large B-cell lymphoma, potentially setting a new standard for early intervention. Tecartus also demonstrated sustained overall survival benefits for patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Supported by real-world evidence and new clinical studies, these therapies reinforced the transformative potential of CAR T-cell treatments in both hospital and outpatient settings, further solidifying Gilead’s position in the oncology space.
Advancements in Liver Disease Therapies
Gilead made significant strides in liver disease treatments during this period. The company announced positive results from studies combining bulevirtide with pegylated interferon for the treatment of chronic hepatitis delta virus, achieving significant efficacy in reducing viral levels post-treatment. Additionally, seladelpar, an investigational drug for primary biliary cholangitis (PBC), continued to show promise, demonstrating sustained efficacy in reducing pruritus and improving liver biomarkers. With regulatory approval for seladelpar anticipated soon, Gilead is poised to expand its impact on liver disease treatment significantly.
Strategic Growth and Financial Performance
Financially, Gilead reported a 5% increase in revenue for Q1 2024, driven by strong sales of Biktarvy, its leading HIV treatment, and a robust performance from its oncology portfolio. However, the company also reported a significant EPS loss due to its acquisition of CymaBay Therapeutics, a strategic move aimed at enhancing Gilead’s liver disease portfolio by adding seladelpar. This acquisition reflects Gilead’s ongoing strategy to diversify and strengthen its therapeutic offerings across key areas of unmet medical need.
Overall, Gilead Sciences’ activities in the first half of 2024 highlight the company’s unwavering commitment to advancing medical science and improving patient outcomes in HIV prevention, oncology, and liver diseases. With several promising therapies progressing through clinical trials and on the cusp of regulatory approval, Gilead continues to lead the way in developing innovative treatments that address some of the world’s most pressing health challenges. As the company looks ahead, these achievements underscore its strategic vision and dedication to making a lasting impact on global health.