Galapagos Launches 15-Year HESPERIA Study to Track Long-Term Outcomes of CAR-T Therapies
核心洞察
Galapagos NV initiates HESPERIA study to monitor long-term safety and efficacy of their CAR-T therapies across multiple hematologic malignancies over a 15-year period.
The company's lead candidate GLPG5101, targeting CD19 (搜索), demonstrates potential 7-day manufacturing time and is being evaluated for various B-cell malignancies including DLBCL (搜索) and follicular lymphoma (搜索).
HESPERIA study aims to enroll 546 patients across European sites, tracking critical endpoints including adverse events, CAR transgene levels, and overall survival rates.
Galapagos NV has launched an ambitious long-term follow-up study to track patients treated with their portfolio of chimeric antigen receptor T-cell (CAR-T) therapies, marking a significant step in understanding the extended impact of cellular therapies in hematologic malignancies.
The phase 3 HESPERIA study (NCT06652633), initiated in September 2024, will monitor patients for up to 15 years post-treatment, with completion expected in July 2039. The study aims to enroll 546 patients across sites in Belgium, the Netherlands, and Spain.
Portfolio of CAR-T Candidates
At the forefront of Galapagos's cell therapy program is GLPG5101, a CD19 (搜索)-targeted CAR-T therapy being evaluated in the phase 1/2 ATALANTA-1 trial. The therapy shows promise for multiple relapsed/refractory conditions, including diffuse large B-cell lymphoma (DLBCL (搜索)), follicular lymphoma (搜索), and primary central nervous system lymphoma.
A key technological advantage of GLPG5101 lies in its manufacturing process, with a median vein-to-vein time of just 7 days – a significant improvement over conventional CAR-T production timelines.
The company's pipeline also includes GLPG5301, targeting BCMA (搜索) for relapsed/refractory multiple myeloma (搜索), and GLPG5201, another CD19 (搜索)-directed therapy currently being deprioritized in favor of GLPG5101's development.
HESPERIA Study Design and Objectives
The HESPERIA study employs a single-arm design, accepting adult patients who have received any GLPG CAR-T product through clinical trials or Managed Access Programs. The study's primary endpoints encompass:
- Percentage of participants experiencing targeted adverse events
- CAR transgene levels in peripheral blood
- Serious adverse events related to therapy
- T-cell levels and new malignancies
- Presence of replication-competent lentivirus
- Mortality rates and causes
Secondary endpoints focus on disease progression, timing of subsequent anticancer therapies, and overall survival.
Strategic Portfolio Optimization
"In line with our goal of becoming a more focused and streamlined organization, we are optimizing our CD19 (搜索) CAR-T portfolio by prioritizing resources where they can have the greatest impact," stated Paul Stoffels, MD, CEO and Chairman of Galapagos. The company is expanding GLPG5101's development into additional aggressive B-cell malignancies while advancing their early-stage pipeline of next-generation cell therapies.
The FDA cleared GLPG5101's investigational new drug (IND) application in August 2024, enabling the expansion of the ATALANTA-1 trial to U.S. sites. The trial is currently recruiting patients in Belgium and the Netherlands, with Boston sites preparing to join.
Manufacturing Innovation
Galapagos's decentralized manufacturing platform aims to address traditional CAR-T production challenges. "Our innovative, decentralized manufacturing platform is designed to overcome many of the challenges faced by existing CAR-T production methods," Stoffels explained. "The Galapagos platform has the potential for greater speed and scalability, with the delivery of fresh, fit cells with a median vein-to-vein time of 7 days, close to patients."
The HESPERIA study represents a crucial step in understanding the long-term implications of CAR-T therapy, potentially informing future developments in cellular immunotherapy and patient care strategies.