FDA Clears IND for Phase I/II Study in Relapsed/Refractory Non-Hodgkin Lymphoma
Trial will evaluate Galapagos’ GLPG5101, an autologous CD19 CAR-T cell therapy product candidate.
The FDA has cleared an Investigational New Drug (IND) application for an open-label, multicenter, Phase I/II trial of GLPG5101 in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). The autologous CD19 CAR-T cell therapy product candidate was manufactured by Galapagos using its decentralized cell therapy manufacturing platform.1
The Phase I/II trial, ATLANTA-1, will first evaluate the safety and efficacy of GLPG5101 to determine the recommended dose for Phase II. The primary objective of the Phase II portion is objective response rate with secondary endpoints of complete response rate, duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. Patients enrolled will be monitored for 24 months.
According to an estimate from the National Cancer Institute, there will be 80,620 new cases of NHL in the US, which accounts for 4% of all cancer cases.2
In a press release, Paul Stoffels, MD, Galapagos’ CEO and Chairman of the Board of Directors said, “We are dedicated to accelerating breakthrough innovation that extends the reach of cell therapies to patients with rapidly progressing cancers. Our innovative, decentralized manufacturing platform is designed to overcome many of the challenges faced by existing CAR-T production methods. 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 seven days, close to patients. The IND clearance for the Phase I/II study of GLPG5101 marks a significant milestone in our cell therapy clinical program, bringing us one step closer to offering our CD19 CAR-T cell therapy to patients in the US.”
ATLANTA-1 is currently ongoing in Europe. In June, Galapagos shared positive data from the study in which GLPG5101 showed an encouraging safety profile and response rate. Data were presented at the annual European Hematology Association (EHA) 2024 Hybrid Congress. More detailed results include:3
- GLPG5101 showed an encouraging safety profile with most TEAEs of Grade 1 or 2; the majority of Grade ≥ 3 events were hematological. Two cases of CRS Grade 3 were observed in Phase I and one case of ICANS Grade 3 was observed in Phase II.
- In Phase I, 14 of 16 efficacy-evaluable patients responded to treatment (objective response rate, ORR 87.5%), with 12 patients achieving a complete response (CR) (CR rate, CRR 75%). In Phase II, 14 of 15 efficacy-evaluable patients responded to treatment (ORR 93.3%), and all responders achieved a complete response (CRR 93.3%).
“We are committed to accelerating breakthrough innovations to extend the reach of CAR-T therapies to patients with rapidly progressing cancers,” Jeevan Shetty, MD, head of clinical development oncology at Galapagos said in an earlier press release. “We are delighted to present promising new data for GLPG5101 at the EHA congress. The high complete response rates, combined with low-grade CRS and ICANS, demonstrates the potential of GLPG5101 in addressing the critical needs of this patient population. The data also confirm the feasibility of our innovative decentralized T-cell manufacturing platform in delivering fresh, fit cells with a median vein-to-vein time of just seven days.”
References
1. Galapagos announces FDA clearance of IND application for Phase 1/2 ATALANTA-1 study of CD19 CAR-T, GLPG5101, in relapsed/refractory non-Hodgkin lymphoma. News release. Galapagos. August 23, 2024. Accessed August 23, 2024. https://www.glpg.com/press-releases/galapagos-announces-fda-clearance-of-ind-application-for-phase-1-2-atalanta-1-study-of-cd19-car-t-glpg5101-in-relapsed-refractory-non-hodgkin-lymphoma/
2. Cancer Stat Facts: Non-Hodgkin Lymphoma. National Cancer Institute. Accessed August 23, 2024. https://seer.cancer.gov/statfacts/html/nhl.html
3. Galapagos presents encouraging new data for CD19 CAR-T candidate GLPG5101 in non-Hodgkin lymphoma at EHA 2024. News release. Galapagos. June 14, 2024. Accessed August 23, 2024. https://www.glpg.com/press-releases/galapagos-presents-encouraging-new-data-for-cd19-car-t-candidate-glpg5101-in-non-hodgkin-lymphoma-at-eha-2024/
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