GLPG - Galapagos presents new encouraging data at ASH 2023 from ongoing CD19 CAR-T studies with GLPG5201 and GLPG5101 | Benzinga
- Additional safety and efficacy data further support potential of innovative, decentralized approach to CAR-T manufacturing and transformational impact on patients with severe hematologic cancers
- Two poster presentations include recent data updates and additional data not included in the ASH abstracts
Galapagos to host a Key Opinion Leader (KOL) event with live webcast on Sunday, 10 December 2023 at 11:00 am PT/20:00 CET
Mechelen, Belgium; 9 December 2023, 18:00 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) to present additional encouraging clinical data from the ongoing Phase 1/2 CD19 CAR-T studies, EUPLAGIA-1 with GLPG5201 and ATALANTA-1 with GLPG5101, in patients with relapsed/refractory chronic lymphocytic leukemia (rrCLL), with or without Richter transformation, and non-Hodgkin lymphoma (rrNHL), during two poster sessions at the 65th American Society of Hematology (ASH) Annual Meeting taking place in San Diego, from 9-12 December.
"We are very pleased to share promising new data from our ongoing CD19 CAR-T cell therapy programs, which further highlight that treatment with both GLPG5201 and GLPG5101 has the potential to deliver clinically meaningful results in these severely compromised patient populations. We are particularly encouraged that the results suggest that a vein-to-vein time of only seven days with fresh CAR-T cells is feasible, which would address the urgent needs of cancer patients who cannot afford to wait for treatment," said Dr. Jeevan Shetty, Head of Clinical Development Oncology at Galapagos. "These results demonstrate the potential of our innovative development and manufacturing approach in CAR-T cell therapy to transform the lives of patients. This data bolsters our confidence in the GLPG5201 and GLPG5101 programs for the treatment of patients with rrCLL and rrNHL, and the potential of our CAR-T pipeline beyond these initial indications."
Galapagos has an interactive booth (#3419) at the ASH congress and will organize a Company Showcase in room 5 A (at the congress center, upper level) on 9 December at 11:30 am PT/22:30 CET, focusing on Galapagos' 7-day vein-to-vein, fresh-to-fresh CAR-T manufacturing model at the point-of-care.?In addition, Galapagos will host a media round table on 10 December at 7:30 am PT/16:30 CET at the Hilton Gaslamp Quarter San Diego, with experts discussing innovative approaches in CAR-T treatment that have the potential to transform the lives of patients around the world, and a KOL event for analysts and investors on 10 December at 11:00 am PT/20:00 CET at the Marriott Gaslamp Quarter San Diego.
GLPG5201 in rrCLL with or without Richter transformation (RT)
Patient recruitment of the Phase 1 dose-finding part of EUPLAGIA-1 has been completed and as of 6 September 2023 (cut-off date), 15 patients (6 at dose level 1 (DL1); and 9 at dose level 2 (DL2)) were enrolled, all of whom were diagnosed with rrCLL, with 9 of 15 with RT. Efficacy data as of Day 28 are available for 14 patients; 1 patient did not yet reach the Day 28 follow-up visit at the time of the analysis. The results (cut-off date: 6 September 2023) included in the poster are summarized below:
- GLPG5201 showed an encouraging safety profile with most treatment emergent adverse events (TEAEs) of Grade 1 or 2, mostly hematological. Cytokine release syndrome (CRS) Grade 1 or 2 was observed in 47% of the patients, and no CRS Grade ? 3 or any immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. No deaths were reported.
- Overall, 13 of 14 efficacy evaluable patients responded to treatment (Objective Response Rate (ORR) of 93%) and 8 of 14 patients achieved a Complete Response Rate (CRR of 57%). 8 of 9 patients with RT responded to treatment (ORR of 89%) and 6 of 9 RT patients achieved a Complete Response (CRR of 67 %). At time of analysis, 10 of 13 of responding patients (77%) were in ongoing response with a median follow-up of 6 months; 2 of 3 patients who progressed after an initial response had confirmed CD19-negative disease.
- On the higher dose level (DL2), 8 of 8 patients responded to treatment (ORR of 100%), 5 of 8 patients achieved a Complete Response (CRR of 63%), and 6 of 6 patients with RT responded to treatment (ORR of 100%).
- DL2 was selected as the recommended dose for the Phase 2 part of the study.
- The data suggest that Galapagos' CAR-T point-of-care manufacturing platform can deliver fresh product in a median vein-to-vein time of seven days.
- Strong and consistent in vivo CAR-T expansion levels and a product consisting of early phenotype T cells were observed in all doses tested.
GLPG5101 in rrNHL
To further build a robust data package, patient recruitment of the Phase 1 dose-finding part of ATALANTA-1 is ongoing. As of 1 September 2023 (cut-off date), 14 heavily pre-treated rrNHL patients with diffuse large B cell lymphoma, mantle cell lymphoma and indolent lymphoma were enrolled (7 at DL1 and 7 at DL2). In parallel, enrollment of the Phase 2 expansion study is ongoing, and the first 9 patients have been dosed. The results (cut-off date: 1 September 2023) included in the poster are summarized below:
- Phase 1 part of the study:
- GLPG5101 showed an encouraging safety profile. Most TEAEs were Grade 1 or 2 and the majority of the few Grade ? 3 events hematological. No CRS Grade > 3 and no ICANS Grade ? 2 were observed.
- 12 of 14 evaluable patients responded to treatment (ORR of 86%), with 11 of 14 patients achieving a Complete Response (CRR of 79%). 6 of 7 patients treated with the higher dose level (DL2) responded to treatment (ORR of 86%) and achieved a Complete Response (CRR of 86%). At the time of the analysis, 8 of 12 responding patients (67%) had an ongoing response, with a duration ...