Galapagos Presents New Encouraging Clinical Data from the Ongoing Phase 1/2 CD19 CAR-T Studies with GLPG5201 and GLPG5101
December 12, 2023 at 07:03 am EST
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Galapagos NV 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 65 American Society of Hematology (ASH) Annual Meeting taking place in San Diego, from 9-12 December. 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 up to 15 months (median follow-up of 8.6 months); 2 of the 4 patients who progressed after an initial response had a CD19 positive relapse and 1 had confirmed CD19-negative disease. Phase 2 part of the study:
GLPG5101 showed an encouraging safety profile with most TEAEs of Grade 1 or 2; the majority of Grade = 3 events were hematological. No CRS Grade > 2 and ICANS was seen in one patient (Grade 3). 6 of 7 evaluable patients responded to treatment (ORR of 86%) and a Complete Response was observed in 4 of 7 patients (57%). At the time of the analysis, all 6 responding patients (100%) had an ongoing response with a median follow-up of 3.2 months.
The data suggest that Galapagos? point-of-care 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.
Galapagos NV is a fully integrated biotechnology company focused on discovering, developing, and commercializing innovative medicines. The company is committed to improving patients' lives worldwide by targeting diseases with high unmet needs. Its R&D capabilities cover multiple drug modalities, including small molecules and cell therapies. Its portfolio comprises discovery through to commercialized programs in immunology, oncology, and other indications. Its first medicine for rheumatoid arthritis and ulcerative colitis is available in Europe and Japan.