- Galapagos NV GLPG presented data from the ongoing EUPLAGIA-1 Phase 1/2 study in heavily pre-treated patients with rrCLL and rrSLL to evaluate GLPG5201, a fresh CD19 CAR-T product candidate.
- As of 9 January 2023, 7 patients diagnosed with rrCLL were enrolled in the study.
- The initial results from these seven patients eligible for efficacy analysis indicated that a 7-day vein-to-vein time is feasible, and demonstrated favorable and consistent in vivo CAR-T expansion levels.
- Initial efficacy results are encouraging, with an objective response rate (ORR) of 100% observed. 6 out of 7 patients (86%) reached a complete response (CR), and all Richter’s patients achieved a CR.
- A duration of response of up to 7.9 months has been reported, and follow-up is ongoing. Only one patient (DL1) progressed (progressive disease, PD, after partial response, PR) and had a CD19-negative relapse with confirmed Richter’s transformation.
- In the safety analysis of these seven patients, adverse events were consistent with the known toxicities of CD19 CAR-T treatment.
- None of the patients experienced a cytokine release syndrome (CRS) higher than grade 2 at both doses, and no immune effector cell-associated neurotoxicity syndrome (ICANS) was reported. No dose-limiting toxicities (DLTs) were reported, and most grade ≥3 adverse events were hematological.
- Only one serious adverse event was reported at DL2 with a patient experiencing a CRS grade 2, but it was resolved after seven days.
- Thursday, Galapagos reported disappointing data from filgotinib study in patients with moderate to severe Crohn’s disease.
- Price Action: GLPG shares are 0.47% lower at $40.19 premarket on the last check Friday.
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