ESMO 2023 BioNTech Data slide image

ESMO 2023 BioNTech Data

BNT211: Dose-Depend Increase in Adverse Events, Further Evaluation Ongoing to Determine RP2D Phase 1/2 FIH study (NCT04503278): Baseline characteristics and safety Haanen J. et al. Presented at ESMO 2023. Abstract #LBA35. Cohort Patient baseline characteristics DL0(n=2) DL1 (n=4) DL1+ CARVac (n=4) DL2 (n=13)1 DL2+ CARVac (n=14)² DL3 (n=7) Total (n=44) Age, years 55.5 (50-61) 54.5 (36-62) 1/1 3/1 51.0 (42-65) 2/2 45.0 (30-69) 7/6 48.0 (26-60) 50.5 (29-63) 8/6 4/3 48.0 (26-69) 25/19 Gender, male/female Indication, n Epithelial ovarian cancer (EOC) 1 1 2 6 Germ cell tumor (GCT) 1 Other indications³ 0 3 1 1 5 2 563 232 17 16 CLDN6 2+/3+ cells, % 82.5 (80-85) 97.5 (80-100) 97.5 (50-100) 95.0 (80-100) Prior treatment lines 3.0 (2-4) 4.0 (3-7) 4.0 (2-9) 4.0 (2-7) 100 (70-100) 4.0 (2-9) 80.0 (50-100) 3.5 (2-6) 11 95 (50-100) 4.0 (2-9) Treatment and safety outcome Duration of follow-up, days 321.5 (242-401) 44.5 (22-87) 90.5 (13-189) 71.5 (30-317) 120.5 (9-199) 90 (44-121) 94.5 (9-401) CARVac injections4, n ΝΑ NA 3 (1-5) ΝΑ 4 (1-7) ΝΑ 4 (1-7) Patients with TEAEs >G3 related to IMPS5, n 1 1 1 12 9 6 30 Patients with TESAES related to IMPs 6, n 1 0 0 4 4 5 14 Patients with DLTs7, n 0 0 0 1 2 1 4 Patients with CRS8, n Patients with ICANS9, n Deaths 10, n 1 0 0 2 6 9 LO 5 0 3 Data cut-off: 10 Sep 2023. 1 Cohort includes 3 patients dosed with 5x107 CAR-T. 2 Cohort includes 1 patient that did not reach full dose (2×107) and 1 patient treated that received full dose after 50% reduced lymphodepletion. 3 Other indications: 4 patients with lung cancer (different subtypes), 3 with desmoplastic round cell tumors, 2 with esophageal cancer, 1 with endometrial carcinoma and 1 with sinonasal carcinoma. 4 Crossover of patients is not indicated, as option was enabled by safety review committee decision after dose decision for monotherapy cohort without impacting efficacy read out. 5 Most TEAES 2G3 were attributed to CAR-T IMP (27/30). Most frequent TEAEs were laboratory findings (43.2%) including decreased blood cell counts, elevated liver function tests as well as levels of bilirubin and ferritin. Accordingly, cytopenia (25%) together with immune system (7%) and hepatobiliary disorders (5%) were reported frequently. 6 Most frequent non- related TESAES were infections. 7 DLTs include 2 cases of pancytopenia, 1 case of hemophagocytic lymphohistiocytosis and 1 case of liver toxicity together with sepsis. 8 CRS was limited to G1-2 for 21/23 patients with 1 G3 and 1 G4 event. 9 Neurotoxicity was mild and self-limiting in 2 patients. 10 Most patient deaths (11/12) were related to disease progression and 1 patient died from sepsis. Values given as median (range). CAR = chimeric antigen receptor; CLDN6 = claudin-6; CRS = cytokine release syndrome; DL = dose level; DLT = dose-limiting toxicity; G = Grade; ICANS immune effector cell-associated neurotoxicity syndrome; IMP investigational medicinal product; TESAE treatment-emergent (serious) adverse event. 0 2 1 2 1 4 0 0 23 2 12 BIONTECH
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