New Data from MajesTEC-1 Study Show Continued Deep and Durable Responses of Teclistamab (BCMAxCD3 Bispecific Antibody) in Treatment of Heavily Pretreated Patients with Multiple Myeloma
The objective responsive rate observed in this study suggests a potential benefit for many patients with triple-class exposed disease with an off-the-shelf therapy.”As of September 2021, 165 patients were treated with teclistamab at the SC 1.5 mg/kg dose across both Phase 1 and Phase 2 of MajesTEC-1.1 The primary objectives of the MajesTEC-1 Phase 1 study (NCT03145181) were to identify the recommended SC RP2D (part 1) and characterize the safety and tolerability of teclistamab at the RP2D (part 2). The primary objective of the MajesTEC-1 Phase 2 study (NCT04557098) was to evaluate the efficacy of teclistamab at the RP2D, established at SC 1.5 mg/kg QW, as measured by ORR. Teclistamab had a tolerable safety profile, and no patients required a dose reduction.1 The most common nonhematologic adverse events (AEs) were cytokine release syndrome (72 percent; all grade 1/2 except for 1 grade 3 event that fully resolved; all resolved with no treatment discontinuation), injection site erythema (26 percent; all grade 1/2) and fatigue (25 percent; 2 percent grade 3/4).1 The most common hematologic AEs were neutropenia (66 percent; 57 percent grade 3/4), anemia (50 percent; 35 percent grade 3/4) and thrombocytopenia (38 percent; 21 percent grade 3/4).1 Five patients (3 percent; all grade 1/2) developed immune effector cell-associated neurotoxicity syndrome (ICANS) all resolved without discontinuation.1“These longer-term data suggest that heavily pretreated patients in need of a new o...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
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