The Janssen Pharmaceutical Companies of Johnson & Johnson announced the first presentation of Phase 2 data and updated Phase 1 data from the MajesTEC-1 study of teclistamab, an off-the-shelf T-cell investigational redirecting bispecific antibody, being studied for the treatment of patients with relapsed or refractory multiple myeloma. With a median follow-up of nearly eight months, an overall response rate (ORR) of 62 percent was observed at the recommended subcutaneous (SC) Phase 2 dose (RP2D) of 1.5 mg/kg in heavily pretreated patients (n=150) across the Phase 1 and 2 studies who had received at least three prior lines of therapy and were triple-class exposed.1 Results were presented during the American Society of Hematology (ASH) 2021 Annual Meeting as an oral presentation (Abstract # 896) and selected as part of the Highlights of ASH program.1
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At the median follow-up of nearly eight months, an ORR of 62 percent (93/150; 95 percent Confidence Interval [CI], range, 53.7–69.8) was observed; ORR was consistent regardless of cytogenetic risk or extent of prior therapy refractoriness.1 At the clinical cutoff, median duration of response was not reached and 88 percent (82/93) of responders were alive and continuing treatment.1 Study results suggest that responses to teclistamab were durable and deepened over time.1 Among patients who responded, the median time to first confirmed response was 1.2 months (range 0.2-5.5 months).1
Fifty-eight percent of patients receiving teclistamab achieved a very good partial response (VGPR) or better; 29 percent achieved a complete response (CR) or better; and 21 percent achieved a stringent complete response (sCR).1 By intent to treat, 25 percent of patients (37/150) achieved MRD negativity at a threshold of 10-5 (95 percent CI, range, 18.0–32.4).1 In patients who achieved CR or better, the MRD negativity rate was 42 percent.1 The progression-free survival (PFS) rate at 9 months was 59 percent (95 percent CI, range, 48.8–67.0). Median overall survival (OS) was not reached.1
“Despite newly approved therapies for triple-class exposed patients with relapsed or refractory multiple myeloma, there remains a high unmet medical need,” said Philippe Moreau, M.D.†, Clinical Hematology, University Hospital Hôtel-Dieu, Nantes, France and study investigator. “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.”