Janssen’s Phase 1 Results for Teclistamab Suggest Deep, Durable Responses

Subcutaneous administration of BCMAxCD3 T-cell redirecting bispecific antibody demonstrated clinical activity and a manageable safety profile according to new data at ASCO.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1 MajesTEC-1 study, the first-in-human dose-escalation study of teclistamab, an off-the-shelf T-cell redirecting bispecific antibody, in the treatment of patients with relapsed or refractory multiple myeloma. With a median follow-up of 6.1 months (range 1.2-12.2), an overall response rate (ORR) of 65 percent was observed at the recommended subcutaneous (SC) Phase 2 dose (RP2D) in a cohort of heavily pretreated patients (n=40) who had received a median of five prior lines of therapy. These data will be featured during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation on Tuesday, June 8th.

Study results showed that responses were durable and deepened over time – 58 percent of patients receiving teclistamab achieved a very good partial response (VGPR) or better, and 40 percent achieved a complete response (CR) or better at the RP2D SC dose of 1500μg/kg. The median time to first confirmed response was one month. The median duration of response was not reached. After a median follow-up of 7.1 months (range, 3.0–12.2 months), median duration of response was not reached and 85 percent (22/26) of responders were alive and continuing treatment.

“Teclistamab exposure was sustained across the dosing interval and exceeded target levels, and consistent T-cell activation was observed. With this latest follow-up data, we present further evidence of promising clinical activity in heavily pre-treated patients, who are in urgent need of new therapeutic options” said Amrita Y. Krishnan, M.D., Director of the Judy and Bernard Briskin Center for Multiple Myeloma Research and Chief, Division of Multiple Myeloma, Department of Hematology and Hematopoietic Cell Transplantation at City of Hope, and study investigator.