Tecvayli(teclistamab)

Tecvayli (teclistamab) is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The recommended phase 2 dose for teclistamab subcutaneous administration is 1500 µg/kg, following priming doses of 60 µg/kg and 300 µg/kg.

Key efficacy findings include an Overall Response Rate (ORR) of 62.0% and 63.0%, with a VGPR or better rate of 58.0% and 58.8%. The median Duration of Response (DOR) was 18.4 months. The median Progression-Free Survival (PFS) was 10.1 months and 11.3 months, with a 95% CI for Median PFS of 8.8 to 17.1. The median Overall Survival (OS) was 18.3 months. The median time to response (PR or better) was 1.2 months.

Safety data were collected from 342 subjects who received at least one dose of teclistamab monotherapy, with a median duration of study treatment of 7.1 months. The median relative dose intensity was 95.9%. Tecvayli received Orphan medicinal product designation on 19 October 2020, and PRIME eligibility was granted on 29 January 2021. The Marketing Authorisation Application was submitted on 31 January 2022, and a CHMP positive opinion for marketing authorisation was issued on 21 July 2022.