Reduced Dose Teclistamab Earns European Approval in R/R Multiple Myeloma

The FDA previously approved teclistamab in relapsed/refractory multiple myeloma in October 2022 based on data from the phase 1/2 MajesTec-1 trial (NCT03145181; NCT04557098).

The European Commission has approved teclistamab-cqyv (Tecvayli) at a reduced dose of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who experience at least a complete response (CR) for 6 or more months, according to a press release from The Janssen Pharmaceutical Companies of Johnson & Johnson.¹

Supporting data for the European Commission’s approval came from the phase 1/2 MajesTEC-1 study (NCT03145181; NCT04557098), in which investigators assessed the safety and efficacy of teclistamab in adult patients with previously treated relapsed/refractory multiple myeloma.

Of 63 patients who achieved a response with 1.5 mg/kg of weekly teclistamab and switched to biweekly dosing, 85.7% had a CR or better, 12.7% experienced a very good partial response (PR), and 1.6% had a PR. With a median follow-up of 12.6 months, the median duration of response was not reached, and 68.7% (95% CI, 53.6%-79.7%) had a sustained response for at least 2 years since the time of their first response.

Investigators a reported a lower rate of onset grade 3 or higher infections in responders who switched to biweekly dosing at or before 12 months (15.6%) compared with those who continued a weekly dosing schedule (33.3%). Additionally, 65% of patients remained on treatment as of the data cutoff point.

“Every patient’s experience with multiple myeloma is unique and requires a different treatment approach, tailored to their specific needs,” Niels van de Donk, MD, professor of Hematology at Amsterdam University Medical Centers, said in the press release. “With a decreased incidence of new onset grade 3 or higher infections, low discontinuation rates and depth of responses maintained, this biweekly dosing option for teclistamab could provide substantial benefit for people living with multiple myeloma, potentially offering reduced time spent in [the] hospital.”

The European Commission granted conditional marketing authorization to teclistamab for treating patients who underwent 3 prior lines of therapy for relapsed/refractory multiple myeloma in August 2022.²

The FDA approved teclistamab in relapsed/refractory multiple myeloma in October 2022 based on data from the phase 1/2 MajesTec-1 trial.³

References

1. European Commission approves reduced dosing frequency for Janssen’s bispecific antibody TECVAYLI® (teclistamab). News release. The Janssen Pharmaceutical Companies of Johnson & Johnson. August 18, 2023. Accessed August 21, 2023. https://shorturl.at/abt37
2. Janssen marks first approval worldwide for TECVAYLI® (teclistamab) with EC authorisation of first-in-class bispecific antibody for the treatment of patients with multiple myeloma. News release. Jansen. August 24, 2022. Accessed August 21, 2023. https://bit.ly/3wsRYFP
3. FDA approved teclistamab-cqvy for relapsed or refractory multiple myeloma. News release. FDA. October 25, 2022. Accessed August 21, 2023. https://bit.ly/3Fgsi4s