FDA Approves Biweekly Teclistamab in Relapsed/Refractory Multiple Myeloma

Supporting data for biweekly teclistamab as a treatment for those with relapsed/refractory multiple myeloma came from the phase 1/2 MajesTEC-1 study (NCT03145181; NCT04557098).

The News

The FDA has granted approval to a supplemental biologics license application (sBLA) for teclistamab-cqvy (Tecvayli) at 1.5 mg/kg every 2 weeks for patients with relapsed/refractory multiple myeloma who have had a sustained complete response (CR) or better for at least 6 months, according to a press release from Johnson & Johnson.¹

Pharma Perspective

“[Teclistamab] is the only BCMA-targeted immune-based therapy with weight-based dosing,” Rachel Kobos, MD, vice president of Oncology Research & Development at Johnson & Johnson Innovative Medicine, said in the press release. “Today's approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules. As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, [teclistamab] is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma.”

Supporting Data

The approval was supported by findings from the phase 1/2 MajesTEC-1 study (NCT03145181; NCT04557098), in which patients initially received the recommended phase 2 dose (RP2D) of teclistamab at 1.5 mg/kg every week. Those who had a CR or better for 6 or more months in phase 2 were eligible to receive the agent at a reduced dose of 1.5 mg/kg every 2 weeks until unacceptable toxicity or progressive disease.

According to findings published in The New England Journal of Medicine, teclistamab produced an overall response rate (ORR) of 63.0% (95% CI, 55.2%-70.4%), with very good partial responses (VGPRs) or better occurring in 58.8% and CRs or better reported in 39.4%.² Additionally, the median duration of progression-free survival (PFS) was 11.3 months (95% CI, 8.8-17.1).

Any-grade and grade 3 or higher adverse effects (AEs), respectively, included cytokine release syndrome (72.1%; 0.6%), neutropenia (70.9%; 64.2%), and anemia (52.1%; 37.0%). Additionally, any-grade and grade or higher infections affected 76.4% and 44.8% of patients, respectively.

MajesTEC-1 Design

Investigators of the open-label MajesTEC-1 study evaluated the efficacy and safety of teclistamab in 165 adult patients with relapsed/refractory multiple myeloma who received at least 3 prior lines of therapy. The RP2D of teclistamab was 1.5 mg/kg subcutaneously every week.

The trial’s primary end point was ORR. Secondary end points included duration of response, time to response, PFS, overall survival, and safety.

The FDA granted accelerated approval to teclistamab as a treatment for those with relapsed/refractory multiple myeloma.³ Supporting data for the approval came from the MajesTEC-1 trial.

References

1. TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma. News release. Johnson & Johnson. February 20, 2024. Accessed February 20, 2024. http://tinyurl.com/3faxuvyj
2. Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):495-505. doi:10.1056/NEJMoa2203478
3. FDA approved teclistamab-cqvy for relapsed or refractory multiple myeloma. News Release. FDA. October 25, 2022. Accessed February 20, 2024. https://bit.ly/3Fgsi4s