FDA OKs less frequent Tecvayli dosing for treatment responders

Every-other-week dose cleared for RRMM patients doing well after 6 months

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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The U.S. Food and Drug Administration (FDA) has cleared an every-other-week dosing regimen of Tecvayli (teclistamab) for relapsed or refractory (hard-to-treat) multiple myeloma (RRMM) patients who have responded well to the therapy’s standard weekly dosing.

Tecvayli was initially approved in 2022 for adults with RRMM who had received at least four prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and a CD38 inhibitor.

The medication from Janssen, now known as Johnson & Johnson Innovative Medicine, was indicated for use at a weight-based dose of 1.5 mg/kg, delivered via a weekly under-the-skin (subcutaneous) injection.

Now, regulators say patients who achieve and maintain a complete response or better with weekly injections for at least six months can switch to the less frequent regimen, which will still be given at the 1.5 mg/kg dose.

“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,” Rachel Kobos, MD, vice president of oncology research and development at J&J Innovative Medicine, said in a company press release.

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Biweekly dose already approved in EU

A similar regimen update was made to Tecvayli’s label last year in the European Union, where it is approved for patients who have received at least three prior lines of therapy.

Tecvayli is a bispecific antibody, meaning it can interact with two different targets. It’s designed to simultaneously target the BCMA protein found on myeloma cells and the CD3 protein on the surface of immune T-cells, which have natural cancer-fighting abilities. The medication serves as a bridge between these two cell types, guiding the T-cells to the cancer cells, where they launch a cancer-killing immune attack.

At its once-weekly dosing regimen, Tecvayli was the first bispecific antibody to be approved for RRMM patients in the U.S. A similar therapy from Pfizer called Elrexfio (elranatamab) was approved last year with once-weekly dosing that can be reduced to every other week if there’s a positive clinical response.

Approval of Tecvayli’s biweekly dosing regimen was supported by findings from the Phase 1 (NCT03145181) and Phase 2 (NCT04557098) parts of the MajesTEC-1 clinical trial.

Phase 1 established the initially recommended dose of 1.5 mg/kg injected weekly, and the same dose was given to all participants in Phase 2. As of January 2023, 165 RRMM patients had received that dose, and about two-thirds of them (63%) responded to the treatment.

Patients who achieved a partial response or better after four treatment cycles in Phase 1, or a complete response or better for six months or longer in Phase 2, could reduce the dosing frequency to every other week. This regimen could be maintained until patients’ myeloma progressed or they experienced unacceptable side effects.

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Once-a-month dose possible for Tecvayli

Dosing could be further reduced, to once a month, in the event of sustained treatment responses.

Results showed that 63 patients switched to biweekly dosing during the trial, and nine later moved to once a month. After a median of about a year following the switch to every-other-week dosing, more than two-thirds of patients (68.7%) continued to respond to treatment.

Fewer serious infections — a possible side effect of the medication — were reported in patients who switched to less-frequent dosing.

Tecvayli is approved in the U.S. under the FDA’s accelerated approval program. This allows the company to market the therapy, but its continued approval is contingent on additional clinical trial evidence backing its safety and efficacy.

J&J says Tecvayli has been prescribed to more than 3,600 patients in the U.S. since its initial approval.

“As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, Tecvayli is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma,” Kobos said.