J&J Maintains Momentum in Multiple Myeloma with Tecvayli Approval

Courtesy of Michael Vi/Getty Images

Courtesy of Michael Vi/Getty Images

The FDA has greenlit the use of Johnson & Johnson’s Tecvayli in heavily pretreated adult patients with relapsed or refractory multiple myeloma.

Courtesy of Michael Vi/Getty Images

The FDA has greenlit the use of Johnson & Johnson’s Tecvayli (teclistamab-cqyv) in heavily pretreated adult patients with relapsed or refractory multiple myeloma, J&J announced Tuesday.

This decision makes Tecvayli the first off-the-shelf bispecific T-cell engager antibody approved for this indication and marks J&J’s fourth approval in multiple myeloma. Tecvayli can now be used to treat patients treated with at least four prior lines of therapy, including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory drug.

Tecvayli is a first-in-class subcutaneous bispecific T-cell engager that addresses multiple myeloma by binding to the CD3 receptor, found on the surface of T cells, and to the B-cell maturation antigen (BCMA), which malignant cells display.

The drug earned its nod under the FDA’s accelerated approval pathway based on data from the Phase II MajesTEC-1 trial. In 110 patients, Tecvayli returned an overall response rate of 61.8%, while nearly 30% of participants reached a complete response or better. The first treatment response occurred at a median of 1.2 months from treatment initiation.

According to the results of MajesTEC-1, J&J estimates Tecvayli to have a duration of response rate of 90.6% at the 6-month follow-up. This dropped to 66.5% by 9 months.

MajesTEC-1 is a Phase I/II single-arm, open-label and multicohort study. The first phase assessed the safety, tolerability and pharmacokinetics of Tecvayli. Efficacy was evaluated in the second phase, which used a subcutaneous 1.5 mg/kg dose of Tecvayli.

All enrolled patients were heavily pretreated, with 78% having received at least four prior lines of therapies. All MajesTEC-1 participants had been exposed to the three major classes of drugs: a proteasome inhibitor, an anti-CD38 monoclonal antibody and an immunomodulatory agent. Nearly 80% were also refractory to these drug classes.

Tecvayli’s label bears safety warnings for cytokine release syndrome, neurologic toxicities and other precautions for infections, hypersensitivities, neutropenia and hepatotoxicity.

In MajesTEC-1, the most common side effects included cytokine release syndrome, pyrexia and upper respiratory tract infection. Adverse events in grade 3 or 4 included lowered lymphocytes, neutrophils and white blood cells.

J&J’s Winning Streak in Multiple Myeloma

Tecvayli is J&J’s second multiple myeloma win this year. In March, the pharma giant, along with partner Legend Biotech, announced the FDA’s approval of Carvykti (ciltacabtagene autoleucel), its CAR-T therapy for multiple myeloma.

As in the case of Tecvayli, Carvykti was approved for heavily pretreated patients relapsed or refractory disease; only those who had had at least four prior lines of therapy were eligible to receive the CAR-T drug. Carvykti also targets The BCMA, and in the CARTITUDE-1 studies, it showed a 98% deep and durable response rate, with 78% of treated patients meeting a stringent complete response threshold, showing no detectable levels of cancer cells.

J&J also owns Darzalex (daratumumab) and Darzalex Faspro (daratumumab and hyaluronidase-fihj), both indicated for multiple myeloma.

Tristan is an independent science writer based in Metro Manila, with more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.