J&J expands multiple myeloma arsenal with FDA approval for first-in-class Talvey

Johnson & Johnson is digging its multiple myeloma moat deeper thanks to FDA approval for another novel drug.

The FDA has signed off on J&J’s Talvey, a.k.a. talquetamab, for the treatment of multiple myeloma after at least four prior lines of therapy, the company said Thursday.

Talvey is the first GPRC5D-targeted therapy to cross the FDA finish line. A bispecific, the drug works by attracting T cells to target blood cancer cells expressing GPRC5D. It’s J&J’s second bispecific drug for multiple myeloma following BCMA-directed Tecvayli.

J&J is marketing Talvey at a list price of $45,000 per month, a J&J spokesperson told Fierce Pharma. That means the entire treatment regimen should cost approximately $270,000 to $360,000 based on the need for 6 to 8 months of treatment seen in clinical trials. Talvey’s per-month price is higher than Tecvayli’s $39,500.

Other companies such as Bristol Myers Squibb and Roche are also working on GPRC5D therapies. But J&J’s growing presence in multiple myeloma may be hard to challenge, especially with the impressive efficacy showing from its Legend-partnered CAR-T Therapy Carvykti.

As is the case with Caryvkti’s approval last year, Talvey won the FDA accelerated approval as a fifth-line treatment even though a phase 1/2 trial had tested the drug one line earlier. J&J asked for a fifth-line approval, “where there is a high unmet medical need,” the J&J spokesperson said.

To be eligible for Talvey, a patient doesn’t need to have undergone a BCMA-targeted treatment like Carvykti or Tecvayli.

Talvey has shown anticancer activity in patients with or without prior exposure to BCMA treatment.

The FDA based the approval on data from the MonumenTAL-1 trial among patients who received Talvey after at least four prior lines of therapy. At a lower dose given weekly, the J&J drug shrank tumors in 73% of patients, including 35% who experienced a complete response or better. At a higher dose given once every other week, Talvey triggered a response in 74% of patients, with 33% showing a complete response or better. The results cover those who had not tried any BCMA agents.

Talvey’s label also includes results from 32 patients who had tried a CAR-T therapy or a bispecific antibody before, including all but two patients who had used a BCMA therapy. In this subgroup, Talvey’s overall response rate was 72%.

The ability to treat patients regardless of BCMA exposure, plus the two different dosing regimens, provides flexibility and versatility for patients and the healthcare system, the J&J spokesperson said.

Given Talvey’s data in both settings, doctors might want to save the drug as an option for patients who relapse after a BCMA treatment, especially as Carvykti has shown a near-100% overall response rate. But on the other hand, continued supply constraints on the BCMA CAR-T therapies—including Bristol Myers’ Abecma—may force doctors to use whatever drug is available to them.

Meanwhile, the multiple myeloma race in the BCMA and GPRC5D classes is getting increasingly competitive. Pfizer is waiting for an FDA decision, expected this month, on its BCMA bispecific elranatamb, which can also be dosed biweekly.

Besides Abecma, BMS is working on a GPRC5D CAR-T coded BMS-986393, which produced some promising early results last year. Roche, an expert in bispecifics for blood cancers, is developing forimtamig, a GPRC5DxCD3 bispecific that poses a direct threat to J&J’s Talvey.

J&J has further plans for Talvey. First, the phase 3 MonumenTAL-3 trial testing Talvey in patients after their first relapse will serve as the confirmatory trial for the current accelerated approval.

At this year’s American Society of Clinical Oncology annual meeting in June, J&J showed results from the early-stage RedirecTT-1 study that the combination of Talvey and Tecvayli produced a 96% remission rate at the recommended phase 2 dose. In the phase 1 TriMM-2 trial, combining Talvey with J&J’s CD38 antibody Darzalex yielded around 71% to 84% response rates at different dosing regimens.

Talvey will be available through an FDA-designated drug safety program because of neurologic toxicity and the potentially life-threatening immune reaction known as cytokine release syndrome, both of which are known side effects of T-cell engagers.