Tec-Dara Demonstrates Superior 3-Year PFS vs Standard Therapy in Functional High-Risk Myeloma: Rahul Banerjee, MD

In a subgroup analysis of the phase 3 MajesTEC-3 trial (NCT05083169), teclistamab plus daratumumab (Tec-Dara) produced a 3-year progression-free survival (PFS) rate of 77% in patients with functional high-risk relapsed or refractory multiple myeloma (R/R MM) vs 0% among those receiving standard treatment, lead investigator Rahul Banerjee, MD, highlighted in an interview with The American Journal of Managed Care^® (AJMC^®) at the European Hematology Association (EHA) 2026 Congress.

Earlier this year, the FDA approved teclistamab (Tecvayli; Janssen Biotech, Inc) plus daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech, Inc) to treat patients with R/R MM in earlier-line settings; it could come as early as the second line for patients who have received at least 1 prior line of therapy.

The decision was supported by data from the open-label, multicenter, ongoing MajesTEC-3 trial, which found that, at 3 years, PFS was 83% in the treatment arm vs 30% in the control arm.

Building on these findings, the MajesTEC-3 subgroup analysis, presented at the EHA 2026 Congress today by Banerjee, examined whether Tec-Dara overcomes poor results historically associated with high-risk MM. In the interview with AJMC, he explained that the analysis focused on 2 traditionally treatment-resistant populations: patients with high-risk cytogenetic abnormalities and those with functional high-risk disease.

Banerjee highlighted that Tec-Dara demonstrated benefit in both subgroups. Among functional high-risk patients receiving standard treatment, 3-year PFS was 0%. By contrast, those receiving Tec-Dara had a 3-year PFS of 77%.

He noted that responses appeared to plateau after approximately 2 years on treatment, suggesting a potential for durable disease control that is not observed with other therapies in this setting, including chimeric antigen receptor T-cell therapy or teclistamab monotherapy. However, Banerjee acknowledged that longer follow-up will be required to confirm these findings.

“Obviously, we need more follow-up to say that, but especially for functional high risk, you don't see that with any other treatment,” he concluded. “Even with [MajesTEC-9], some of the other data on teclistamab monotherapy, you don't see that level of patients just maintaining, holding the line for years and years. With Tec-Dara, that very well may be possible.”