Tec-Dara Shows MRD-Negative, PFS Benefit in High-Risk Myeloma, But Longer Follow-Up Needed: Rahul Banerjee, MD

Teclistamab plus daratumumab (Tec-Dara) produced consistently higher rates of minimal residual disease (MRD)-negative complete response (CR) than standard therapy across risk groups in the phase 3 MajesTEC-3 trial (NCT05083169), supporting its emerging role in relapsed/refractory multiple myeloma (MM), according to a subgroup analysis presented by Rahul Banerjee, MD, at the European Hematology Association (EHA) 2026 Congress.

In the first part of his interview with The American Journal of Managed Care^® at EHA, Banerjee discussed subgroup data from MajesTEC-3, the trial that supported the FDA approval of Tec-Dara earlier this year. He noted a 3-year progression-free survival (PFS) rate of 77% in patients with functional high-risk relapsed or refractory MM compared with 0% in the standard therapy arm.

He added that responses appeared to plateau after about 2 years, suggesting a level of durability not typically seen with other therapies in this setting, such as chimeric antigen receptor (CAR) T-cell therapy or teclistamab monotherapy. However, Banerjee cautioned that longer follow-up is needed 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 said.

In part 2, Banerjee highlighted that about one-third of patients with functional high-risk MM achieved MRD-negative CR with Tec-Dara compared with none in the control arm. He explained that although MRD negativity is a key milestone, durable disease control remains the greater challenge in high-risk disease.

Therefore, Banerjee characterized MRD negativity as a potential starting point for prolonged remission. However, he emphasized that PFS remains the end point he prioritizes most.

Regarding treatment burden, Banerjee noted that Tec-Dara dosing, along with immunoglobulin replacement therapy to prevent infection, can be tapered to a once-monthly schedule, helping patients remain on treatment without an excessive burden on quality of life. He said he would not yet recommend stopping treatment based on MRD status alone, citing ongoing studies of bispecific antibody discontinuation.

Banerjee also addressed how Tec-Dara fits into an expanding treatment landscape at first relapse that includes BCMA-targeted CAR T-cell therapies such as ciltacabtagene autoleucel (cilta-cel) and idecabtagene vicleucel (ide-cel), as well as belantamab mafodotin, a BCMA-targeting antibody-drug conjugate. He said BCMA targeting is now the default approach at first relapse, with CAR T-cell therapy and bispecific antibodies increasingly viewed as comparable options.

Looking ahead, Banerjee said longer follow-up, particularly through 5 years, will help clarify whether sustained MRD negativity could indicate a functional cure. He also pointed to remaining questions from the MajesTEC-9 trial (NCT05572515) of teclistamab monotherapy, including patient selection for combination vs monotherapy approaches and what benefit daratumumab adds for those previously exposed to, but not refractory to, CD38-targeted therapy.

"I actually think that the synergy is real," Banerjee concluded. “I think that daratumumab, again, maintains myeloma effect for these Dara-exposed but sensitive patients but is also helping shape the T cells to respond better to teclistamab; that we need more data on to say for sure.”