Salomon Manier, MD, PhD, University of Lille, Lille, France presents data from the first safety run-in from the phase 3 MajesTEC-7 study on bispecific antibody teclistamab in combination with daratumumab and lenalidomide (DR) vs DR and dexamethasone (DRd) as frontline therapy for patients with multiple myeloma (MM) who are ineligible or not intended for autologous stem cell transplant (ASCT).

This research was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

“These results from the first [safety run-in] of MajesTEC-7 demonstrate a manageable safety profile with early efficacy of [teclistamab] plus DR in [newly diagnosed] MM,” Manier and coauthors wrote. “[2] additional [safety run-ins] are ongoing investigating [teclistamab] (less frequent dosing) plus DR and talquetamab plus DR.”

Transcript:

My name is Salomon Manier. I'm a physician scientist from Lille University in France. At the ASCO annual meeting, we reported the safety running of MajesTEC-7. So MajesTEC-7 is a phase 3 trial, assessing the role of the bispecific antibody teclistamab in combination with daratumumab and lenalidomide in frontline treatment for elderly patients who are not transplant-eligible, or not intended for transport.

The study design is a first safety run-in and then a randomized part, and we are reporting here this safety run-in. 26 patients were included. The median age is 72 years old and 95% of the patients were not transplant-eligible. Some patients were, most of the patients, were fit per the [International Myeloma Working Group Frailty] (IMWFG) score, but some patients were intermediate or frail, which is interesting information.

We observed a good safety profile. The most common side effects were hematological side effects with grade 3 and 4 neutropenia in 57% of the cases. The patients had CRS in 65 % of the case, but only grade 1 and 2, and no grade 3 CRS. Just 1 patient had an ICANN grade 1, reversible. And the infection rate, of course, was very important and a good safety profile because it's 30% of the patients who had grade 3  or 4 infections, mostly COVID-19, 11.5 % [of that], and 1 patient actually died from infection.

What we observe is a remarkable efficacy of the treatments—92% of the patients had a response. It's 80% of the patients with a complete remission at 13.8 months of median follow-up. And the responses are very rapid. We could see that all but 1 patient had a response already at the end of cycle 1. And the median PFS, of course, was not reached, but the PFS rate at 1-year is 96%.

So it's excellent efficacy, very promising for the safety running, and the safety profile is manageable. So the trial is now moving on, with the randomized phase on 1,500 patients.

Source:

Touzeau C, Beksac M, Terpos E, et al. Safety results from the phase 3 MajesTEC-7 study in patients (pts) with transplant ineligible/not intended newly diagnosed multiple myeloma (NDMM). Presented at the ASCO Annual Meeting. May 31–June 4, 2024; Chicago, IL. Abstract 7506