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ASH 2025 | IFM2021-01 trial Cohort A: teclistamab + daratumumab in older patients with newly diagnosed myeloma
Salomon Manier, MD, PhD, Lille Hospital University, Lille, France, presents the results of Cohort A of the IFM2021-01 trial (EU CT 2024-514101-65; NCT05572229) evaluating the combination of teclistamab and daratumumab in older patients with newly diagnosed multiple myeloma (MM) who are ineligible for high-dose chemotherapy with autologous stem cell transplantation (autoSCT). Dr Manier highlights that all patients responded to the treatment, with most achieving complete response (CR) and all evaluable patients achieving measurable residual disease (MRD) negativity at 6 months. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
Yes, so we reported the IFM 2021-01 Teclille study at ASH 2025. And so it’s a phase 2 study dedicated to transplant non-eligible patients. And they received the combination of teclistamab and daratumumab and all antibody regimens. So patients were transplant non-eligible, 37 patients were included, and they received the monthly schedule of teclistamab and daratumumab with the regular schedule...
Yes, so we reported the IFM 2021-01 Teclille study at ASH 2025. And so it’s a phase 2 study dedicated to transplant non-eligible patients. And they received the combination of teclistamab and daratumumab and all antibody regimens. So patients were transplant non-eligible, 37 patients were included, and they received the monthly schedule of teclistamab and daratumumab with the regular schedule.
So what we see in terms of efficacy is that at best response, all patients responded and all patients had a VGPR or better, with most of the patients achieving a complete remission. We evaluated the MRD for all patients at six months, and we observed for evaluable samples a 100% of MRD negativity at 10 to the minus 6 by NGS. There was no event of progression or death in the trial with this 10.3 months median follow-up. So, the rate of PFS and OS are 100%. And what was interesting is for the safety profile, the concern is always the infections with the bispecific antibodies. And here we had a strong recommendation for systematic immunoglobulin prophylaxis as soon as cycle 1 for all the patients in the trial. And this prophylaxis was actually well-followed – 95% of the patients actually received this prophylaxis of immunoglobulin at cycle 1. And the rate of grade 3/4 infection is 14%, which is quite good. And what we can see is that with this, we’re able to maintain the IgG level at a level around seven grams per liter across the course of the treatment. So I think this strategy is well preventing the risk of infection. So overall, the combination is highly effective and the safety profile is very good.
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