Meletios A. Dimopoulos, MD, of National and Kapodistrian University of Athens School of Medicine, discusses efficacy and safety findings from part 1 dose level G of the MagnetisMM-6 trial (NCT05623020), which is investigating elranatamab-bcmm (Elrexfio) at 76 mg every 4 weeks plus daratumumab (Darzalex) at 1800 mg and lenalidomide (Revlimid) at 25 mg in transplant-ineligible patients with newly diagnosed multiple myeloma. Early efficacy was reported at the 2025 EHA Congress, with a confirmed overall response rate (ORR) of 97.3% (95% CI, 85.8%-99.9%), which included a very good partial response or better rate of 94.6% and a complete response (CR) or better rate of 27.0%. Responses were observed early, at a median of 1.5 months (range, 0.3-4.2). The safety profile of the regimen is aligned with the known toxicities of the components.
Lydia Scarfò, MD, of the Università Vita-Salute San Raffaele, discusses updated safety and efficacy data from the ongoing phase 1 CADANCE-101 trial (NCT05006716) evaluating the BTK degrader BGB-16673 in patients with relapsed/refractory CLL and small lymphocytic lymphoma. Data presented at the 2025 EHA Congress indicated that the agent led to an ORR of 84.8% in 66 evaluable patients; this was comprised of a CR/CR with incomplete marrow recovery rate of 4.5%, a partial response (PR) rate of 66.7%, and PR with lymphocytosis rate of 13.6%. The stable and progressive disease rates were 3.0% and 4.5%, respectively. The median time to first response was 2.8 months (range, 2.0-19.4), and the median time to best response was 3.4 months (range, 2.0-19.4). At a median follow-up of 15.6 months (range, 0.3- 30.6+), the 12-month PFS rate was 77.4% (95% CI, 63.1%-86.8%). Only 2 patients discontinued treatment with BGB-16673 because of a treatment-related adverse effect (TRAE), and no TRAEs proved fatal.
Amitkumar Mehta, MD, of the University of Alabama at Birmingham, discusses the clinical significance of the FDA approval of tafasitamab-cxix (Monjuvi) in combination with lenalidomide and rituximab (Rituxan) for relapsed or refractory follicular lymphoma. The approval, which occurred on June 18, 2025, was based on findings from the phase 3 inMIND trial (NCT04680052), which showed a significant PFS benefit with the triplet regimen compared with placebo plus lenalidomide and rituximab (HR, 0.43; P < .0001). The median PFS reached 22.4 months in the tafasitamab group vs 13.9 months in the control group by investigator assessment, with consistent benefit observed across key subgroups. Mehta explained that the addition of tafasitamab to this established backbone represents a novel dual-targeted approach that offers improved disease control in an indolent but relapsing B-cell lymphoma.
Jason S. Starr, DO, of Mayo Clinic, discusses the potential of delta-like ligand 3 as a therapeutic target in extrapulmonary neuroendocrine carcinomas (epNECs). DLL3, known for its high expression in small cell lung cancer, is similarly overexpressed in approximately 80% of epNEC cases, prompting evaluation of DLL3-directed therapies in this setting. During the 2025 ASCO Annual Meeting, Starr presented phase 1 NCT04429087) data showing that the DLL3/CD3 bispecific T-cell engager obrixtamig (BI 764532) yielded an ORR of 40% with a disease control rate (DCR) of 67% in DLL3-high epNECs, compared with an ORR of 3% and DCR of 27% in DLL3-low tumors. Starr noted that these findings, along with the agent’s FDA fast track designation in October 2023, support ongoing investigation in the phase 2 DAREON-5 trial (NCT05882058).