An interim phase 3 analysis showed mezigdomide plus carfilzomib and dexamethasone reduced the risk of progression or death in relapsed/refractory multiple myeloma. The SUCCESSOR-2 study remains ongoing and will assess overall survival and safety.
Phase 3 trial data show daratumumab reduced relapse risk by 74% in NMOSD. Separately, the FDA accepted an NDA for iberdomide plus daratumumab/dexamethasone in relapsed/refractory multiple myeloma, with a PDUFA date of August 17, 2026.
The 2026 Tandem Meetings featured new data on CAR-T, allogeneic transplantation, and supportive care. Highlights included early efficacy signals for EB-103, KITE-753, Orca-T, and NXC-201, plus comparative cardiovascular safety data for lisocabtagene maraleucel.
CD28 and CD38 have been identified as new therapeutic targets for peripheral T-cell lymphomas, with a trispecific antibody showing in vitro efficacy. The targets are expressed in 57% and 42% of PTCL cases respectively, covering most entities. Separately, low CD38 expression on circulating tumor-reactive T cells predicts better response to immune checkpoint inhibitors in lung cancer.
MajesTEC-9 trial demonstrates teclistamab's superiority over standard care in second-line multiple myeloma treatment, with significant progression-free survival and overall survival benefits supporting earlier use of the BCMA-targeting bispecific antibody.
C4 Therapeutics has initiated its Phase 2 MOMENTUM trial of cemsidomide in relapsed/refractory multiple myeloma, targeting enrollment completion in Q1 2027 and a registrational dataset by 2028. The company plans a combination study with elranatamab in Q2 2026.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
The FDA has accepted Bristol Myers Squibb's new drug application for iberdomide combined with daratumumab and dexamethasone for relapsed or refractory multiple myeloma, with a target action date of August 17, 2026.
The U.S. FDA has accepted Bristol Myers Squibb's New Drug Application for iberdomide combined with daratumumab and dexamethasone in patients with relapsed or refractory multiple myeloma, with a PDUFA date of August 17, 2026.
Shanghai Henlius Biotech received U.S. FDA approval to begin phase 1 trials of HLX15-SC, a subcutaneous biosimilar of daratumumab, for multiple myeloma treatment with significant commercial potential.
