This year’s American Society of Hematology (ASH) meeting will be celebrated at the Georgia World Congress Center in Atlanta, Georgia, or virtually, from December 11-14, 2021, featuring the newest advances in hematology and offering several key updates on the multiple myeloma space.
Anti-CD38 monoclonal antibody quadruplets continue to demonstrate superiority versus triplets in the early stages of multiple myeloma. Janssen will present updated data from the phase II GRIFFIN study with Darzalex as part of a non-yet approved quadruplet therapy in transplant-eligible newly diagnosed myeloma patients and will also share updated MRD results from the CASSIOPEIA study of Darzalex in the maintenance setting. In addition, Sanofi will release new data from the phase III GMMG-HD7 on the effect of Sarclisa as a quadruplet regimen in transplant-ineligible newly diagnosed multiple myeloma.
Additionally, Takeda will announce updated efficacy and safety results from the phase I trial of TAK-573 in relapsed/refractory multiple myeloma patients, developed to minimise off-target toxicity demonstrated in other anti-CD38 monoclonal antibodies.
Nevertheless, the focus will likely be on the B cell maturation antigen (BCMA)-targeting agents with the presentation of Janssen’s updated results of the CARTITUDE-1 study of Ciltacabtagene Autoleucel (cilta-cel), whose PDUFA target date was recently extended by the US FDA from November 29, 2021, to February 28, 2022.
BCMA-bispecific antibodies, however, seem to be gathering greater popularity versus CAR-T therapies. Particularly, Regeneron’s REGN5458 (BCMAxCD3 bispecific antibody) and its updated phase I/II results, as the phase II portion of the study is currently enrolling with registrational intent. Also, Janssen’s own BCMAxCD3 bispecific antibody, teclistamab, with updated results from the MajesTEC-1 study; phase II also registrational.
Abbreviations: Prescription Drug User Fee Act (PDUFA); Overall Response Rate (ORR); Grade (Gr); Cytokine Release Syndrome (CRS); Follow-up (f/u); Progression Free Survival (PFS); Overall Survival (OS); Real-World Clinical Practice (RWCP); Relapsed or Refractory Multiple Myeloma (RRMM); Treatment Emergent Adverse Event (TEAE); Adverse Events (AEs); Very Good Partial Response (VGPR); Inducible Co-Stimulatory T-cell molecule (ICOS, CD278) agonist (aICOS); Dose Limiting Toxicities (DLT); Recommended Phase II Dose (RP2D); Partial Response (PR); Not Reached (NR); Placebo (PBO).