Recent trials on J& J's Darzalex (daratumumab) have shown positive results for the therapy as a standalone and in combination with existing maintenance therapies. In the AQUILA trial, daratumumab significantly delayed progression to active multiple myeloma in 63.1% of high-risk smoldering MM patients over five years, compared to 40.8% with active monitoring. The PERSEPHONE trial also demonstrated that adding daratumumab to lenalidomide maintenance therapy after transplant in multiple myeloma patients significantly increased MRD-negative conversion rates to 50.5% compared to 18.8% withlenalidomide alone.

In response to the influx of T-cell therapies entering the market for multiple myeloma treatments, the International Myeloma Working Group recently issued their recommendations for sequencing of these therapies.The working group, and the industry as a whole, view T-cell redirectingtherapies, including CAR T-cell and bispecific T-cell engagers (TCE), as significant advancements in treating multiple myeloma, particularly targeting B-cell maturation antigen (BCMA) and G protein-coupledreceptor class C group 5 member D (GRPC5D). The nine recommendations for sequencing intend to address safety concerns such as washout periods between therapies, and advocate for the prioritizationof CAR T-cell therapy over TCEs when feasible, based on higher activity levels and better treatment outcomes post-sequencing.

Dr. Reddy's recently announced a licensing agreement with Shanghai Henlius Biotech to jointly develop and market a biosimilar of J& J's Darzalex for multiple myeloma.HLX15 successfully completed its Phase I clinical trial in June 2024, demonstrating comparable pharmacokinetics, safety, and immunogenicity to the reference drug,with further efficacy studies underway. Under the deal, Dr. Reddy's will secureexclusive marketing rights in the U.S. and Europe for the biosimilar HLX15 in bothintravenous and subcutaneous forms, in exchange for up to $131.6 million, including an upfront payment of $33 million. Henlius will lead the development, manufacturing,and commercial supply, while also receiving royalties on annual net sales.

The UK's Medicines and Healthcare Regulatory Agency (MHRA) and the European Medicines Agency recently approved Sanofi's Sarclisa(isatuximab) combined VRd for newly diagnosed transplant-ineligiblemultiple myeloma patients, based on the Phase III IMROZ study. The drug,designed to target the CD38 receptor on multiple myeloma cells, is the first and only anti-CD38 quadruplet therapy available for transplantineligible multiple myeloma patients in the UK.

Opna Bio recently received orphan drug designation from the FDA for OPN-6602, a novel therapeutic for relapsed or refractory (R/R)multiple myeloma (MM). Preclinical data demonstrates that OPN6602 suppresses tumor growth and enhances efficacy when combined with dexamethasone, pomalidomide and mezigdomide.The ongoing Phase I trial is expected to complete its doseescalation phase by 2026, with plans for further combination studies. The orphan designation offers Opna Bio benefits such asseven years of market exclusivity and other financial incentives with the objective of getting the novel therapy into patients' hands.

Results from a recent study published by a coalition of Chineseuniversities revealed that Epstein-Barr virus, a contagious type ofherpesvirus, is a risk factor for multiple myeloma. The Mendelianrandomization study using the FinnGen Consortium's MM R11 and R10datasets found that Epstein-Barr virus EBNA-1 antibodies are associated with a 36% increased risk of multiple myeloma. The research revealed that EBNA-1 antibodies may downregulate HLA-DR* myeloid dendritic cells,suggesting a mechanism for MM development and highlighting potential pharmaceutical intervention targets.