Daratumumab/Hyaluronidase-fihj

Johnson & Johnson on Monday shared detailed survival data from a Phase III study evaluating a combination of its anti-BCMA bispecific Tecvayli (teclistamab-cqyv) plus Darzalex Faspro (daratumumab/hyaluronidase-fihj) in patients with relapsed/refractory multiple myeloma (MM) who had received one to three prior lines of treatment. Yusri Elsayed, J&J's global therapeutic area head for oncology, had said the duo was "poised to be a new standard of care option" when top-line results from the 587-patient MajesTEC-3 trial were shared last month (see – ViewPoints: J&J continues to raise its own bar in MM).Physicians also see Tecvayli as the preferred bispecific for MM. The results of a recent FirstWord poll showed that it was the top choice for 47% of US haematologists and oncologists, ranking it above other bispecifics including Talvey (talquetamab), Elrexfio (elranatamab) and Lynozyfic (linvoseltamab). For more on which treatments doctors are picking for their MM patients, see Physician Views In-Depth: US oncologists heavily favour Tecvayli among MM bispecifics.'Clinically remarkable'The pharma had reported in October that the Tecvayli-Darzalex Faspro combo helped patients with MM live significantly longer without their disease worsening than those on two standard-of-care comparators — investigator's choice of either Darzalex Faspro plus pomalidomide and dexamethasone, or Darzalex Faspro plus bortezomib and dexamethasone (DPd/DVd).Now, J&J has pulled back the curtain on the study's survival specifics in a late-breaking abstract posted ahead of the American Society of Hematology (ASH) meeting (see – Spotlight On: Late-breakers to watch at ASH 2025).The drugmaker revealed that its Tecvayli-Darzalex Faspro combo achieved a 36-month progression-free survival (PFS) rate of 83.4%, versus 29.7% for the DPd/DVd comparator arm. While the standard-of-care group saw a median PFS of 18.1 months, that milestone was not reached after a median follow-up of 34.5 months for those taking the experimental regimen. Overall survival "significantly favoured" the doublet, with a hazard ratio of 0.46 and 45 patient deaths, compared to 96 deaths the standard-of-care arm. More than 90% of patients taking Tecvayli-plus-Darzalex Faspro who were alive after 6 months remained alive at the 30-month mark, and close to half remained on treatment as of the data cut-off. J&J's duo also bested DPd/DVd on several key secondary measures, including complete response rate (81.8% versus 32.1%), overall response rate (89% vs 75.3%) and MRD-negativity rate (58.4% vs 17.1%), all of which were statistically significant results. The rate of treatment-emergent adverse events (TEAEs) was comparable between the two study arms. Serious TEAEs occurred in 70.7% of those taking Tecvayli-Darzalex Faspro with a discontinuation rate of 4.6%, versus 62.4% and 5.5%, respectively, for the comparator group. Grade 1 and 2 cytokine release syndrome (CRS) was reported in 44.2% and 15.9% of doublet recipients, respectively; the rate of immune effector cell-associated neurotoxicity syndrome (ICANS) was 1.1%.The abstract authors described the findings as "clinically remarkable," adding that the off-the-shelf immunotherapy combination could represent a new standard-of-care for relapsed/remitting MM as early as first relapse.

The FDA on Wednesday made a series of regulatory decisions, including the accelerated approval of Bayer's Hyrnuo (sevabertinib) for certain patients with lung cancer.The oral, small molecule tyrosine kinase inhibitor (TKI), which was assessed under priority review, was cleared for adults with locally advanced or metastatic non-squamous second-line non–small-cell lung cancer (NSCLC) whose tumours have HER2 TK domain activating mutations.In conjunction, the US regulator also approved the Oncomine Dx Target Test from Life Technologies as a companion diagnostic to detect HER2 mutations and determine eligibility for Hyrnuo. The green light for Bayer's TKI was based on findings from the Phase I/II SOHO-01 trial, which enrolled 70 patients with HER2-mutant NSCLC who had received a prior systemic therapy, but not a HER2-targeting treatment. Hyrnuo achieved an confirmed objective response rate of 71%, with a median duration of response of 9.2 months.More from the FDASeparately, the FDA also expanded the label of AstraZeneca's Koselugo (selumetinib). First approved in 2020 for paediatric patients one year and older with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas, the MEK inhibitor is now cleared to treat adults.Meanwhile, the US regulator also converted two accelerated clearances into full approvals: Amgen's bispecific T-cell engager Imdelltra (tarlatamab-dlle), initially cleared last year to treat patients with extensive-stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy; and Johnson & Johnson's subcutaneous Darzalex Faspro (daratumumab/hyaluronidase-fihj), cleared for newly diagnosed light-chain amyloidosis in 2021. The full approval for Darzalex Faspro comes shortly after the FDA cleared the CD38-targeting antibody for high-risk smouldering multiple myeloma.