The FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will meet on March 15 to discuss applications from Janssen Biotech and Celgene to use their chimeric antigen receptor (CAR) T-cell therapies—ciltacabtagene autoleucel (cilta-cel; Carvykti) and idecabtagene vicleucel (ide-cel; Abecma), respectively—earlier in the treatment regimen for multiple myeloma (see https://public-inspection.federalregister.gov/2024-02229.pdf). The committee will focus on overall survival (OS) data from the CARTITUDE-4 and KarMMa-3 trials, respectively, as well as the risks and potential benefits associated with each treatment. Last month, based on reports that about two dozen patients who received CAR T-cell therapies developed secondary T-cell cancers, the FDA called for boxed warnings on all such products, including cilta-cel and ide-cel.
Gilead Sciences will no longer pursue the development of magrolimab for hematologic cancers. In an interim analysis of the phase III ENHANCE-3 study, the CD47 monoclonal antibody plus venetoclax (Venclexta; Genentech/AbbVie) and azacitidine increased the risk of death compared with venetoclax and azacitadine alone in patients with acute myeloid leukemia (AML). Primary analyses of two other magrolimab studies—one for myelodyplastic syndromes (MDS) and one for AML with TP53 mutations—also demonstrated futility and showed an increased risk of death. The FDA has placed a full clinical hold on all studies of magrolimab in AML and MDS.
In a head-to-head study, belantamab mafodotin (Blenrep) plus bortezomib and dexamethasone (BVd) significantly improved progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma compared with daratumumab plus bortezomib and dexamethasone (DVd), according to data presented at the February 2024 session of the American Society of Clinical Oncology (ASCO) Plenary Series. In the phase III DREAMM-7 study, researchers noted a 59% reduction in the risk of disease progression or death with the BVd regimen compared with standard-of-care DVd. Median PFS for patients who received BVd was nearly triple that of those who received DVd—36.6 months vs. 13.4 months.
The combination of Takeda’s fruquintinib (Fruzaqla) plus paclitaxel significantly improved progression-free survival compared with placebo plus paclitaxel—5.6 months vs. 2.7 months, respectively—in patients with advanced stomach cancers that progressed while on or after receiving first-line chemotherapy. However, in presenting findings of the FRUTIGA trial during the ASCO Plenary Series, researchers said that the improvement in OS—9.6 months vs. 8.4 months, respectively—was not statistically significant. Fruquintinib, a VEGFR 1/2/3 inhibitor, was approved in November 2023 for the treatment of certain metastatic colorectal cancers.
Embroiled in expensive patent litigation and facing some unfavorable court rulings, NanoString Technologies filed for bankruptcy. However, the company has secured $40 million in financing to keep the company going while it explores “strategic alternatives,” including the potential sale of the company or its product lines. NanoString’s technologies include the GeoMx Digital Spatial Profiler, which combines whole tissue imaging with gene expression and protein data for spatial whole transcriptomics and proteomics.
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