July 3, 2024 - ­čžČ [nGram] TodayÔÇÖs Oncology Scoop: Legend Biotech's CARTITUDE-4, Biogen's Acquisition, Full-Life's FDA Fast Track

  1. Legend Biotech announces positive overall survival results of landmark phase 3 CARTITUDE-4 trial in multiple myeloma
    • Legend Biotech announced positive overall survival results from the ongoing Phase 3 CARTITUDE-4 trial.
    • The trial evaluates CARVYKTI (ciltacabtagene autoleucel) against PVd or DPd in relapsed and lenalidomide-refractory multiple myeloma patients.
    • CARVYKTI demonstrated statistically significant and clinically meaningful improvement in overall survival.
    • Safety results were consistent with the established profile of CARVYKTI, with no new safety signals identified.
    • These results will be presented at an upcoming medical meeting and shared with regulatory agencies for label updates worldwide.
    • Data from CARTITUDE-4 supported the FDA approval of CARVYKTI in April 2024 for patients with relapsed or refractory multiple myeloma.
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  2. CARVYKTI® shows significant improvement in overall survival in CARTITUDE-4 study
    • CARVYKTI┬« (ciltacabtagene autoleucel) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) in the Phase 3 CARTITUDE-4 study.
    • The study compared CARVYKTI┬« to standard therapies (pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone) for patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy.
    • Safety data were consistent with the approved label, and CARVYKTI┬« is the first cell therapy to significantly improve OS versus standard of care for myeloma patients as early as the second line.
    • Updated results will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.
    • CARVYKTI┬« received FDA approval in February 2022 for relapsed or refractory multiple myeloma after four or more prior lines of therapy and was approved in April 2024 for patients with at least one prior line of therapy.
    • The European Medicines Agency (EMA) and Japan's Ministry of Health, Labour and Welfare (MHLW) have also approved CARVYKTI┬« for similar indications.
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  3. Full-Life Technologies granted FDA fast track designation for 225Ac-FL-020 for the treatment of metastatic castration-resistant prostate cancer
    • Full-Life Technologies received FDA Fast Track Designation for 225Ac-FL-020, targeting PSMA for mCRPC treatment.
    • The Fast Track program aims to expedite the development and review of therapies for serious conditions with unmet needs.
    • 225Ac-FL-020 uses targeted alpha-radiotherapy to selectively attack cancer cells, minimizing damage to healthy tissues.
    • Preclinical models showed promising biodistribution, high tumor uptake, and fast systemic clearance.
    • Phase I clinical trial will assess the safety, tolerability, and anti-tumor activity of 225Ac-FL-020.
    • Full-Life received IND clearance from the FDA in May 2024 for clinical trials of 225Ac-FL-020.
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  4. Delta-Fly Pharma initiates patient enrollment in Phase III trial of DFP-14323
    • Delta-Fly Pharma has started enrolling patients in a Phase III clinical trial for DFP-14323 in combination with Afatinib.
    • The trial targets stage III/IV non-small cell lung cancer (NSCLC) patients with uncommon EGFR mutation positive.
    • Approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in February 2024.
    • Conducted at 30 sites in Japan, focusing on the add-on effect of DFP-14323 on progression-free survival (PFS).
    • DFP-14323 binds to aminopeptidase N, potentially offering a novel cancer immunotherapy independent of EGFR mutation types.
    • Plans to expand the trial to other Asian countries and promote out-licensing activities.
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  5. Biogen completes acquisition of Human Immunology Biosciences
    • Biogen has completed the acquisition of Human Immunology Biosciences (HI-Bio), a clinical-stage biotech company.
    • The acquisition includes felzartamab, a late-stage therapeutic candidate for severe immune-mediated diseases.
    • Felzartamab has shown positive interim results in Phase 2 studies for IgA nephropathy (IgAN) and antibody-mediated rejection (AMR).
    • Plans are in place to advance felzartamab to Phase 3 trials for AMR, IgAN, and primary membranous nephropathy (PMN).
    • Felzartamab is a monoclonal antibody targeting CD38, aimed at depleting CD38+ plasma cells to improve clinical outcomes.
    • HI-Bio had exclusive rights to develop and commercialize felzartamab outside of China, including Macau, Hong Kong, and Taiwan.
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  6. MaaT Pharma announces first DSMB positive review of ongoing phase 2 clinical trial evaluating MaaT033 for patients receiving allo-HSCT
    • MaaT Pharma's Phase 2b trial PHOEBUS received its first positive safety review from the DSMB.
    • The trial is the largest to date for a microbiome therapy in oncology, involving 387 patients across 56 sites.
    • The DSMB reviewed safety data from the first 20 patients and found MaaT033 to be safe and well-tolerated.
    • MaaT033 is an oral freeze-dried formulation designed for ambulatory use and chronic treatment.
    • The trial aims to enhance clinical outcomes in patients undergoing allogeneic stem cell transplantation.
    • MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).
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  7. Positive phase 1 clinical data of MTX110 in DMG brain cancer demonstrating increased survival presented at ISPNO 2024
    • Biodexa Pharmaceuticals presented Phase 1 data of MTX110 in Diffuse Midline Glioma (DMG) at ISPNO 2024.
    • The study showed a median overall survival (OS) of 16.5 months, compared to 10.0 months in a historical cohort.
    • The treatment was well tolerated, with most adverse events related to infusion and deemed Grade 2 to 3.
    • The open-label study was conducted by Columbia University Irving Medical Center using convection enhanced delivery (CED).
    • Nine patients were treated with two infusions each, and the primary endpoint was to evaluate safety and maximum tolerated dose.
    • MTX110 is a water-soluble form of panobinostat, delivered directly to the tumor site to bypass the blood-brain barrier.
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