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OSAKA, Japan & CAMBRIDGE, Mass. - Takeda Pharmaceutical Company Limited announced that its therapy, ADCETRIS® (brentuximab vedotin), in combination with a chemotherapy regimen, has been approved by the European Commission for adult patients with Stage IIb with risk factors/III/IV Hodgkin lymphoma. This approval is based on the Phase 3 HD21 trial results, which showed the combination, known as BrECADD, to be safer and as effective as the current standard of care, eBEACOPP, in Europe.
The HD21 trial, conducted by the German Hodgkin Study Group, aimed to minimize side effects while maintaining efficacy. The study met its co-primary safety and efficacy endpoints, with BrECADD demonstrating a significantly superior safety profile and non-inferior progression-free survival compared to eBEACOPP.
Teresa Bitetti, president of the Global Oncology Business Unit at Takeda, stated that this approval underlines ADCETRIS as a core treatment for specific lymphomas, offering healthcare professionals more flexibility in tailoring treatment plans. The company’s strong commercial execution is reflected in its impressive 65.5% gross profit margin and 7.45% revenue growth over the last twelve months, with total revenue reaching $30.5 billion. Peter Borchmann, MD, PhD, from the University Hospital of Cologne and trial chairman, suggested that BrECADD could become a new standard of care for frontline treatment of adult patients with advanced Hodgkin lymphoma.
ADCETRIS is an antibody-drug conjugate targeting CD30, a marker of Hodgkin lymphoma, and has six distinct indications previously approved in the EU. The new approval marks the second for an ADCETRIS-based combination regimen for frontline Hodgkin lymphoma, expanding treatment options for patients.
The HD21 study was a randomized, multicenter trial with a PET-response adapted design, assessing the feasibility, efficacy, safety, and tolerability of BrECADD. Patients were randomized to receive two cycles of either escalated BEACOPP or BrECADD, followed by interim PET staging, and then further cycles based on the results.
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In other recent news, Takeda Pharmaceutical Company Limited has shared promising results from its Phase 2b clinical trial for oveporexton, a drug aimed at treating narcolepsy type 1 (NT1). The data, published in the New England Journal of Medicine, indicates that oveporexton significantly improved wakefulness and reduced symptoms compared to a placebo. The trial involved 112 adults globally, who were randomized to receive either the drug or a placebo over eight weeks. Key findings included improvements in mean sleep latency on the Maintenance of Wakefulness Test and reductions in Epworth Sleepiness Scale scores and Weekly Cataplexy Rate. Most treatment-emergent adverse events were mild to moderate, with insomnia and increased urinary urgency among the reported issues. Oveporexton has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for excessive daytime sleepiness in NT1. Takeda anticipates Phase 3 trial results in 2025, hoping oveporexton will become a first-in-class treatment option. Additionally, Takeda is advancing other orexin agonists for various sleep-wake disorders, demonstrating its commitment to addressing unmet medical needs.
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