FDA approves Iovance's Amtagvi as first T-cell therapy for melanoma
16 Feb 2024
Cell TherapyImmunotherapyPhase 2Clinical ResultDrug Approval
As the cell therapy revolution gave rise to several groundbreaking treatments for blood cancers, patients with solid tumours were a bit left behind – but no longer. The FDA approved Iovance’s tumour-infiltrating lymphocyte (TIL) therapy lifileucel as Amtagvi to treat certain forms of melanoma, and the drugmaker is already investigating other solid cancers, including lung.
Friday’s accelerated approval comes a week ahead of the expected decision date. The agency cleared Amtagvi to treat adults with unresectable or metastatic melanoma previously treated with an anti-PD-1 antibody; and if the patient is positive for a BRAF V600 mutation, they must have progressed on a BRAF inhibitor with or without a MEK inhibitor.
Melanoma key opinion leaders (KOLs) who spoke with FirstWord ahead of the approval are excited by the promise of TIL therapy, especially for patients that progress on anti-PD-1 therapy. According to Iovance, before Amtagvi, there were no approved treatments for patients with advanced melanoma who did not respond to an immune checkpoint inhibitorimmune checkpoint inhibitor. For more, check out Spotlight On: First cell therapy for melanoma nears US approval.
One-third response rate
Amtagvi’s approval was based on data from the Phase II C-144-01 study, which enrolled patients with metastatic melanoma who were previously treated with at least one systemic therapy.
In a pooled analysis of 153 patients from two treatment cohorts, 31.4% achieved an objective response. At the 21.5-month mark, a median duration of response had not yet been reached, though more than half of the responses had a duration greater than one year.
Pooled clinical data also showed that at least 30% of patients experienced a Grade 3 or 4 treatment-emergent adverse event. Consequently, Amtagvi will carry a boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary and renal impairment.
Rollout and follow-up
The company plans to manufacture its cell therapy, which will carry a $515,000 list price, at the Iovance Cell Therapy Center (iCTC) in Philadelphia, where it expects to have capacity for up to "several thousand patients annually." That figure is set to increase over the next few years as Iovance completes additional expansions at iCTC.
While the drugmaker did not disclose how many authorised treatment centres are up and running, it had previously laid out plans to offer the cell therapy at an initial 30 centres, with near-term expansion to another 20 facilities. Analysts at Jefferies have suggested that up to 500 patients could be treated with Amtagvi this year, and that very early launch metrics could be superior to initial CAR-T launches due to preferable patient reimbursement status.
To secure full approval, Iovance will have to show Amtagvi’s benefit in the confirmatory Phase III TILVANCE-301 study compared with Merck & Co.’s PD-1 inhibitor Keytruda (pembrolizumab).
The company is also running a Phase II trial to evaluate the cell therapy’s efficacy to treat advanced, recurrent, or metastatic squamous cell carcinoma of the head and neck, and locally advanced or metastatic non-small-cell lung cancer.
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