First T-cell treatment for a solid tumor Amtagvi approved by the FDA from Iovance

The emergence of T-cell therapy has revolutionized the treatment of certain blood cancers, and now it is making strides in the realm of solid tumors, thanks to the FDA’s approval of a groundbreaking immunotherapy developed by Iovance Biotherapeutics. Known as Amtagvi, or lifileucel, this medication marks the first individualized tumor-infiltrating lymphocyte (TIL) therapy to enter the market. Specifically, the FDA has granted accelerated approval for Amtagvi for patients with advanced melanoma who have previously undergone treatment with a PD-1 inhibitor, as well as a BRAF inhibitor if the tumor carries a BRAF V600 mutation.

Iovance has set the wholesale acquisition cost of Amtagvi at $515,000 per patient for this one-time treatment, a figure slightly above the prices of existing CAR-T cell therapies used in blood cancer treatment. This pricing decision reflects Amtagvi’s unique value as the initial drug approved for post-PD-1 melanoma treatment and aligns with the company’s analysis of pertinent benchmarks.

Similar to CAR-T cell therapies, Amtagvi is manufactured using immune cells obtained from individual patients. The process involves collecting TIL cells from a portion of the patient’s resected tumor, expanding them outside the body, and reintroducing them into the patient’s system. Essentially, Amtagvi replenishes the body with cancer-fighting immune cells as their naturally produced counterparts diminish over time.

Unlike CAR-T therapies, which targets blood cancer due to the lack of appropriate biomarkers on solid tumors, TIL therapy addresses this limitation by harnessing TIL cells, which are naturally equipped to identify cancer biomarkers.

Clinical studies have demonstrated promising results for Amtagvi, with tumor shrinkage observed in 31.5% of patients who had previously received anti-PD-1 therapy. Furthermore, a significant percentage of responders remained in remission for over a year. Additional pooled efficacy analysis indicated comparable objective response rates and durable responses among patients.

Despite its groundbreaking potential, Amtagvi has limitations. Patients with unresectable tumors are ineligible for the therapy, and the drug carries a boxed warning for treatment-related adverse events, necessitating its administration in designated treatment centers under intensive monitoring.

However, Amtagvi’s boxed warning differs from existing CAR-T therapies, offering certain advantages in terms of safety monitoring and adverse event profiles. Iovance has initiated plans to expand treatment centers and ensure sufficient capacity to accommodate patient demand during the launch phase.

The lengthy manufacturing process and complex treatment regimen associated with Amtagvi pose challenges for patients, including additional costs and physical burdens. However, payers have recognized the value proposition of Amtagvi, indicating potential coverage similar to existing CAR-T therapies.

While Amtagvi has received accelerated approval, ongoing clinical trials aim to confirm its clinical benefit in larger patient populations. Despite encountering regulatory hurdles during development, Iovance remains committed to advancing TIL therapy and is concurrently exploring other TIL-based treatments for various cancers

In summary, Amtagvi represents a significant advancement in the treatment of solid tumors, offering new hope for patients with advanced melanoma. As research and development in T-cell therapy continue to evolve, the potential for transformative cancer treatments remains promising.

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