FDA Lifts Partial Hold on Iovance’s Cancer Therapy Trial

Iovance Biotherapeutics has had a partial clinical hold imposed by the FDA. This regulatory setback stemmed from a severe adverse event, classified as grade 5, resulting in the unfortunate death of a patient. The incident raised concerns about the pre-conditioning regimen’s potential link to the fatality, as elucidated by Iovance.

At the time of the hold, the phase 2 trial, designated as IOV-LUN-202, had already recruited over 100 participants afflicted with non-small cell lung cancer. These individuals had experienced disease progression despite prior chemotherapy and anti-PD-1 therapy. Initial data from a subset of 23 patients, disclosed in July 2023, were deemed by Iovance as potentially sufficient for securing accelerated approval for LN-145.

However, the FDA’s intervention halted these plans for more than two months. Yet, a resolution has now been reached. Through collaborative efforts with the regulatory authority and an independent data monitoring committee, Iovance devised additional safety protocols and monitoring mechanisms for the trial.

Following a thorough evaluation of the proposed measures, the FDA granted clearance for Iovance to resume enrollment in IOV-LUN-202, as stated in a release on March 4. Iovance anticipates completing enrollment of around 120 patients in the registrational cohorts of IOV-LUN-202 by 2025.

This development marks another positive turn for Iovance in 2024, building upon the recent FDA approval of its flagship product, lifileucel, for advanced melanoma. Notably, this approval represents a milestone as the first of its kind for T-cell therapy targeting solid tumors. The company capitalized on this achievement by generating $211 million through the sale of common stock.

In premarket trading today, Iovance’s share price surged nearly 10% to $18.45, up from a closing price of $16.79 at the end of last week. This rebound follows a slump in December when the stock plummeted to below $9 due to the clinical hold. However, the approval of lifileucel, set to be marketed as Amtagvi, has since propelled the stock’s recovery.

Nevertheless, Amtagvi’s road to market has been full of ups and downs . Initially slated for submission in 2020, Iovance delayed the filing after the FDA raised concerns regarding the potency assays for each therapy dose. Overcoming this obstacle, the company managed to have its application accepted under priority review in May 2023. However, the FDA extended the review timeline due to resource constraints.

While Iovance faced challenges with the partial clinical hold, collaboration with regulatory authorities has enabled the resumption of the trial, setting the stage for continued progress in advancing its cancer treatment.