Iovance receives more good news as FDA lifts hold on lung cancer cell therapy trial

Iovance Biotherapeutics ended 2023 on a downer courtesy of a partial clinical hold from the FDA, but the situation has been resolved relatively quickly.

The agency implemented the hold on the phase 2 trial of tumor-infiltrating lymphocyte therapy LN-145 on Dec. 22 after a grade 5 adverse event—which signifies a patient fatality—was reported. The death was potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen, Iovance explained at the time.

By that point, the trial, dubbed IOV-LUN-202, had already enrolled over 100 patients whose non-small cell lung cancer had progressed on or after chemotherapy and anti-PD-1 therapy. Preliminary data from 23 patients were shared in July 2023, which Iovance said “may be acceptable” to secure an accelerated approval for LN-145. 

Those plans have been frozen for more than two months in the wake of the FDA’s partial hold, but a solution has now been found. Specifically, Iovance worked with the agency and an independent data monitoring committee to develop additional safety measures and monitoring for the trial.

After reviewing the proposal, the FDA has given the green light for the biotech to restart enrollment in IOV-LUN-202, according to a March 4 release. “Iovance expects to complete enrollment of approximately 120 patients in the IOV-LUN-202 registrational cohorts in 2025,” the company said.

The lift is just the latest good news for Iovance in 2024, following the FDA’s approval of lead asset lifileucel in advanced melanoma last month. It marked the first approval for a T-cell therapy in a solid tumor indication, and Iovance used the decision to bring in $211 million from a sale of common stock.

Iovance’s share price was up almost 10% to $18.45 in premarket trading this morning from a Friday closing price of $16.79. After slumping down to less than $9 a share in December in the wake of the hold, the stock has since made up for lost ground courtesy of the approval of lifileucel, which will be marketed as Amtagvi.

But even Amtagvi didn’t have a smooth journey to market. Iovance had originally hoped to submit a filing in 2020 but delayed the plan after the FDA raised questions about the assays used to measure the potency of each therapy dose. The company cleared the assay hurdle and got the application accepted by the FDA under priority review in May 2023, but the agency extended its review because of resource constraints.