Iovance, familiar with the long way around, gets FDA OK to pursue accelerated review for lung cancer therapy

Iovance Biotherapeutics has never taken a straight path from A to B when it comes to developing its tumor-infiltrating lymphocyte (TIL) therapies. But this time, the California biotech seems to have found a solution that could mean an accelerated nod for a lung cancer medicine.

Iovance reported a positive outcome from a type B pre-phase 3 meeting with the FDA, according to a July 10 press release. The agency has indicated that data from the ongoing registrational single-arm phase 2 IOV-LUN-202 trial “may be acceptable” to secure an accelerated approval for the med, called LN-145. The therapy is in the midstage trial for advanced, difficult-to-treat non-small cell lung cancer (NSCLC).

With the door opened for a swift review, Iovance took a cut of the available data, which included a preliminary analysis of 23 patients who received LN-145. The early results show a 26.1% objective response rate, or one complete and five partial responses, plus a disease control rate of 82.6%, Iovance said. The median duration of response has not yet been reached, however, rates of 1.4-plus months to 9.7-plus months were observed.

Iovance will now move to enroll about 120 patients into the registrational study, a process that is expected to complete in the second half of 2024.

Later this year, Iovance will meet again with the FDA to discuss a randomized confirmatory trial for LN-145 in NSCLC for front-line advanced patients. The confirmatory trial is expected to be underway by the time a potential accelerated approval comes through, according to the company. This is key, as the FDA has tightened its requirements for offering accelerated approvals in the past year. The agency now prefers to see a confirmatory trial underway by the time a regulatory nod is offered.

The regulatory clarity is good news for Iovance, which has never navigated a straight path for its therapies. In May 2022, the company’s melanoma data for TIL candidate lifileucel disappointed investors when the fresh data cut did not match up favorably to a previous readout.

A few months before that, the same drug was debated at the FDA when the agency asked for more assay data. Providing an update on that process today, Iovance said the biologics license application “remains on track” under priority review in advanced melanoma. The due date for a decision is Nov. 25, 2023. Iovance had previously hoped for a 2022 launch.

Iovance's shares gained nearly 12% to $8.10 as the markets opened July 10 compared to a previous close of $7.24.