On July 10, Iovance Biotherapeutics announced they received positive feedback from the FDA on the design of their Phase II IOV-LUN-202 study evaluating tumor-infiltrating lymphocyte (TIL) therapy LN-145 in patients with advanced non-small cell lung cancer (NSCLC). Following their Pre-Phase III meeting with the agency, the therapy may be acceptable for accelerated approval, says GlobalData, a leading data and analytics company.

Iovance released preliminary data from 23 NSCLC patients who progressed on or after chemotherapy and anti-PD1 therapy but lacked epidermal growth factor receptor, reactive oxygen species, or anaplastic lymphoma genetic mutations. As of July, the single-arm study observed an objective response rate of 26.1%, with one complete response and five partial responses, and a disease control rate of 82.6%. A median duration of response has yet been reached and adverse events were consistent with the underlying disease.

Israel Stern, Oncology & Hematology Analyst at GlobalData, comments: “For Iovance, receiving encouraging feedback from the FDA on their trial design is quite significant, as they’ve had a bit of a rough go with the agency in the past. In the spring of 2021, the FDA revealed they were unsatisfied with the potency assay for Iovance’s TIL therapy, lifileucel, in metastatic melanoma, causing their shares to drop nearly 40% overnight, prompting the resignation of their then CEO.”

Iovance intends to enroll around 120 patients and complete enrollment by the second half of 2024. The company also plans to initiate a confirmatory trial in front-line advanced NSCLC prior to receiving accelerated approval. There are ongoing Phase II trials for the therapy in other indications as well, such as ovarian, breast, and thyroid cancers. If approved, sales for LN-145 are projected to reach $889 million by 2029, according to GlobalData, a leading data and analytics company.

Stern continues: “Prioritizing the initiation of a confirmatory trial is wise thinking by Iovance as the FDA has shown to prefer these trials underway prior to granting accelerated approval.”

In addition to the news surrounding the meeting, Iovance also provided an update on the aforementioned lifileucel, stating that the biologics licensing application for the TIL is under priority review and a decision will be made by November. Following these announcements, Iovance proposed a public offering of common stock, for which they closed with gross proceeds of $172.5 million.

Stern concludes: “With an anticipated approval for lifiluecel on the horizon, the money raised will help fund the commercial launch of the product, the expansion of the LN-145 registrational trial, and other ongoing programs. It’s been a long road for the TIL pioneers, but they’re nearly there.”