On December 27, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported a clinical program update for LN-145 TIL therapy in non-small lung cancer (NSCLC) (Press release, Iovance Biotherapeutics, DEC 27, 2023, View Source [SID1234638803]).

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The U.S. Food and Drug Administration (FDA) placed a clinical hold on the IOV-LUN-202 trial on December 22, 2023, in response to a recently reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen. IOV-LUN-202 is investigating LN-145 in patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable or metastatic) non-small cell lung cancer (NSCLC) without EGFR, ROS or ALK genomic mutations and had received at least one line of an FDA-approved targeted therapy if indicated by other actionable tumor mutations. These patients have a poor prognosis, limited treatment options, and a real-world overall survival of less than six months.1 The clinical hold for IOV-LUN-202 has no impact on any other Iovance clinical trials and is independent of the FDA’s Priority Review of the biologics license application (BLA) for lifileucel in advanced melanoma. The BLA remains on track toward the Prescription Drug User Fee Act (PDUFA) action date of February 24, 2024.

Iovance will pause enrollment and the LN-145 TIL treatment regimen for new patients in IOV-LUN-202 during the clinical hold. Patients previously treated with LN-145 in the IOV-LUN-202 trial will continue to be monitored and followed according to the trial protocol. Patients who have already undergone tumor resection will continue to receive the LN-145 TIL treatment regimen with additional precautions and risk mitigations.

Preliminary data for IOV-LUN-202 was reported in July of 2023. An updated analysis in November of 2023 showed additional ongoing responses and duration of response greater than six months for 71% of the confirmed responders in the trial. These results from IOV-LUN-202 in previously treated patients with advanced NSCLC continue to support the potential benefit of one-time TIL therapy, including the opportunity for more durable responses than available second line chemotherapies. Iovance is committed to bringing TIL therapy to patients with NSCLC and to continuing activities that support regulatory approval in this indication.

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "Iovance remains dedicated to addressing a significant unmet medical need for patients with advanced NSCLC, who have poor prognosis following disease progression and limited treatment options. We will work with the FDA to safely resume enrollment in the IOV-LUN-202 trial as soon as possible."

More than 700 patients have been treated with Iovance TIL therapies across multicenter clinical trials in solid tumor cancers, including more than 100 patients treated with LN-145 for lung cancer. In clinical trial results reported to date, treatment-emergent adverse events were consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and interleukin-2.

1National Cancer Database, NSCLC survival from >1 million patients assessed. Lou Y et al. Survival trends among non-small-cell lung cancer patients over a decade: impact of initial therapy at academic centers. Cancer Med. 2018.