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FDA Places Clinical Hold on Iovance Biotherapeutics Lung Cancer TIL Therapy Trial

NEW YORK – Iovance Biotherapeutics is pausing a clinical trial of its LN-145 tumor-infiltrating lymphocyte treatment after a patient with non-small cell lung cancer died due to a serious adverse event.

On Wednesday, the San Carlos, California-based firm said that the US Food and Drug Administration placed a clinical hold on the IOV-LUN-202 trial of the TIL therapy on Dec. 22 after a patient had a fatal, grade 5 adverse event that Iovance believes was potentially related to the non-myeloablative lymphodepletion preconditioning regimen this patient received.

LN-145 is a ready-to-infuse TIL therapy that uses an autologous TIL manufacturing process that the National Cancer Institute developed, but which the company further optimized for treating metastatic NSCLC. In the IOV-LUN-202 trial, Iovance is studying LN-145 in patients with unresectable or metastatic NSCLC who have progressed with chemotherapy and anti-PD-1 treatment; do not harbor EGFR, ROS, or ALK alterations; and have received at least one targeted treatment that is indicated for other tumor molecular biomarkers they harbor.

The company had previously said that this trial could provide data supporting accelerated approval of LN-145. However, after this adverse event, Iovance said it will stop enrolling and administering LN-145 to new patients in the study. Those patients who have had their tumors resected will continue to receive LN-145 but with additional precautions and risk mitigations.

More than 100 NSCLC patients have received LN-145 to date. Iovance reported in an updated analysis from the IOV-LUN-202 trial in November that 71 percent of patients who had responded to the TIL therapy had experienced responses lasting more than six months.

"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," the firm said, adding that the treatment-emergent adverse events seen in clinical trials to date have been "consistent with the underlying disease and known adverse event profiles on non-myeloablative lymphodepletion and interleukin-2."

Iovance is also developing lifileucel, another TIL therapy, for advanced melanoma. The FDA earlier this year accepted the firm's biologics license application for lifileucel in this setting after a series of filing delays and roadblocks

The FDA's clinical hold for IOV-LUN-202 doesn't impact Iovance's other clinical trials or the agency's priority review of its lifileucel BLA, the firm said in a statement. According to Iovance, the lifileucel application is on track to receive an FDA decision by Feb. 24, 2024.