FDA Slaps Clinical Hold On Iovance Biotherapeutics' Lung Cancer Study After Patient Death

Wednesday, Iovance Biotherapeutics Inc IOVA announced a clinical program update for LN-145 TIL therapy in non-small lung cancer (NSCLC).

The 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. 

During the clinical hold, Iovance will pause enrollment and the LN-145 TIL treatment regimen for new patients in IOV-LUN-202. 

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.

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) NSCLC without EGFR, ROS, or ALK genomic mutations and had received at least one line of an FDA-approved targeted therapy. 

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.

Preliminary data for IOV-LUN-202 was reported in July of 2023. 

An updated analysis in November of 2023 showed additional ongoing responses and a duration of response greater than six months for 71% of the confirmed responders in the trial.

Price Action: IOVA shares are down 20.60% at $7.06 on the last check Wednesday.