Iovance’s lung cancer hold proves short lived

Last week during its fourth-quarter earnings call Iovance promised that the clinical hold on the IOV-LUN-202 trial of its tumour infiltrating lymphocyte (TIL) therapy would soon be lifted, and today this came to pass. With more stringent monitoring now in place, Iovance expects to complete enrolment of 120 registrational patients in 2025; IOV-LUN-202 is testing lifileucel in second-line post-chemo and checkpoint blockade NSCLC, where the therapy is known as LN-145. In December Iovance blamed both the preconditioning regimen and progressive disease for the patient death that led to the hold, but gave no further details today. Separately, lifileucel got the FDA nod in mid February for second-line melanoma, where it is branded Amtagvi, and Iovance said T cells were collected from the first patient the following business day. Manufacturing began the day after; generally speaking, production of Amtagvi is expected to take around 34 days. The company added that there were currently “at least” 20 patients in process, including 10 with scheduled or pending manufacturing slots. This will need to be the tip of the iceberg if Iovance is to justify its market cap, which crept up another 6% this morning to nearly $5bn.