Iovance Sinks 50% As Pivotal Cell Therapy Data Disappoint Investors, But Approval Plan Pushes Ahead Anyway
By Nick Paul Taylor
Last summer, Iovance set the bar for its TIL candidate lifileucel by posting data on the second cohort of its phase 2 trial. In the 66-subject cohort, the biotech saw three complete responses and 21 partial responses, giving it an objective response rate of 36 per cent. After a median of 33.1 months of follow-up, the study was yet to hit its median duration of response. The cohort is still yet to reach the median duration of response after 36.6 months.
California-based Iovance shared data from the 87-subject pivotal fourth cohort of the clinical trial late on Thursday. The objective response rate came in at 29 per cent, reflecting the three complete responders and 22 partial responders. After a median follow-up of 23.5 months, the median duration of response was 10.4 months.
“The expected durability of responses with the available therapy, which is monotherapy chemo, sometimes doublet chemo, is as low as 3.5 months. So 10.4 months is definitely meaningful,” chief medical officer at Iovance, Friedrich Graf Finckenstein said on a conference call with analysts to discuss the data. Finckenstein said chemotherapy has a 4 per cent to 10 per cent response rate in the targeted population.
However, investors compared the data unfavorably to the second cohort. Shares in Iovance fell around 50 per cent in after-hours trading, sinking the stock to below US$8 and wiping more than US$1 billion off the market cap of the biotech.
Iovance addressed the differences between the cohort two and four data on the conference call. As Iovance sees things, the data reflect differences between the baseline characteristics of participants in the two cohorts.
“Patients in cohort four had higher baseline disease burden in comparison to patients in cohort two. This finding was supported by a higher proportion of cohort four patients with elevated baseline lactate dehydrogenase or LDH levels, which is a well known negative prognostic factor in melanoma. Patients in cohort four also had a greater number of IRC-identified tumor lesions at baseline,” Finckenstein said.
