Iovance Biotherapeutics Inc. (NASDAQ:IOVA) has announced preliminary data from vital Cohort 4 as well as updated Cohort 2 data in its C-144-01 lifileucel study in advanced melanoma.
Iovance releases Cohort 4 study data
Maria Fardis, the CEO and President of Iovance Biotherapeutics, indicated that they were delighted to release the preliminary vital Cohort 4 results from the clinical C-144-01 study in advanced melanoma. Maria indicated that the Cohort 4 data were from 68 patients with an overall response rate of 32.4% at an average study follow up of 5.3 months. The CEO added that this was consistent with the outcomes of the comparable Cohort 2 study follow up.
However, for Cohort 2, the median response duration is not enough to reach a follow-up of 18.7 months. Maria indicated that the available care in the company’s program for enrolled metastatic melanoma patients is chemotherapy that is said to offer between 4% and 10% response rate but with a short median response duration. The combination of this data supports the possible benefit of a one-off administration of lifileucel TIL therapy in patients with advanced melanoma.
Cohort 4 C-144-01 results consistent with those of Cohort 2
The primary endpoint in Cohort 4 C-144-01 study was the overall response rate by independent committee review, while the secondary endpoint was ORR in the investigator’s radiological assessment. Lifileucel demonstrated ORR of 32.4% and a 72.1% disease control rate. The data is consistent with Cohort 2 data at 6 months, whereby the overall response rate was 33%.
The advanced melanoma patients in Cohort 4 have similar characteristic profiles as those in Cohort 2. They have shown progress in various prior therapies that include BRAF/MEK inhibitors and anti-PD-1. In Cohort 4 study, 89 patients were dosed, and the company is planning to offer more updates in the study in the upcoming medical meeting.
The company indicates that it is in the process of submitting a biologics license application for lifileucel towards the end of this year. Also, Iovance will offer data from the Cohort 4 and Cohort 2 C-144-01 study as part of the BLA submission.