Benzinga | Jun 7, 2021 08:27AM EDT

Iovance's Lifileucel Shows Meaningful Increase in Response Time with Primary Anti-PD-1 Resistance in Melanoma Trial

* Iovance Biotherapeutics Inc (NASDAQ:IOVA) announced updated clinical data for lifileucel from Cohort 2 of C-144-01 clinical study in patients with advanced melanoma.

* Data were presented at the ASCO 2021 Annual Meeting.

* All patients in Cohort 2 had a high baseline disease burden and were heavily pretreated (3.3 mean prior therapies).

* Median Duration of Response (DOR) was not reached at 33.1 months of median study follow-up, and the Overall Response Rate (ORR) remained at 36.4% (data extraction: April 2021).

* Responses deepened over time, and one patient converted from partial to complete response at 24 months post lifileucel infusion.

* A multivariable model showed that for every six-month decrease in the cumulative duration of prior anti-PD-1 therapy, DOR to lifileucel would be nearly doubled, suggesting early intervention with lifileucel at the time of initial progression on anti-PD-1 therapy may maximize benefit.

* The adverse event profile was consistent with the underlying advanced disease, lymphodepletion, and IL-2 regimens, with no new safety risks identified during long-term follow-up.

* Last month, the company reported results for lifileucel as an earlier treatment in combination with Merck & Co Inc's (NYSE: MRK) Pembrolizumab (Keytruda), demonstrating an overall response rate (ORR) of 86% in patients who are na?ve to anti-PD-1 therapy.

* Price Action: IOVA shares are up 2.01% at $18.28 during the premarket session on the last check Monday.