Metastatic Melanoma Study Mixed Results Could Be a Positive

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Iovance Biotherapeutics Inc. (NASDAQ: IOVA) announced results from a subgroup analysis of metastatic melanoma patients in its Phase 2 study of lifileucel. These results were released in an abstract for the International Congress of the Society for Melanoma Research (SMR) meeting being held currently in Salt Lake City. Although results in the study were mixed, investors ultimately sent shares lower.

In 42 primary refractory patients enrolled in the second cohort of C-144-01 study, defined as having had the best response of progressive disease (PD) on their first anti-PD-1/L1 treatment, an objective response rate of 41% was observed.

However, the median duration of response was not reached at 12 months of study follow-up (range: 2.8+ to 21.2+ months).

Also, 71% of responders who are primary refractory to anti PD-1/L1 therapy remain in the study.

Maria Fardis, Ph.D., MBA, president and CEO of Iovance, commented:

Patients who are primary refractory to prior anti-PD-1/L1 therapy have very limited therapeutic options and yet form a large population of diagnosed metastatic melanoma patients. Tumor infiltrating lymphocyte (TIL) therapy developed by Iovance has shown strong efficacy for patients with relapsed or refractory metastatic melanoma. In the subgroup analysis conducted for primary refractory patients in our Cohort 2 of the C-144-01 study, TIL demonstrates excellent efficacy and durability of response thus far. We are very pleased to see that the Iovance TIL may offer a therapeutic option for this patient population.

Shares of Iovance traded down about 5% on Thursday, at $21.79 in a 52-week range of $7.26 to $26.59. The consensus price target is $35.25.


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