Healthcare Business

Melanoma Treatment Takes a Big Step Forward

Iovance Biotherapeutics Inc. (NASDAQ: IOVA) shares jumped on Friday after the firm announced results from its mid-stage metastatic melanoma study at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. Specifically, the results are coming from Iovance’s Phase 2 lifileucel metastatic melanoma study.

Objective response rate as determined by an independent review committee was 35%, which aligns well with the investigator-assessed objective response rate of 36%. The median duration of response was not reached as assessed by the committee or investigators at 11.3 months of study follow-up. Median duration of response was not reached at a longer study follow-up of 12.8 months as assessed by investigator for 66 patients.

The study had an overall concordance rate of 89.4% between investigator assessment and independent review committee assessment.

The adverse event profile of lifileucel treatment in the C-144-01 study continued to be consistent with the underlying advanced disease and the profile of the lymphodepletion and IL-2 regimens.

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

We are pleased to see continued evidence of durability with lifileucel therapy as patients are evaluated with longer term follow-up. In addition, concordance between IRC assessment and investigator reported results is highly favorable in this metastatic disease setting as compared with the published literature. These results continue to show that lifileucel offers a potential therapeutic option for the metastatic melanoma patients enrolled in this study. We continue to enroll patients in the pivotal cohort of the study, Cohort 4, which is expected to serve as the basis for an expected Biologics License Application (BLA) submission for lifileucel in late 2020.

Shares of Iovance traded up about 14% at $23.50, in a 52-week range of $7.26 to $26.59. The consensus price target is $34.50.

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