On November 21, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported results of a subgroup analysis of Cohort 2 of the Phase 2 lifileucel metastatic melanoma study C-144-01 in patients who were primary refractory to prior anti-PD-1/L1 therapy (Press release, Iovance Biotherapeutics, NOV 21, 2019, View Source [SID1234551581]). An abstract with details of the analysis was accepted as a late-breaking poster at the 16th International Congress of the Society for Melanoma Research (SMR) being held Nov. 20-22 in Salt Lake City.
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Highlights from the poster, presented by study investigator Omid Hamid, M.D., Chief of Translational Research and Immunotherapy and Director of Melanoma Therapeutics at the Angeles Clinic and Research Institute of Los Angeles, on Thursday, Nov. 21, 2019, include:
In 42 primary refractory patients enrolled in Cohort 2 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 (ORR) of 41 percent, as assessed by the investigator, was observed
Median duration of response (DOR) was not reached at 12 months of study follow-up (range: 2.8+ to 21.2+ months)
71 percent of responders who are primary refractory to anti PD-1/L1 therapy remain on study
"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," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance. "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."
Cohort 2 in the ongoing C-144-01 study includes consecutively dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma who also have received BRAF/MEK therapy if clinically indicated. In this study, patients had experienced a mean of 3.3 lines of prior therapy including anti-PD1 blocking antibody, and the patients had a high baseline tumor burden. Primary refractory patients included 42 of the 66 dosed patients in Cohort 2 who had a best response of progressive disease to the first anti-PD-1/L1.
About the Society for Melanoma Research (SMR) 2019 Congress
SMR 2019 is a global congress that unites melanoma clinicians and researchers to focus on multidisciplinary management of melanoma/skin cancer. This is the leading meeting for cutting edge data in melanoma.