- Cohort 2 objective response rate (ORR) as determined by independent review committee (IRC) was 35 percent, which aligns well with the investigator assessed ORR of 36 percent -
- Median duration of response (DOR) was not reached as assessed by IRC or investigator at 11.3 months of study follow-up; median DOR was not reached at a longer study follow-up of 12.8 months as assessed by investigator for 66 patients in Cohort 2of C-144-01 study -
SAN CARLOS, Calif., Nov. 08, 2019 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that new data from Cohort 2 of the ongoing Phase 2 lifileucel metastatic melanoma study (C-144-01) were presented Friday, Nov. 8, 2019, at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting in National Harbor, Maryland (Abstract P865).
Highlights from the poster presentation include:
- An objective response rate (ORR) of 35 percent as assessed by IRC as compared to 36 percent as assessed by investigator
- Median DOR was not reached as assessed by either IRC (range: 1.6+ to 21.2+ months) or investigator (range: 2.2 to 21.2+ months) at 11.3 months median follow up. In addition, based on the most recent data cut from the study, median DOR was not reached as assessed by investigator at 12.8 months of median study follow-up.
- An overall concordance rate of 89.4 percent between investigator assessment and IRC assessment (n=66)
“We are pleased to see continued evidence of durability with lifileucel therapy as patients are evaluated with longer term follow-up,” commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. “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.”
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. 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.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics intends to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient’s own immune cells to attack cancer. TIL cells are extracted from a patient’s own tumor tissue, expanded through a proprietary process, and infused back into the patient. After infusion, TIL reach tumor tissue, where they attack tumor cells. The company is currently conducting pivotal studies in patients with metastatic melanoma and advanced cervical cancer. In addition, the company’s TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. Clinical studies of T cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy are being planned. For more information, please visit www.iovance.com.
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