FT-538 is under clinical development by Fate Therapeutics and currently in Phase I for Relapsed Acute Myeloid Leukemia. According to GlobalData, Phase I drugs for Relapsed Acute Myeloid Leukemia have a 71% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how FT-538’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

FT-538 overview

FT-538 is under development for the treatment of relapsed and refractory multiple myeloma and acute myelocytic leukemia (AML), solid tumors including cutaneous melanoma, non-small cell lung cancer, small cell lung cancer, renal cell carcinoma, head and neck squamous cell cancer, gastric cancer, esophageal cancer, cervical cancer, merkel cell carcinoma, endometrial carcinoma, cutaneous squamous cell carcinoma, triple-negative breast cancer, human epidermal growth factor receptor 2 positive breast cancer (HER2+ breast cancer), colorectal cancer, epithelial ovarian cancer, fallopian tube, primary peritoneal cancer and HIV viremia. The therapeutic candidate constitutes induced pluripotent stem cell (iPSC)-derived NK cells expressing a high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, that are knocked out of CD38 gene. It is developed based on iPSC technology off-the-shelf using renewable engineered pluripotent cell lines. It is administered through intravenous route.

Fate Therapeutics overview

Fate Therapeutics is a biopharmaceutical company that develops programmed cellular therapies for cancer and immune disorders. The company’s pipeline includes various off-the-shelf, iPSC-derived cellular immunotherapies for the treatment of several hematological malignancies and advanced solid tumors. Its pipeline also includes a donor-derived cell product candidate for the treatment of hematological malignancies. Fate uses its proprietary human-induced pluripotent stem cell (iPSC) platform for product development. The company also has research collaborations with companies, academic centers, and medical centers for the advancement of products and technologies. Fate Therapeutics is headquartered in San Diego, California, the US.

For a complete picture of FT-538’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.