FDA Pipeline: Fast Track Designations in Liver and Pancreatic Cancers

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Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designations to novel agents in the treatment of liver and pancreatic cancers.

Fast Track Designation for SRF388 in Liver Cancer

The FDA granted Fast Track designation to SRF388 for the treatment of patients with hepatocellular carcinoma who have been previously treated with standard therapies, such as vascular endothelial growth factor (VEGF) targeted agents and PD-L1 inhibitors.

SRF388 is a fully human anti–IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Particular tumor types, including liver and kidney cancer, have been identified as potential diseases in which IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. SRF388 targets the rate-limiting p28 subunit of IL-27, and preclinical studies have shown that treatment with SRF388 blocks the immunosuppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies and potent antitumor effects as a monotherapy. Furthermore, a potential biomarker associated with IL-27 has been identified that may be useful in helping to select patients most likely to respond to SRF388.

A phase I monotherapy dose-escalation study is currently enrolling patients with advanced solid tumors—with planned expansions in liver and kidney cancer—to further evaluate SRF388 as a monotherapy and in combination with other cancer therapies.

Fast Track Designation for Devimistat in Pancreatic Cancer

The FDA granted Fast Track designation to devimistat (CPI-613) for the treatment of metastatic pancreatic cancer.

Devimistat is designed to target the mitochondrial tricarboxylic acid cycle, a process essential to tumor cell multiplication and survival, selectively in cancer cells. Devimistat substantially increases the sensitivity of cancer cells to a diverse range of chemotherapeutic agents. This synergy allows for potential combinations of devimistat with lower doses of these generally toxic drugs to be more effective with lower patient’s side effects.

The FDA has given approval to initiate pivotal phase III clinical trials in pancreatic cancer (AVENGER 500) and acute myeloid leukemia (ARMADA 2000), and has designated devimistat as an orphan drug for the treatment of pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, peripheral T-cell lymphoma, Burkitt’s lymphoma, and soft-tissue sarcoma.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.