FDA accepts new drug application for liver cancer T-cell therapy
Eureka Therapeutics announced that the FDA has cleared its investigational new drug application for ET140202 ARTEMIS T-cell therapy for patients with hepatocellular carcinoma who are positive for alpha-fetoprotein, according to a press release.
“This is an exciting time for Eureka as we prepare to initiate our U.S. clinical trial in patients with hepatocellular carcinoma,” Cheng Liu, PhD, president and CEO of Eureka Therapeutics, said in the release. “HCC is an area of significant unmet medical need and patient options are currently limited. We intend to advance ET140202 as rapidly as possible in the U.S. and to build upon the experience from our promising proof-of-concept study in China.”
Eureka plans to initiate a phase 1/2 multicenter clinical trial in the U.S. during the first half of 2019. Investigators will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ET140202 through dose escalation in phase 1 followed by dose expansion in phase 2.
Previously reported results from a first-in-human study in China showed that ET140202 demonstrated a favorable safety profile in six patients with no observed cytokine release syndrome or drug-related neurotoxicity. Additionally, three of the six patients achieved tumor regression.