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For unresectable or metastatic liver cancer, the TPST-1120-301 trial of amezalpat combination therapy has received a “Study May Proceed” letter from the FDA.
The Food and Drug Administration (FDA) issued a “Study May Proceed” letter, allowing a phase 3 trial to evaluate first-line treatment with amezalpat (TPST-1120) in combination with the current standard of care, Tecentriq (atezolizumab) and Avastin (bevacizumab), versus standard of care alone in patients with unresectable or metastatic hepatocellular carcinoma, a type of liver cancer.
According to the FDA’s website, a “Study May Proceed” letter is a notification to the sponsor of a clinical trial that the agency reviewed the Investigational New Drug Application and determined that the proposed study can move forward. This letter indicates that the FDA has found the study to be scientifically sound and ethically acceptable, and that the risks to participants are outweighed by the potential benefits of the research.
“The clinical and regulatory team at Tempest are thrilled to receive this notice from FDA with respect to the planned pivotal phase 3 trial to evaluate amezalpat as a potential treatment for first-line liver cancer,” Dr. Sam Whiting, chief medical officer and head of R&D at Tempest Therapeutics, stated in a news release from Tempest Therapeutics, the manufacturer of amezalpat. “Previously reported positive phase 2 data underscore amezalpat’s potential to improve the survival of patients facing this life-threatening disease.”
This phase 3, global trial will include patients with unresectable or metastatic hepatocellular carcinoma, according to the release. Patients will be randomly assigned to receive either amezalpat plus Tecentriq and Avastin or placebo plus Tecentriq and Avastin in first-line treatment. The news release also noted that Tempest Therapeutics is working to enable a phase 3 study to start in the first quarter of 2025.
Metastatic: cancer that has spread from where it originated.
Unresectable hepatocellular carcinoma: a type of liver cancer that is too advanced to be treated with surgery.
Overall survival: the time when a patient with cancer is still alive.
Progression-free survival: the time during and after treatment when a patient with cancer lives with the disease without worsening.
According to the trial’s ClinicalTrials.gov listing, the overarching goal of this phase 3 study is to best understand if amezalpat given in combination with Tecentriq and Avastin benefits individuals, allowing them to live longer compared with the standard-of-care treatment in patients with hepatocellular carcinoma that cannot be removed by surgery or has spread outside of the liver. In particular, researchers will be assessing overall survival and progression-free survival.
As noted in the release, previous data suggest that amezalpat treats cancer by directly targeting tumor cells and modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In other words, amezalpat targets cancer cells to stop or slow down their growth while changing the environment around the tumor to make it less ideal for cancer cell growth and spread.
Although enrollment has not started yet, according to ClinicalTrials.gov, researchers are aiming to enroll an estimated 740 patients with unresectable or metastatic hepatocellular carcinoma into this phase 3 trial, with an estimated primary completion date of March 2028.
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