Is AstraZeneca finally ready to score with underachieving cancer drug tremelimumab?

After years of failing to live up to expectations in a variety of cancer types, is AstraZeneca’s tremelimumab staging a better-late-than-never rally?

Less than a year ago came positive results from a trial in non-small cell lung cancer. Now, the drug could be nearing an approval in unresectable hepatocellular carcinoma (HCC).

The FDA has accepted AZ’s biologics license application (BLA) and granted a priority review of treme as a single-dose primer added to the company's PD-L1 inhibitor Imfinzi for treating first-line HCC. The company also has submitted a supplemental BLA for Imfinzi in this indication, it said.

AZ refers to the combo regimen as single tremelimumab regular interval durvalumab (STRIDE). It is due for a regulatory decision during the fourth quarter of this year following the use of a priority review voucher.

The BLA is based on results of a phase 3 trial that showed STRIDE achieved a 22% reduction in the risk of death versus Bayer’s Nexavar. After three years, 31% of those on STRIDE were still alive compared to 20% for the Nexavar group.

HCC is the most common type of liver cancer. In the U.S. roughly 26,000 people are diagnosed with it annually. Liver cancer is the third-leading cause of cancer death worldwide.

“The trial showed an unprecedented three-year overall survival in this setting,” Susan Galbraith, AZ’s EVP oncology and R&D, said in a release.

Competition in HCC is rigorous, however, with Roche’s Tecentriq and Avastin leading the way.

The FDA also is reviewing an Imfinzi-treme-chemo combination, which was found in the phase 3 Poseidon trial to extend the lives of patients with Stage IV or metastatic non-small cell lung cancer.

That win came after a series of defeats for AZ with the drug. In a phase 3 trial against extensive-stage small-cell lung cancer, treme added to Imfinzi and standard-of-care chemo added no survival benefit.

The drug has also posted trial flops in the first-line treatment of head and neck squamous cell carcinoma, in untreated NSCLC, where treme performed worse than Imfinzi alone, and in in front-line metastatic bladder cancer, where the Imfinzi-treme combo failed to top chemo alone.