The combination of Cabometyx and Tecentriq failed to improve overall survival in patients with advanced hepatocellular carcinoma, the most common type of primary liver cancer, compared with single-agent Tecentriq or Nexavar.
The use of Cabometyx (cabozantinib) plus Tecentriq (atezolizumab) did not improve or worsen overall survival outcomes in patients with previously untreated advanced hepatocellular carcinoma (HCC), compared with Tecentriq or Nexavar (sorafenib), according to findings from the phase 3 COSMIC-312 clinical trial.
Since the Cabometyx/Tecentriq combo did not impact survival compared with Tecentriq or Nexavar, Exelixis, the pharmaceutical company developing Cabometyx, does not plan to submit a supplemental New Drug Application (NDA) to the Food and Drug Administration (FDA) for the regimen. NDAs are submitted to the agency for review and potential FDA approval of a particular drug.
“Exelixis has a longstanding commitment to patients with liver cancer, exemplified by the 2019 approval of Cabometyx for previously treated advanced liver cancer, and we remain steadfast in our journey to further therapies for this and other difficult-to-treat cancers,” Dr. Vicki L. Goodman, the executive vice president of Product Development and Medical Affairs, and chief medical officer at Exelixis, said in a news release.
COSMIC-312 was a randomized phase 3 clinical trial conducted across 281 cancer centers around the world. It involved 837 patients who were randomly assigned to one of three groups: 40 milligrams (mg) of Cabometyx plus Tecentriq (432 patients); Nexavar (217 patients); 60 mg Cabometyx (188 patients).
Findings from the trial presented in November 2021 showed that Cabometyx plus Tecentriq improved progression-free survival (defined as the time from treatment until a patient’s disease gets worse), with a 37% decrease in the risk of disease progression or death compared with Nexavar. Average progression-free survival was 6.8 months for the Cabometyx/Tecentriq group, compared with 4.2 months in the Nexavar group.
The findings also showed that at an average of 13.6 months of follow-up, the interim overall survival was slightly better in the Cabometyx/Tecentriq group, though the findings were not statistically significant, meaning that the survival rates for each of the groups was so close that the researchers could not say for sure that one treatment was better than the other.
“We are grateful to the investigators and patients who participated in the COSMIC-312 trial and contributed greatly to this research,” Goodman said.
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