Durvalumab regimen improves 3-year survival in advanced biliary tract cancers
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The addition of durvalumab to chemotherapy doubled 3-year survival among patients with advanced biliary tract cancers, according to data released by the agent’s manufacturer.
Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1. The agent is approved in the United States for treatment of locally advanced or metastatic biliary tract cancer. It also is approved for treatment of unresectable hepatocellular carcinoma and multiple lung cancer indications.
The randomized phase 3 TOPAZ-1 trial assessed the addition of durvalumab to chemotherapy as first-line treatment for adults with unresectable locally advanced or metastatic biliary tract cancers.
OS served as the primary endpoint. PFS, objective response rate and safety served as secondary endpoints.
After median follow-up of 41.3 months, results showed the addition of durvalumab to chemotherapy reduced risk for death by 26% (HR = 0.74; 95% CI, 0.63-0.87).
Researchers reported median OS of 12.9 months for durvalumab-chemotherapy vs. 11.3 months for chemotherapy alone.
Twice as many patients assigned the durvalumab regimen remained alive at 3 years (14.6% vs. 6.9%).
“[This is] an especially meaningful advance in a setting where historically the prognosis has been poor,” principal investigator Do-Youn Oh, MD, PhD, professor in the division of medical oncology at Seoul National University Hospital and Seoul National University College of Medicine, said in an AstraZeneca press release. “These results reinforce the long-term benefit of this immunotherapy-based combination as a standard of care for patients with this devastating disease.”
The most common adverse reactions reported among patients assigned the durvalumab regimen included fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%) and pyrexia (20%).
The most common serious adverse reactions included cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%) and acute kidney injury (2.4%).
Researchers reported fatal adverse reactions among 3.6% of patients assigned the durvalumab regimen. These included ischemic or hemorrhagic stroke (n = 4), sepsis (n = 2) and upper gastrointestinal hemorrhage (n = 2).
Full results will be presented April 18 at the Cholangiocarcinoma Foundation Conference in Salt Lake City.
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