AstraZeneca Plc AZN released updated exploratory results from the TOPAZ-1 Phase 3 trial of Imfinzi (durvalumab) in combination with standard-of-care chemotherapy for advanced biliary tract cancer (BTC).
The data showed that Imfinzi plus standard-of-care chemotherapy demonstrated a clinically meaningful long-term overall survival (OS) benefit in advanced biliary tract cancer patients at three years.
The company says the TOPAZ-1 results are the longest survival follow-up ever reported for a global, randomized Phase 3 trial in this setting.
Related: New Hope for Aggressive Lung Cancer: AstraZeneca’s Imfinzi Shows Promising Results in Phase 3 Trial.
At more than three years (median follow-up of 41.3 months), results showed that Imfinzi plus chemotherapy reduced the risk of death by 26% versus chemotherapy alone.
The median OS was 12.9 months for Imfinzi plus chemotherapy versus 11.3 months for chemotherapy alone.
More than twice as many patients on the Imfinzi-based regimen were alive at three years versus chemotherapy alone (14.6% versus 6.9%).
Do-Youn Oh, principal investigator in the trial, said: “The latest data from TOPAZ-1 show that twice as many patients with advanced biliary tract cancer were still alive at three years with durvalumab and chemotherapy, an especially meaningful advance in a setting where historically the prognosis has been poor.”
The TOPAZ-1 trial met the primary endpoint of OS in October 2021 at a planned interim analysis, showing that the combination reduced the risk of death by 20% versus chemotherapy alone.
Median OS was 12.8 months versus 11.5 for chemotherapy. An estimated 25% of patients were still alive at two years versus 10% for chemotherapy.
Results also showed a 25% reduction in the risk of disease progression or death with Imfinzi plus chemotherapy.
Median progression-free survival (PFS) was 7.2 months for the combination versus 5.7 for chemotherapy.
Patients treated with Imfinzi plus chemotherapy achieved an objective response rate (ORR) of 26.7% versus an ORR of 18.7% for patients treated with chemotherapy alone.
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Price Action: AZN shares are down 0.01% at $68.72 during the premarket session on the last check Tuesday.
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