IMFINZI® (durvalumab) plus chemotherapy further improved overall survival benefit in advanced biliary tract cancer in the TOPAZ-1 Phase III trial, reducing the risk of death by 24% in additional follow-up

HIMALAYA Phase III trial exploratory results support the benefit of tremelimumab added to IMFINZI in unresectable liver cancer regardless of etiology

Excerpt from the Press Release:

WILMINGTON, Del.–(BUSINESS WIRE)–Updated results from the TOPAZ-1 Phase III trial showed AstraZeneca’s IMFINZI^® (durvalumab), in combination with standard-of-care chemotherapy demonstrated a clinically meaningful and durable overall survival (OS) benefit as a treatment for patients with advanced biliary tract cancer (BTC).

These results from TOPAZ-1, the first Phase III trial to show improved OS with an immunotherapy combination in this setting, will be presented today at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris (abstract #56P).

The updated results for IMFINZI plus chemotherapy (gemcitabine plus cisplatin) showed enhanced clinical efficacy after an additional 6.5 months of follow-up, demonstrating a 24% reduction in the risk of death versus chemotherapy alone (based on an HR of 0.76; 95% CI, 0.64–0.91). Updated median OS was 12.9 months versus 11.3 with chemotherapy. More than two times as many patients were estimated to be alive at two years versus chemotherapy alone (23.6% versus 11.5%). Results were seen across all prespecified subgroups, regardless of disease status, tumor location or PD-L1 expression. In addition, OS benefit was observed in patients whose tumors stayed the same size (stable disease) as well as in patients whose tumors got smaller or disappeared (responders).

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