AstraZeneca Imfinzi combo cuts risk of death by 24% in biliary tract cancer patients in trial
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AstraZeneca (NASDAQ:AZN) said Imfinzi, in combination with standard-of-care chemotherapy, showed a clinically meaningful and durable overall survival (OS) benefit for patients with advanced biliary tract cancer (BTC) in a phase 3 trial called TOPAZ-1.
As per updated data, Imfinzi plus chemotherapy (gemcitabine plus cisplatin) showed better clinical efficacy after an additional 6.5 months of follow-up, showing a 24% reduction in the risk of death versus chemotherapy alone, the company said in a Sept. 12 press release.
Updated median OS was 12.9 months, compared to 11.3 months with chemotherapy.
The British pharma giant added that 23.6% of patients on Imfinzi combo were estimated to be alive at two years versus 11.5% on chemotherapy alone.
Results were seen across all subgroups, regardless of disease status, tumor location or PD-L1 expression, the company added.
AstraZeneca noted that grade 3 or 4 treatment-related adverse events ((AEs)) were experienced by 60.9% of patients treated with Imfinzi combo, and by 63.5% of patients on chemo alone.
The safety profile of Imfinzi plus chemo was well-tolerated, with no new safety signals seen with the longer follow-up, according to the company.