AstraZeneca's Flagship Cancer Drug Imfinzi Fails On Main Goal In Lung Cancer Trial When Combined With Chemoradiotherapy

AstraZeneca Plc AZN said its PACIFIC-2 Phase 3 trial for Imfinzi (durvalumab) concurrently administered with chemoradiotherapy (CRT) did not achieve statistical significance for the primary endpoint of progression-free survival versus CRT alone for unresectable, Stage III non-small cell lung cancer.

Imfinzi sequentially administered after platinum-based CRT is the established, global standard of care for unresectable Stage III NSCLC based on the PACIFIC Phase 3 trial results. 

The PACIFIC-2 trial was initiated to evaluate concurrent Imfinzi administration with CRT to address patients who progress or discontinue treatment during CRT and are ineligible for the PACIFIC regimen.

Also Read: AstraZeneca Joins Anti-Obesity Race Dominated By Eli Lilly And Novo Nordisk, Reports Mixed Q3 Earnings.

Initial analysis of the safety and tolerability for Imfinzi and CRT showed that the profiles were broadly consistent with the known profiles of these treatments. However, an increased infection rate was observed during the concurrent treatment period in the experimental arm.

Separately, China approved AstraZeneca's Imfinzi (durvalumab) for the 1st-line treatment of adult patients with locally advanced or metastatic biliary tract cancer in combination with chemotherapy (gemcitabine and cisplatin).

The approval was based on the primary results from the TOPAZ-1 Phase 3 trial.

In an interim analysis of the TOPAZ-1 Phase 3 trial, Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone. The median overall survival was 12.8 months versus 11.5 for chemotherapy. 

Additionally, efficacy results from a prespecified exploratory analysis in an additional cohort of TOPAZ-1 patients enrolled in China were consistent with those in the overall global trial population, showing Imfinzi plus chemotherapy reduced the risk of death by 22% versus chemotherapy alone.

Price Action: AZN shares are up 1.51% at $64.66 on the last check Tuesday.