AstraZeneca's Imfinzi gets recommended for fresh EU approval

(Sharecast News) - AstraZeneca announced on Monday that Imfinzi, or durvalumab, has been recommended for approval in the European Union for adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and without EGFR mutations or ALK rearrangements. The FTSE 100 pharmaceuticals giant said the recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency was based on data from the AEGEAN phase three trial.

It said the AEGEAN study showed that an Imfinzi-based perioperative regimen, which includes Imfinzi plus neoadjuvant chemotherapy before surgery followed by Imfinzi monotherapy after surgery, reduced the risk of recurrence, progression, or death by 32% compared with neoadjuvant chemotherapy alone.

The event-free survival hazard ratio was 0.68, with a 95% confidence interval of 0.53 to 0.88 and a p-value of 0.003902.

Pathologic complete response rates were also higher with the Imfinzi regimen, reaching 17.2% compared with 4.3% for chemotherapy alone.

Interim overall survival results presented at the 2024 World Conference on Lung Cancer indicated a favourable trend for Imfinzi, although statistical significance was not assessed at this stage.

Median overall survival was not reached in the Imfinzi arm, compared with 53.2 months for the control group.

The final analysis would further evaluate overall survival as a key endpoint.

AstraZeneca said lung cancer remained a leading cause of cancer-related mortality, with over 450,000 new cases annually in Europe.

While up to 30% of NSCLC patients are diagnosed early enough for surgery, the majority experienced disease recurrence.

Five-year survival rates for resectable NSCLC remained low, underscoring the need for effective perioperative treatment options.

Imfinzi was well tolerated in the study, with a safety profile consistent with previous data.

The treatment was already approved for perioperative NSCLC in the US and several other countries, and was under regulatory review in China, Japan, and other markets.

It was also a standard of care for unresectable stage three NSCLC following chemoradiotherapy, based on the PACIFIC trial results.

"This recommendation highlights the potential of Imfinzi to address an unmet need for patients with resectable lung cancer who need new treatment options that increase the time they live without recurrence or progression," said Susan Galbraith, AstraZeneca's executive vice-president of oncology haematology research and development.

"AEGEAN underscores our commitment to transforming care in the early stages of lung cancer where there is the greatest potential for cure."

At 0821 GMT, shares in AstraZeneca were down 0.22% at 11,942p.

Reporting by Josh White for Sharecast.com.