AstraZeneca posts mixed results from recent Imfinzi trials

AstraZeneca announced contrasting results from two phase three trials involving its immunotherapy drug ‘Imfinzi’, or durvalumab, on Tuesday.

The FTSE 100 pharmaceuticals giant said the ADJUVANT BR.31 trial, sponsored by the Canadian Cancer Trials Group (CCTG), investigated Imfinzi in early-stage non-small cell lung cancer (NSCLC).

It said the trial did not achieve statistical significance in its primary endpoint of disease-free survival (DFS) compared to placebo in patients with PD-L1 expression on 25% or more tumour cells.

Despite that, the safety profile of Imfinzi remained consistent with previous data, and no new safety concerns were identified.

Detailed findings would be presented at an upcoming medical meeting, AstraZeneca said.

“We are disappointed in the ADJUVANT BR.31 results,” said the company’s executive vice-president of oncology research and development, ​Susan Galbraith.

“Imfinzi has helped change the treatment landscape and achieved multiple positive Phase III trials for patients with earlier stages of lung cancer.

“We are committed to addressing the remaining unmet need in lung cancer through our broad development programme.”

In contrast, the NIAGARA phase three trial yielded positive results for Imfinzi in combination with chemotherapy for muscle-invasive bladder cancer (MIBC).

The study showed a statistically significant and clinically meaningful improvement in event-free survival (EFS) and overall survival (OS) compared to neoadjuvant chemotherapy alone.

Patients received Imfinzi alongside chemotherapy before cystectomy, followed by Imfinzi as an adjuvant monotherapy.

The combination was generally well-tolerated, with no new safety concerns and no increase in adverse event-related discontinuations.

AstraZeneca said those results would also be discussed at a forthcoming medical meeting, and shared with regulatory authorities.

“The NIAGARA results support our strategy to move immunotherapy to the early stages of cancer treatment,” Susan Galbraith added.

“This perioperative regimen with Imfinzi improved survival and reduced the rate at which patients experience disease recurrence or progression.

“We are eager to bring this regimen with the potential to transform the standard of care to patients as soon as possible.”

Imfinzi was still the only approved immunotherapy for unresectable, stage three NSCLC in patients whose disease had not progressed following chemoradiotherapy, based on the PACIFIC phase three trial, AstraZeneca noted.

It was also under investigation for various other early-stage lung cancer settings.

At 0825 BST, shares in AstraZeneca were up 0.34% at 12,522p.

Reporting by Josh White for Sharecast.com.