AstraZeneca gets fresh designation for Enhertu while Imfinzi trial fizzles

(Sharecast News) - AstraZeneca on Monday reported mixed regulatory and clinical news, with its breast cancer drug Enhertu securing a US breakthrough therapy designation in early disease, while a late-stage lung cancer trial of ceralasertib in combination with Imfinzi failed to meet its primary survival endpoint. The FTSE 100 pharmaceutical giant said the designation, intended to accelerate the development and regulatory review of medicines addressing serious conditions with significant unmet need, was based on phase three 'DESTINY-Breast05' trial results for Enhertu presented at the 2025 European Society for Medical Oncology Congress and published in the New England Journal of Medicine.

"For patients with residual disease after neoadjuvant treatment, the post-neoadjuvant setting represents a critical opportunity to reduce the risk of recurrence and prevent progression to metastatic disease," said Susan Galbraith, executive vice president of oncology haematology research and development at AstraZeneca.

"This breakthrough therapy designation highlights the impressive clinical benefit of Enhertu over the current standard of care and underscores its potential to become an important treatment option in the post-neoadjuvant setting."

Daiichi Sankyo's global head of research and development, Ken Takeshita, added that the tenth breakthrough therapy designation "reinforces how Enhertu continues to deliver transformational results that advance the treatment of breast cancer."

"DESTINY-Breast05 clearly demonstrated that Enhertu may help halt invasive disease recurrence over the current standard of care, resulting in potentially more patients achieving a cure."

DESTINY-Breast05 enrolled 1,635 patients globally and compared Enhertu with trastuzumab emtansine in patients with residual invasive disease after neoadjuvant therapy.

It was the second positive Enhertu trial in early breast cancer reported in 2025, following DESTINY-Breast11 in the neoadjuvant setting, which is currently under FDA review.

Enhertu is a HER2-directed antibody-drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialised with AstraZeneca.

Separately, AstraZeneca said the phase three LATIFY trial evaluating ceralasertib in combination with Imfinzi in previously treated patients with locally advanced or metastatic non-small cell lung cancer did not meet its primary endpoint of overall survival compared with standard-of-care docetaxel.

The study enrolled patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy.

"Our goal in the LATIFY trial was to reinvigorate the immune response of patients with lung cancer whose tumours stopped responding to available therapies by combining ATR inhibition with immunotherapy," Galbraith said.

"While we are disappointed by this result, we remain committed to pioneering new medicines to address the urgent need to improve outcomes for patients with lung cancer through our industry-leading portfolio."

AstraZeneca said the combination was generally well tolerated, with a safety profile consistent with the known profiles of each medicine and no new safety concerns identified, and that full data would be presented at an upcoming medical meeting.

At 0831 GMT, shares in AstraZeneca were down 0.86% at 13,554p.

Reporting by Josh White for Sharecast.com.