|
AstraZeneca PLC on Monday said a phase three trial in a potential treatment for a form of non-small cell lung cancer failed to meet a key aim, while its early breast cancer drug has been granted a breakthrough therapy designation in the US. The Cambridge, England-based pharmaceutical company said the trial of ceralasertib in combination with Imfinzi, or durvalumab, did not meet its overall survival primary endpoint when compared to standard-of-care docetaxel in patients with locally advanced or metastatic non-small cell lung cancer. Susan Galbraith, the executive vice president of Oncology Haematology R&D at AstraZeneca said: ‘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.’ ‘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.’ More positively, AstraZeneca on Monday also said the US Food & Drug Administration has granted a breakthrough therapy designation - or BTD - for Enhertu, a post-neoadjuvant therapy for patients with HER2-positive early breast cancer. A BTD accelerates the development and regulatory review of potential new medicines intended to treat serious conditions with unmet medical need. The designation follows the results from the Destiny-Breast05 phase three trial, which was the second positive trial of Enhertu in early breast cancer in 2025. Enertu was discovered by Tokyo-based pharmaceutical maker Daiichi Sankyo Co Ltd, and is being jointly developed and commercialised by the two companies. The first trial, Destiny-Breast11, which evaluated patients with high-risk HER2-positive disease in the neoadjuvant setting, is currently under review by the FDA. HER2 is a receptor protein, which in cancer cells promotes excessive cell growth. AstraZeneca said post-neoadjuvant therapy ‘represents a key opportunity to minimise the risk of recurrence and prevent progression to metastatic disease for patients with residual disease’. Galbraith said: ‘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.’ Ken Takeshita, the global head of R&D at Daiichi Sankyo said: ‘We look forward to working with the FDA with the goal of bringing Enhertu to the post-neoadjuvant setting of HER2-positive early breast cancer, as 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.’ Shares in AstraZeneca were down 0.6% to 13,584.00 pence on Monday morning in London. Shares in Daiichi Sankyo closed down 0.5% at JP¥3,285.00 in Tokyo. Copyright 2025 Alliance News Ltd. All Rights Reserved.
|
