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華爾街日報AstraZeneca's Lung Cancer Combo Falls Short In Phase 3 Trial
On Monday, AstraZeneca Plc (NASDAQ:AZN) released topline data from the LATIFY Phase 3 trial of ceralasertib in combination with Imfinzi (durvalumab).
The trial did not meet the primary endpoint of overall survival (OS) versus standard-of-care docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
The trial evaluated patients without actionable genomic alterations (AGAs) whose disease progressed on or after prior immunotherapy and platinum-based chemotherapy.
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The combination of ceralasertib and Imfinzi was generally well tolerated, and the safety profile was consistent with the known profiles of each medicine, with no new safety concerns identified.
Enhertu Secures FDA Breakthrough Designation
Concurrently, AstraZeneca and Daiichi Sankyo Co., Ltd.’s (OTC:DSNKY) Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the U.S.
The designation covers adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.
The FDA granted the BTD based on results from the DESTINY-Breast05 Phase 3 trial presented in a Presidential Symposium at the 2025 European Society for Medical Oncology (ESMO) Congress and subsequently published in The New England Journal of Medicine.
DESTINY-Breast05 is the second positive trial of Enhertu in early breast cancer in 2025. The first trial, DESTINY-Breast11, evaluating patients with high-risk HER2-positive disease in the neoadjuvant setting, is currently under review by the FDA.
Jacobio Pharma Collaboration
On Sunday, Jacobio Pharma announced an agreement with AstraZeneca for its proprietary Pan-KRAS inhibitor JAB-23E73.
AstraZeneca will receive exclusive development and commercialisation rights outside of China, while Jacobio and AstraZeneca will jointly develop and commercialise JAB-23E73 in China.
JAB-23E73 is an innovative Pan-KRAS inhibitor developed using Jacobio’s induced allosteric drug discovery platform, designed to target multiple KRAS mutation subtypes.
KRAS is the most frequently mutated oncogene in human cancers, present in approximately 23% of all patients. JAB-23E73 is being evaluated in Phase I trials in both China and the United States, where early signs of anti-tumor activity have been observed.
Under the terms of the agreement, Jacobio will receive an upfront payment of $100 million and is eligible for additional development and commercial milestone payments of up to $1.915 billion, as well as tiered royalties on net sales achieved outside of China.
AstraZeneca will be responsible for all clinical development, regulatory submissions, and commercialization activities for JAB-23E73 outside of China.
AZN Price Action: AstraZeneca shares were up 0.40% at $90.79 at the time of publication on Monday. The stock is approaching its 52-week high of $94.01, according to Benzinga Pro data.
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