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On March 6, AstraZeneca and Daiichi Sankyo jointly announced the Phase II DESTINY-PanTumor02 study of Enhertu (trastuzumab deruxtecan) for the treatment of patients with HER2-expressing solid tumors.Achieving the primary endpoint of Objective Response Rate (ORR)。
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Moreover, in this study, patients with advanced solid tumors expressing HER2 who underwent extensive pretreatment showed durable responses to Enhertu. Both parties stated,The detailed results of the study will be announced at an upcoming medical conference and submitted to global regulatory authorities.
DESTINY-PanTumor02 Study is a global, multi-center, open-label, multi-cohort Phase II clinical trial that enrolled a total of 268 patients. It aims to evaluate the efficacy and safety of Enhertu (5.4mg/kg) in patients with locally advanced, unresectable, or metastatic HER2-expressing solid tumors who have received prior treatment. The study includes seven cohorts: biliary tract cancer, urothelial cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare cancers.
Enhertu is an antibody-drug conjugate (ADC) targeting HER2, jointly developed by AstraZeneca and Daiichi Sankyo. It was first approved for marketing in December 2019 for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens. On February 21, 2023, Enhertu was approved for marketing in China for the first time. To date, Enhertu has been approved for five oncology indications worldwide: 1) HER2-positive breast cancer; 2) gastric cancer; 3) gastroesophageal junction cancer; 4) HER2-low breast cancer; 5) non-small cell lung cancer.
AstraZeneca’s Chief Medical Officer and Chief Development Officer, Oncology, Cristian Massacesi, said: “Enhertu has demonstrated its potential to improve outcomes for patients with HER2-expressing breast, gastric, and lung cancers. These positive preliminary results are highly encouraging for other tumor types with significant unmet needs. The results of the DESTINY-PanTumor02 study mark an important step forward in our understanding of Enhertu’s potential role across multiple HER2-expressing tumor types.”
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, said: "The clinically meaningful responses observed in the DESTINY-PanTumor02 study further reinforce our confidence in the potential of Enhertu to treat a variety of HER2-expressing cancers. The results observed so far across multiple study cohorts will guide the next steps in our extensive development program, and we hope to bring this important drug to as many patients as possible as soon as possible."
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