![]() 2 Prognosis is particularly poor for patients with metastatic NSCLC as only approximately 9% will live beyond five years after diagnosis. 2 Lung cancer is also the leading cause of cancer-related deaths in Europe, with nearly 400,000 deaths reported in 2020. 1 In Europe, lung cancer is the third most commonly diagnosed cancer with more than 477,000 cases diagnosed in 2020. Lung cancer is the second most common form of cancer globally with more than two million cases diagnosed in 2020. The safety profile of Enhertu in the DESTINY-Lung02 trial was consistent with previous clinical trials with no new safety signals identified. This CHMP opinion is a positive step forward in advancing this HER2-directed antibody drug conjugate for these patients and we look forward to the European Commission decision.” ![]() Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “ Enhertu is the first therapy to demonstrate a strong and durable tumour response in patients with previously treated HER2-mutant advanced non-small cell lung cancer, validating HER2 as an actionable target in lung cancer and supporting the potential to provide a much-needed option for these patients. This milestone recognises the unmet need in the European Union and if approved, Enhertu will provide the first targeted treatment option for these patients.” ![]() Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “HER2-mutant non-small cell lung cancer is an aggressive form of lung cancer that often affects younger patients and has a poor prognosis, with limited approved therapies. Median follow-up was 11.5 months at time of data cut-off of 23 December 2022. The median duration of response (DoR) was 16.8 months (95% CI 6.4-not estimated ). One (1.0%) complete response (CR) and 49 (48.0%) partial responses (PR) were observed. In the trial, Enhertu (5.4mg/kg) demonstrated a confirmed objective response rate (ORR) of 49.0% (95% confidence interval 39.0-59.1) and a disease control rate (DCR) of 93.1% (95% CI 86.4-97.2), as assessed by blinded independent central review (BICR), in patients with previously treated advanced or metastatic HER2-mutant (HER2m) NSCLC. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on the primary results from the DESTINY-Lung02 Phase II trial, which were presented at the IASLC 2023 World Conference on Lung Cancer and simultaneously published in the Journal of Clinical Oncology. Partnerships, alliances and recognitionĪstraZeneca and Daiichi Sankyo’s (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.Įnhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.To encourage potential witnesses to come forward, the whistleblower legislation forbids any federal employee from retaliating against anyone providing authorized disclosure. Imagine what we could do with even a grain of knowledge about how they operate.” It could be more transformative for humanity than what the microprocessor accomplished. “What might be represented here could be hundreds of technology revolutions ahead of us. Studying even small samples of purported anomalous material could lead to currently inconceivable benefits for humanity, he said. “Human civilization was utterly transformed by something as small as a grain of silicon or germanium-creating the underpinning of the integrated circuits that underly computation and now even artificial intelligence,” Nolan said. ![]() Stanford professor Garry Nolan (Credit: Timothy Archibald) Nolan has previously applied some of those technologies to the analysis of exotic materials, publishing the first peer-reviewed paper examining such materials. Garry Nolan, a Professor in the Department of Pathology at Stanford University and a renowned inventor and entrepreneur with more than three hundred published papers, has started over half a dozen companies based on technologies out of his laboratory. In addition, the legislation asks for reporting on “material retrieval, material analysis, reverse engineering, research, and development” involving unidentified anomalous phenomena currently and going back decades.ĭr.
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