AstraZeneca and Daiichi Sankyo Withdraw Lung Cancer Drug Application in EU: A Setback in Oncology Innovation
December 25, 2024, 4:35 am
Location: United Kingdom, England, Cambridge
Employees: 10001+
Founded date: 1999
Total raised: $1.4B
In a significant turn of events, AstraZeneca and Daiichi Sankyo have voluntarily withdrawn their marketing authorization application for datopotamab deruxtecan (Dato-DXd) in the European Union. This decision, announced on December 24, 2024, marks a setback for the experimental drug aimed at treating advanced nonsquamous non-small cell lung cancer (NSCLC). The withdrawal stems from feedback received from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), which raised concerns about the drug's efficacy based on recent trial results.
The TROPION-Lung01 Phase III trial, which served as the backbone for the application, yielded mixed results. While Dato-DXd demonstrated a potential to prolong progression-free survival (PFS) compared to docetaxel, the overall survival (OS) results were not statistically significant across the broader patient population. This dichotomy in outcomes has left stakeholders questioning the drug's viability in the competitive oncology landscape.
Lung cancer remains a formidable adversary, with nearly 2.5 million cases diagnosed globally in 2022. In Europe alone, approximately half a million new cases were reported. NSCLC accounts for about 80% of lung cancer cases, and despite advancements in immunotherapy and targeted treatments, many patients eventually face disease progression, often resorting to chemotherapy. This traditional approach, while a mainstay for decades, is fraught with limitations and side effects.
Datopotamab deruxtecan is an antibody-drug conjugate (ADC) designed to target the TROP2 protein, which is prevalent in many NSCLC tumors. This innovative treatment strategy aims to deliver chemotherapy directly to cancer cells, minimizing damage to healthy tissue. However, the absence of an approved TROP2-directed ADC for lung cancer highlights the challenges faced in this therapeutic area.
The TROPION-Lung01 trial enrolled around 600 patients across multiple continents, including Asia, Europe, North America, Oceania, and South America. The dual primary endpoints of the trial focused on PFS and OS, with key secondary endpoints assessing various response metrics. Despite the promising PFS results presented at the European Society for Medical Oncology 2023 Congress, the subsequent OS data presented at the IASLC 2024 World Conference on Lung Cancer did not meet the expectations set by earlier findings.
AstraZeneca and Daiichi Sankyo remain committed to advancing Dato-DXd for lung cancer treatment. They are not abandoning the ship; instead, they are redirecting their efforts. The companies have emphasized their dedication to bringing this drug to patients who may benefit from it, citing ongoing clinical trials in various lung cancer settings. Currently, they are pursuing seven pivotal trials aimed at solidifying the drug's place in the treatment landscape.
While the EU application for Dato-DXd in lung cancer has been withdrawn, the companies continue to seek approval for its use in hormone receptor-positive, HER2-negative metastatic breast cancer, which remains under review. In the United States, a new application for Dato-DXd targeting a smaller subset of lung cancer patients has been submitted, indicating that the drug's journey is far from over.
The landscape of lung cancer treatment is evolving, and AstraZeneca is at the forefront of this revolution. The company is not just focused on Dato-DXd; it has a robust portfolio of lung cancer therapies, including Tagrisso and Imfinzi, among others. AstraZeneca's commitment to innovation is evident in its extensive clinical development program, which encompasses over 20 trials across various cancers, including NSCLC and breast cancer.
The collaboration between AstraZeneca and Daiichi Sankyo has been pivotal in advancing ADC technology. This partnership, initiated in 2019, aims to harness the potential of ADCs to deliver targeted therapies that can transform cancer treatment. The vision is clear: to redefine cancer care and ultimately eliminate cancer as a cause of death.
Despite the setback in the EU, the withdrawal of the application does not signify defeat. It is a recalibration, a moment to reassess and refine strategies. The commitment to patient care remains unwavering. AstraZeneca and Daiichi Sankyo are determined to navigate the complexities of oncology, pushing the boundaries of science to improve outcomes for patients battling lung cancer.
In conclusion, the withdrawal of the Dato-DXd application in the EU is a reminder of the challenges inherent in drug development. The path to innovation is often fraught with obstacles, but it is also paved with resilience and determination. As AstraZeneca and Daiichi Sankyo continue their quest to bring effective treatments to patients, the oncology community watches closely, hopeful for breakthroughs that can change the course of cancer care. The fight against lung cancer is ongoing, and every setback is a stepping stone toward future success.
The TROPION-Lung01 Phase III trial, which served as the backbone for the application, yielded mixed results. While Dato-DXd demonstrated a potential to prolong progression-free survival (PFS) compared to docetaxel, the overall survival (OS) results were not statistically significant across the broader patient population. This dichotomy in outcomes has left stakeholders questioning the drug's viability in the competitive oncology landscape.
Lung cancer remains a formidable adversary, with nearly 2.5 million cases diagnosed globally in 2022. In Europe alone, approximately half a million new cases were reported. NSCLC accounts for about 80% of lung cancer cases, and despite advancements in immunotherapy and targeted treatments, many patients eventually face disease progression, often resorting to chemotherapy. This traditional approach, while a mainstay for decades, is fraught with limitations and side effects.
Datopotamab deruxtecan is an antibody-drug conjugate (ADC) designed to target the TROP2 protein, which is prevalent in many NSCLC tumors. This innovative treatment strategy aims to deliver chemotherapy directly to cancer cells, minimizing damage to healthy tissue. However, the absence of an approved TROP2-directed ADC for lung cancer highlights the challenges faced in this therapeutic area.
The TROPION-Lung01 trial enrolled around 600 patients across multiple continents, including Asia, Europe, North America, Oceania, and South America. The dual primary endpoints of the trial focused on PFS and OS, with key secondary endpoints assessing various response metrics. Despite the promising PFS results presented at the European Society for Medical Oncology 2023 Congress, the subsequent OS data presented at the IASLC 2024 World Conference on Lung Cancer did not meet the expectations set by earlier findings.
AstraZeneca and Daiichi Sankyo remain committed to advancing Dato-DXd for lung cancer treatment. They are not abandoning the ship; instead, they are redirecting their efforts. The companies have emphasized their dedication to bringing this drug to patients who may benefit from it, citing ongoing clinical trials in various lung cancer settings. Currently, they are pursuing seven pivotal trials aimed at solidifying the drug's place in the treatment landscape.
While the EU application for Dato-DXd in lung cancer has been withdrawn, the companies continue to seek approval for its use in hormone receptor-positive, HER2-negative metastatic breast cancer, which remains under review. In the United States, a new application for Dato-DXd targeting a smaller subset of lung cancer patients has been submitted, indicating that the drug's journey is far from over.
The landscape of lung cancer treatment is evolving, and AstraZeneca is at the forefront of this revolution. The company is not just focused on Dato-DXd; it has a robust portfolio of lung cancer therapies, including Tagrisso and Imfinzi, among others. AstraZeneca's commitment to innovation is evident in its extensive clinical development program, which encompasses over 20 trials across various cancers, including NSCLC and breast cancer.
The collaboration between AstraZeneca and Daiichi Sankyo has been pivotal in advancing ADC technology. This partnership, initiated in 2019, aims to harness the potential of ADCs to deliver targeted therapies that can transform cancer treatment. The vision is clear: to redefine cancer care and ultimately eliminate cancer as a cause of death.
Despite the setback in the EU, the withdrawal of the application does not signify defeat. It is a recalibration, a moment to reassess and refine strategies. The commitment to patient care remains unwavering. AstraZeneca and Daiichi Sankyo are determined to navigate the complexities of oncology, pushing the boundaries of science to improve outcomes for patients battling lung cancer.
In conclusion, the withdrawal of the Dato-DXd application in the EU is a reminder of the challenges inherent in drug development. The path to innovation is often fraught with obstacles, but it is also paved with resilience and determination. As AstraZeneca and Daiichi Sankyo continue their quest to bring effective treatments to patients, the oncology community watches closely, hopeful for breakthroughs that can change the course of cancer care. The fight against lung cancer is ongoing, and every setback is a stepping stone toward future success.