The European Medicines Agency (EMA) has accepted the Type II Variation application for ENHERTU to treat adult patients with HER2-positive unresectable or metastatic solid tumors who have already had prior treatments and don’t have good alternatives. ENHERTU is a specialized HER2-targeted antibody-drug conjugate developed by Daiichi Sankyo and AstraZeneca. This validation means the application is complete and begins the EMA’s review process through its Committee for Medicinal Products for Human Use. The application is supported by data from three phase 2 clinical trials—DESTINY-PanTumor02, DESTINY-CRC02, and DESTINY-Lung01—that showed meaningful clinical responses across various tumor types.
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Ken Takeshita, MD, Global Head of Research and Development at Daiichi Sankyo, said ENHERTU has shown promising benefits for HER2-positive metastatic solid cancers. He sees the EMA validation as an important step in making this treatment available to patients in the European Union. He is also hopeful about working with the EMA to get a tumor-agnostic approval for ENHERTU in Europe, similar to approvals in other regions.
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The DESTINY-PanTumor02 trial is a global phase 2, multi-cohort study that checks the safety and effectiveness of ENHERTU in previously treated HER2-expressing tumors, including biliary tract, bladder, cervical, endometrial, ovarian, and pancreatic cancers. The main measure of success is the confirmed objective response rate based on investigator assessments. Secondary outcomes include response duration, disease control rate, progression-free survival, overall survival, safety, and pharmacokinetics. This trial involved 267 patients across Asia, Europe, and North America.
DESTINY-Lung01 is a phase 2 trial that evaluates ENHERTU in patients with HER2 mutant or HER2 overexpressing non-small cell lung cancer (NSCLC) who have progressed despite previous treatments. The main focus is on confirmed objective response rate, with additional outcomes such as response duration and survival rates. The study included 181 patients worldwide. Results from the HER2 mutant group were published in The New England Journal of Medicine, and findings from the HER2 overexpressing group appeared in The Lancet Oncology.
DESTINY-CRC02 is a randomized phase 2 trial that assesses two doses of ENHERTU in patients with advanced HER2-positive colorectal cancer who have had standard treatments. The main outcome is the confirmed objective response rate, with secondary goals covering response duration, disease control, clinical benefit, survival, and safety. A total of 122 patients took part in this trial across various global locations. Results were published in The Lancet Oncology.
HER2 is a protein receptor that helps cells grow normally, but when it’s amplified or mutated in cancer cells, it can lead to aggressive disease and worse outcomes. Although HER2-targeted therapies are well established for breast, gastric, and lung cancers in Europe, testing and treatment for HER2 expression in other solid tumors like biliary, bladder, cervical, endometrial, ovarian, and pancreatic cancers are not widely available. HER2 overexpression rates vary among these cancers, with some tumors showing levels as high as 31 percent. For example, 1 to 5 percent of non-small cell lung cancer cases and 2 to 4 percent of colorectal cancers show HER2 overexpression, underscoring the need for new treatment options like ENHERTU for these patient groups.
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