AstraZeneca has added a European Union approval for Enhertu plus pertuzumab in first-line HER2-positive metastatic breast cancer to a series of oncology advances that also includes a global lung-cancer licensing deal and positive Phase III data for Tagrisso plus Orpathys.
The European Commission approved Enhertu, or trastuzumab deruxtecan, in combination with pertuzumab for adults with unresectable or metastatic HER2-positive breast cancer. AstraZeneca and Daiichi Sankyo said the decision makes the regimen the first new first-line treatment option in more than a decade for the patient group.
The approval was based on the Phase III DESTINY-Breast09 trial, which compared Enhertu plus pertuzumab with a regimen of taxane chemotherapy, trastuzumab and pertuzumab, known as THP. The combination reduced the risk of disease progression or death by 44%, producing a hazard ratio of 0.56.
Median progression-free survival reached 40.7 months for Enhertu plus pertuzumab, compared with 26.9 months for THP, as assessed by blinded independent central review. The global trial enrolled 1,157 patients who had not received prior chemotherapy or HER2-targeted therapy for metastatic disease, or whose earlier HER2-targeted treatment had ended more than six months before advanced disease was diagnosed.
The safety profile was consistent with those previously established for the individual medicines, with no new safety concerns identified. The EU decision triggers a $100 million milestone payment from AstraZeneca to Daiichi Sankyo. Daiichi Sankyo recognizes Enhertu sales in most EU markets.
In lung cancer, AstraZeneca completed an exclusive global license agreement with Dizal Pharmaceutical for Zegfrovy, or sunvozertinib, an oral irreversible EGFR inhibitor. AstraZeneca will pay $600 million upfront and could pay up to $900 million in development, regulatory and sales milestones, alongside tiered royalties.
Zegfrovy is approved in the United States and China for previously treated adults with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations. AstraZeneca expects to launch the treatment in the United States during the fourth quarter of 2026. It has also submitted Zegfrovy for potential first-line approvals in the United States and China.
Separately, AstraZeneca and HUTCHMED reported positive high-level Phase III SANOVO results for Tagrisso, or osimertinib, plus Orpathys, or savolitinib, in previously untreated EGFR-mutated non-small cell lung cancer with MET overexpression.
The trial enrolled 326 patients with locally advanced or metastatic disease in China. The all-oral combination achieved a statistically significant and highly clinically meaningful improvement in progression-free survival compared with Tagrisso plus placebo, both in patients with high MET expression and in the broader intention-to-treat population.
An encouraging overall-survival benefit was also observed, although follow-up is continuing. The safety results aligned with the known profiles of the individual drugs, and no new safety findings emerged.
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