阿斯利康/和黄医药 Tagrisso+Orpathys（赛沃替尼）SAFFRON 全球III期OS阳性并已向FDA提交NDA，但数据今晨ESMO已披露、盘前几乎无反应

AstraZeneca (AZN) and HUTCHMED reported Phase 3 results showing that Tagrisso (osimertinib) combined with Orpathys (savolitinib) significantly improved progression-free and overall survival in patients with EGFR-mutated non-small cell lung cancer (NSCLC) whose disease progressed following prior Tagrisso treatment.
The findings come from the global Phase 3 SAFFRON trial, which evaluated the combination against doublet platinum-based chemotherapy in patients whose tumors had high levels of MET overexpression or amplification, a mechanism associated with resistance to EGFR-targeted treatment.
The combination reduced the risk of disease progression or death by 45% compared with chemotherapy.
Median progression-free survival (PFS), assessed by blinded independent central review, was 7.6 months with Tagrisso plus Orpathys versus 5.4 months with chemotherapy.
An estimated 36% of patients receiving the combination remained progression-free at one year, compared with 10% in the chemotherapy group. The PFS benefit was consistent across prespecified subgroups, including patients whose tumors showed MET overexpression or amplification.
The study also demonstrated a significant overall survival benefit, with Tagrisso plus Orpathys reducing the risk of death by 32% compared with chemotherapy. Median overall survival increased to 17.8 months from 12.9 months, extending survival by 4.9 months.
At one year, an estimated 70% of patients treated with the combination were alive, compared with 53% of those receiving chemotherapy. The results establish a significant survival benefit in a setting where MET-driven resistance can limit the effectiveness of EGFR-targeted therapies.
The safety profile of Tagrisso plus Orpathys was manageable and consistent with the known profiles of the individual medicines, with no new safety concerns reported.
Grade 3 or higher treatment-emergent adverse events from all causes occurred in 64% of patients receiving the combination and 63% of those in the chemotherapy group. Median treatment exposure was 8.5 months with the combination versus 3.5 months with chemotherapy.
The SAFFRON results were presented during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026 and simultaneously published in The New England Journal of Medicine.
Based on the findings, a New Drug Application for Tagrisso plus Orpathys has been submitted to the U.S. Food and Drug Administration for patients with locally advanced or metastatic NSCLC whose tumors have MET overexpression or amplification and whose disease progressed during or after EGFR tyrosine kinase inhibitor therapy.
The results further support the evaluation of biomarker-directed treatment strategies for EGFR-mutated lung cancer, targeting MET-driven resistance while maintaining EGFR suppression.
AZN has traded between $153.41 and $212.71 over the past 52 weeks. The stock closed Friday's trade at $171.49, down 0.63%.
In pre-market trading, AZN is up 0.36% at $172.08.
HCM has traded between $9.77 and $16.33 over the last year. The stock closed Friday's trade at $14.36, up 0.56%.
In pre-market trading, HCM is up 0.63% at $14.45.
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October 16, 2026 16:06 ET Monthly consumer price inflation data and retail sales figures were the main news from the U.S. economy this week. In Europe, monthly GDP figures from the U.K. gained attention. External trade data from China was in focus in Asia. Elsewhere, the International Monetary Fund released its latest projections for the global economy.