HUTCHMED reports 32% lower death risk in lung cancer trial

• HUTCHMED reported Phase III SAFFRON trial results showing that ORPATHYS plus TAGRISSO extended median overall survival to 17.8 months, compared with 12.9 months for chemotherapy.
• The combination reduced the relative risk of death by 32% and the risk of disease progression or death by 45%, with both results statistically significant.
• HUTCHMED confirmed that a U.S. regulatory application has been submitted, while submissions in Europe and Japan are progressing.

HUTCHMED (NASDAQ:HCM) reported positive results from its 338-patient Phase III SAFFRON lung cancer trial, showing that ORPATHYS plus TAGRISSO significantly improved survival compared with platinum-based chemotherapy.

Median overall survival reached 17.8 months with the combination versus 12.9 months with chemotherapy, representing a 32% reduction in the relative risk of death.

“These data show combining ORPATHYS with backbone therapy TAGRISSO directly addresses MET-driven resistance while maintaining EGFR suppression,” said AstraZeneca Executive Vice President Susan Galbraith.

Median progression-free survival increased to 7.6 months from 5.4 months, corresponding to a 45% reduction in the relative risk of disease progression or death.

HUTCHMED confirmed a U.S. New Drug Application for the combination and said regulatory submissions in Europe and Japan were progressing as planned.

Grade 3 or higher adverse events from all causes occurred in 64% of combination-treated patients compared with 63% receiving chemotherapy, with no new safety concerns reported.

The findings were presented at the ESMO 2026 Congress and simultaneously published in The New England Journal of Medicine, supporting the potential use of the combination after progression on EGFR-targeted therapy.

ORPATHYS plus TAGRISSO is approved for a specified EGFR-mutated lung cancer population in China, but the combination remains under regulatory review for this proposed use in the United States.