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HUTCHMED Highlights Publication of Phase III SACHI Results in The Lancet

HCM
  • The SACHI Phase III trial results confirming the efficacy of savolitinib combined with osimertinib for EGFR-mutated NSCLC with MET amplification were published in The Lancet.
  • The combination therapy received regulatory approval in China in June 2025 based on interim data showing significant progression-free survival benefits.
  • In the intention-to-treat population, investigator-assessed median progression-free survival was 8.2 months for the combination arm versus 4.5 months for chemotherapy (hazard ratio 0.34; p<0.0001).
  • The independent review committee assessed median progression-free survival as 7.2 months for the combination arm versus 4.2 months for chemotherapy (hazard ratio 0.40; p<0.0001).
  • Investigator-assessed objective response rate was 58% for the combination therapy compared to 34% for chemotherapy, with disease control rates of 89% versus 67%.
  • Median duration of response was 8.4 months for the combination arm versus 3.2 months for chemotherapy, while median time to response was similar between arms (1.4 vs 1.5 months).
  • Overall survival data remained immature at the interim analysis, with a median OS of 22.9 months for the combination arm versus 17.7 months for chemotherapy (hazard ratio 0.84).
  • Sensitivity analyses adjusting for crossover to MET inhibitor therapy in the chemotherapy arm showed more significant overall survival benefits for the combination therapy (hazard ratios ranging from 0.24 to 0.62).
  • In the subgroup of patients previously treated with third-generation EGFR TKIs, investigator-assessed median progression-free survival was 6.9 months for the combination versus 3.0 months for chemotherapy (hazard ratio 0.32).
  • The safety profile was tolerable with no new safety signals, as Grade 3 or higher treatment-emergent adverse events occurred in 57% of patients in both the combination and chemotherapy arms.
  • Common Grade 3 or higher adverse events included decreased neutrophil count, decreased white blood cell count, and anemia, with lower incidence rates in the combination arm for neutrophil and white blood cell counts.
  • Savolitinib (ORPATHYS ®) is a selective MET tyrosine kinase inhibitor developed by AstraZeneca 1 HUTCHMED 1 commercialized by AstraZeneca.
  • Osimertinib (TAGRISSO ®) is a third-generation irreversible EGFR tyrosine kinase inhibitor used in the combination to address MET amplification resistance.
  • The SACHI trial enrolled 211 patients who were randomized to receive the savolitinib and osimertinib combination or chemotherapy.
  • Other ongoing global trials evaluating this combination include SAFFRON (US Fast Track designation) 1 SANOVO (China) 1 TATTON 1 1 SAVANNAH.
  • Approximately 15-50% of patients progressing on third-generation EGFR TKIs exhibit MET aberrations, highlighting the clinical need for this targeted approach.