HUTCHMED trial results show that ORPATHYS combined with TAGRISSO improved survival compared with chemotherapy in a defined group of patients with advanced lung cancer, the company said on October 25, 2026. The Phase III SAFFRON study tested the combination in patients whose disease had progressed after TAGRISSO treatment.

Key Takeaways

  • The combination reduced the risk of disease progression or death by 45% versus platinum-based chemotherapy.
  • Median overall survival was 17.8 months with the combination and 12.9 months with chemotherapy.
  • A US application has been submitted, while submissions in Europe and Japan are progressing.

HUTCHMED trial results and patient group

SAFFRON enrolled 338 patients with locally advanced or metastatic non-small cell lung cancer whose tumors had an EGFR mutation and high levels of MET overexpression or amplification. All had experienced disease progression following first- or second-line treatment with TAGRISSO.

Patients received either ORPATHYS, also known as savolitinib, plus TAGRISSO, or doublet platinum-based chemotherapy. The trial’s primary endpoint was progression-free survival, with overall survival a key secondary endpoint.

The combination reduced the risk of death by 32% compared with chemotherapy. Progression-free survival measures how long patients live without their disease worsening; overall survival measures how long they live after entering the study.

ItemDetails
Patients assigned171 received ORPATHYS plus TAGRISSO; 167 received chemotherapy.
Median progression-free survival7.6 months with the combination versus 5.4 months with chemotherapy.
Progression-free at 12 monthsAn estimated 36% with the combination versus 10% with chemotherapy.
Median overall survival17.8 months with the combination versus 12.9 months with chemotherapy.
Alive at 12 monthsAn estimated 70% with the combination versus 53% with chemotherapy.

Safety findings and regulatory status

Grade 3 or higher treatment-emergent adverse events from all causes occurred in 64% of patients receiving the combination and 63% of those receiving chemotherapy. Median treatment exposure was 8.5 months and 3.5 months, respectively. HUTCHMED said the safety profile was consistent with the known profiles of the medicines and that no new safety concerns were identified.

HUTCHMED said a new drug application for the combination has been submitted to the US Food and Drug Administration for patients with locally advanced or metastatic disease whose tumors have high levels of MET overexpression or amplification and who progressed on or after EGFR inhibitor therapy. Submissions in Europe and Japan are progressing.

The combination is already approved in China for a narrower group of patients with EGFR mutation-positive non-squamous lung cancer and MET amplification after progression on EGFR inhibitor therapy. It also has temporary authorization in Switzerland for a specified patient group.

Presentation and development partnership

The SAFFRON results were presented at the European Society for Medical Oncology Congress in Madrid and published simultaneously in The New England Journal of Medicine. The survival data cutoff was July 6, 2026.

ORPATHYS is being jointly developed by HUTCHMED and AstraZeneca and commercialized by AstraZeneca.

Next milestone

A separate Phase III study, SANOVO, evaluating the combination in previously untreated patients in China, was scheduled for presentation at the congress on October 26, 2026.

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