Hutchmed, the Hong Kong-based cancer drug developer, said its drug Orpathys (savolitinib) combined with AstraZeneca's Tagrisso (osimertinib) cut the risk of death by 32% in a phase III trial of a resistant form of lung cancer.
The SAFFRON trial compared the combination with platinum-based chemotherapy in 338 patients whose EGFR-mutated non-small cell lung cancer had progressed on Tagrisso and whose tumours showed high levels of MET, a protein that can drive resistance.
Median overall survival was 17.8 months for the combination against 12.9 months for chemotherapy, a gain of 4.9 months.
About 70% of patients on the combination were alive at one year, compared with 53% on chemotherapy.
The risk of disease progression or death fell by 45%, with median progression-free survival of 7.6 months against 5.4 months.
Some 36% of patients on the combination had not progressed after a year, against 10% on chemotherapy.
Results were presented at the European Society for Medical Oncology congress in Madrid and published in The New England Journal of Medicine.
Grade 3 or higher adverse events occurred in 64% of patients on the combination and 63% on chemotherapy, and Hutchmed reported no new safety concerns.
Hutchmed said it is the first global phase III trial to show a significant survival benefit in this setting.
AstraZeneca commercialises Orpathys, which the two companies develop jointly.
A new drug application has been submitted to the US Food and Drug Administration, with filings in Europe and Japan progressing.
The combination is already approved in China for patients with MET amplification who progressed on an EGFR inhibitor.
Professor Shun Lu, the trial's lead investigator, said the results could set a new global standard of care for these patients.
