Tagrisso combined with Orpathys shows statistically significant and highly clinically meaningful gains in progression free survival for first line MET overexpressing EGFR mutated lung cancer

Results from the Phase III SANOVO trial in China build on the established success of the global SAFFRON trial and the China based SACHI trial, extending the clinical value of this all oral combination into the first line treatment setting

Findings further establish Tagrisso as the backbone therapy across EGFR mutated lung cancer

Top line results from the Phase III SANOVO trial showed that Tagrisso (osimertinib) combined with Orpathys (savolitinib) produced a statistically significant and highly clinically meaningful improvement in progression free survival compared with Tagrisso alone in treatment naïve patients with epidermal growth factor receptor mutated, locally advanced or metastatic non small cell lung cancer who also had MET overexpression. This progression free survival benefit held true in both the high MET group (IHC 3+) and the broader intention to treat population (IHC 2+ and IHC 3+ combined).

Across both patient groups, the combination also showed encouraging early signals of benefit in overall survival, a secondary endpoint of the trial. Follow up on these results is continuing.

Professor Yi-Long Wu of Guangdong Provincial People’s Hospital, the trial’s leading principal investigator, said that when MET overexpression occurs alongside EGFR mutations in treatment naïve non small cell lung cancer, it often undermines the long term durability of EGFR inhibitor monotherapy. He said the positive SANOVO findings demonstrate that tackling both pathways from the outset with an all oral, biomarker guided regimen offers a powerful new approach for patients whose tumors show MET overexpression. He said combining Orpathys with Tagrisso produced a clear clinical benefit that could reshape the primary treatment strategy for this distinct group of patients.

Leora Horn, senior vice president of late development in oncology research and development at AstraZeneca, said the positive SANOVO data build on a growing body of evidence showing the value of adding Orpathys to backbone Tagrisso treatment in order to intercept MET driven resistance, delay disease progression, and improve outcomes for these patients. She said that by developing novel, biomarker guided combinations that build on established standards of care, AstraZeneca continues to raise expectations for patients with EGFR mutated lung cancer.

Weiguo Su, chief executive officer and chief scientific officer of HUTCHMED, said the company is pleased with the positive SANOVO results, which validate its strategy of addressing MET driven disease across multiple stages of lung cancer treatment. He said that building on the strong foundation established by the global Phase III SAFFRON study and the China based SACHI study in previously treated patients, the SANOVO findings further confirm the therapeutic strength and flexibility of the Orpathys and Tagrisso combination, now extended to first line patients. He thanked all patients and investigators who took part in the trial and said HUTCHMED looks forward to sharing the results with regulatory authorities in order to bring this innovative, all oral combination to first line use in China.

The safety profile observed for the Tagrisso and Orpathys combination was consistent with what is already known about each medicine individually, and no new safety concerns arose. These results are expected to be presented at an upcoming medical conference and shared with regulatory authorities.

The combination of Tagrisso and Orpathys is currently approved in China for patients with locally advanced or metastatic EGFR mutated non small cell lung cancer with MET amplification who have progressed on prior EGFR inhibitor therapy, based on the Phase III SACHI trial. The combination also recently reported positive top line results from the global Phase III SAFFRON trial in EGFR mutated non small cell lung cancer with MET overexpression or amplification following progression on Tagrisso, showing a statistically significant and clinically meaningful improvement in both progression free survival and overall survival.

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Related Topics and Keywords

egfr mutated lung cancer, lung cancer, MET overexpressing EGFR, mutated lung cancer, Orpathys, Tagrisso