Tagrisso combined with Hutchmed drug clears lung cancer test

Tagrisso and Hutchmed have revealed positive Phase II data on their combination drug, which prompts the two partners to progress into a Phase III programme.

The SAVANNAH trial tested Tagrisso and savolitinib in patients with EGFR-mutated non-small cell lung cancer (NSCLC), which had progressed on earlier Tagrisso therapy, including a subgroup with high levels of MET over-expression or amplification.

Preliminary results reveal a 32% overall response rate (ORR) with the combination across the entire study, rising to 49% in the high MET group, and falling to 9% in subjects without MET mutations.

These data show evidence for the use of MET-targeting drugs to offset Tagrisso resistance, and accelerates the process towards regulatory approvals of the combination as an alternative to chemotherapy for patients.

Savolitinib has been approved in China as Orpathys for the treatment of NSCLC patients whose tumours have mutations meaning they are unable to receive chemotherapy. Savolitinib has not yet been approved in the US, and has been beaten to market by numerous other MET inhibitors. Tagrisso, on the other hand, has been FDA approved as a second-line treatment for EGFR mutation-positive NSCLC since 2015.

“The results from SAVANNAH suggest savolitinib added to Tagrisso at the time of disease progression could possibly provide these biomarker-selected patients with a potentially less toxic, more effective treatment option,” said AZ’s chief oncology development officer Cristian Massacesi.

The combination of Tagrisso and savolitinib has kickstarted a Phase III trial called SAFFRON, which will compare the duo with chemotherapy in EGFR-positive NSCLC with MET mutations. Results are due in 2025.

Lina Adams