AstraZeneca (LSE:AZN) said its combination of Tagrisso (osimertinib) and Orpathys (savolitinib) delivered a statistically significant and clinically meaningful improvement in progression-free survival versus Tagrisso alone in the Phase III SANOVO trial.
The China-based trial enrolled 326 treatment-naïve patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR mutations and MET overexpression, a biomarker combination known to blunt the durability of EGFR-targeted monotherapy.
The benefit held across both the high-MET subgroup and the wider intention-to-treat population, and the combination also showed encouraging early results on overall survival, a secondary endpoint still being followed.
"By combining Orpathys with Tagrisso, we have observed a clear clinical benefit that could reshape primary treatment strategy for this distinct patient population," said Professor Yi-Long Wu of Guangdong Provincial People's Hospital, the trial's leading investigator.
The result builds on the combination's existing Chinese approval in later-line MET-amplified disease, granted following the SACHI trial, and follows recent positive Phase III data from the global SAFFRON study in patients who progressed on Tagrisso.
Orpathys is developed jointly by AstraZeneca and HUTCHMED, with AstraZeneca handling commercialisation.
The safety profile in SANOVO matched the known profiles of both drugs, with no new safety signals reported.
Full data will be presented at an upcoming medical meeting and submitted to regulators, as AstraZeneca pursues approval of the all-oral combination in the first-line setting in China.
News Intelligence what this means for the company
AstraZeneca's Tagrisso-Orpathys combination met its primary endpoint in the Phase III SANOVO trial, showing statistically significant progression-free survival improvement over Tagrisso monotherapy in treatment-naïve patients with EGFR-mutated, MET-overexpressing lung cancer. This extends the combination into first-line treatment in China—a new indication beyond the existing approval in later-line MET-amplified disease—and follows positive Phase III data from SAFFRON in patients who progressed on Tagrisso, building a multi-indication franchise for the all-oral pairing.
- HUTCHMED, AstraZeneca's joint development partner on Orpathys, gains regulatory and commercial validation of the combination across a broader patient population, potentially strengthening its stake in the asset's value.
The result validates the Tagrisso-Orpathys strategy in an earlier treatment line where durability of EGFR monotherapy is known to be compromised by MET overexpression, opening a new revenue stream in a large first-line market. Regulatory submissions in China are expected, though the company has not disclosed timelines or probability of approval.
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