SANOVO trial supports Tagrisso and Orpathys combination in untreated EGFR mutated lung cancer

AstraZeneca and HUTCHMED have reported positive Phase III results showing that Tagrisso (osimertinib) combined with Orpathys (savolitinib) significantly extended progression free survival compared with Tagrisso alone in previously untreated patients with locally advanced or metastatic epidermal growth factor receptor mutated non small cell lung cancer and MET overexpression.

The findings come from the SANOVO Phase III study in China. A statistically significant and highly clinically meaningful progression free survival benefit was observed both among patients with high MET expression, defined as IHC 3+, and across the intention to treat population, which included patients with IHC 2+ and IHC 3+ disease.

Encouraging overall survival results were also seen with the combination in both populations. Overall survival is a secondary endpoint of SANOVO, and follow up will continue as the data mature.

Professor Yi Long Wu of Guangdong Provincial People’s Hospital, the study’s leading principal investigator, said the presence of MET overexpression alongside EGFR mutations can reduce the durability of treatment with an EGFR tyrosine kinase inhibitor alone in previously untreated patients. He said the SANOVO findings indicate that targeting EGFR and MET from the outset with a fully oral, biomarker guided regimen could provide a new treatment approach for this specific group of patients. According to Wu, the clinical benefit observed with Orpathys and Tagrisso could influence future first line treatment strategies for tumours with MET overexpression.

Leora Horn, Senior Vice President of Late Development, Oncology R&D at AstraZeneca, said the SANOVO results add to evidence supporting the addition of Orpathys to Tagrisso as a way of addressing resistance associated with MET, delaying disease progression and improving patient outcomes. She added that AstraZeneca is continuing to develop biomarker guided combinations designed to improve on existing standards of care for EGFR mutated lung cancer.

Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said SANOVO supports the company’s strategy of targeting MET related disease at different stages of lung cancer treatment. He noted that the findings extend evidence from the global Phase III SAFFRON trial and the Phase III SACHI study in China, both of which evaluated previously treated patients, by demonstrating the potential of the Orpathys and Tagrisso combination in the first line setting. HUTCHMED plans to work with AstraZeneca to share the results with regulatory authorities in China.

No new safety signals were identified in SANOVO. The safety profile of the combination remained consistent with the established profiles of Tagrisso and Orpathys individually. Full results are expected to be presented at an upcoming medical meeting and will also be submitted to regulatory authorities.

In China, Tagrisso plus Orpathys is already approved for patients with locally advanced or metastatic EGFR mutated non small cell lung cancer and MET amplification whose disease has progressed following treatment with an EGFR tyrosine kinase inhibitor. That approval was supported by results from the Phase III SACHI trial.

The combination has also produced positive results in the global Phase III SAFFRON study, which evaluated patients with EGFR mutated non small cell lung cancer and MET overexpression or amplification following progression on Tagrisso. In that trial, the regimen achieved statistically significant and clinically meaningful improvements in both progression free survival and overall survival.

Orpathys is jointly developed by AstraZeneca and HUTCHMED, with AstraZeneca responsible for its commercialisation.

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AstraZeneca, Biopharma, Cancer, cancer research, clinical trials, egfr, hutchmed, lung cancer, NSCLC, Oncology, Orpathys, pharma news, Tagrisso