LONDON (ShareCast) - (Sharecast News) - Hutchmed announced on Monday that China's National Medical Products Administration (NMPA) has approved the new drug application for the combination of 'Orpathys'. Or savolitinib, and 'Tagrisso', or osimertinib, to treat patients with locally advanced or metastatic EGFR mutation-positive non-squamous non-small cell lung cancer (NSCLC) with MET amplification following progression on EGFR TKI therapy.
The AIM-traded firm said the approval triggered an $11m milestone payment from AstraZeneca, which markets both drugs in China.

It said the approval was based on the SACHI phase three trial, which met its primary endpoint of progression-free survival in an interim analysis.

Results presented at the ASCO annual meeting in June showed the combination reduced the risk of disease progression by 66%, with a median progression-free survival (PFS) of 8.2 months versus 4.5 months for chemotherapy.

The independent review committee reported a 60% risk reduction with a median PFS of 7.2 months compared to 4.2 months.

It said the safety profile was favourable, with no new safety signals observed.

"The approval of the Orpathys and Tagrisso combination is a significant milestone in addressing the complex challenges of lung cancer treatment in China, where the EGFR mutation is common amongst NSCLC patients," said professor Shun Lu, principal investigator of the trial.

"For patients who develop MET amplification after progressing on EGFR inhibitors, the combination offers a continued all-oral, chemotherapy-free approach to tackle a critical resistance mechanism."

The approval further strengthened Hutchmed's position in targeted oncology, the company said, while the ongoing global SAFFRON phase three trial was continuing to evaluate the combination for potential registration outside China.

"The NMPA approval marks an important step forward in our mission to address MET-driven progression following first-line EGFR-inhibitor therapy in NSCLC patients," commented Dr Weiguo Su, CEO and chief scientific officer of Hutchmed.

"Our collaboration with AstraZeneca, built on a shared vision to transform oncology care, has been crucial in reaching this achievement."

At 1039 BST, shares in Hutchmed China were up 0.72% at 220.58p.

Reporting by Josh White for Sharecast.com.

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