LONDON (ShareCast) - (Sharecast News) - Hutchmed China announced on Thursday that the Center for Drug Evaluation of China's National Medical Products Administration (NMPA) has granted breakthrough therapy designation (BTD) to the combination of 'Orpathys', or savolitinib, and 'Tagrisso', or osimertinib.
The AIM-traded firm said the designation would apply to the treatment of patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET amplification after progression on EGFR inhibitor therapy.

It said the Orpathys and Tagrisso combination was being investigated in the phase three 'SACHI' trial in China.

It explained that the multi-centre, open-label study was comparing the efficacy and safety of the combination against platinum-based doublet chemotherapy, the current standard of care.

The trial's primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival, objective response rate, and safety.

BTD status is granted to therapies addressing life-threatening diseases or serious conditions with significant advantages over existing treatments.

The designation would allow for expedited development and review, potentially accelerating the time to bring the chemotherapy-free, biomarker-specific treatment to patients.

Hutchmed noted that NSCLC is the most common form of lung cancer, accounting for between 80% and 85% of cases.

Among patients with advanced EGFR-mutated NSCLC, MET amplification was a major mechanism of resistance to EGFR inhibitors, including third-generation therapies such as Tagrisso.

Approximately 15% to 50% of patients progressing on osimertinib presented with MET aberrations, underscoring the significance of targeting the pathway.

Orpathys, a selective MET tyrosine kinase inhibitor, was already approved in China for NSCLC patients with MET exon 14 skipping alterations.

It had been included in China's National Reimbursement Drug List since March 2023.

Tagrisso, an EGFR inhibitor developed by AstraZeneca, had meanwhile become a global standard of care for EGFRm NSCLC, supported by extensive clinical evidence.

Hutchmed said the combination of Orpathys and Tagrisso had shown promise in earlier studies, including the 'TATTON' and 'SAVANNAH' trials.

Encouraging data from the studies led to the initiation of three phase three trials - 'SACHI' in China, 'SANOVO' for treatment-naïve patients in China, and the global 'SAFFRON' trial.

The company said the trials aimed to establish the combination as a superior option for patients with MET-amplified EGFRm NSCLC.

Hutchmed and AstraZeneca are jointly developing and commercializing Orpathys.

While Hutchmed oversees development and supply in China, AstraZeneca was managing commercialisation efforts globally.

At 1139 GMT, shares in Hutchmed China were up 1.15% at 263p.

Reporting by Josh White for Sharecast.com.

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