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Highlights
- HUTCHMED's combination of ORPATHYS® and TAGRISSO® receives Breakthrough Therapy Designation (BTD) from NMPA.
- Combination treatment aims to address unmet needs in EGFR mutation-positive NSCLC with MET amplification.
- Ongoing Phase III SACHI trial to evaluate efficacy and safety compared to standard chemotherapy.
HUTCHMED (China) Limited (Nasdaq/AIM: HCM; HKEX: 13) has announced that the Center for Drug Evaluation of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for 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 disease progression on EGFR inhibitor therapy.
ORPATHYS® is an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI), while TAGRISSO® is a third-generation, irreversible EGFR TKI. This treatment combination is being evaluated in the ongoing Phase III SACHI trial, a multi-center, open-label, randomized, controlled study being conducted in China. The trial is investigating the efficacy and safety of the combination therapy compared to platinum-based doublet-chemotherapy (pemetrexed plus cisplatin or carboplatin), the current standard-of-care treatment for patients with advanced NSCLC after failure of EGFR inhibitor therapy.
The primary endpoint of the trial is progression-free survival (PFS) as assessed by investigators, with secondary endpoints including PFS assessed by an independent review committee, overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety (NCT05015608).
The BTD status is granted by the NMPA to drugs that treat serious conditions or life-threatening diseases where there are no effective treatments available, and where clinical evidence indicates significant advantages over existing therapies. Drugs that receive BTD may be eligible for priority review and conditional approval when submitting a New Drug Application (NDA), allowing the therapy to reach patients more quickly.
This designation highlights the potential of the ORPATHYS® and TAGRISSO® combination to address the unmet medical needs of patients with EGFR mutation-positive NSCLC with MET amplification, providing a promising new treatment option for those who have progressed on prior EGFR inhibitor therapy.
