TORONTO, June 24 – The National Medical Products Administration (NMPA) of China officially granted conditional approval of savolitinib by HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) and AstraZeneca PLC (“AstraZeneca”) (LSE/STO/Nasdaq: AZN) for the treatment of non-small cell lung cancer (NSCLC) patients with mesenchymal-epithelial transforming factor (MET) exon 14 skipping alterations.
More than a third of the world’s lung cancer patients are in China and, among those with NSCLC, around 2-3% have tumors with MET exon 14 skipping alterations, a targetable mutation in the MET gene. Patients with pulmonary sarcomatoid carcinoma (PSC) a rare and aggressive subtype of NSCLC usually resistant to chemotherapy, carry this mutation at a high chance of (20%-30%). This approval marks the first global regulatory approval granted for this oral, potent, and selective MET tyrosine kinase inhibitor (TKI).
The approval was based on positive results from a Phase II trial conducted in China across 32 hospitals. This multi-center, single-arm, Phase II trial screened 593 patients and identified 87 patients with MET exon 14 skipping, 70 of which were treated. At a median follow-up time of 17.6 months, savolitinib demonstrated an objective response rate (ORR) of 42.9%, a disease control rate (DCR) of 82.9%, a median time to response of 1.4 months with a median duration of response as 8.3 months, and a median progression-free survival (mPFS) of 6.8 months1.
Nanjing Geneseeq Technology Inc. (Geneseeq) was the only designated next-generation sequencing (NGS) testing center in the approval process. Geneseeq, HUTCHMED and AstraZeneca are currently collaborating on the potential development of savolitinib companion diagnostics (CDx) kit in China for detecting MET mutations in lung cancer patients in order to provide patients with more treatment options, and better outcomes.