The NMPA approval was based on positive results from a single-arm Phase 2 trial conducted in NSCLC patients in China
AstraZeneca Cambridge R&D Centre aerial view. (Credit: AstraZeneca.)
AstraZeneca and HUTCHMED have received China’s National Medical Products Administration (NMPA) approval for Orpathys (savolitinib) to treat a type of non-small cell lung cancer (NSCLC).
The drug was indicated for NSCLC patients with MET exon 14 skipping alterations, whose disease progressed despite prior systemic therapy, or those not eligible for chemotherapy.
Orpathys has showed clinical activity in advanced solid tumours and is currently being developed for multiple tumour types, as a monotherapy and in combination with other drugs.
The approval follows a priority review designation by the NMPA’s Centre for Drug Evaluation and marks the first approval for an oral MET tyrosine kinase inhibitor (TKI).
AstraZeneca and HUTCHMED reached a global licensing agreement in 2011 to jointly develop and commercialise Orpathys.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “This approval makes Orpathys the only targeted medicine approved for these biomarker-selected patients in China, and it adds another novel medicine to our already diverse lung cancer portfolio.
“We are proud that this first-ever regulatory approval of Orpathys is in China, where we have a long-standing commitment to improving patient outcomes and working with the right partners to achieve that goal.
“Alongside HUTCHMED, we look forward to the continued development of this medicine across a range of cancers where MET alterations and amplification are drivers of tumour growth and treatment resistance.”
The NMPA approval was based on positive results from a single-arm Phase 2 trial conducted in NSCLC patients in China, including patients with the PSC subtype.
In the trial, Orpathys enhanced anti-tumour activity based on an independent review of objective response rate (ORR), the primary endpoint and the disease control rate (DCR).
The drug demonstrated an ORR of 42.9% and median progression-free survival (PFS) of 6.8 months in the overall trial population, which was clinically meaningful across subgroups.
Orpathys showed a consistent safety and tolerability profile with previous trials, with no new safety signals identified.
HUTCHMED is evaluating Orpathys in combination with Tagrisso and other medicines to treat NSCLC in the Phase 2 ORCHARD and SAVANNAH trials, as part of the joint global development programme.
HUTCHMED chief executive officer Christian Hogg said: “It is with great pleasure that today we announce the first regulatory approval of Orpathys globally, HUTCHMED’s third self-discovered oncology drug to be commercialized.
“Our collaboration with AstraZeneca in 2011 has been an important driver in the development of this novel targeted oncology drug, involving both a China-based biotech and a global pharmaceutical company.
“This approval is a testament to the perseverance and scientific ingenuity of this long-standing alliance, and we are hopeful that this is only the beginning of the progress we can achieve for patients with MET-altered tumours.”