China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the publication of an abstract detailing the SAVANNAH Phase II trial results at the World Conference of Lung Cancer (WCLC). The study evaluates the combination of HutchMed’s Orpathys (savolitinib) and AstraZeneca’s Tagrisso (osimertinib) in EGFR-mutated, MET-driven non-small cell lung cancer (NSCLC) patients with disease progression after prior Tagrisso treatment.
Trial Design
The trial enrolled 294 patients, testing Orpathys doses (300 mg once daily, 300 mg twice daily, 600 mg once daily) combined with Tagrisso. Results from 193 evaluable patients receiving 300 mg Orpathys + 80 mg Tagrisso daily (data cutoff: Aug 27, 2021) showed:
- ORR: 32% overall; 49% in high MET patients (n=108).
- Median DoR: 8.3 months overall; 9.3 months in high MET patients.
- Median PFS: 5.3 months overall; 7.1 months in high MET patients.
The safety profile aligned with prior studies, with no new safety signals.
Commercial Context
Orpathys, HutchMed’s third commercial product and China’s first MET inhibitor, was approved in June 2023 for NSCLC with MET exon 14 skipping. The July 12 launch triggered a $25 million milestone payment from AstraZeneca under their 2011 licensing deal, with 30% royalties payable to HutchMed. Tagrisso, an EGFR-TKI effective against CNS metastases, was approved in China in March 2017 and included in the NRDL in 2018.-Fineline Info & Tech
