HUTCHMED's ORPATHYS® and TAGRISSO® Combo: A Game Changer in Lung Cancer Treatment

HUTCHMED (China) Limited has made a significant stride in the fight against lung cancer with the acceptance of its New Drug Application (NDA) for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) in China. The NDA was granted priority review status by the China National Medical Products Administration (NMPA), indicating a potential accelerated market entry for this promising treatment option.

The ORPATHYS® and TAGRISSO® combination targets 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 first-line EGFR inhibitor therapy. This patient population is estimated to be approximately 15-50% of patients who experience disease progression post-osimertinib treatment, representing a substantial addressable market size.

The NDA is supported by data from the SACHI trial, a multi-center, open-label, randomized, controlled, Phase III study that evaluated the efficacy and safety of the combination therapy compared to platinum-based doublet-chemotherapy. The primary endpoint of the study was progression-free survival (PFS) as assessed by investigators. The Independent Data Monitoring Committee (IDMC) of SACHI considered that the study had met the pre-defined primary endpoint of PFS in a planned interim analysis, leading to the conclusion of enrollment into the study.



The breakthrough therapy designation granted by the NMPA in December 2024 further validates the potential of this combination as a new treatment that could target a serious condition where clinical evidence demonstrates substantial advantages over existing therapies. The priority review status typically correlates with accelerated market entry, which could translate to earlier revenue generation for HUTCHMED.

The estimated prevalence of MET amplification in EGFR-mutated NSCLC patients in China is approximately 30-40%, which is higher than the global average of 10-15%. Given the high incidence of EGFR mutations in Asian populations, this positions HUTCHMED to potentially capture a substantial market share in its primary market.

The combination therapy's efficacy and safety profile, as demonstrated by the SACHI trial, is expected to have a significant impact on market adoption and market share. The chemotherapy-free, biomarker-specific, and orally administered nature of the combination therapy addresses a critical unmet need in NSCLC treatment, representing a significant commercial opportunity. The collaboration with AstraZeneca, a global pharmaceutical leader, provides strategic advantages in market penetration and distribution.



In conclusion, HUTCHMED's ORPATHYS® and TAGRISSO® combination offers a promising treatment option for lung cancer patients with MET amplification after progression on first-line EGFR inhibitor therapy. With the NDA acceptance and priority review status in China, this combination therapy has the potential to revolutionize the treatment landscape for this challenging disease. As the global development program suggests potential expansion beyond China, HUTCHMED is well-positioned to capture a substantial market share and generate significant revenue in the lung cancer treatment market.