Savolitinib's Promising Gastric Cancer Data Positions HUTCHMED for Regulatory Milestone in China

HUTCHMED has taken a significant step forward in its pursuit of expanding Savolitinib’s indications, with interim results from its Phase II trial in advanced gastric cancer showing robust efficacy and a manageable safety profile. The data, particularly the 45% objective response rate (ORR) in patients with MET amplification, underscores the drug’s potential as a precision therapy for a subset of patients with limited treatment options. This milestone positions HUTCHMED to submit a marketing application for the drug in China by late 2025, with the Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) accelerating its path to market.

Trial Results Highlight Biomarker-Driven Efficacy

The Phase II trial enrolled 64 patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who had progressed after at least two prior therapies. Interim analysis revealed an IRC-confirmed ORR of 45%, with a median duration of response (DOR) of 4 months and an 85.7% DOR rate at four months. Notably, patients with high MET gene copy numbers—a key biomarker—achieved a 50% ORR, suggesting MET amplification could serve as a critical predictive biomarker. Safety data showed manageable adverse events, including thrombocytopenia and hepatic dysfunction, with only one treatment discontinuation due to a grade 4 liver toxicity event. These results align with Savolitinib’s existing profile in lung cancer, where it demonstrated activity in patients with MET exon 14 skipping mutations.

Regulatory Pathway Accelerated by Breakthrough Status

The NMPA’s Breakthrough Therapy designation, granted in August 2023, enables HUTCHMED to pursue an expedited regulatory review. This designation allows for rolling submissions of data, priority review, and conditional approval options, which could shorten the timeline for market access. The trial’s design, which uses ORR as the primary endpoint, is aligned with accelerated approval strategies, a pathway increasingly adopted for oncology drugs targeting molecular subsets. Assuming final data maintains the interim results’ consistency, HUTCHMED aims to file its application by late 2025, potentially bringing Savolitinib to patients as early as 2026.

Market Opportunity in a High-Unmet-Need Setting

Gastric cancer, the third leading cause of cancer-related deaths globally, remains poorly treated in its advanced stages, especially for patients with specific genetic alterations like MET amplification. In China, an estimated 4–6% of gastric cancer patients (approximately 18,000 new cases annually) harbor MET amplification, a subset with limited therapeutic options after progressing through standard therapies. Savolitinib’s efficacy in this group—achieved with a median of two prior treatments—could carve out a niche in a crowded but underserved space. Its existing approval in China for lung cancer, coupled with inclusion in the National Reimbursement Drug List, also suggests strong potential for reimbursement and market adoption in gastric cancer.

Risks and Considerations

While the data is promising, risks remain. Final Phase II results must confirm the interim ORR and durability of response, and the NMPA may require additional data for full approval. Additionally, the small patient population—though commercially viable—could limit peak sales unless the drug gains broader label extensions. Competition is also a factor: while no MET inhibitors are yet approved in gastric cancer, rivals like Incyte’s capmatinib and Merck KGaA’s tepotinib are in trials for similar indications. However, Savolitinib’s head start in China’s regulatory process and its existing commercial footprint could provide a critical advantage.

Conclusion: A Strategic Investment in Precision Oncology

HUTCHMED’s Savolitinib represents a compelling opportunity in the growing field of precision oncology. With a 45% ORR in a hard-to-treat population, Breakthrough Therapy status, and a clear regulatory pathway, the drug is well-positioned to address a critical unmet need in China’s gastric cancer market. The 18,000 annual cases of MET-amplified gastric cancer alone suggest a $100–200 million annual revenue potential, assuming a price point and reimbursement rate comparable to its lung cancer indication.

Investors should also note HUTCHMED’s broader pipeline, including other oncology assets and collaborations, which mitigate reliance on a single drug. While risks such as final data confirmation and regulatory hurdles remain, the interim results and Breakthrough designation strongly suggest Savolitinib’s path to market is on track. For those seeking exposure to China’s oncology innovation boom, HUTCHMED’s progress in gastric cancer with Savolitinib makes it a compelling play.