HUTCHMED Sees $1 Billion Opportunity as Lung Cancer Combo Advances Toward Approvals

HUTCHMED (NASDAQ:HCM) executives and a lung cancer researcher outlined results from two studies of savolitinib combined with osimertinib, as the company and its partner AstraZeneca pursue regulatory approvals for the treatment in non-small cell lung cancer.

The studies examined different stages of treatment in patients with EGFR mutations and abnormalities involving the MET protein or gene. HUTCHMED Chief Executive and Chief Scientific Officer Weiguo Su said the results support targeting both pathways and could expand savolitinib’s commercial opportunity.

First-line study results

Professor Yi-Long Wu of Guangdong Provincial People’s Hospital presented results from SANOVO, a Chinese study testing the combination as an initial treatment in patients with EGFR-mutated lung cancer and MET overexpression. Patients received either savolitinib plus osimertinib or a placebo plus osimertinib.

Wu said median progression-free survival reached 22.5 months in the overall study population receiving the combination. He also cited median overall survival figures of 40.5 months for the combination and 34.9 months for the comparison group. Progression-free survival measures how long patients live without their disease worsening.

Wu said 14.8% of patients discontinued treatment because of adverse effects. He said the combination’s safety profile was consistent with known effects of the medicines, with no unexpected toxicities.

Discussing patient selection, Wu said testing for MET overexpression using immunohistochemistry, or IHC, could become a routine part of first-line screening. He described the method as simpler and less restrictive in clinical practice than FISH testing, which detects gene amplification.

SAFFRON and regulatory plans

In the international SAFFRON study, patients whose disease had progressed after a third-generation EGFR inhibitor received either savolitinib plus osimertinib or platinum-based chemotherapy with pemetrexed. Wu said median progression-free survival was 7.6 months for the combination, compared with 5.4 months for chemotherapy. Median overall survival was 17.8 months versus 12.9 months, he said.

Wu said the study enrolled 324 patients and included participants from Asia, Europe and the United States. He said the findings were published in the New England Journal of Medicine.

Su said AstraZeneca, which is responsible for global SAFFRON filings, submitted a U.S. application in September and that the companies expect a result by year-end. Applications in Europe and Japan have been accepted, he said, with approvals anticipated in 2027.

For SANOVO, Su said a Chinese drug application would be completed soon. AstraZeneca is also discussing global filing opportunities with regulators, he said, although whether the Chinese study can support approvals elsewhere remains under discussion. Su suggested bridging studies might be an option.

Commercial outlook

Su said savolitinib combined with osimertinib could help AstraZeneca defend osimertinib’s market share in China as competing third-generation treatments enter the market. He said the combination has potential to reach a $1 billion market opportunity, without specifying a timeframe.

Wu and Su also discussed studying savolitinib in other patient populations and tumor types, including lung cancer without EGFR mutations. Su said further research would require discussions with AstraZeneca and an assessment of whether enough data exist to support it.

About HUTCHMED (NASDAQ:HCM)

HUTCHMED (NASDAQ:HCM) is a biopharmaceutical company focused on discovering, developing and commercializing medicines for cancer and other serious diseases. The company combines research and development capabilities in China with international development and commercial operations, serving patients and healthcare providers in China, the United States, Europe and other global markets.

HUTCHMED’s oncology portfolio includes fruquintinib, a targeted therapy for certain patients with metastatic colorectal cancer.