Hutchmed (China) Limited announced positive high-level results from its Phase III SANOVO trial in China. The study showed significant progression-free survival benefits for a new lung cancer combination therapy.

The trial evaluated ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) in treatment-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). These patients harbored epidermal growth factor receptor (EGFR) mutations and MET overexpression.

Trial Results and Clinical Impact

The combination therapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to TAGRISSO alone. This benefit was observed in both the high MET patient population and the intention-to-treat (ITT) population.

Overall survival (OS), a secondary endpoint, also showed very encouraging clinical benefit in both groups. The trial will continue follow-up on these results, with data scheduled for presentation at a forthcoming medical meeting.

Strategic Context for Hutchmed

The SANOVO results build upon Hutchmed’s existing pipeline validation. ORPATHYS plus TAGRISSO is already approved in China for patients with EGFR-mutated NSCLC and MET amplification after disease progression on EGFR-TKI therapy, based on the SACHI Phase III trial.

Additionally, the global SAFFRON Phase III trial reported positive high-level results in August 2026, demonstrating significant improvements in both PFS and OS for similar patients who progressed on TAGRISSO.

Industry Perspective

Professor Yi-Long Wu of the Guangdong Provincial People’s Hospital, the leading Principal Investigator of the SANOVO trial, noted that co-occurring MET overexpression often compromises the durability of EGFR-TKI monotherapy. He stated that addressing both pathways upfront offers a powerful new approach for this distinct patient population.

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of Hutchmed, said the data validate the company’s strategy of addressing MET-driven disease across multiple stages of lung cancer. He highlighted the therapeutic strength and versatility of the all-oral combination in first-line patients.

Safety Profile

The safety profile for ORPATHYS plus TAGRISSO was consistent with the known profiles of each individual medicine. The company reported no new safety findings from the trial.

About the Study

SANOVO is a blinded, randomized, controlled Phase III study conducted in China. A total of 326 treatment-naïve patients were randomized in a 1:1 ratio to receive TAGRISSO 80 mg once daily plus either ORPATHYS or placebo at 300/200 mg twice daily, dosed based on body weight.

The primary endpoint was PFS as assessed by investigators. Other endpoints included PFS by independent review committee, OS, objective response rate, duration of response, disease control rate, time to response, and safety.

HUTCHMED (China) Limited secured conditional approval from the China National Medical Products Administration (NMPA) for its novel oral inhibitor fanregratinib, branded as ATLED. The drug is approved for treating adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) harboring FGFR2 fusions or rearrangements who have received prior systemic therapy.

The regulatory milestone follows data from the pivotal Phase II/IIIb clinical trial (NCT04353375). Results presented at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2026 demonstrated strong clinical activity in this aggressive malignancy subtype.

Clinical Performance Data

The study met its primary endpoint with an Independent Review Committee-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%). Secondary endpoints highlighted rapid onset and durable control:

Median time to response was 1.4 months, while median duration of response stood at 6.9 months (95% CI: 5.6–8.5). These figures underscore the drug’s efficacy in pretreated advanced ICC patients.

What the Numbers Show

The divergence between the high disease control rate (83.9%) and the moderate objective response rate (42.5%) suggests significant tumor stabilization even among non-responders. This pattern is critical in ICC, where the five-year overall survival rate is approximately 9%, indicating that ATLED offers a meaningful extension of life beyond historical standards.

Commercial Outlook

Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, stated the company is prepared to leverage its established commercial infrastructure to bring ATLED to patients rapidly. The approval addresses a critical therapeutic gap, as ICC accounts for 8.2-15.0% of primary liver cancers globally.

Enrollment for the confirmatory Phase IIIb cohort began in January 2026 to further validate clinical benefits and safety. HUTCHMED retains all worldwide rights to fanregratinib, positioning the asset for potential global expansion beyond China.