HUTCHMED Highlights FRUSICA-2 Registration Trial Data to be Presented at the 2025 ESMO Congress

Rhea-AI Summary

HUTCHMED (Nasdaq/AIM: HCM) reported Phase III FRUSICA-2 results for the fruquintinib plus sintilimab combination in second-line advanced renal cell carcinoma, to be presented at ESMO on Oct 17, 2025.

Key outcomes at PFS cutoff Feb 17, 2025: median PFS 22.2 months vs 6.9 months (HR 0.373, p<0.0001); ORR 60.5% vs 24.3% (OR 4.622, p<0.0001); median DoR 23.7 vs 11.3 months. Overall survival data remain immature (~20% mature). The safety profile was tolerable with grade ≥3 TEAEs 71.4% vs 58.8%. An NDA has been accepted by China NMPA for review.

Positive

• PFS 22.2 months vs 6.9 months (HR 0.373, p<0.0001)
• ORR 60.5% vs 24.3% (Odds Ratio 4.622, p<0.0001)
• DoR 23.7 months vs 11.3 months
• NDA for the combination accepted by China NMPA for review

Negative

• Grade ≥3 treatment-emergent adverse events in 71.4% vs 58.8%
• Overall survival data immature at approximately 20% maturity

Insights

Clinical Oncology Strategist

Phase III FRUSICA-2 shows large PFS and ORR advantages for fruquintinib+sintilimab; NDA accepted by NMPA, with safety trade-offs.

The combination of fruquintinib and sintilimab produced a median PFS of 22.2 months versus 6.9 months for axitinib/everolimus, with a stratified HR of 0.373 and a blinded independent central review result showing a highly significant p-value (p<0.0001). The ORR reached 60.5% versus 24.3%, and median DoR was 23.7 versus 11.3 months, indicating both deeper and more durable responses in the experimental arm.

The evidence directly supports regulatory progression: a New Drug Application for this combination was accepted for review by the China NMPA. The safety profile shows higher serious toxicity: grade ≥3 TEAEs occurred in 71.4% of combination patients versus 58.8% in the control arm. This raises a clear benefit–risk trade-off that regulators and clinicians will weigh, particularly given ongoing overall survival data with approximately 20% maturity at cutoff Feb 17, 2025.

Key dependencies and near-term milestones to watch include the formal presentation at the ESMO Congress on Oct 17, 2025, the evolving overall survival readout as follow-up continues, and the outcome and review timeline from the NMPA. Expect regulators to scrutinize safety management, patient selection, and durability of survival benefit; these elements will determine the practical clinical adoption window over the next 6–18 months.

The fruquintinib and sintilimab combination demonstrated significant PFS improvements in advanced renal cell carcinoma patients after progression on first-line therapies

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 13, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) announces results from the FRUSICA-2 registration clinical trial of the fruquintinib and sintilimab combination for the treatment of patients with locally advanced or metastatic renal cell carcinoma. Results of the Phase III part of the study will be presented on Friday, October 17, 2025 during the European Society for Medical Oncology (“ESMO”) Congress in Berlin, Germany.

FRUSICA-2 is a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced renal cell carcinoma (NCT05522231). A total of 234 patients were randomized into a group that received fruquintinib plus sintilimab combination therapy, or into a group that received axitinib or everolimus monotherapy. As of the progression free survival (“PFS”) final analysis cutoff of February 17, 2025, the median follow-up was 16.6 months.

The median PFS as assessed by blinded independent central review (BICR) was 22.2 months with fruquintinib plus sintilimab, compared to 6.9 months with axitinib/everolimus (stratified hazard ratio [HR] 0.373; stratified log-rank p<0.0001). The objective response rate (ORR) was 60.5% vs 24.3% (Odds Ratio 4.622, p<0.0001), and the median duration of response (DoR) was 23.7 vs 11.3 months, respectively. Overall survival data were still evolving at the time of data cutoff with maturity of approximately 20%. Efficacy benefits were observed in all prognostic risk groups, as defined by the International mRCC Database Consortium (IMDC) criteria.

The safety profile of the fruquintinib and sintilimab combination was tolerable and consistent with the known profiles of each individual treatment. Treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 71.4% of patients in the fruquintinib plus sintilimab group compared to 58.8% for patients in the axitinib/everolimus group.

“The FRUSICA-2 trial results provide compelling evidence that fruquintinib and sintilimab may offer a valuable new treatment option for patients with advanced renal cell carcinoma,” said Professor Dingwei Ye of Fudan University Shanghai Cancer Center and the co-leading Principal Investigator of the FRUSICA-2 study. “These findings show the combination’s potential to address a critical unmet need for this patient population, delivering consistent benefits across varied patient profiles and prognostic risk groups.”

“The FRUSICA-2 study suggests that fruquintinib and sintilimab could play a meaningful role in shaping second-line treatment strategies for advanced renal cell carcinoma,” said Professor Zhisong He of Peking University First Hospital and the co-leading Principal Investigator of the FRUSICA-2 study. “These results point to the combination’s potential to enhance clinical outcomes, providing a new option for managing this challenging disease.”

Supported by data from FRUSICA-2, a New Drug Application (NDA) for the combination of fruquintinib and sintilimab in patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment has been accepted for review by the China National Medical Products Administration (NMPA).

About Kidney Cancer and Renal Cell Carcinoma
It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.¹ In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.² Approximately 90% of kidney tumors are renal cell carcinoma.

The safety and efficacy of fruquintinib for the investigational uses discussed above have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated.

About Fruquintinib
Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to limit off-target kinase activity and improve drug exposure to achieve sustained target inhibition.³

Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE^®.  It is approved for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable to receive anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type) in China. The combination of fruquintinib and sintilimab has received conditional approval in China for the treatment of patients with advanced pMMR endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation.

Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA^®.

About HUTCHMED
HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, the further clinical development for fruquintinib, its expectations as to whether any studies on fruquintinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as sintilimab as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

CONTACTS

Investor Enquiries	+852 2121 8200 / ir@hutch-med.com
Media Enquiries
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Brunswick – Zhou Yi	+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Panmure Liberum	Nominated Advisor and Joint Broker
Atholl Tweedie / Emma Earl / Rupert Dearden	+44 20 7886 2500
Cavendish	Joint Broker
Geoff Nash / Nigel Birks	+44 20 7220 0500
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Freddie Barnfield / Jeffrey Wong / Duncan Monteith	+44 20 7260 1000

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¹   The Global Cancer Observatory, kidney cancer fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf. Accessed February 19, 2025.
²   The Global Cancer Observatory, China fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed February 19, 2025.
³   Sun Q, et al. Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy. Cancer Biol Ther. 2014;15(12):1635-45. doi: 10.4161/15384047.2014.964087.

FAQ

What did HUTCHMED announce about FRUSICA-2 results on Oct 13, 2025 for HCM?

HUTCHMED announced Phase III FRUSICA-2 results showing PFS 22.2 vs 6.9 months, higher ORR and DoR for fruquintinib plus sintilimab; results to be presented at ESMO Oct 17, 2025.

How much did fruquintinib plus sintilimab improve PFS in FRUSICA-2 (HCM)?

Median PFS was 22.2 months with the combination versus 6.9 months with axitinib/everolimus (HR 0.373, p<0.0001).

What were the response rates in FRUSICA-2 for HCM's combination therapy?

Objective response rate was 60.5% for fruquintinib plus sintilimab versus 24.3% for axitinib/everolimus (Odds Ratio 4.622, p<0.0001).

Has HUTCHMED filed regulatory applications after FRUSICA-2 (HCM)?

Yes. A New Drug Application for the fruquintinib and sintilimab combination has been accepted for review by China NMPA.

Are there safety concerns from FRUSICA-2 that investors should note for HCM?

Grade ≥3 treatment-emergent adverse events occurred in 71.4% of patients on the combination versus 58.8% on comparator therapies.

Is overall survival (OS) definitive in the FRUSICA-2 data for HCM?

No. Overall survival data were still evolving with approximately 20% maturity at the data cutoff.