What study supported the approval of Elunate plus Tyvyt?

The approval was supported by FRUSICA-2, a randomized, open-label, active-controlled registration study evaluating fruquintinib plus sintilimab versus axitinib or everolimus monotherapy in second-line renal cell carcinoma.

What were the main FRUSICA-2 results?

At the final analysis, the combination achieved a median progression-free survival of 22.2 months versus 6.9 months with axitinib or everolimus. The objective response rate was 60.5% versus 24.3%, and the median duration of response was 23.7 months versus 11.3 months.

How many patients were enrolled in FRUSICA-2?

A total of 234 patients were randomized in the FRUSICA-2 study.

China Approves Elunate Plus Tyvyt for Second-Line Renal Cell Carcinoma | iPharmaCenter

Q: What did China’s NMPA approve for advanced renal cell carcinoma?

China’s National Medical Products Administration approved the combination of Elunate (fruquintinib) and Tyvyt (sintilimab injection) for patients with locally advanced or metastatic renal cell carcinoma who previously failed VEGFR-TKI therapy and had not received PD-1 or PD-L1 inhibitors in the first-line setting.

Badari Andukuri
2 days ago
3 min read

Hutchmed and Innovent have announced that China’s National Medical Products Administration (NMPA) has approved a new treatment combination of Elunate (fruquintinib) and Tyvyt (sintilimab injection) for patients with locally advanced or metastatic renal cell carcinoma (RCC).

This approval specifically applies to individuals whose disease has progressed following prior therapy with VEGFR tyrosine kinase inhibitors (VEGFR-TKIs) and who have not previously received PD-1 or PD-L1 inhibitors as part of first-line treatment.

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What clinical trial supported this approval?

The approval is based on results from the Phase 3 FRUSICA-2 trial (NCT05522231), a randomized, open-label, active-controlled study evaluating the combination of fruquintinib and sintilimab.

The study compared the combination therapy against axitinib or everolimus monotherapy in second-line RCC treatment.

What were the key efficacy results from the FRUSICA-2 trial?

The combination therapy demonstrated significant clinical benefit:

Median progression-free survival (PFS): 22.2 months vs 6.9 months (control group).
Objective response rate (ORR): 60.5% vs 24.3%.
Median duration of response (DoR): 23.7 months vs 11.3 months.
Odds ratio: 4.622 (p<0.0001), indicating strong statistical significance.
At the data cutoff (February 17, 2025), the median follow-up period was 16.6 months.
Overall survival data were still immature, with approximately 20% maturity.

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What is fruquintinib and it's mechanism of action?

Fruquintinib is an oral small-molecule inhibitor that selectively targets VEGFR-1, VEGFR-2, and VEGFR-3. These receptors are critical drivers of tumor angiogenesis, the process by which tumors develop new blood vessels to sustain growth. The drug has been engineered for high selectivity, minimizing off-target effects while maintaining continuous inhibition of its intended targets. This pharmacologic profile supports its use both as a standalone therapy and in combination with other anticancer agents.

Regulatory Status of Fruquintinib

In China, fruquintinib is jointly developed and marketed by Hutchmed and Eli Lilly under the brand name Elunate. It is approved for patients with metastatic colorectal cancer who have previously been treated with standard chemotherapy regimens including fluoropyrimidine, oxaliplatin, and irinotecan, as well as those who have received or are unsuitable for anti-VEGF or anti-EGFR therapies (in RAS wild-type populations). The drug has been included in China’s National Reimbursement Drug List since January 2020.

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The fruquintinib and sintilimab combination has also received conditional approval in China for patients with advanced mismatch repair-proficient (pMMR) endometrial cancer who have failed prior systemic treatments and are not eligible for curative surgery or radiation.

Outside mainland China, Hong Kong, and Macau, Takeda holds exclusive rights to develop, manufacture, and commercialize fruquintinib, where it is marketed under the name Fruzaqla. The drug has received approvals in multiple regions, including the United States, Europe, and Japan, for previously treated metastatic colorectal cancer.

What is sintilimab and it's mechanism of action

Sintilimab, sold as Tyvyt in China, is a PD-1 inhibitor developed through a collaboration between Innovent and Eli Lilly. It is a fully human IgG4 monoclonal antibody that targets the PD-1 receptor on T cells. By blocking interaction with PD-L1, sintilimab restores T-cell activity, enabling the immune system to recognize and attack cancer cells more effectively.

Burden of kidney cancer

Globally, kidney cancer accounted for an estimated 435,000 new cases in 2022. In China alone, approximately 74,000 new diagnoses were reported during the same year. Renal cell carcinoma represents the vast majority of these cases, comprising about 90% of all kidney cancers.

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