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(Sharecast News) - Hutchmed China, alongside Innovent Biologics, announced on Wednesday that the FRUSICA-2 phase two and three clinical trial evaluating the combination of fruquintinib and sintilimab as a second-line treatment for advanced renal cell carcinoma (RCC) in China had met its primary endpoint of progression-free survival.
The AIM-traded firm said the results, assessed by blinded independent central review, demonstrated a significant benefit over monotherapy with axitinib or everolimus.
It said the combination therapy had already received conditional approval from China's National Medical Products Administration for treating advanced endometrial cancer with mismatch repair proficient (pMMR) tumors based on data from the FRUSICA-1 study.
The FRUSICA-2 trial - a randomised, open-label study - also showed improvements in secondary endpoints, including objective response rate and duration of response.
Full results would be presented at an upcoming scientific conference.
"The encouraging results from our study provide clear evidence for the combination of fruquintinib and sintilimab as a viable new treatment option for advanced renal cell carcinoma patients who have progressed on previous therapy," said Hutchmed's head of research and development and chief medical officer Dr Michael Shi.
"This not only reaffirms our commitment to advancing cancer therapies but also represents an important step forward in addressing unmet medical needs within this patient population.
"We look forward to sharing detailed findings with regulatory authorities and progressing toward NDA filings in the coming months."
At 0936 GMT, shares in Hutchmed China were up 4.35% at 240p.
Reporting by Josh White for Sharecast.com.
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