Fruzaqla Plus Sintilimab May Slow Renal Cell Carcinoma Progression

Fruzaqla plus sintilimab slowed progression in the second line for locally advanced or metastatic renal cell carcinoma: © Dr_Microbe - stock.adobe.com

Among patients with locally advanced or metastatic renal cell carcinoma, Fruzaqla (fruquintinib) in combination with sintilimab has been found to slow progression when administered as a second-line treatment.

The treatment combination met the primary endpoint of progression-free survival in the phase 2/3 FRUSICA-2 clinical trial, according to a news release from Hutchmed Limited and Innovent Biologics, Inc.

“The positive results from this phase 3 study of the [Fruzaqla] and sintilimab combination represent a significant advancement in the treatment of advanced renal cell carcinoma. We are optimistic about the clinical implications of the findings as we strive to provide more effective treatment options for patients who may not have had adequate responses to previous therapies,” said professor Zhisong He of Peking University First Hospital and the co-leading principal investigator of the FRUSІCA-2 study, in the news release.

Fruzaqla, according to the National Cancer Institute, is an inhibitor of vascular endothelia growth factor receptors (VEGFRs) and may result in effects including the inhibition of tumor cell proliferation and tumor cell death. Sintilimab may restore patients’ immune function through the activation of T cells and T cell-mediated immune responses against tumor cells, the National Cancer Institute explained.

“The rapid advancements in targeted therapies, immunotherapies, and their combination regimens have led to a significant evolution in the treatment landscape for advanced renal cell carcinoma. Targeted therapy remains an indispensable and crucial component in systemic treatment of advanced [renal cell carcinoma] in China. Optimizing the selection of targeted therapy, either as monotherapy or in combination with immunotherapy, for individual patients is a key focus of clinical interest. The results from the FRUSІCA-2 study underscore the potential of the [Fruzaqla] and sintilimab combination to address the pressing medical needs of patients with this challenging disease,” said professor Dingwei Ye of Fudan University Shanghai Cancer Center and the co-leading principal investigator of the FRUSІCA-2 study in the news release.

The FRUSICA-2 trial, held at 48 locations in China, began in October 2022 and has an enrollment of 265 patients. The trial has an estimated completion date of March 2025.

The trial is evaluating the effectiveness and safety of Fruzaqla in combination with sintilimab versus Inlyta (axitinib) or Afinitor (everolimus) monotherapy as a second-line treatment for advanced renal cell carcinoma. The trial also showed improvements in secondary end points including objective response rate and duration of response, with full results planned to be submitted for presentation at an upcoming scientific conference, according to the news release.

Fruzaqla with sintilimab has already received conditional approval from the China National Medical Products Administration for the treatment of patients with advanced endometrial cancer with mismatch repair proficient tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, the news release stated.

“The encouraging results from our study provide clear evidence for the combination of [Fruzaqla] and sintilimab as a viable new treatment option for [patients with] advanced renal cell carcinoma who have progressed on previous therapy. 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. І extend my heartfelt gratitude to the patients and investigators who participated in this research; their contributions have been vital to our success. We look forward to sharing detailed findings with regulatory authorities and progressing toward NDA filings in the coming months,” said Dr. Michael Shi, head of R&D and chief medical officer of Hutchmed, in the news release.

“We are encouraged by the positive results in the FRUSІCA-2 clinical trial,” said Dr. Hui Zhou, senior vice president of Іnnovent, in the news release. “These outcomes not only underscore the great potential of the combination therapy of sintilimab and [Fruzaqla] but also bring new hope to previously-treated patients with advanced renal cell carcinoma. We look forward to working closely with Hutchmed to jointly advance the registrational communication of this innovative combo therapy and make it available to patients as soon as possible.”

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