423P Fruquintinib plus sintilimab in refractory repair-proficient (pMMR)/microsatellite stable (MSS) metastatic colorectal cancer (mCRC): Preliminary clinical results and biomarker analyses from a phase II study

Zhang, W.; Sun, Yulin; Jiang, Zhichao; Liu, T.; Gong, Changlin; Yang, Lingling; Xin, Y.; Huang, D.; Zhou, Ai-Ping

doi:10.1016/j.annonc.2022.07.561

Cited by 6 publications

(3 citation statements)

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“…Fifty-three patients with liver metastasis were included in this study. In the FS and FT groups, there was no statistical difference in ORR between patients with liver metastasis and patients without liver metastasis (P>0.05), which was inconsistent with the findings of Zhang et al ( 34 ) (whether it was related to different doses of fruquintinib). Meanwhile, mPFS was 6.0 months in the FS group and 3.5 months in the FT group, and mPFS was longer in the FS group.…”

Section: Discussioncontrasting

confidence: 93%

Fruquintinib in combination with sintilimab or TAS-102 as third-line or above treatment in patients with metastatic colorectal cancer: a real-world study

Li,

Wang,

et al. 2023

Transl Cancer Res

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Background For metastatic colorectal cancer (mCRC), the efficacy of third-line or above treatments is not ideal. Combining targeted vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) biological agents with chemotherapy or anti-programmed death receptor 1 (PD-1) treatment can bring longer survival benefits to patients with mCRC compared with the application of a single drug. In this study, fruquintinib was used as the research drug, and the main purpose was to compare the efficacy and safety of fruquintinib in combination with sintilimab (FS) or trifluridine and tipiracil (TAS-102) (FT) in the third-line or above treatment in mCRC patients. Methods Based on real-world clinical practice, mCRC patients who progressed after second-line or higher-line chemotherapy regimens and received FS or FT as third-line or above treatment from December 2020 to November 2022 were analyzed. Progression-free survival (PFS) was the primary endpoint. Safety, disease control rate (DCR) and objective response rate (ORR) were secondary end points. Results In the FS group, 47 patients received FS, and in the FT group, 45 patients received FT. The DCR values in the FS and FT groups were 80.9% (38/47) and 55.6% (25/45), respectively (P<0.05). The median PFS (mPFS) in the FS group was 6.0 months, and the mPFS in the FT group was 3.5 months (P<0.05). Most adverse events (AEs) were grade 1–2 in severity. Conclusions As a third-line or above regimen in mCRC patients, compared to FT, treatment with FS provides a higher DCR and longer mPFS and is better tolerated. The combination of fruquintinib and sintilimab may become a new treatment option for mCRC patients.

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Section: Discussioncontrasting

confidence: 93%

Fruquintinib in combination with sintilimab or TAS-102 as third-line or above treatment in patients with metastatic colorectal cancer: a real-world study

Li,

Wang,

et al. 2023

Transl Cancer Res

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“…In 2019, the REGONIVO study 8 resulted in a new era of immunotherapy for patients with pMMR/MSS mCRC. Subsequent investigations of fruquintinib in association with sintilimab, 9 the LEAP-005 study 10 and the CAMILLA study 11 indicated that a tyrosine kinase inhibitor (TKI) in combination with immunotherapy is effective in patients with pMMR/MSS mCRC. However, the REGONIVO study (North America), 12 the REGONIVO Plus study, 13 the REGOTORI study 14 and the Regomune research 15 failed to do again the excellent ORR of REGONIVO (Japan).…”

Section: Introductionmentioning

confidence: 99%

Later lines in pMMR/MSS metastatic colorectal cancer: News opportunities with immunotherapy and local treatments

Colombo,

Porretto

2024

Int J Gastrointest Interv

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Colorectal cancer (CRC) is one of the most prevalent malignancies, and most patients are diagnosed with metastatic disease at first presentation. However, immunotherapy is particularly useful only in a limited number of patients with mismatch repair-deficient/high microsatellite instability metastatic CRC (mCRC), while most patients have proficient mismatch repair (pMMR)/microsatellite stability (MSS). Currently, many clinical research on immunotherapy in association with tyrosine kinase inhibitors are aiming to modulate the immune microenvironment of pMMR/MSS mCRC and turn "cold tumors" into "hot tumors," which has not only unanticipated implications, but also good results. Some consequences include that the response may not be selective for metastases. This review summarizes recent studies on potential mechanisms of immunotherapy combined with local therapy (including radiotherapy, ablation, and transcatheter arterial chemoembolization) in the treatment of metastases.

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“…In 2019, the REGONIVO(Japan) [ 8 ] study opened a new era in the immunotherapy of patients with pMMR/MSS mCRC. Subsequent studies of fruquintinib combined with sintilimab [ 9 ], LEAP-005 study [ 10 ], and CAMILLA study [ 11 ] all suggested the great potential of tyrosine kinase inhibitors (TKIs) combined with immunotherapy in patients with pMMR/MSS mCRC. However, the REGONIVO study (North America) [ 12 ], REGONIVO Plus study [ 13 ], REGOTORI study [ 14 ], and Regomune study [ 15 ] could not reproduce the satisfying ORR of REGONIVO (Japan), and the efficacy was uneven.…”

Section: Introductionmentioning

confidence: 99%

Immunotherapy combined with local therapy in the late-line treatment of repair-proficient (pMMR)/microsatellite stable (MSS) metastatic colorectal cancer

Ding,

Weng,

Zhu

et al. 2023

Heliyon

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423P Fruquintinib plus sintilimab in refractory repair-proficient (pMMR)/microsatellite stable (MSS) metastatic colorectal cancer (mCRC): Preliminary clinical results and biomarker analyses from a phase II study

Cited by 6 publications

References 0 publications

Fruquintinib in combination with sintilimab or TAS-102 as third-line or above treatment in patients with metastatic colorectal cancer: a real-world study

Fruquintinib in combination with sintilimab or TAS-102 as third-line or above treatment in patients with metastatic colorectal cancer: a real-world study

Later lines in pMMR/MSS metastatic colorectal cancer: News opportunities with immunotherapy and local treatments

Immunotherapy combined with local therapy in the late-line treatment of repair-proficient (pMMR)/microsatellite stable (MSS) metastatic colorectal cancer

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