ESMO Voice of China| furuquintinib combined with sindilimonumab applied to the phase II study of colorectal cancer patients in China

The 2022 Annual Meeting of the European Society of Oncology (ESMO) was held

The combination of targeted immunity strategies for colorectal cancer has been highly anticipated, and several clinical trials have evaluated

Anti-angiogenic therapy combined with immune checkpoint inhibitors is expected to enhance the clinical benefits

This is a prospective, one-arm, Phase II clinical trial

From 18 September 2020 to 19 April 2022, the study included a total of 55 patients

Table 1 Patient baseline

Patients with ORRs of 16% (95% CI, 7% to 31%), all of which were partial remissions (PR), and another 26 patients achieved disease stabilization (SD) and patient disease control rates (DCRs) of 77% (95% CI, 61% to 88%)

Figure 1 Patients with PFS(A) and OS(B)

As shown in Figure 2, patients with and without liver metastases had ORRs of 7.
1% and 33.
3%, respectively (P=0.
0398), and median PFS of 4.
1 months and 6.
4 months (P=0.
0364),
respectively.

Figure 2 OrR(A) and PFS(B) of patients in subgroup

The most common adverse events were proteinuria (53.
4%), hand-foot syndrome (46.
5%), and hypothyroidism (37.
2%)
.

The incidence of grade 3 or 4 treatment-related adverse events was 18.
6%.


Exploratory analysis found that the median blood tumor mutation burden (bTMB) in patients was 11.
35 muts/Mb, and no statistical differences
were found between ORR and PFS and bTMB status.

CtDNA analysis showed that three patients with MYC amplification may have worse PFS (1.
3 months, 1.
3 months, 2.
1 months) and OS (3.
0 months, 3.
7 months, 5.
4 months).

Fruquintinib combined with sindilizumab is effective and safe
in patients with pMMR/MSS refractory mCRC.

CTDNA suggests that MYC amplification appears to be associated with a poor prognosis in patients and requires follow-up studies to further evaluate this finding
.

References:

1.
 W.
Zhang, et al.
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.
423P 2022 ESMO Congress.

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