402P - Updated results from the multicenter phase II, ALTER-C001 trial: Efficacy and safety of anlotinib plus XELOX regimen as first-line treatment followed by maintenance monotherapy of anlotinib for patients with mCRC

Background

The combination of anti-VEGF or anti-EGFR targeted drugs with chemotherapy is the standard first-line therapy for metastatic colorectal cancer (mCRC). However, studies regarding the maintenance strategies based on antiangiogenic TKIs are limited currently. Anlotinib, a novel oral multi-target TKI which can inhibit tumor angiogenesis and growth, substantially prolonged the PFS with manageable toxicity for refractory mCRC in the phase III ALTER0703 clinical trial (NCT02332499). Previous results were reported at the 2022 ASCO GI (104 Poster Session), updated results for longer follow-up and additional enrollment are presented here.

Methods

mCRC patients (pts) without prior systemic treated, aged 18-75 and an ECOG PS of 0/ 1 were recruited. Eligible pts received capecitabine (1000 mg/m², po, d1-14, q3w) and oxaliplatin (130 mg/m², iv, d1, q3w) plus anlotinib (10mg, po, d1∼14, q3w) treatment for 6 cycles. Then, pts would receive anlotinib (12mg, po, d1∼14, q3w) as maintenance therapy until disease progression or intolerable adverse events (AEs). The primary endpoint was PFS; Secondary endpoints included ORR, DCR, DOR and safety.

Results

At data cut-off (April 22, 2022), a total of 31 pts were enrolled, of which 24 pts were available for efficacy assessment. In best overall response assessment, the ORR was 62.5% (95% CI: 40.6-81.2%) and DCR was 91.7% (95% CI: 73.0-99.0%). The mPFS was 7.79 months (mo) (95% CI: 6.80-8.78) and the mDOR was 5.98 mo (95% CI: 4.32-7.64). The longest duration of treatment was 17.5 mo. Safety profile exhibited that the regimen was tolerable. Grade 3/4 TRAEs (≥10%) were hypertension (16%), neutropenia (13%), and hypertriglyceridemia (10%). One grade 5 TRAE was pancytopenia that occurred at 2.7 mo.

Conclusions

Anlotinib combined with XELOX as first-line regimen followed by anlotinib monotherapy showed a promising clinical benefit, with a manageable safety profile, supporting the further investigation in randomized studies.

Clinical trial identification

ChiCTR1900028417.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.