424P - Update results from ALTER-C-001 study: Efficacy and safety of anlotinib plus XELOX regimen as first-line treatment followed by maintenance monotherapy of anlotinib for patients with mCRC: A single arm, multi-center, phase II clinical trial

Background

The standard therapy followed by maintenance treatment is an optional approach to balance the efficacy and toxicity for metastatic colorectal cancer (mCRC). But clinical trials have largely remained inconclusive regarding the maintenance strategy. Anlotinib, a novel multi-target TKI, significantly prolonged the PFS of refractory mCRC in a phase III clinical trial. The preliminary results of anlotinib plus XELOX regimen followed by anlotinib as first-line treatment (ALTER-C-001) exhibited antitumor efficacy and manageable toxicity for mCRC. Here we updated the results with more patients enrolled.

Methods

53 patients with unresectable mCRC, aged 18-75, without prior systemic treatment and ECOG performance status 0-1 will be prospectively recruited. Anlotinib 10mg and capecitabine 1000mg/m² was given for 14 days, q3w; oxaliplatin 130mg/m² was given by intravenous infusion on day 1, q3w. After 6 cycles of inducing therapy, patients would receive anlotinib (12mg, po, d1∼14, q3w) until disease progression or intolerable adverse events. The primary endpoint was PFS; Secondary endpoints included ORR, DCR, DOR and safety.

Results

At the data cut-off date of April, 2021, a total of 21 patients were enrolled, the median (range) age was 58 (48-66) years, 15 (71%) were males, ECOG PS 0/1 was 10 (48%)/11 (52%), 18 (86%) had more than one metastatic tumor. Among 17 efficacy-available patients, the ORR (CR/PR) was 53% (9/17) and the DCR (CR/PR/SD) was 88% (15/17) in best overall response assessment, of which the longest duration of treatment was 12.1 months and the response was still ongoing. The median PFS was not reached. The Grade 3/4 treatment related adverse events(TRAE, ≥10%) were hypertension (19%), hypertriglyceridemia (14%), neutropenia (14%), lipase elevated (10%). One grade 5 TRAE was pancytopenia that occurred at 2.7 mths.

Conclusions

The update results suggested that anlotinib combined with XELOX as first line regimen followed by anlotinib monotherapy showed a promising clinical benefit and favorable safety profile for mCRC. And the results needed to be confirmed in trials continued subsequently.

Clinical trial identification

ChiCTR1900028417.

Editorial acknowledgement

Legal entity responsible for the study

Jin Yan.

Funding

Chia Tai Tianqing Pharmaceutical Group Co.,Ltd.

Disclosure

All authors have declared no conflicts of interest.