Abstract CT170: ALTAS: A phase II trial of anlotinib in combination with TAS-102 in patients with metastatic colorectal cancers

Abstract Background: The management of metastatic colorectal cancer (mCRC) in late-line settings remains a formidable challenge, as existing therapies yield limited clinical benefits. The SUNLIGHT trial, which evaluated TAS-102 in combination with bevacizumab, reported a median progression-free survival (PFS) of 5 months and an objective response rate (ORR) of 6.3%. Anlotinib, a multi-target tyrosine kinase inhibitor, has shown promising efficacy and safety profiles across various tumor types. This study aims to explore the potential of combining anlotinib with TAS-102 as a third-line treatment for mCRC patients. Methods: In this open-label, single-arm phase 2 study, mCRC patients who had experienced disease progression following at least two prior standard treatment regimens were enrolled. Patients received a combination of anlotinib (12 mg, PO, QD, days 1-14, q3w) and TAS-102 (35 mg/m2, PO, BID, days 1-5, q2w). The primary endpoint was the ORR. Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), and safety. Results: As of December 30, 2024, twenty-one patients with mCRC were enrolled in the trial. The median age was 62 years (range: 36-78), with 71.4% male participants. All patients received the combination therapy of anlotinib and TAS-102. Among the 20 evaluable patients, 2 achieved a partial response (PR), 17 experienced stable disease (SD), and 1 exhibited progressive disease (PD) at the first evaluation. The objective response rate (ORR) was 10% (2/20), while the disease control rate (DCR) reached 95.0% (19/20). Based on Kaplan-Meier estimates, the median PFS was 5.6 months. The most common grade ≥3 treatment emergent adverse event (TEAEs) included neutropenia (25%) and decreased platelet count (5%). Conclusions: The combination of anlotinib and TAS-102 has shown promising efficacy and manageable safety, suggesting its potential as a favorable late-line treatment option for mCRC. Clinical trial information: ChiCTR2400079535 Citation Format: Qing Liu, Chi Zhang, Xiaojing Xu, Yiyi Yu, Tianshu Liu. ALTAS: A phase II trial of anlotinib in combination with TAS-102 in patients with metastatic colorectal cancers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT170.