At the American Society of Clinical Oncology (ASCO) Annual Meeting, being held 31 May – 3 June, results from the randomised, Chinese multicenter Phase III ANCHOR clinical trial (NCT04854668) were presented. The non-inferiority trial evaluated the efficacy and safety of the combination of Advenchen Laboratories’ Focus V (anlotinib, catequentinib), an oral multi-targeted anti-angiogenic tyrosine kinase inhibitor. It was tested in combination with standard-of-care (SOC) chemotherapy, oxaliplatin and capecitabine (CAPEOX), in previously untreated patients with wild-type RAS/BRAF unresectable metastatic colorectal cancer (mCRC).
CRC is the third most common cancer worldwide, with nearly two million new cases diagnosed and approximately 900,000 deaths each year. According to GlobalData’s Colorectal Cancer: Epidemiology Forecast to 2031 report, the number of diagnosed incident cases in the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and China) is projected to increase from 1.1 million in 2025 to 1.3 million by 2031.
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In the ANCHOR trial, a total of 748 patients with unresectable mCRC were randomised 1:1 into experimental arm A (Focus V + CAPEOX; n=373) and comparator arm B (bevacizumab + CAPEOX; n=375). The primary endpoint, median independent review committee-assessed progression-free survival (PFS) was 11 months (hazard ratio (HR), 1.00; 95% CI 0.84 – 1.18) for both arms. Secondary endpoints, including objective response rate (61.93% versus 62.13%; p=0.9487), disease control rate (92.76% versus 93.07%; p=0.8681), and duration of response (9.66 months versus 9.69 months; HR, 1.04), also showed no statistically significant differences between the two groups. The safety profile was comparable across both arms, with Grade 3 treatment-related adverse events (AEs) reported in 73.99% of patients in Arm A and 59.20% in Arm B, with six Grade 5 AEs in the Focus V arm and four in the bevacizumab arm.
Although the trial results demonstrate non-inferiority of Focus V compared to bevacizumab, confirming Focus V utility as a potential treatment option, the therapy has shown limited PFS benefit, a high incidence of AEs, and no demonstrated improvement in overall survival. As a result, it is unlikely to become the first choice among clinicians over the current SOC regimen of chemotherapy plus bevacizumab in China. Although the convenience of oral administration is an advantage, it alone is not sufficient to shift the SOC, though some clinicians may still consider its use.
If this trial had demonstrated superiority of the Focus V regimen over the SOC, Focus V could have captured a broad patient population, translating into significant revenue. Focus V is the leading asset for Advenchen Laboratories, and the company plans to submit its first new drug application for the US market in 2025. However, as the trial results do not change the current SOC in first-line RAS/BRAF wild-type mCRC, it won’t be easy for Focus V to enter the global market. Focus V is currently approved in China for multiple cancers, including thyroid, endometrial, soft tissue sarcoma, small cell lung cancer, and non-small cell lung cancer. The drug is also being evaluated in ten ongoing Phase III clinical trials across China for various solid tumors. According to GlobalData’s analyst consensus forecast, Focus V is expected to generate global sales of $692m by 2030. All sales are anticipated to come from the Chinese market, where the drug has been approved since 2018. Meanwhile, Advenchen Laboratories is actively seeking partners to advance their pipeline of anti-angiogenic tyrosine kinase inhibitors, which includes AL8326, AL2846, and AL58805 according to information available on its website.
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