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Key clinical point: HLX04, a potential bevacizumab biosimilar, demonstrated efficacy equivalence with reference bevacizumab with comparable safety and immunogenicity in patients with recurrent/metastatic colorectal cancer (CRC).
Major finding: The progression-free survival rate at week 36 in HLX04 vs. bevacizumab group was 46.4% vs. 50.7% leading to rate difference (4.2%; 90% confidence interval [CI], −10.6 to 2.1) and rate ratio (0.92; 90% CI, 0.80 to −1.05) within the prespecified equivalence margins. Grade 3 or higher treatment-emergent adverse events were reported by 65.5% vs. 70.6% of patients in the HLX04 vs. bevacizumab group. Detection of antidrug and neutralizing antibodies was comparable.
Study details: Findings are from a phase 3 equivalence study including 677 patients with recurrent/metastatic CRC randomly allocated to either HLX04 or reference bevacizumab in combination with modified FOLFOX6 or XELOX.
Disclosures: The study was sponsored by the Shanghai Henlius Biotech, Inc. W Kang declared being an employee of Shanghai Henlius Biotech, Inc. The other authors declared having no directly relevant conflicts of interest.
Source: Qin S et al. BioDrugs. 2021 May 20. doi: 10.1007/s40259-021-00484-9.
Key clinical point: HLX04, a potential bevacizumab biosimilar, demonstrated efficacy equivalence with reference bevacizumab with comparable safety and immunogenicity in patients with recurrent/metastatic colorectal cancer (CRC).
Major finding: The progression-free survival rate at week 36 in HLX04 vs. bevacizumab group was 46.4% vs. 50.7% leading to rate difference (4.2%; 90% confidence interval [CI], −10.6 to 2.1) and rate ratio (0.92; 90% CI, 0.80 to −1.05) within the prespecified equivalence margins. Grade 3 or higher treatment-emergent adverse events were reported by 65.5% vs. 70.6% of patients in the HLX04 vs. bevacizumab group. Detection of antidrug and neutralizing antibodies was comparable.
Study details: Findings are from a phase 3 equivalence study including 677 patients with recurrent/metastatic CRC randomly allocated to either HLX04 or reference bevacizumab in combination with modified FOLFOX6 or XELOX.
Disclosures: The study was sponsored by the Shanghai Henlius Biotech, Inc. W Kang declared being an employee of Shanghai Henlius Biotech, Inc. The other authors declared having no directly relevant conflicts of interest.
Source: Qin S et al. BioDrugs. 2021 May 20. doi: 10.1007/s40259-021-00484-9.
Key clinical point: HLX04, a potential bevacizumab biosimilar, demonstrated efficacy equivalence with reference bevacizumab with comparable safety and immunogenicity in patients with recurrent/metastatic colorectal cancer (CRC).
Major finding: The progression-free survival rate at week 36 in HLX04 vs. bevacizumab group was 46.4% vs. 50.7% leading to rate difference (4.2%; 90% confidence interval [CI], −10.6 to 2.1) and rate ratio (0.92; 90% CI, 0.80 to −1.05) within the prespecified equivalence margins. Grade 3 or higher treatment-emergent adverse events were reported by 65.5% vs. 70.6% of patients in the HLX04 vs. bevacizumab group. Detection of antidrug and neutralizing antibodies was comparable.
Study details: Findings are from a phase 3 equivalence study including 677 patients with recurrent/metastatic CRC randomly allocated to either HLX04 or reference bevacizumab in combination with modified FOLFOX6 or XELOX.
Disclosures: The study was sponsored by the Shanghai Henlius Biotech, Inc. W Kang declared being an employee of Shanghai Henlius Biotech, Inc. The other authors declared having no directly relevant conflicts of interest.
Source: Qin S et al. BioDrugs. 2021 May 20. doi: 10.1007/s40259-021-00484-9.