Shanghai Henlius Biotech Inc. said the first patient has been dosed in an open-label, randomized, multicenter phase 2/3 study in Chinese Mainland evaluating HLX22 (recombinant humanised anti-HER2 monoclonal antibody) in combination with HLX87 (HER2-targeted antibody-drug conjugate) as first-line treatment for HER2-positive recurrent or metastatic breast cancer. In the phase 2 stage, patients will be randomized 2:2:1:1 to receive HLX22 plus HLX87, pertuzumab plus HLX87, pertuzumab plus trastuzumab deruxtecan, or pertuzumab plus trastuzumab and docetaxel, with primary endpoints of objective response rate and progression-free survival assessed by blinded independent central review. In the phase 3 stage, patients will be randomized 1:1 to receive HLX22 plus HLX87 or pertuzumab plus trastuzumab and docetaxel, with progression-free survival by blinded independent central review as the primary endpoint. The company said that, as of the announcement date, no similar combination has been approved for marketing in Chinese Mainland.

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