BCD-022 + paclitaxel

BCD-022 + paclitaxel is a combination therapy used in the treatment of metastatic HER2-positive breast cancer. This combination consists of BCD-022, which is a trastuzumab biosimilar developed by BIOCAD, and paclitaxel, a well-established chemotherapy agent. The combination was evaluated in an international multicenter phase III clinical trial (NCT01764022) that compared BCD-022 with reference trastuzumab (Herceptin), both in combination with paclitaxel. The study enrolled 225 patients with previously untreated metastatic HER2-positive breast cancer. The primary endpoint, overall response rate, was 49.6% in the BCD-022 arm compared to 43.6% in the reference trastuzumab arm, demonstrating therapeutic equivalence. The safety profile of BCD-022 + paclitaxel was similar to that of reference trastuzumab + paclitaxel, with no unexpected adverse reactions. Pharmacokinetic assessment also showed equivalent parameters between BCD-022 and reference trastuzumab.