Alphamab Oncology (HKG: 9966) and CSPC Pharma (HKG: 1093) have jointly announced that their Phase III clinical study application for the combination of HER2 bispecific antibody KN026 and nab-paclitaxel HB1801 (Study Protocol Number: KN026-004) has received approval from the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) for neoadjuvant treatment of HER2-positive early or locally advanced breast cancer.
KN026, an independently developed HER2 bispecific antibody by Alphamab Oncology, has shown good tolerability and clinical benefits in a Phase II clinical study (KN026-201, NCT04165993) in combination with docetaxel for the first-line treatment of HER2-positive recurrent or metastatic breast cancer. In the realm of neoadjuvant treatment, Phase II study data (KN026-208, NCT04881929) presented at the 2023 ESMO Congress demonstrated that the combination of KN026 with docetaxel for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer had significant efficacy and good tolerability: the overall pathological complete response (tpCR) rate was 56.7%, the breast pathological complete response (bpCR) rate was 60%, and the confirmed objective response rate (ORR) was 86.7%. The posterior probability of a tpCR rate greater than 40% was 96.7%, indicating that the KN026 combination with docetaxel for neoadjuvant treatment may be superior to existing standard neoadjuvant treatment regimens.
In August 2021, Alphamab Oncology signed a development and commercialization licensing agreement with CSPC Pharma’s wholly-owned subsidiary, Jinmant Biotech, for KN026 in mainland China. Jinmant Biotech obtained exclusive development and exclusive commercialization rights for KN026 in mainland China (excluding Hong Kong, Macau, and Taiwan) for indications in breast cancer and gastric cancer.- Flcube.com
