Zhitong Financial APP News, Corning Jerry Pharmaceutical-B (09966) issued an announcement KN046 (a recombinant humanized PD-L1/ CTLA-4 bispecific antibody developed by the group) combined with KN026 (a HER2 targeted bispecific antibody developed by the group) has been used in the treatment of locally advanced unresectable or metastatic HER2 positive solid tumors (except breast cancer or gastric cancer). The preliminary results of the phase II clinical trial (study number: KN026-203) have been from April 8, 2022 to April 2022. It will be displayed at the 2022 AACR Annual meeting, which ends on the 13th. Preliminary positive results of KN026-203in the treatment of breast and stomach cancer were presented at the 2021 San Antonio Breast Cancer Symposium.
KN026-203is an open-label, multicenter and chemotherapy-free II phase clinical trial to evaluate the efficacy and safety of KN046 combined with KN026 in the treatment of HER2-positive solid tumors. A total of 102patients with locally unresectable or metastatic HER2-positive solid tumors (including HER2-positive GC/GEJ, breast cancer and other HER2-positive solid tumors) were enrolled in this trial.
As of August 10, 2021, a total of 24 patients with locally unresectable or metastatic HER2-positive solid tumors (except breast cancer or gastric cancer) who had previously received at least first-line system treatment were enrolled, including 14 patients with colorectal cancer, 4 patients with NSCLC, 4 patients with gallbladder cancer, 1 patient with carcinoma of the renal pelvis and 1 patient with PDAC. The median age of subjects in the group was 56 years old (range: 37 to 66 years old). All subjects received KN046 of 5mg/kg Q3W plus KN026 of 30mg/kg Q3W intravenously, and received loading dose on day 1 and 8 (first cycle) until disease progression, intolerable toxicity or patient withdrawal. The primary end point was the ORR that the researchers evaluated every six weeks according to RECIST v1.1.
All 24 subjects were included in the safety assessment, of which 20 were included in the efficacy assessment.
Conclusion: the non-chemotherapy regimen of KN046 combined with KN026 shows considerable clinical efficacy and controllable toxicity in the treatment of HER2 positive non-breast cancer and non-gastric solid tumor patients who have received at least first-line system treatment. The experiment is currently under way.