lphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK) jointly announced that two posters highlighting data from two clinical studies of the anti-HER2 bispecific antibody KN026 were presented at the 44th San Antonio Breast Cancer Symposium (SABCS 2021).
Title: Preliminary Safety and Efficacy Results of KN026 (a HER2-targeted Bispecific Antibody) in combination with KN046 (an anti-PD-L1/CTLA-4 Bispecific Antibody) in Patients with Metastatic HER2-positive Breast Cancer: a Phase II Trial
Publication Number: P5-16-04
First author: Professor Jieqiong Liu, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Professor Chuangui Song, Department of Breast Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China
KN026-203 is an open-label, multi-center, phase II study to evaluate the efficacy, safety and tolerability of KN026 in combination with KN046 in subjects with HER2-positive solid tumors. The primary endpoint is the objective response rate (ORR) assessed by the investigator according to RECIST 1.1. The preliminary results from this ongoing study is reported in patients with HER2-positive metastatic breast cancer (MBC). Female patients with HER2-positive MBC who were previously treated with at least one HER2-targeted combination therapy were enrolled to receive KN026 (iv. 30 mg/kg Q3W) plus KN046 (iv. 5 mg/kg Q3W).
As of August 10, 2021, a total of 36 patients were enrolled, with a mean age of 53.0 years (range, 33-67 years). 30 patients (83.3%) had received > 2 lines of HER2-targeted combination therapy. 33 patients were evaluable for overall response, the objective response rate (ORR) was 48.5% (16/33, 95% CI: 30.8-66.5), and 1 patient achieved complete response (CR); the disease control rate (DCR) was 78.8% (26/33, 95% CI: 61.1-91.0).
36 patients were evaluable for safety, of whom 32 (88.9%) experienced at least one treatment-related adverse event (TRAE) and 5 (13.9%) experienced ≥grade 3 TRAE. The most common (≥ 10%) TRAEs were infusion-related reaction (41.7%), pruritus (22.2%), diarrhea (19.4%), rash (16.7%), elevated alanine aminotransferase (16.7%), elevated aspartate aminotransferase (16.7%), hypothyroidism (13.9%), decreased weight (11.1%), and abnormal hepatic function (11.1%). No treatment-related deaths were observed.
Title: First-in-human HER2-targeted bispecific antibody KN026 for the treatment of patients with HER2-positive metastatic breast cancer: Results from a phase I study
Publication Number: P2-13-10
First author: Professor Jian Zhang, Fudan University Shanghai Cancer Center
Dr. Dongmei Ji, Fudan University Shanghai Cancer Center
This first-in-human Phase I study evaluated the safety, tolerability, pharmacokinetics (PK), preliminary efficacy of KN026 administered as monotherapy to HER2-positive metastatic breast cancer (MBC) patients. Female patients with HER2 positive MBC who failed prior anti-HER2 therapies received intravenous KN026 monotherapy at 5 mg/kg (QW), 10mg/kg (QW), 20 mg/kg (Q2W), or 30 mg/kg (Q3W). Dose escalation was guided by a 3+3 dose escalation rule followed by dose expansion. The primary endpoint of the study was to assess safety and ascertain the recommended phase 2 dose (RP2D).
63 patients were enrolled with a median of 3 prior lines of systemic therapies and 2 prior lines of HER2 targeted therapies. Treatment was well tolerated with no DLTs observed. KN026 is well tolerated, with a favorable safety profile and promising anti-tumor activity in the context of its class in patients with HER2-positive breast cancer.
The most common treatment related adverse events (TRAEs) were pyrexia (23.8%), diarrhea (22.2%), aspartate aminotransferase increased (22.2%), alanine aminotransferase increased (22.2%). 4 patients reported Grade 3 TRAEs.
Results from exposure-response analysis supported the selection of the RP2Ds at 20 mg/kg Q2W or 30 mg/kg Q3W, which had corresponding median progression-free survival (PFS) of 5.5 and 7.4 months, respectiv...
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