Found 1 Presentation For Request "1293P"
1293P - KN046 (an anti-PD-L1/CTLA-4 bispecific antibody) in combination with platinum doublet chemotherapy as first-line (1L) treatment in patients with advanced NSCLC harboring resistant oncogenic driver alterations
- Wenfeng Fang (Guangzhou, China)
Abstract
Background
KN046 (a novel bispecific antibody that bifunctionally targets CTLA4 and PD-L1) in combination with platinum doublet chemotherapy as 1L therapy showed promising efficacy and acceptable safety in stage IV NSCLC patients. Here, we report results from a cohort of systemic therapy naive NSCLC pts with resistant oncogenic driver alterations.
Methods
Patients (pts) with systemic treatment naive, stage IV NSCLC harboring a driver oncogenic alteration were enrolled and received KN046 at 5mg/kg Q3W in combination with 4 cycles’ pemetrexed (500 mg/m2, for non-squamous NSCLC) or paclitaxel (175 mg/m2, for squamous NSCLC) and carboplatin (area under the curve 5 mg/m2) until progressive disease, unacceptable toxicity, withdrawal of informed consent or death. Efficacy evaluation was performed by investigators per RECIST 1.1.
Results
As of January 19, 2021, 12 pts (EGFR exon 20 insertion mutation, n=8; HER2 exon 20 insertion mutation, n=1; EGFR amplification, n=2; RET fusion, n=1) were enrolled. Median age was 53 (range: 44, 69). 66.7% were females. The median treatment duration of KN046 was 21 weeks. ORR (confirmed PR) was 50% (6/12; 95% CI: 21.1‒78.9). Disease control rate (DCR) was 91.7% (11/12; 95% CI: 61.5–99.8). 5 pts had best response of SD and 1 patient had PD. Median PFS was 8.7 months (95% CI: 4.1, NE). Median overall survival (OS) was not reached, and OS rate was 100% at 6 months. TEAEs (
Conclusions
KN046 combined with platinum-based chemotherapy is well tolerated and has demonstrated promising, albeit preliminary anti-tumor activity as 1L treatment for stage IV NSCLC pts with resistant oncogenic driver alterations (including EGFR and HER2 exon 20 insertion mutation, EGFR amplification, RET fusion).
Clinical trial identification
NCT04054531.
Legal entity responsible for the study
Jiangsu Alphamab Biopharmaceuticals Co., Ltd.
Funding
Jiangsu Alphamab Biopharmaceuticals Co., Ltd.
Disclosure
J. Xu: Financial Interests, Personal, Full or part-time Employment: Jiangsu Alphamab Biopharmaceuticals Co., Ltd. H. Van: Financial Interests, Personal, Full or part-time Employment: Jiangsu Alphamab Biopharmaceuticals Co., Ltd. L. Zhi: Financial Interests, Personal, Full or part-time Employment: Jiangsu Alphamab Biopharmaceuticals Co., Ltd. Y. Xia: Financial Interests, Personal, Full or part-time Employment: Jiangsu Alphamab Biopharmaceuticals Co., Ltd. L. Li: Financial Interests, Personal, Full or part-time Employment: Jiangsu Alphamab Biopharmaceuticals Co., Ltd. F. Yang: Financial Interests, Personal, Full or part-time Employment: Jiangsu Alphamab Biopharmaceuticals Co., Ltd. Y. Xia: Financial Interests, Personal, Full or part-time Employment: Jiangsu Alphamab Biopharmaceuticals Co., Ltd. T. Xu: Financial Interests, Personal and Institutional, Ownership Interest: Jiangsu Alphamab Biopharmaceuticals Co., Ltd. All other authors have declared no conflicts of interest.