Found 1 Presentation For Request "1034P"
1034P - A phase II study of KN046 (a bispecific anti-PD-L1/CTLA-4) in patients with metastatic non-small cell lung cancer (NSCLC) who failed prior EFGR-TKIs
- Caicun Zhou (Shanghai, China)
Abstract
Background
KN046 is a novel bispecific antibody that blocks both PD-L1 interaction with PD1 and CTLA-4 interaction with CD80/CD86. In the phase II study, promising anti-tumor activity was seen with KN046 in subjects with non-small cell lung cancer (NSCLC). Here, we reported the efficacy and safety results of KN046 combined with chemotherapy in treatment of advanced NSCLC with EGFR sensitivity mutation who failed prior tyrosine kinase inhibitors (TKIs) from Cohort D in this study.
Methods
This is an open-label, multi-center, multiple cohorts, single arm study to evaluate the efficacy, safety and tolerability of KN046 in NSCLC. Subjects with EGFR sensitivity mutation (Ex19del or L858R), who had failed from prior EFGR-TKIs without platinum-based chemotherapy were enrolled. All subjects enrolled will receive KN046 5 mg/kg Q3W combined with chemotherapy (Pemetrexed, 500 mg/m2, Q3W and carboplatin AUC5, Q3W), until disease progression, intolerable toxicity and other discontinuation criteria. Primary endpoint was objective response rate (ORR) per RECIST version 1.1.
Results
Between Jan 7, 2020 and Dec17, 2021, 26 subjects with metastatic NSCLC were enrolled. At the data cutoff of Jan 25, 2022, the median follow-up was11.56 months (95% CI, 7.66, 12.52). Among all 26 subjects, the ORR was 26.9% (7/26, 95% CI, 11.57，47.79%), disease control rate (DCR) was 80.8% (21/26, 95% CI, 60.65, 93.45%) with 7 PR and 14 SD. Clinical benefit rate (CBR) was 65.4% (17/26, 95% CI, 44.33, 82.79%). Median progression-free survival (mPFS) was 5.52 months (95% CI, 4.17, 6.77) and median overall survival (mOS) was 12.68 months (95% CI, 11.4, -). 14(53.8%) out of the 26 subjects had experienced treatment-related adverse event (TRAE) at grade 3 or higher levels. The most common TRAEs of grade 3 or higher were infusion reaction (6/26 [23.1%]), decreased platelet cell count (4/26 [15.4%]) and anemia(3/26 [11.5%]), etc.
Conclusions
The bispecific antibody, KN046 was well tolerated and effective in treatment of advanced NSCLC with EGFR sensitivity mutation who failed prior EGFR-TKIs. Prospective study is needed to validate the clinical outcome.
Clinical trial identification
NCT03838848.
Editorial acknowledgement
Writing support was provided by Jiangsu Alphamab Biopharmaceuticals, Co., Ltd, funded by Jiangsu Alphamab Biopharmaceuticals, Co., Ltd.
Legal entity responsible for the study
Jiangsu Alphamab Biopharmaceuticals, Co., Ltd.
Funding
Jiangsu Alphamab Biopharmaceuticals, Co., Ltd.
Disclosure
C. Zhou: Financial Interests, Personal, Invited Speaker, Honoraria: Eli Lily, Roche, Sanofi, Qilu Pharma, Hengrui, Innovent Biologics, C-Stone, Luye Pharma, TopAlliance Biosciences Inc; Financial Interests, Personal, Invited Speaker, BI: BI; Financial Interests, Personal, Invited Speaker, MSD: MSD; Financial Interests, Personal, Advisory Board, Advisor: Amoy Diagnostics. All other authors have declared no conflicts of interest.