Alphamab Oncology announced that data from the Phase II clinical study of the PD-L1/CTLA-4 bispecific antibody KN046 combined with platinum doublet chemotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) is presented in a poster session at the ASCO 2021(2021 American Society of Clinical Oncology Annual Meeting).
Topic: A Phase 2, Open-Label, Multi-Center Study to evaluate the efficacy, safety, and tolerability of KN046 in combination with chemotherapy in subjects with advanced non-small cell lung cancer
Poster number: 200614
Session Title: Lung Cancer-Metastatic Non-Small Cell Lung Cancer
First author: Professor Yunpeng Yang, PhD, Sun Yat-sen University Cancer Center
KN046-202 (NCT04054531) is a phase II, open-label, multi-center clinical study to evaluate the efficacy, safety and tolerability of KN046 combined with platinum doublet chemotherapy in patients with advanced non-small cell lung cancer. The results show that KN046 combined with platinum doublet chemotherapy is well tolerated and has shown promising clinical benefit as IL treatment for stage IV NSCLC particularly in PD-L1≥1% tumors and squamous histology. The progression-free survival (PFS) and overall survival (OS)were longer than usually seen in this population. Similar survival was observed in patients with PD-L1≥1% and PD-L1<1%.
As of January 19, 2021, 87 patients with advanced NSCLC who had not received systemic treatment were enrolled, including 51 patients with non-squamous NSCLC and 36 patients with squamous NSCLC. 46 patients PD-L1≥1%, and 37 patients PD-L1<1%. The median treatment duration of KN046 was 21 weeks.
In 81 efficacy evaluable patients, the objective response rate (ORR) was 50.6% (95% CI: 39.3%, 61.9%), and the disease control rate (DCR) was 87.7% (95% CI: 78.5%,93.9%). In patients with non-squamous NSCLC, the objective response rate (ORR) and disease control rate (DCR) were 45.8% (95% CI: 31.4%, 60.8%) and 89.6% (95% CI: 77.3%, 96.5%) respectively. In patients with squamous NSCLC, the objective response rate (ORR) and disease control rate (DCR) were 57.6% (95% CI: 39.2%, 74.5%) and 84.8% (95% CI: 68.1%, 94.9) respectively.
The median progression-free survival (mPFS) is 5.9 months (95% CI: 5.3, 8.7), and the median overall survival (OS) was not reached; OS rate at 12 and 15 months were both 74.9%.; Similar OS curves have been observed in PD-L1 ≥1% and PD-L1<1% patients. In PD-L1 ≥1% patients, the median PFS is 6.7 months, and 10.8 months for PD-L1 ≥1% squamous NSCLC patients.
22 patients (25.3%) experienced Grade≥3 treatment-related adverse events (TRAE). The most common TRAEs were diarrhea (5.7%), alanine aminotransferase increased (4.6%), infusion related reaction (3.4 %), rash (3.4%) and aspartate aminotransferase increased, dermatitis allergic and immune-mediated pneumonitis (2.3%, respectively). Adverse events are manageable.
Professor Zhang Li from Sun Yat-sen University Cancer Center, the principal investigator, commented, "Lung cancer is the malignant tumor with the highest incidence and mortality in China. In recent years, immunotherapy has significantly improved the long-term survival of patients with advanced NSCLC. However, the overall prognosis and long-term efficacy still need to be improved. We are very pleased to see that Alphamab Oncology's bispecific antibody KN046 demonstrates clinical benefit such as ORR, PFS and OS, which means that patients with advanced NSCLC may get better treatment options. We look forward to further results of KN046 as a first-line treatment in follow-up studies."
Dr. Ting Xu, Chairman and CEO of Alphamab Oncology commented, "In recent years, immunotherapies have radically improved treatment for non-small cell lung cancer (NSCLC) patients. Alphamab Oncology has conducted a number of clinical studies to explore innovative and better treatment options focusing on the post-PD-1 era. KN046 showed good tolerability, safety and efficacy in the phase II study for the first-line treatment of patients with advanced squamous -NSCLC or non-squamous NSCLC. Phase III clinical study of KN046 combined with chemotherapy for the treatment of squamous NSCLC is ongoing, and the first interim analysis expected to be available by the end of 2021. This is the world's first phase III clinical study of a PD-L1/CTLA-4 bispecific antibody. We hope that the results of this study will ch...
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