As of August 21, 2022, the ORR from 25 efficacy evaluable TNBC patients was 44.0%, the DCR was 96.0%, and the CBR was 52.0%. The median follow-up time was 27.93 months. The median PFS was 7.33 months. Among the PD-L1 ≥1% pts, the median PFS was 8.61 months. The median OS was not mature yet. The 24 months survival rate is 60.1% with projected mOS around 28 months.
SUZHOU, China, Dec. 12, 2022 /PRNewswire/ — Alphamab Oncology (stock code: 9966.HK) announced that data from phase Ib/II clinical study (clinical trial No.: KN046-203) of PD-L1/CTLA-4 bispecific antibody KN046 in combination with nab-paclitaxel for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) presented was selelcted as spotlight poster presentation at the 45th San Antonio Breast Cancer Symposium (SABCS 2022).
From a one-day regional conference, the SABCS has grown to a five-day program attended by a broad international audience of academic and private researchers and physicians from over 90 countries. The SABCS aims to achieve a balance of clinical, translational, and basic research, providing a forum for interaction, communication, and education for a broad spectrum of researchers, health professionals, and those with a special interest in breast cancer. The preliminary results of the KN046-203 study were published online on AACR in 2021, the final analysis of this trial were presented for Spotlight Poster Discussion presentation of SABCS 2022.
Presentation Format: Spotlight Poster Discussion
Poster Title: Efficacy, Safety, and Tolerability of KN046 (an anti-PD-L1/CTLA-4 Bispecific Antibody) in combination with Nab-paclitaxel in Metastatic Triple-negative Breast Cancer (mTNBC)：Final results of the Phase II trial
Poster ID: PD11-10
Corresponding author: Prof. Binghe Xu, Cancer Hospital Chinese Academy of Medical Sciences.
launch time: Thursday, December 8, 2022: 7:00 am (CST)
KN046-203 is a phase Ib/II, open label, multi-center clinical study, evaluating the efficacy, safety, and tolerability of KN046 in combination with nab-paclitaxel in patients with TNBC. A total of 27 female patients were enrolled with with ocally advanced inoperable or metastatic TNBC without exposure to previous systemic treament.
The ORR, DCR, and CBR was evaluated based on the evaluable (EAS) population. The PFS and OS were evaluated based on the Intend-to-treat (ITT) population. As of August 21, 2022, based on the IRC evaluation, the ORR from 25 efficacy evaluable TNBC patients was 44.0% (95% CI: 21.1~61.3%), the DCR was 96.0% (95% CI: 79.6~99.9%), and the CBR was 52.0% (95% CI: 31.3~72.2%). The median follow-up time was 27.93 months (95% CI: IQR: 20.73~30.46). The median PFS was 7.33 months (95%CI: 3.68~11.07). Among the PD-L1 ≥1% pts, the median PFS was 8.61 (95%CI, 1.61 – NE) months. The median OS is immature, the preliminary result is 27.73 (95% CI, 14.75 – NE) months, and the 2-year OS rate was 60.1% (95%CI, 37.2~76.9%).
As of December 21, 2022, no treatment-related adverse events (TRAEs) leading to death occurred. Grade ≥ 3 TRAEs occurred in 18 patients (66.7%). Immune-related adverse events (irAEs) occurred in 13 patients (48.1%). Most irAEs were of grade 1 or 2 except that 3 patients experienced two grade 3 immune-mediated hepatic disorders and one grade 3 rash.
The results showed that KN046 combined with nab-paclitaxel is well tolerated and efficacious, Both PD-L1 negative and positive patients could derive OS benefit from the therapy.
KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a novel mechanism – CTLA-4 fused with PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg (suppress tumor immunity) clearing function.
There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, pancreatic cancer, thymic cancer, HCC, ESCC and TNBC in Australia, the US and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab Oncology has received FDA clearance to enter phase II trial of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA’s orphan drug designation for thymic epithelial tumor in September 2020. Four pivotal clinical trials are currently being conducted, among which the interim analysis of the phase III clinical study of KN046 combined with chemotherapy as the first-line treatment of NSCLC successfully met the prespecified PFS endpoint.
About Alphamab Oncology
Alphamab Oncology is a leading biopharmaceutical company dedicated to the discovery, development manufacturing and commercialization of world-class innovative biotherapeutics for cancer treatment. On December 12, 2019, Alphamab Oncology was listed on the Main Board of Hong Kong Stock Exchange, with the stock code:9966.
We have converged a professional R&D team led by top scientists, and have a complete industrial chain from early research and development of innovative drugs, process development, commercial production to clinical research.
With multiple in-house proprietary platforms of bispecifics, protein engineering and antibody screening, Alphamab Oncology has established a globally competitive and differentiated pipeline which consists of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Among them, 2 varieties were selected into the national special project of ” New Drug Development”, and 3 varieties were granted 4 orphan drug qualifications by FDA. The world’s first subcutaneous PD-L1 inhibitor injection (Envafolimab) has been obtained the market approval by the Chinese National Medical Products Administration. More than 30 clinical studies have been carried out in 6 varieties in China, the United States and Australia, among which 8 studies of 3 varieties have entered the critical clinical stage in China and the United States.
To make cancer manageable and curable，Alphamab Oncology has always been guided by clinical value and patient needs, and focuses on the development of innovative, safe and affordable anti-tumor drugs to benefit patients in China and around the world.
Visit http://www.alphamabonc.com for more information.