Golden Biotechnology Corp.’s Antroquinonol Phase 2 NSCLC Clinical Study Presents Brilliant Results in ASCO Meeting Abstract.
ASCO Meeting Abstract :
Phase II multicenter study of antroquinonol in patients with stage IV non-small cell lung cancer who have failed at least two lines of anti-cancer therapy.
Meeting: 2019 ASCO Annual Meeting
Session Title: Lung Cancer—Non-Small Cell Metastatic: Publication Only
Track:Lung Cancer—Non-Small Cell Metastatic
Subtrack: Metastatic Non-Small Cell Lung Cancer
Abstract #: e20522
Clinical Trial Registry Number:NCT02047344
Citation:J Clin Oncol 37, 2019 (suppl; abstr e20522)
Ching-Liang Ho, David S. Ettinger, Pei-Ni Chen, Howard Cheng, Wu-Che Wen, Shang-Yin Wu, Thierry Marie Jahan, Mary J. Fidler, Bradley Walter Lash, Igor I. Rybkin, Natalie Stanton; Division of Hematology and Oncology, Tri-service General Hospital, National Defense Medical Center, Taipei, Taiwan; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD; Golden Biotechnology Corporation, New Taipei City, Taiwan; Golden Biotechnology Corp., New Taipei City, Taiwan; Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan; University of California San Francisco, San Francisco, CA; Rush University Medical Center, Chicago, IL; Guthrie Clinic, Sayre, PA; Henry Ford Cancer Institute, Detroit, MI; Arizona Clinical Research Center, Tucson, AZ
Background:The aim of this study was to assess the efficacy of Antroquinonol in patients with stage IV NSCLC after failure in two-lines of anti-cancer therapy.
Patients with stage IV non-squamous NSCLC who have failed at 2-4 lines of anti-cancer therapy were eligible, though early stage or naïve patients may voluntarily participate. A maximum of 30 evaluable patients were to receive Antroquinonol 600mg per day, of which 15 patients were to be KRAS-positive and 15 patients KRAS negative. The primary endpoint of the study was progression-free survival from the start of treatment to week 12 with disease control rate and overall survival as key secondary endpoints.
There were 31 patients enrolled with evaluable population 30 patients, of which 15 patients were KRAS positive and 15 patients KRAS negative. 73% were with at least two prior chemotherapy. The median PFS of 7 patients with 2 prior chemotherapy was 22.9 weeks (95% confidence interval [CI]: 5.0, 31.1); and 11 patients with more than 2 prior chemotherapy was 11.9 weeks (95% confidence interval [CI]: 6.0, 14.1), with a 1-year PFS of 11.4%. Of 11 patients who had had more than 2 prior chemotherapy, the median OS was 47.3 weeks (95% CI: 14.1,-), with a 1-year OS of 39.3%, and the overall disease control rate was 72.7%, with 100% in KRAS negative and 50% in KRAS positive. No systemic toxicities were observed.
The monotherapy of Antroquinonol brought up higher disease control rates and longer progression-free survival and overall survival, compared with historical data. Although KRAS negative shows much better than KRAS positive group, Antroquinonol still work well with KRAS positive patients. Clinical trial information: NCT02047344