Abstract 5083
Background
DHP107 is a novel oral formulation composed of lipid based components and paclitaxel. DHP107 showed efficacy and safety comparable to IV paclitaxel in patients (pts) with AGC {Ann Oncol 2018}. DHP 107 was approved for marketing in 2016 for gastric cancer in Korea as first oral paclitaxel in the world. Another phase II clinical trial of DHP107 for PKs in breast cancer is ongoing in USA.
Methods
This trial is conducted using Simon’s optimal two stage design, and planned to proceed to stage 2, if ≥ 2 of 9 pts showed objective response in stage 1. DHP107 is considered adequately effective to proceed into phase III trial if ≥ 9 of 34 showed PR in stage 2. Subjects are eligible for the study regardless lines of endocrine therapy. Pts are administrated with DHP107 (200mg/m2 po bid D1, 8 & 15 q4wks) and response evaluation (RECIST v1.1) was done every 8wks (±1w). The primary tumor assessment was done by investigator’s review (IR). Independent central review (ICR) was followed for sensitivity analysis. Primary endpoint is objective response rate (ORR) and secondary endpoints are progression free survival (PFS), overall survival (OS), disease control rate (DCR) and safety.
Results
Total 36 subjects (including 11 TNBC pts) were enrolled during Dec 2017 until Oct 2018. Per Protocol set (PPS) was composed of 33 pts and 14 pts are still on treatment. Safety Analysis set (SAS) included 36 pts. ORR was 48.5% (CR 0%; PR 48.5%) by the IR vs 36.4% (CR 0%; PR 36.4%) by ICR. DCR was similar between the investigator’s decision (90.9%) and ICR (84.9%). Most common adverse events (AEs) were neutropenia; Gr. 3/4 Neutropenia (75%), Anemia (16.7%) and Peripheral neuropathy (5.6%). There were 2 SAEs related to Gr. 3/4 neutropenia without fever. One patient discontinued due to Gr 3 peripheral neurotoxicity. There was no treatment-related toxic death.
Conclusions
Based on confirmed PR (n = 16/33, 48.5%), DHP107 demonstrated adequate efficacy with manageable toxicity in the first line HER2 negative recurrent/metastatic breast cancer patients. Phase III trial in breast cancer is ongoing in Korea and China.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Daehwa Pharmaceuticals. Co. Ltd.
Funding
Daehwa Pharmaceuticals. Co. Ltd.
Disclosure
K.S. Lee: Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Norvatis; Advisory / Consultancy: Lilly; Research grant / Funding (institution): Dong-A pharm. K. Lee: Advisory / Consultancy, Speaker Bureau / Expert testimony, Consulting role & Lecture fee: AstraZeneca; Advisory / Consultancy, Lecture fee: Bayer; Advisory / Consultancy, Lecture fee: Eisai; Advisory / Consultancy, Lecture fee: Ono Pharmaceuticals; Advisory / Consultancy, Speaker Bureau / Expert testimony, Consulting role & Lecture fee: Roche; Speaker Bureau / Expert testimony, Lecture fee: Eli Lilly; Advisory / Consultancy, Lecture fee: Samsung Bioepis. J. Sohn: Research grant / Funding (institution): MSD; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Norvatis; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): GSK; Research grant / Funding (institution): CONTESSA; Research grant / Funding (institution): Diichi Sankyo. S. Kim: Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Sanofi-Genzyme; Research grant / Funding (institution): Dongkook. All other authors have declared no conflicts of interest.
Resources from the same session
5658 - Detection of 5-hydroxymethylcytosine in Circulating-Free DNA for Early Diagnosis of Colorectal Cancer
Presenter: Tianyu Liu
Session: Poster Display session 2
Resources:
Abstract
5779 - Detection of 5-hydroxymethylcytosine in Circulating-Free DNA for Prediction of The Efficacy of Conversion Therapy for Colorectal Cancer Liver Metastases
Presenter: Wenju Chang
Session: Poster Display session 2
Resources:
Abstract
4672 - mCRC gene profiling using the Idylla platform
Presenter: Christopher Bricogne
Session: Poster Display session 2
Resources:
Abstract
3393 - PIK3CA mutation in metastatic colorectal cancer (mCRC): association with clinico-pathological features and outcome
Presenter: Valentina Fanotto
Session: Poster Display session 2
Resources:
Abstract
1317 - Patient-Derived Xenografts (PDX) Identifies JMJD6 Inhibitor as an Effective Therapeutic Medicine in Colorectal Cancer.
Presenter: Feng Ye
Session: Poster Display session 2
Resources:
Abstract
1228 - DACH1 induced stemness of intestinal organoids by directly suppressing BMP signaling and contributes to intestinal tumorigenesis
Presenter: Xiang Hu
Session: Poster Display session 2
Resources:
Abstract
1147 - miR-148a inhibits early relapsed colorectal cancers and the secretion of VEGF by indirectly targeting HIF-1α under non-hypoxia/hypoxia conditions
Presenter: Hsiang-lin Tsai
Session: Poster Display session 2
Resources:
Abstract
1158 - Long noncoding RNA CASC21 promotes cell proliferation and metastasis in colon cancer.
Presenter: Qun Zhang
Session: Poster Display session 2
Resources:
Abstract
1259 - Prognostic and Predictive Impact On FMS-like Tyrosine Kinase 3 (FLT3) Amplification In Patients With Metastatic Colorectal Cancer
Presenter: Hiroko Hasegawa
Session: Poster Display session 2
Resources:
Abstract
1452 - RBP-Jκ in colon cancer cells facilitates tumor associated macrophages (TAMs)-induced cell metastasis by secreting CXCL11
Presenter: Meng jie Liu
Session: Poster Display session 2
Resources:
Abstract