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
2672 - Changes in clinico-pathological characteristics of vulvar cancer in Japan: increasing oldest-old, stage-shifting, and decreasing cohort-level survival
Presenter: Shin Nishio
Session: Poster Display session 2
Resources:
Abstract
4306 - Tumor Treating Fields (200 kHz) concomitant with weekly paclitaxel for platinum-resistant ovarian cancer: Phase 3 INNOVATE-3/ENGOT-ov50 study
Presenter: Ignace Vergote
Session: Poster Display session 2
Resources:
Abstract
5136 - Randomized, phase 1b/2 study of M6620 + avelumab + carboplatin vs standard care (sc) in patients (pts) with platinum-sensitive poly (ADP-ribose) polymerase inhibitor-(PARPi)-resistant ovarian cancer
Presenter: Susana Banerjee
Session: Poster Display session 2
Resources:
Abstract
2296 - An umbrella study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer: A Korean Gynecologic Oncology Group study (KGOG 3045), AMBITION
Presenter: Jung-Yun Lee
Session: Poster Display session 2
Resources:
Abstract
2732 - A phase 2 study of pembrolizumab in combination with doxorubicin in advanced, recurrent or metastatic endometrial cancer
Presenter: Ana Oaknin
Session: Poster Display session 2
Resources:
Abstract
4404 - ENGOT-EN9/LEAP-001: a phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer
Presenter: Christian Marth
Session: Poster Display session 2
Resources:
Abstract
4564 - Phase 1/2 trial of tisotumab vedotin plus bevacizumab, pembrolizumab, or carboplatin in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8)
Presenter: Ignace Vergote
Session: Poster Display session 2
Resources:
Abstract
4933 - Updated data of Epitopes-HPV02 trial and external validation of efficacy of DCF in prospective Epitopes-HPV01 study in advanced anal squamous cell carcinoma. Pooled analysis of 115 patients
Presenter: Stefano Kim
Session: Poster Display session 2
Resources:
Abstract
2301 - Pre-specified pilot analysis of a randomised pilot/phase II/III trial comparing standard dose vs dose-escalated concurrent chemoradiotherapy (CRT) in anal cancer (PLATO-ACT5)
Presenter: Alexandra Gilbert
Session: Poster Display session 2
Resources:
Abstract
5773 - A prospective study of diffusion-weighted magnetic resonance imaging for predicting outcome following chemoradiotherapy, in squamous cell carcinomas of the anus.
Presenter: Rebecca Muirhead
Session: Poster Display session 2
Resources:
Abstract