Abstract 265P
Background
Paclitaxel is an antimitotic agent with demonstrated antineoplastic effect in various cancers including breast cancer. DHP107 (Liporaxel®) is an oral paclitaxel based on a novel lipid formulation approved in Korea for gastric cancer in 2016. This phase II randomized trial aimed to evaluate the efficacy and safety of DHP107 compared with IV paclitaxel (ptx).
Methods
Patients with HER2-negative metastatic or locally recurrent breast cancer with up to 3 lines of previous chemotherapy were randomized 2:1 to receive DHP107 (200 mg/m2 orally twice daily) or IV ptx (80 mg/m2) on D1, 8 & 15 in a 28-day cycle until progressive disease (PD) or intolerable toxicity. Eligible patients had measurable disease, no prior taxane for MBC and neuropathy ≤G1. Stratification factors included ‘triple negative or not’ and ‘disease-free interval ≤ 12 vs. > 12 m’. Tumor assessments were performed every 8 wks from C1D1 until PD or before subsequent chemotherapy. The primary endpoint was ORR by investigators. Secondary endpoints included PK, progression free survival (PFS), overall survival (OS), quality of life (QoL) and safety.
Results
72 pts were enrolled from Jul 2018 to Jun 2021 in the US and Czech Republic. The Full Analysis Set included 69 pts, 48 for DHP107 and 21 for control; 5 pts (4 DHP107) are still receiving study therapy (cut-off: Dec 2021). ORR was 18.8% (CR: 2.1%, PR: 16.7%) for DHP107 vs. 28.6% (No CR, PR: 28.6%) for IV ptx (p= 0.363). Median PFS was 5.5 and 5.2 m and median OS was 14.8 and 11.1 m in DHP107 and IV arms respectively. The most common all grade adverse events (AEs) were diarrhea (66.7%, 10.4% G3) for DHP107 and fatigue (47.6%) for IV ptx. All grade neuropathy was less frequent with DHP107 vs IV ptx (25.0% vs. 57.1%, p=0.050). The most frequent ≥G3 AE was neutropenia (43.8 vs 19.1%, DHP107 vs. IV ptx, p=0.018). Serious AEs were 18.8% vs. 28.6% (p=0.363).
Conclusions
The oral paclitaxel, DHP107 showed comparable efficacy and a differential safety including less neuropathy compared to IV ptx in pts with MBC. The ongoing OPTIMAL Phase III will enroll 556 subjects with MBC in Korea, China and Europe to test non-inferiority of DHP107 to IV ptx (NCT03315364).
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Daehwa Pharmaceutical Co., Ltd.
Funding
Daehwa Pharmaceutical Co., Ltd.
Disclosure
H.S. Rugo: Financial Interests, Institutional, Research Grant: Pfizer, Merck, Novartis, Lilly, Roche, Daiichi, Seattle Genetics, Macrogenics, Sermonix, Boehringer Ingelheim, Polyphor, AstraZeneca, Ayala, Astellas and Gilead; Financial Interests, Personal, Advisory Role: Puma, Samsung, Blueprint, Stemline, and NAPO. P. Sharma: Financial Interests, Institutional, Research Grant: Novartis, Merck, BMS; Financial Interests, Personal and Institutional, Advisory Board: AstraZeneca, Novartis, Merck, GSK, Pfizer, Genomic Health, Seattle Genetics, Immunomedics, Gilead, Sanofi. N. Vidula: Financial Interests, Institutional, Research Grant: Daehwa, Merck, Pfizer, Radius, and Novartis; Financial Interests, Personal and Institutional, Advisory Board: AbbVie, OncoSec. K.E. Yoon: Financial Interests, Personal, Full or part-time Employment: Daehwa. H.J. Cho: Other, Personal, Full or part-time Employment: Daehwa. All other authors have declared no conflicts of interest.