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Poster display session

981 - A Global Phase III Clinical Study Comparing NK105 and Paclitaxel in Metastatic or Recurrent Breast Cancer Patients

Date

11 Sep 2017

Session

Poster display session

Presenters

Toshiaki Saeki

Citation

Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365

Authors

T. Saeki1, H. Mukai2, J. Ro3, Y. Lin4, Y. Fujiwara5, S. Nagai6, K.S. Lee7, J. Watanabe8, S. Ohtani9, S. Kim10, K. Kuroi11, K. Tsugawa12, Y. Tokuda13, H. Iwata14, Y.H. Park15, Y. Yang16, Y. Nambu17

Author affiliations

  • 1 Department Of Breast Oncology, Saitama Medical University International Medical Center, 3501298 - Saitama/JP
  • 2 Breast And Medical Oncology, National Cancer Center Hospital East, Kashiwa/JP
  • 3 Graduate School Of Cancer Science And Policy, National Cancer Center, 410-769 - Goyang/KR
  • 4 Division Of Haematology And Oncology, Chang-Gung Memorial Hospital, Linko, Taoyuan/TW
  • 5 Department Of Breast And Medical Oncology, National Cancer Center Hospital, Tokyo/JP
  • 6 Division Of Breast Oncology, Saitama Cancer Center, Saitama/JP
  • 7 Center For Breast Cancer, National Cancer Center, Seoul/KR
  • 8 Breast Oncology, Shizuoka Cancer Center, Shizuoka/JP
  • 9 Department Of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, 730-0011 - Hiroshima/JP
  • 10 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 11 Department Of Surgery, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Tokyo/JP
  • 12 Division Of Breast And Endocrine Surgery, Department Of Surgery, St. Marianna University School of Medicine, Kawasaki/JP
  • 13 Department Of Breast And Endocrine Surgery, Tokai University School of Medicine, 259-1193 - Isehara/JP
  • 14 Department Of Breast Oncology, Aichi Cancer Center Hospital, Nagoya/JP
  • 15 Division Of Hematology-oncology, Samsung Medical Center, Seoul/KR
  • 16 Department Of Hematology-oncology, Taichung Veterans General Hospital, Taichung/TW
  • 17 Pharmaceuticals Group, Nippon Kayaku Co., Ltd., Tokyo/JP
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Resources

Abstract 981

Background

Paclitaxel (PTX) is a standard chemotherapy drug for metastatic or recurrent breast cancer (m/r BC). However, it presents problems such as hypersensitivity and peripheral sensory neuropathy (PSN). NK105 is a novel nanoparticle drug delivery formulation that encapsulates PTX in polymeric micelles. In a murine model, passive targeting was shown and NK105 accumulated in tumors. We expected NK105 to have similar efficacy and a better safety profile, regarding hypersensitivity and PSN, compared with PTX, considering a past phase II study in gastric cancer patients (pts). This study aimed to verify the non-inferiority of NK105 to PTX in terms of progression-free survival (PFS) in m/r BC pts.

Methods

Eligible pts were randomly assigned at a 1:1 ratio to either the NK105 (N) or PTX (P) arm. NK105 (65 mg/m2) and PTX (80 mg/m2) were administered via intravenous infusion weekly for 3 weeks followed by a 1-week rest period until disease progression. Tumor responses were assessed every 6 weeks by RECIST Ver. 1.1. The primary endpoint was PFS, while the secondary endpoints were overall response rate (ORR), overall survival (OS), and safety. PSN was evaluated by CTCAE Ver. 4.03 and FACT/GOG-NTX Ver. 4 (FACT).

Results

From September 2012 to July 2014, 436 pts were randomized and 422 pts were included in the efficacy analysis. The median PFS (95% CI) for the N and P arms was 256 (212–302) and 260 days (211–350), respectively. The adjusted hazard ratio (95% CI) was 1.255 (0.989–1.592), exceeding the set non-inferiority margin. The ORR and median OS for the N and P arms were 31.6% vs. 39.0%, and 950 vs. 1103 days, respectively. Adverse drug reactions occurred in 96.7% pts in the N arm and 98.1% in the P arm. PSN incidences in the N and P arms were 52.8% and 70.0%, respectively and incidence of Grade 3 or more was lower in the N arm than in the P arm pts. Cumulative PSN incidences between the N and P arms were significantly different (P 

Conclusions

The efficacy of 65 mg/m2 of NK105 could not be verified in terms of non-inferiority of PFS relative to PTX in this study. NK105 safety profile was generally similar to that of PTX, but the NK105 PSN profile was better than that of PTX. NK105 efficacy should be re-evaluated in future studies.

Clinical trial identification

Legal entity responsible for the study

Nippon Kayaku Co., Ltd.

Funding

Nippon Kayaku Co., Ltd.

Disclosure

Y. Tokuda: Obtained financial support for research activity from Nippon Kayaku Co., Ltd. in 2014, 2015, and 2016. Y. Nambu: Managing Director and Head of Pharmaceuticals Group of Nippon Kayaku Co., Ltd. All other authors have declared no conflicts of interest.

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