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Poster lunch

987 - Multicenter Phase 2 trial of varlitinib versus lapatinib in combination with capecitabine in patients with HER2+ metastatic breast cancer (MBC) who failed prior trastuzumab therapy. (102P)


18 Nov 2017


Poster lunch


Cytotoxic Therapy;  Breast Cancer


Soo Chin Lee


Annals of Oncology (2017) 28 (suppl_10): x26-x34. 10.1093/annonc/mdx654


S.C. Lee1, S. Chen2, M. Dai3, G.E. Lee4, C. Liu5, A. Chan6, H. Chang7, L. Tseng8, W.Y. Chay4, L.W.C. Chow9, J.L. Peneyra10, K. Rau11, H. Wang12, A.A. Guancia13, M. Head14, J.W.Y. Chiu15, B. Robinson16, B. Lindmark17, N. McIntyre18, C. Hsieh19

Author affiliations

  • 1 Haematology-oncology, National University Cancer Institute, Singapore, 119228 - Singapore/SG
  • 2 General Surgery, Chang Gung Memorial Hospital, 105 - Taipei/TW
  • 3 Hematology/oncology, Tri-Service General Hospital, 114 - Taipei/TW
  • 4 Medical Oncology, National Cancer Center, 169610 - Singapore/SG
  • 5 Breast Surgery, Mackay Memorial Hospital, 104 - Taipei/TW
  • 6 Breast Cancer Research Centre Wa, Breast Cancer Research Centre WA and Curtin University, 6009 - Nedlands/Bentley/AU
  • 7 Medical Oncology, Chang Gung Memorial Hospital, 333 - Taoyuan/TW
  • 8 General Surgery, Taipei Veterans General Hospital, 112 - Taipei/TW
  • 9 Comprehensive Centre For Breast Diseases, UNIMED Medical Institute Limited, Hong Kong/HK
  • 10 Internal Medicine , De La Salle Health Sciences Institute, Dasmarinas Cavite/PH
  • 11 Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung/TW
  • 12 Breast Surgery, China Medical University Hospital, Taichung/TW
  • 13 Internal Medicine /oncology, Dr. Pablo O. Torre Memorial Hospital, Bacolod City/PH
  • 14 Medical Oncology, Tauranga Hospital, Bay of Plenty/NZ
  • 15 Medicine, Queen Mary Hospital, Hong Kong/HK
  • 16 Oncology, Christchurch Hospital, Christchurch/NZ
  • 17 Medical, ASLAN pharmaceuticals, 239920 - Singapore/SG
  • 18 Statistics, ASLAN pharmaceuticals, 239920 - Singapore/SG
  • 19 Medical, ASLAN pharmaceuticals, 110 - Taipei/TW


Abstract 987


Varlitinib, a tyrosine kinase inhibitor of the ErbB family (EGFR, HER2 and HER4), showed anti-tumor activity in trastuzumab-resistant models and in patients with trastuzumab-resistant, chemotherapy-refractory MBC in a phase 1 study. This study compared the efficacy and safety of varlitinib plus capecitabine (VC) versus lapatinib plus capecitabine (LC) in HER2+ MBC patients who failed prior trastuzumab therapy.


The primary objective was to assess percentage change in tumor size at week 12. Objective response rate (ORR), safety and drug exposure were also assessed. Patients who received at least one dose of study treatment were included in primary analysis. Sensitivity analysis for primary objective and ORR were performed in patients who remained on study for more than 30 days.


From Dec 2014 to Aug 2016, 24 patients were randomized to the VC arm (400mg BID) and 26 to the LC arm (1250mg QD) in 16 sites in 6 countries. Percentage of tumor size reduction was numerically higher in VC than LC (-31.00% vs. -19.37%, one-sided p = 0.132). ORR in the VC arm (40.9%) was similar to LC arm (45.5%), p = 1.000. Sensitivity analysis showed numerically superior ORR and statistically significant higher reduction of tumor size in VC compared to LC (60% vs. 45.5%, p = 0.508; mean, -34.6% vs.-19.4%, one-sided p = 0.075) All patients had at least 1 AE. Severe AE(s) were observed in 13 patients (54.2%) in the VC arm and 11(42.3%) in the LC arm. The most common AE was diarrhea (66.7%) in the VC arm and were diarrhea and palmar-plantar erythrodysaesthesia syndrome (both 50%) in the LC arm. Median intended exposure and percentage of intended dose were lower in the VC arm (115.5 days, 74.6%) indicating more frequent dose interruption, dose reduction and treatment discontinuation than the LC arm (135.0 days, 99.05%).


Sensitivity analysis showed greater tumor size reduction and improved ORR for VC arm when the combination was administrated for more than 30 days. Reduced intended exposure and dose intensity for the VC arm suggests a dose reduction of varlitinib may be considered when combined with capecitabine for the 2nd line treatment of HER2+ MBC.

Clinical trial identification


Legal entity responsible for the study

ASLAN pharmaceuticals


ASLAN pharmaceuticals


All authors have declared no conflicts of interest.

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