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Proffered paper session 1

1230 - A global Phase II study of Olmutinib (HM61713) in patients with T790M-positive NSCLC after failure of first-line EGFR-TKI (412O)


18 Nov 2017


Proffered paper session 1


Cytotoxic Therapy;  Clinical Research;  Non-Small Cell Lung Cancer


Keunchil Park


Annals of Oncology (2017) 28 (suppl_10): x124-x143. 10.1093/annonc/mdx671


K. Park1, P.A. Jänne2, C. Yu3, L. Bazhenova4, L. Paz-Ares5, E. Baek6, O. Han6, K.Y. Hong6, H. Kwon6, Y. Kim6, S.R. Kim6

Author affiliations

  • 1 Division Of Hematology-oncology, Department Of Medicine, Samsung Medical Center, 06351 - Seoul/KR
  • 2 Medical Oncology, Dana-Farber Cancer Institute, 2215 - Boston/US
  • 3 Department Of Internal Medicine, National Taiwan University Hospital, Taipei/TW
  • 4 Medicine, Moores UCSD Cancer Center, 92093 - La Jolla/US
  • 5 Medical Oncology, University Hospital 12 De Octubre, 28041 - Madrid/ES
  • 6 Clinical Research, Hanmi Pharmaceutical Co., Ltd, Seoul/KR


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Abstract 1230


Olmutinib (HM61713) is an oral EGFR mutant specific tyrosine kinase inhibitor (TKI) which has shown modest clinical activity and tolerability in patients with EGFR TKI pretreated NSCLC harboring a T790M mutation in a phase I study. The global Phase II trial was designed to evaluate the efficacy and safety of olmutinib 800mg monotherapy in patients with T790M-positive NSCLC.


Patients received olmutinib 800 mg/day in 21-day cycles. Primary endpoint was centrally confirmed objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), disease control rate (DCR), and safety. This study was conducted at 68 sites in 10 countries (Korea, Malaysia, Taiwan, the Philippines, Australia, Italy, Spain, Germany, US and Canada).


162 patients (median age: 63) were enrolled in the study. After median 5.9 months of follow up, median treatment duration was 5.3 months (range: 0.03-13.01). Among 115 patients evaluable for independent reviewer response assessment, 59 (51.3%) patients achieved objective response, including 51 (44.4%) patients with confirmed response. Median PFS was 6.9 months (95% CI 5.8–not reached) and DCR was 87.8% (101/115). In post-hoc subgroup analysis, ORR was 43.3% (95% CI 30.6-56.8) in patients with brain metastases and 45.5% (95% CI 32.0-59.5) without brain metastases at baseline. Median PFS in patients with brain metastases (6.8 months; 95% CI 5.4-not reached) was similar to that in patients without brain metastases (9.5 months; 95% CI 5.8-not reached). In this study, the most common treatment-related AEs were diarrhea (37.7%), hyperkeratosis, nausea, and rash (25.3% of each). The proportion of patients with treatment-related AEs (Grade3) was 45.1% and 9 (5.6%) patients discontinued treatment. Dose reductions to 600mg and to 400mg were reported in 54 (33.3%) patients and in 7 (4.3%) patients, respectively. One case of toxic epidermal necrolysis (TEN) with fatal outcome was reported.


Olmutinib showed modest activity with tolerable safety profile in patients with T790M+ NSCLC who had previously received an EGFR TKI. Optimal dose of olmutinib is being determined by additional translational studies, to produce more improved therapeutic outcome in phase III clinical trials.

Clinical trial identification


Legal entity responsible for the study

Hanmi Pharmaceutical Co., Ltd.


Hanmi Pharmaceutical Co., Ltd.


All authors have declared no conflicts of interest.

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