Author of

• 18374

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  P3.02b - Poster Session with Presenters Present (ID 494)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 18500

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    P3.02b-126 - Clinical Activity of Olmutinib (HM61713) Used on a Compassionate IND Basis for Patients with Lung Adenocarcinoma (LADC) in Korea (ID 5605)

    14:30 - 14:30  |  Author(s): G.K. Lee
    • Abstract

    Background:
    Olmutinib (HM61713) is an oral EGFR tyrosine kinase inhibitor (TKI), which selectively inhibits EGFR mutations, including both activating mutations and T790M, but not EGFR wild-type. It showed good safety profile and promising anti-tumor activity in patients with EGFR mutated NSCLC that progressed after EGFR-TKIs, especially in those with T790M mutation.
    
    Methods:
    Between 08/2014 and 05/2016, we treated 27 LADC patients (11 male, 16 female) with Olmutinib on a compassionate IND basis, which was provided by Hanmi Pharmaceutical Co. Ltd. The starting dose of oral Olmutinib was 650 mg/day in 12 patients and 800 mg/day in 15 patients. The EGFR mutation status was assessed either by direct sequencing after PCR or by PNA mediated real-time PCR clamping or both, and ddPCR of cell-free plasma DNA. Tumor response was assessed using RECICT criteria every 2-3 cycles of treatment with repeat CT chest, MRI brain, and PET/CT, as appropriate.
    
    Results:
    The median age was 62 years (range 42-74); ECOG was 0/1/2/3 in 6/12/7/2 patients. All but one patient had prior treatment with EGFR-TKIs (17 as first[t]-line therapy, 9 upon PD after chemotherapy). In 5 patients, EGFR-TKI was the only treatment given before Olmutinib while 21 patients received median of 2 (range 1-5) chemotherapy regimens in addition (18 platinum-based, 3 non-platinum-based). Prior EGFR-TKIs used were gefitinib in 14, erlotinib in 10, and both in 2 patients; 2 patients received afatinib in addition. Overall, 15 of 27 received 3 or more regimens of chemo and/or EGFR-TKI (median, 3; range, 0-7). While one patient had wild type EGFR only, 26 patients had EGFR mutations. One patient had de novo EGFR T790M mutation in resected tumor sample, and 14 had Ex19 del, 9 had L858R mutation, 1 had both Ex19 del & L858R and 1 had Ex 20 P772S mutation. T790M mutation was detected in 18, not detected in 7, and unknown in 2 patients. Of 24 patients evaluable for tumor response, 14(58.3%) achieved PR, 2 SD, and 8 PD. Patients with T790M mutation tend to have better ORR than those without or unknown (12/16 [75.0%] vs. 2/6 [33.3%] vs. 0/2 [0.0%]). Olmutinib was well tolerated with no additional major adverse effects other than what was previously reported in phase I/II studies.
    
    Conclusion:
    Olmutinib showed promising anti-tumor activity for patients with EGFR mutated LADC that progressed after prior treatment with EGFR-TKIs, especially in those with T790M mutation, including the one who had de novo T790M mutation.