Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
responses) and disease control rate (DCR) was 44% and 85% respectively. In the
dose cohorts between 150 mg BID and 300 mg BID (n=95 pts), the ORR and DCR
were 51% and 89%. PK shows rapid absorption with a T max
of 2-4h and a median
T1/2 of 8 h. At 300 mg BID, total 32 patients were treated and ORR and DCR are
53% and 90% respectively. Based on the efficacy, safety and PK results, the
300 mg BID was selected as RP2D. The phase II, AEGIS-1 study has started.The
Phase II result will be presented. Conclusion: AC0010 shows a safe profile and
antitumor activity against T790M mt NSCLC. Phase II, AEGIS-1 study is ongoing
to evaluate therapeutic outcomes as a second line treatment for T790M
positive NSCLC patients. Clinical trial information: NCT02330367
Keywords: Phase I/II study, NSCLC, T790M, AC0010
MA16: NOVEL STRATEGIES IN TARGETED THERAPY
WEDNESDAY, DECEMBER 7, 2016 - 14:15-15:45
MA16.07 DRUG REPURPOSING TO OVERCOME DE NOVO
RESISTANCE OF NON-TRADITIONAL EGFR MUTATIONS
Jacqulyne Robichaux 1 , Zhi Tan 2 , Monique Nilsson 1 , Shuxing Zhang 2 , Kwok-Kin
Wong 3 , John Heymach 4
1 Thoracic/head and Neck Medical Oncology, University of Texas MD Anderson
Cancer Center, Houston/TX/United States of America, 2 Experimental Therapeutics,
University of Texas MD Anderson Cancer Center, Houston/TX/United States of
America, 3 Medical Oncology, Dana Farber Cancer Institute, Boston/MA/United
States of America, 4 Thoracic/Head & Neck Medical Oncology, University of Texas
MD Anderson Cancer Center, Houston/TX/United States of America
This abstract is under embargo until December 3, 2016 at 07:00 CET.
America, 4 University of Colorado Cancer Center, Aurora/CO/United States of America,
5 University of Pittsburgh Medical Center, Pittsburg/PA/United States of America,
6 Unc Lineberger Comprehensive Cancer Center, Chapel Hill/NC/United States of
America, 7 Peter MacCallum Cancer Center, Melbourne/VIC/Australia, 8 Massachusetts
General Hospital, Boston/MA/United States of America, 9 Dana-Farber Cancer
Institute, Boston/MA/United States of America, 10 Pfizer Oncology, La Jolla/CA/United
States of America, 11 Rho Inc, Chapel Hill/NC/United States of America
Background: MET alterations leading to exon 14 skipping occur in ~4% of nonsquamous
nonsmall cell lung cancer (NSCLCs) and 20–30% of sarcomatoid lung
carcinomas, resulting in MET activation and sensitivity to MET inhibitors in
vitro. 1–4 Crizotinib, initially developed as a MET inhibitor, is currently approved
for the treatment of ALK-rearranged and ROS1-rearranged advanced NSCLC.
We present crizotinib antitumor activity and safety data in patients (pts) with
MET exon 14-altered advanced NSCLC. Methods: Advanced NSCLC pts positive
for MET exon 14-alteration status determined locally by molecular profiling
were enrolled into an expansion cohort of the ongoing phase I PROFILE 1001
study (NCT00585195) and received crizotinib at a starting dose of 250 mg
BID. Objective responses were assessed using RECIST v1.0. Results: As of the
data cut-off of Feb 01, 2016, 21 pts with MET exon 14-altered NSCLC received
crizotinib treatment (18 response-evaluable, 3 not yet evaluable). Median
age was 68 y (range: 53−87). Tumor histology was: 76% adenocarcinoma,
14% sarcomatoid adenocarcinoma, 5% adenosquamous carcinoma, and 5%
squamous cell carcinoma. Sixty-two percent (62%) of pts were former-smokers,
38% never-smokers, and there were no current smokers. Duration of treatment
ranged from 0.2 to 12.2 mo, with 76% of pts (16/21) still ongoing. Five pts
discontinued treatment (1 due to AE, 3 due to clinical or disease progression,
and 1 preferred alternative treatment formulation). PRs were observed in 8
pts, for an objective response rate of 44% (95% CI: 22–69); 9 pts had stable
disease. Median time to response was 7.8 weeks (range: 7.0–16.3), which was
the approximate time of the scheduled first on treatment tumor scans for
patients. Median progression-free survival could not be calculated. The most
common (≥25%) treatment-related AEs (TRAEs) were edema (43%) diarrhea
(33%), nausea (33%), vision disorder (33%), and vomiting (29%). Most TRAEs
were grade 1/2 in severity and consistent with the known safety profile of
crizotinib. Four grade 3 TRAEs (edema, bradycardia, anemia, and weight
increased) and no grade 4 or 5 TRAEs were reported. Enrollment of pts with
MET exon 14-altered NSCLC continues, and updated data will be available
at the time of presentation. Conclusion: Crizotinib has clinically meaningful
antitumor activity in pts with MET exon 14-altered advanced NSCLC. The drug
has a tolerable AE profile, consistent with that previously reported for pts
with ALK-rearranged or ROS1-rearranged advanced NSCLC. Further study of
crizotinib in this pt population is warranted.
Keywords: non-small cell lung cancer, crizotinib, MET
MA16: NOVEL STRATEGIES IN TARGETED THERAPY
WEDNESDAY, DECEMBER 7, 2016 - 14:15-15:45
MA16: NOVEL STRATEGIES IN TARGETED THERAPY
WEDNESDAY, DECEMBER 7, 2016 - 14:15-15:45
MA16.09 ANTITUMOR ACTIVITY AND SAFETY OF CRIZOTINIB IN
PATIENTS WITH MET EXON 14-ALTERED ADVANCED NON-SMALL
CELL LUNG CANCER
Alex Drilon 1 , Sai-Hong Ou 2 , Jeffrey Clark 3 , D. Ross Camidge 4 , Mark Socinski 5 ,
Jared Weiss 6 , Benjamin Solomon 7 , Gregory Riely 1 , Rebecca Heist 8 , Geoffrey
Shapiro 9 , Sherry Wang 10 , Maria Winter 10 , Katherine Monti 11 , Keith Wilner 10 ,
Paul Paik 1
1 Memorial Sloan Kettering Cancer Center, New York/NY/United States of
America, 2 University of California at Irvine, Irvine/CA/United States of America,
3 Massachusetts General Hospital Cancer Center, Boston/MA/United States of
MA16.10 LUNG-MAP (S1400) LUNG MASTER PROTOCOL: ACCRUAL
AND GENOMIC SCREENING UPDATES
Vassiliki Papadimitrakopoulou 1 , Mary Redman 2 , David R. Gandara 3 , Fred
R. Hirsch 4 , Philipp Mack 5 , Hossein Borghaei 6 , Corey Langer 7 , James Wade 8 ,
Martin Edelman 9 , Kathy Albain 10 , Primo Lara 5 , Charu Aggarwal 11 , Mark
Socinski 12 , Scott Gettinger 13 , Lyudmila Bazhenova 14 , Shakun Malik 15 , Vincent
Miller 16 , Shannon Mcdonough 17 , Ellen V. Sigal 2 , Karen Kelly 18 , Roy Herbst 19
1 MD Anderson Cancer Center, Houston/TX/United States of America, 2 Friends of
Cancer Research, Washington/DC/United States of America, 3 Division of Hem-
Oncology, UC Davis Comprehensive Cancer Center, Sacramento/CA/United States
of America, 4 Other, Univ. of Colorado Cancer Center, Aurora/CO/United States of
America, 5 UC Davis Comprehensive Cancer Center, Sacramento/CA/United States
of America, 6 Medical Oncology, Fox Chase Cancer Center, Philadelphia/PA/United
States of America, 7 Hematology/Oncology, University of Pennsylvania Health System,
Philadelphia/PA/United States of America, 8 Heartland Ncorp, Decatur/IL/United
States of America, 9 University of Maryland Medical Center, Baltimore/MD/United
States of America, 10 Dept of Medicine, Division of Hematology/Oncology, Loyola
Univ Chicago Stritch School of Medicine, Maywood/IL/United States of America,
11 Hematology/Oncology, University of Pennsylvania, Philadelphia/PA/United
States of America, 12 Medicine, University of Pittsburgh, Pittsburgh/United States
of America, 13 Yale Cancer Center, New Haven/CT/United States of America, 14 Moores
Cancer Center, University of California San Diego, La Jolla/United States of America,
15 Ctep, NCI/NIH, Rockville/MD/United States of America, 16 Clinical Development,
Foundation Medicine, Inc, Cambridge/MA/United States of America, 17 Swog Statistical
Center, Seattle/WA/United States of America, 18 Hematology Oncology, UC Davis
Comprehensive Cancer Center, Sacramento/CA/United States of America, 19 Medical
Oncology, Yale Cancer Center, New Haven, Ct/CT/United States of America
Background: Lung-MAP (S1400), is a master protocol that incorporates
genomic testing of tumors through a next generation sequencing (NGS)
platform (Foundation Medicine) and biomarker-driven (matched) therapies
for patients with squamous cell lung cancer (SCCA) after progression on firstline
chemotherapy. Methods: The Lung-MAP trial, activated June 16, 2014,
includes 3 matched- and 1 non-match study. Matched studies include: S1400B
evaluating taselisib, a PI3K inhibitor, S1400C evaluating palbociclib, a CDK
Copyright © 2016 by the International Association for the Study of Lung Cancer
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