Jlume 32 Issue 'lSS Part | of II
`
`“a
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`May 20: 2014
`
`JOURNAL oF
`CLINICAL
`
`ONCOLOGY
`
`Official Journal of the
`American Society of Clinical Oncology
`
`Journal of clinical oncology : official journal of the
`American Society of Clinical Oncology.
`v. 32 no 15 suppi pt1(2014)
`General Collection
`W1 305894H
`
`1964-2014
`
`2014 ASCO'Annual Meeting Proceedings
`
`50th Annual Meeting
`May 30-June 3, 2014
`McCormick Place
`
`Chicago. IL
`
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`Genome & Co. v. Univ. of Chicago
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`ASCQ
`
`

`

`50th
`
`Annual Meeting of the
`
`American Society of Clinical Oncology
`
`May 30-June 3, 2014
`
`Chicago, Illinois
`
`2014 Annual Meeting Proceedings Part I
`
`(a supplement to the Journal of Clinical Oncology)
`
`
`
`Copyright 2014 American Society of Clinical Oncology
`
`

`

`Editor: Michael A. Carducci, MD
`
`Managing Editor: Amy Hindman
`Editorial Coordinator: Devon Carter
`
`Production Manager: Donna Dottellis
`
`Requests for permission to reprint abstracts should be directed to Intellectual Property
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`Editorial correspondence and production questions should be addressed to Managing Editor,
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`Copyright © 2014 American Society of Clinical Oncology. All rights reserved. No part Of
`this publication may be reproduced or transmitted in any form or by any means, electronic or
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`
`The American Society of Clinical Oncology assumes no responsibility for errors or
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`
`Special Award Lecture Abstracts
`
`2014 ASCO ANNUAL MEETING PROCEEDINGS
`
`
`Plenary (Abstracts LBAl - LBA4)
`
`Breast Cancer-HERZ/ER
`Scheduled presentations (Abstracts 500 - TP5672)
`
`
`
`
`
`Breast Cancer-Triple-Neqative/Cytotoxics/Local Therapy
`
`Scheduled presentations (Abstracts 1000" - TPSli49)
`
`.......
`
`Cancer Prevention/Epidemiology
`Scheduled presentations (Abstracts 1500 - TP51618)
`
`Central Nervous System Tumors
`Scheduled presentations (Abstracts 2000 - TPSZHZ)
`
`Developmental Therapeutics-Clinical Pharmacology and Experimental Therapeutics
`Scheduled presentations (Abstracts 2500 - TP82647)
`
`Developmental Therapeutics-lmmunotherapy
`Scheduled presentations (Abstracts 3000 - TPS3l34)
`
`Gastrointestinal (Colorectal) Cancer
`Scheduled presentations (Abstracts 3500 - TPS3667)
`
`Gastrointestinal (Noncolorectal) Cancer
`Scheduled presentations (Abstracts 4000 — TPS4163)
`
`Genitourinary (Nonprostate) Cancer
`Scheduled presentations (Abstracts 4500 - TPS4607)
`
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`2965
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`continued on following page
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`

`

`
`
`Genitourinary (Prostate) Cancer
`Scheduled presentations (Abstracts 5000 — TPS5111)
`
`.......................................... . ............
`
`..........................
`
`Gynecologic Cancer
`Scheduled presentations (Abstracts LBA5500 ~ TPS5632)
`
`...........................................................................
`
`Head and Neck Cancer
`
`Scheduled presentations (Abstracts 6000 - TP56106)
`
`...................................................
`
`Health Services Research
`
`Scheduled presentations (Abstracts 6500 — TPS6639) ........................................................................................
`
`Leukemia, Myelodysplasia, and Transplantation
`Scheduled presentations (Abstracts 7002 - TPS7128)
`
`.......................................................................................
`
`Lunq Cancer—Non-Small Cell Local-Reqional/Small Cell/Other Thoracic Cancers
`Scheduled presentations (Abstracts 7500 ~ TPS7612) ...........................................
`.........................
`
`.............
`
`Lunq Cancer-Non-Small Cell Metastatic
`Scheduled presentations (Abstracts 8000 - 8135) ............................................................. r. ............ . ...... l...............
`
`Lymphoma and Plasma Ce|l Disorders
`Scheduled presentations (Abstracts 8500 - TP58630) .............. l ..........................................................................
`
`Melanoma/Skin Cancers
`Scheduled presentations (Abstracts LBA9000" - TPS9121) .................................................................................
`
`Patient and Survivor Care
`
`Scheduled presentations (Abstracts LBA9500" - TPS9664) .................................... i............................................
`
`Pediatric Oncology
`Scheduled presentations (Abstracts 10000 - TP510095) ....................... , ........ . ......................................................
`Sarcoma
`
`Scheduled presentations (Abstracts 10500 - TPS10604) ....................................
`
`.....................................................
`
`Tumor Biology
`Scheduled presentations (Abstracts 11000 - TP511136)
`
`...........i ...........................................................................
`
`Author Index ........................................................................................................................... i...............................
`
`323s
`
`351s
`
`3845
`
`4105
`
`4455
`
`4775
`
`5065
`
`5395
`
`5715
`
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`
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`
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`

`

`American Society of Clinical Oncology
`50th Annual Meeting
`
`2014 Abstracts
`
`Descriptions of Scientific Sessions
`
`The Plenary Sessio
`
`Plenary Session
`n includes abstracts selected by the Scientific Program Committee as having
`practice-changing findings of the highest scientific merit.
`
`OralAbstract Sessions
`Oral Abstract Sessions include didactic presentations of abstracts of the highest scientific merit, as
`determined by the Scientific Program Committee. Experts in the field serve as Discussants and
`provide comprehensive themed discussions of the findings from the abstracts.
`Clinical Science S ymposia
`Clinical Science Symposia provide a forum for science in oncology, combining didactic lectures on a
`Specific topic with the presentation of abstracts. Experts in the field serve as discussants to place
`studies in the appropriate context and critically discuss the conclusions in terms of their applicability
`to clinical practice.
`
`Poster Highlights Session
`Posters are grouped by topic and are on
`followed by a discussion session in w
`
`Poster Highlights Sessions
`5 feature selected abstracts of clinical research in poster format. The
`display for a specified time with opportunities for networking,
`hich experts provide commentary on the research findings.
`
`General Poster Sessions
`General Poster Sessions include selected abstracts of clinical research in poster format. The posters
`are grouped by topic and are on display for a specified time. Trials in Progress abstract presentations
`are presented within each track, and are designed to facilitate awareness of open, ongoing clinical
`trials of any phase.
`
`Publication-Only Abstracts
`Publication-only abstracts were selected to be published online in conjunction with the Annual
`Meeting, but not to be presented at the Meeting.
`
`AIIpresented and publication-only abstracts are citable to this Journal of Clinical Oncology supplement.
`For citation examples, please see the Letter from the Editor.
`
`ins abstracts selected by the ASCO Scientific Program Committee for
`This publication conta
`al Meeting. Abstracts selected for electronic publication only are
`Presentation at the 2014 Annu
`line through ASCO.org and JCO.org. The type of session, the day,
`available in full-text versions on
`and the session start/end times are located to the right of the abstract number for scheduled
`presentations. To determine the location of the abstract session, refer to the Annual Meeting
`Program or the iPlanner, the online version of the Annual Meeting Program, available at am.asco.org.
`Dates and times are subject to change.
`All modifications will be posted on am.asco.org.
`adline for abstract submission for the 2015 Annual Meeting is
`Tuesday, February 3, 2015, at 11:59 PM (EST).
`
`The de
`
`

`

`
`This material may be protected by Copyright law (Title 17 US. Code)
`
`
`
`
`Lung Cancer—Non-Small Cell Metastatic
`
`51 is
`
`8020
`
`Poster Highlights Session (Board #34), Tue, 8:00 AM-11:00 AM and
`11:30 AM-12:45 PM
`
`Safety and clinical activity of MK-3475 in previously treated patients (pts)
`with non-small cell lung cancer (NSCLC). Presenting Author: Edward B.
`Garon, University of California, Los Angeles, LosAnge/es, CA
`Background: This Phase I study evaluated the safety.
`tolerability, and
`clinical activity of MK-3475, a selective anti-PD-l antibody that blocks the
`interaction between programmed death-1 (PD-1) on T-cells and PD-L1 and
`PD-L2 on tumor cells in pts with previously-treated, progressive locally
`advanced or metastatic NSCLC. Methods: Previously—treated pts with
`NSCLC whose tumors expressed any detectable PD—L1 using a preliminary
`immunohistochemical assay were randomized to MK-3475 at 10 mg/kg
`every 2 weeks (02W) or 3 weeks (Q3W). Some pts with tumors without
`PD-L1 expression who had received 22 prior lines of therapy were treated
`with MK-3475 at 10 mg/kg Q2W. At least
`1 measurable tumor lesion,
`ECOG performance status of 0-1, adequate organ function, and new tumor
`biopsy 360 days prior to study entry were required. Tumor response was
`assessed every 9 wks until disease progression by investigator review using
`immune-related response criteria (irRC) and independent central review
`using RECIST 1.1. Results: 450 pts provided tissue for PD-L1 assessment;
`305 were eligible based on PD-L1 tumor staining. 221 pts (n=102, Q2W
`[including 43 whose tumors did not express PD-L1]; n=119, Q3W) began
`treatment between Feb 2013 and Oct 2013. 48% of pts experienced
`drug-related adverse events (AEs), usually grade 1-2 in severity, most
`commonly fatigue (13%), decreased appetite (6.5%), arthralgia (6.1%),
`pruritus (5.4%), rash (4.7%), and pyrexia (3.6%). The incidence of grade
`3/4 drug-related AEs was 6%. There were 3 cases of drug-related grade 3/4
`pneumonitis. Thevpreliminary ORR (confirmed & unconfirmed by irRC/
`RECIST) in all pts was 15%l21% (16%l24% for pts with PD-L1 expressing
`tumors l19%/31% 10 mg/kg 02W, 15%l22% 10 mg/kg Q3W], 10%/8%
`for pts without PD-L1 tumor expression. 40% of pts had <18 wks of
`follow-up and 69 pts (33%) remain on treatment. A mature dataset will be
`available for presentation,
`including correlation between level of tumor
`PD-L1 expression and response rates. Conclusions: In this cohort of over
`200 pts,
`treatment with MK-3475 was generally well
`tolerated and
`provided robust antitumor activity in previously-treated pts with progressive
`locally advanced or metastatic NSCLC that expressed PD-L1. Clinical trial
`information: NCT01295827.
`
`8021 "
`
`Poster Highlights Session (Board #35), Tue, 8:00 AM-11:00 AM and
`11:30 AM-12:45 PM
`
`Clinical activity and biomarkers of MEDl4736, an anti-PD-Ll antibody, in
`patients With NSCLC. Presenting Author: Julie R. Brahmer, The Sidney
`Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
`Background: Lung cancer is the leading cause of cancer death in both men
`and women. PD-L1 is upregulated in NSCLC and may be associated with a
`poor prognosis. MEDl4736 is a human lgG1 antibody which binds
`specifically to PD-L1 preventing binding to PD-1 and CD80. Methods: An
`ongoing phase 1, multicenter, open‘label study (NCT01693562) is evalu-
`ating the safety and efficacy of MEDl4736 administered lV every 2 wks
`(q2w) or every 3 wks (q3w) using a 3+3 dose escalation followed by
`expansion cohorts. NSCLC pts were assigned to expansion cohorts by
`histology and line of therapy (including treatment- naive pts). Retreatment
`was permitted for progression after 12 mos of therapy. Response is
`assessed by immune~re|ated response criteria (irRC)
`in escalation and
`RECIST v1.1 in expansion. Results: As of Jan 17, 2014, 13 NSCLC pts in
`dose escalation (median age 65 yrs; 40-76), all PS 0-1, with a median of 4
`prior treatments, received a median of 7 doses (1-25) of MEDl4736 across
`6 cohorts (0.1 — 10 mg/kg q2w; 15 mg/kg q3w). Treatment-related AEs
`occurred in 43% of pts, all of which were Grade 1-2; none led to
`discontinuation of study drug. No pneumonitis or colitis was reported in
`dose escalation. Of 13 pts, 3 PRs were observed, with 2 additional pts
`achieving tumor shrinkage not meeting PR per irRC (46% and 48%
`decreases). Tumor shrinkage was reported as early as first assessment (6
`wks) and benefit was durable; 4l13 pts remain on study (10+, 10+,
`11.1+, 14.9+ mos) as of the data cutoff. Expansion cohorts opened Sep
`2013; 43 pts (including treatment-naive pts) have been dosed, with the
`opportunity to enroll > 300 NSCLC pts in total. Preliminary clinical activity
`has been observed with acceptable safety, no 2 grade 3 pneumonitis, and
`no apparent differences in toxicity between treatment-naive vs pretreated
`pts. Assessment of clinical activity by PD-L1 expression, underlying
`mutation, smoking history, and line oftherapy patient-reported outcomes is
`ongoing. Conclusions: The preliminary safety and durable clinical efficacy
`profile of MEDl4736 in NSCLC supports continued clinical development;
`AEs are manageable, even in highly pretreated pts. Recruitment continues
`and development of MEDl4736 in NSCLC as monotherapy and in combina-
`tion is ongoing. Clinical trial information: NCT01693562.
`
`8022
`
`Poster Highlights Session (Board #36), Tue, 8:00 AM-11:00 AM and
`11:30 AM-12:45 PM
`
`8023
`
`Poster Highlights Session (Board #37), Tue, 8:00 AM-11:00 AM and
`11:30 AM-12:45 PM
`
`Nivolumab(anti-PD-1; EMS-936558, ONO-4538) and ipilimumab iniirst-Iine
`NSCLC: Interim phase I results. PresentingAuthor: ScottJoseph Antonia, H. Lee
`Moffitt Cancer Center & Research Institute, Tampa, FL
`Background: Nivolumab, a fully human lgG4 programmed death-1 (PD-1)
`immune checkpoint
`inhibitor antibody, and ipilimumab, an lgGI CTLA»4
`Che?kpoint receptor blocking antibody, have shown actiVIty in advanced NSCLC;
`clinical data in melanoma showed improved responses and a manageable safety
`profile when combined. We report interim results from a phase I studyevaluating
`first-line nivolumab + ipilimumab (N+l) in advanced NSCLC patients (pts).
`Methods: Chemotherapy—naive pts (n=46) with squamous (sq) or non~sq NSCLC
`received the 3 + 1 mg/kg or 1 + 3 mg/kg combination dose IV (13W for 4 cycles
`followed by nivolumab 3 mg/kg IV (12W until progression/unacceptable toxiCIty.
`Objective response rate (ORR; RECIST 1.1) was evaluated overall and by
`baseline tumor PD—Ll status (Dako immunohistochemistry .assay). After an
`amendment, a 1 + 1 mg/kg cohort was added (n=30, data immature at Dec
`2013 analysis). Results: In the 4 cohorts with 24 months fONOW UP. any-grade
`treatment~related adverse events (managed wrth protocol algorithms) were
`reported in 39 pts (85%; grade 3-4 in 22 pts [48%]) and led to discontinuation
`in 16 pts. Treatment-related deaths (n=3) were due to respiratory failure.
`bronchopulmonary hemorrhage and toxic epidermal necrolysis. Responses
`occurred in all 4 cohorts (Table); overall ORRb was 22% (median duration of
`reSPOI'lSE [mDOR] not reached [NR]) and stable disease (SD)"33% (range 13 —
`34.1+ wks); 2 pts exhibited unconventional “immune related responses. in 29
`evaluable tumor samples from the study, ORR did not correlate With PD-Ll
`status. Conclusions: These interim data in pts wrthadvanced NSCLC suggest that
`a nivolumab + ipilimumab immunotherapy regimen is feaSible and demon-
`strates antitumor activity in both PD—L1+ and PD-Ll— pts. Safety will be further
`assessed at the 1 + 1 mg/kg dose. The recommended combinatton dose. for
`phase ll/lll evaluation has not been determined. Clinical
`trial
`information:
`NCT01454102.
`
`Safety and response with nivolumab (anti-PD-l; EMS-936558, ONO-
`4538) plus erlotinib in patients (pts) with epidermal growth factor receptor
`mutant (EGFR MT) advanced NSCLC. Presenting Author: Naiyer A. Rizvi,
`Memorial Sloan-Kettering Cancer Center, New York, NY
`Background: Erlotinib is FDA-approved for the first-line treatment of EGFR
`MT NSCLC, with a median progression free survival (PFS) of 10.4 months.
`Nivolumab, a fully human lgG4 programmed death-1 (PD-1) immune
`checkpoint inhibitor antibody, demonstrated encouraging safety and sur-
`vival outcomes as monotherapy in advanced NSCLC pts. Preclinical data
`support EGFR pathway activation of PD-L1 expression and immune escape
`in EGFR driven lungtumors. interim results from a phase I study evaluating
`nivolumab + erlotinib in an EGFR MT advanced NSCLC cohort are
`reported. Methods: Stage lllB/IV EGFR MT chemotherapy-naive NSCLC pts
`(EGFR TKI naive or progression post prior TKI therapy) received nivolumab
`3 mg/kg lV Q2W + erlotinib 150 mg PO daily until progression/
`unacceptable toxicity. Objective response rate (ORR) and PFS were
`evaluated by RECIST 1.1. Results: All pts (n=21) began study treatment
`210 months prior to data analysis; only 1 pt was EGFR TKI naive.
`Any-grade treatment—related AEs were reported in all 21 pts; treatment-
`related grade 3—4 AEs (4 pts) were increased AST (n=2) or ALT (n=1),
`weight decrease and diarrhea (1 pt each); 2 pts discontinued due to
`treatment-related AEs (grade 3 AST increase and grade 2 nephritis). No
`pneumonitis (any grade) was observed. ORR was 19% (4/21 pts) and 24 wk
`PFS rate was 47%; median duration of response (DOR) was not reached
`(range 6.1+ to 27.1+ wks). Of
`the 20 pts with acquired erlotinib
`resistance, 3 (15%) achieved partial response (PR, all ongoing; DOR 6.1+,
`16.3+ and 27.1+ wks); 9 pts (45%) had stable disease with 3/9 (33%)
`ongoing (time to progression/death 9.9+, 15.7, 21, 22.3, 24.4+, 31.1+,
`35.9, 52.7 and 53 wks), and 1 pt had an unconventional “immune
`related" response (ongoing), with 46% reduction in target lesions after
`progression in non-target lesions. The EGFR TKl-naive pt achieved PR with
`DOR 24.3+ wks (ongoing). Conclusions: These interim results suggest that
`nivolumab + erlotinib may provide durable clinical benefit and an accept—
`able safety profile in TKl refractory, EGFR MT advanced NSCLC, supporting
`further evaluation of nivolumab in pts with EGFR MT NSCLC. Additional
`follow up will be presented. Clinical trial information: NCT01454102.
`
`N
`0RR.‘ n (%)
`0RR,”n (%)
`
`N1+I3
`Sq
`7
`1(14)
`1(14)
`
`N1+I3
`Non-sq
`15
`1(7)
`2 (13)
`3 (14)
`6 (40)
`2 (29)
`SD. n (%)
`mDOR (Kaplan-Meier),' NR (9+) NR (21+)
`wk (range)
`Ongoing responders,‘
`n (%)
`
`1 (100)
`
`1 (100)
`
`N3+|1
`Sq
`8
`2 (25)
`3 (38)
`
`N3+l1
`Non-sq
`16
`2 (13)
`4 (25)
`
`7 (29)
`
`3 (19)
`4 (50)
`17 (12, 21) NR (24+, 25+)
`
`O
`
`2 (100)
`
`3 Confirmed OR only. b Confirmed + unconfirmed OR.
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