Volume 33, Issue 15S, Part | of Il
`
`May 20, 2015
`
`tat] moma
`ODT MOLL
`American Society of Clinical Oncology
`
`Journal ofclinical oncology:official journal of the
`American SocietyofClinical Oncology.
`v.33, no.15, suppl. pt.1 (2015)
`General Collection
`W1 JO5894H
`
`‘2015 ASCO Annual Meeting Proceedings
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`OURNAL OF
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`(ONCOLOGY
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`5ist
`
`Annual Meeting of the
`American Society of Clinical Oncology
`May 29-June 2, 2015
`Chicago, Illinois
`2015 Annual Meeting ProceedingsPart|
`(a supplementto the Journalof Clinical Oncology)
`
`
`
`Copyright 2015 American Society of Clinical Oncology
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`Editor: Michael A. Carducci, MD
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`Managing Editor: Amy Hindman
`Editorial Coordinator: Devon Carter
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`Merya aa
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`CONTENTS:
`
`
`
`
`
`2015 ASCO ANNUAL MEETING PROCEEDINGS
`Special Award Lecture ADStracts «wnrmnanirnnnsinnnenninnncanannn
`Plenary Session
`(Abstracts LBA1~ LBAA) cere
`PathwaysClinical Science Symposia
`(Abstracts LBA1IOO - LBA109) «--ssserceererserrreresrrrrer ne
`Global Oncology Symposium
`(AbStract ZOO) uo... esseseerrrrsreccenenecererees
`Breast Cancer-HER2/ER
`acts 500 - TPS642) .
`Scheduled presentations (Abstr
`ive/Cytotoxics/Local Therapy
`Breast Cancer-Triple-Negat
`PSU13) cccccscsescceeresescessseserecsetnsncnceceerseceestreascensaeseneransiasssamaoragenenes
`Scheduled presentations (Abstracts 1000 - T
`netics, and Epidemiology
`Cancer Prevention, Ge
`500 - 1592) cssssvvsessvssessseceenneneenessesseneeassssansasnansoenceneceecennennsirearsanicaninia
`Scheduled presentations (Abstracts 1
`Central Nervous System Tumors
`00 — TPSZO81) sessssntesstssinstesteseenstensnnseusteneeanrntnnseeetnntneteste
`Scheduled presentations (Abstracts 20
`Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
`Scheduled presentations (Abstracts 2500 - TPS2624) vesecsececereessesssessecnsussessessseneccasecsaveceestcanvetensinesvercesateanrent
`peutics~-Immunotherapy
`Developmental Thera
`§ 3000 - TPS3106) sosreccsersesessenetssstneenennansarnennenestanernerrornatstint
`Scheduled presentations (Abstract
`
`
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`1s
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`45s
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`73s
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`96s
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`117s
`148s
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`continued on following page
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`JournalofClinicslOncology(SSN (732-183Nispublished 36timesayearythreetimesmonthlybytheAmerican SocietyofClinical Oncology, 2318 Mill Road, Suite 800,
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`JournalofClinical Oncology®is 3 registered trademarkofAmerican Societyof ClinicalOncology, Inc,
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`A
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`ene CORED Rhee R eee Hae eee R OHS R RE ERO R EE
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`AONE RON NOTE C EE COME ETRE E ERAN DHOOM ODORS EES OM COED
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`269s
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`eee ee eee ee eee WOOL aeRO EOE mee DOE E eRe E ENN eM EaD
`
`Gastrointestinal (Colorectal) Cancer
`aoreeee teres beveree
`hep onnneesanenenene Fe vcenereneune tenet
`175s
`Scheduled presentations (Abstracts 3500 - TPS3635) we.
`Gastrointestinal (Noncolorectal) Cancer
`Scheduled presentations (Abstracts 4000 - TPS4153)
`Genitourinary (Nonprostate) Cancer
`Scheduled presentations (Abstracts 4500 - 4586) vessccccccscscsscssoseeoeesesseese,
`Genitourinary (Prostate) Cancer
`Scheduled presentations (Abstracts 5000 - TPSS5S084)
`Gynecologic Cancer
`Scheduled presentations (Abstracts LBASSOO - TPS5619) wo.
`Head and Neck Cancer
`Scheduled presentations (Abstracts 6000 - TPS6088) ....... Oheneeentasnseneseesvvepnesuesssconecesssnenennaasnananenseaenmeneenaer sever
`Health Services Research and Quality of Care
`Scheduled presentations (Abstracts 6500 - TPS6625) wove
`Leukemia, Myelodysplasia, and Transplantation
`Scheduled presentations (Abstracts 7000 - TPS7103) .....cssssccssesssssnercesesssseccssesnersueesepressnensGusevacananeseresnneensereess
`Lung Cancer-Non-Small Cell Local-Regional/Small Cefl/Other Thoracic Cancers
`Scheduled presentations (Abstracts 7500 ~ TPS7586) voceccccccsccssessnccececersyeresSetesanneganseveseueneceeessanaceceresecensaneeae
`Lung Cancer~Non-Small Cell Metastatic
`Scheduled presentations (Abstracts 8000 - TPSBIN1) vo .ccceesuceees deeevshatsensnaeesnareaanereseneesdeeenneeves tresereacaaescenesens tees
`Lymphoma and Plasma Cell Disorders
`Scheduled presentations (Abstracts 8500 - TPSB614) ooiececcescsscenssceneseeeseaseessceestcvnoneees teeeseanenenersee tnesenseee teens
`Melanoma/Skin Cancers
`Scheduled presentations (Abstracts 9000 - TPS9094) voc ceceicecusetanecsstecosessteeeeeese
`Patient and Survivor Care
`Scheduled presentations (Abstracts 9500 - TPS9G64B) oceccsesesscccneestsesenueusectesneseenscssscopeusecacensseseecesnsenesesenen sas
`Pediatric Oncology
`Scheduled presentations (Abstracts 10000 - TPS10083) ....... deveeeeseesens cecaceseeseeceeesereeeeeceeecereasenseceeseess desenennenees .
`Sarcoma
`Scheduled presentations (Abstracts 10500 - TPSIO5S7B&) iicccccccecceeccccceccccuevusseseuaveeevseeeseespesceseseseseneeers devensaee bee
`Tumor Biology
`vieeeeeecstecssessssreeeenscceesssuaseeessesperstescesssavsuveeecassaaunsaverssasnnuneneee
`Scheduled presentations (Abstracts 11000 - T1113)
`Author Idex occ cccccccsessssssseseccansvevecssavesessevsecersssssecausessesnnacacssaveccausecesstessestuseessasaveceeassesssnsnescessavesscanreeeee
`
`
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`342s
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`bode neers ere meena TEE ee Benue ODES
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`3745s
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`400s
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`422s
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`450s
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`479s
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`503s
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`539s
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`560s
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`580s
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`609s
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`150s
`
`3008
`
`Ora! Abstract Session, Mon, 1:15 PM-4:15 PM
`
`Developmental Therapeutics-Immunotherapy
`3009
`Poster Discussion Session;Displayed in Poster Session (Board #33
`Sat, 8:00 AM-11:30 AM,Discussed in Poster Discussion el '
`Autologous HER2 CMVbispecific CARTcells for progressive glioblastoma:
`Sat, 3:00 PM-4:1
`Results from a phase | clinical trial. First Author: Nabil M. Ahmed, Texas
`Pembrolizumab (MK-3475) plus low-dose ipilimumab (IPI) in patiens
`Children's Hosp Baylor Coll Of Medcn, Houston, TX
`(pts) with advanced melanoma (MEL) orrenal cel! carcinoma (RCC): pe
`Background: Glioblastoma (GBM) remains virtually incurable. T-cell therapy
`from the KEYNOTE-029 phase 1 study. First Author: Michael B. Atkins
`holds the promise to improve outcomesfor GBM patientssince it does not
`Georgetown-Lombardi Comprehensive Cancer Center, Washington,
`rely on the cytotoxic mechanismsof conventional therapies. We have shown
`Background: Pembrolizumab is a potent, highly selective, humane
`in preclinical studies that HER2 and CMV are potential T-cell
`therapy
`monoclonal antibody against PD-1 that has shown robust antitumor ac
`targets for GBM. Methods: We report the initial results of the phase| clinical
`against several advanced malignancies.
`In phase 1 testing, combina
`study, NCTO1109095, administering autologous CMV.pp65Tcells grafted
`therapy with the anti-PD-1 antibody nivolumabandfull-dose !PI (3 melt
`with a second generation HER2 chimeric antigen receptor (CAR; with a
`CD28.zeta signaling domain) to patients with progressive GBM. Results:
`was seemingly associated with improved response rates but also increas
`toxicities (NEJM 2013;369:122-33), Here, we report the phase 1 date
`Sixteen CMV-seropositive patients with HER2-positive GBM and radiologi-
`cal evidence of progression aged 11-70 (median age 49) were enrolled.
`concurrent administration of pembrolizumab and low-dose IPIin pts a
`Autologous HER2-CAR CMV T cells were successfully generated for all
`advanced MEL or RCC, Methods: KEYNOTE-029 (NCTO2089689) 0b
`phase 1/2 study of pembrolizumab plus IPI or pegylated interferon alfas
`patients from a peripheral blood draw (maximum 90mL). T-cell products
`contained HER2-CAR expressing T cells as judged by FACS analysis
`(PEG-IFN). Assessment of the safety and tolerability of pembrolizum
`(median: 67% (range: 46-82) %), and CMV. pp65-specific T cells as judged
`plus PEG-IFN is ongoing. Safety and tolerability of pembrolizumab 2 m by
`by IFN-gamma Elispot assays (median 985.5 (range 390 to 1292)
`plus low-dose IPI 1 mg/kg every 3 weeks (Q3W) for 4 doses, followe
`SFC/10° T cells). Infusions of 1x10°%/m?, 3x10°/m?, 1x107/m?, 3x107/m2
`pembrolizumab 2 me/kg Q3W for up to 2 years, were assesse?:
`or 1x108/m?HER2-CAR.CMV-Tcells were well tolerated without systemic
`confirmation continued until 18 pts completed the 6-wk observation per
`side effects and no dose limiting toxicity was observed. HER2-CAR CMV T
`(Cycle 1). DLTs were evaluated in pts who completed the first c¥C% ,
`cells were detected in the peripheral blood for up to 12 weeks postinfusion
`combination therapy or who discontinued due to a treatment-relate
`Ts.
`as judged by real-time PCR of a CAR-specific amplicon. Out offifteen
`The dose would be considered tolerable if <6 pts experienced
`12
`evaluable patients, 10 had progressive disease. Five out of fifteen patients
`Toxicities were graded by CTCAE v4.0. Response is assessed at W
`5
`had objective responses:
`1 patient had a partial response with a ~62%
`every 6 wk thereafter until wk 30, and every 12 wk thereafter. Results:
`ts):
`reduction in tumor volume lasting 8 months, 1 patient had stable disease
`were observed in 6 of 19 evaluable pts (2 of 9 RCCpts,4 of 10
`L Ph
`lasting 4 months and 3 patients have stable disease and are currently alive
`All DLTs were of grade 3 severity. Two pts experienced 2 DLTs nd
`with a follow up of 18 to >24 months, after T cell infusion. Conclusions:
`elevation of pancreatic enzymes and hyperthyroidism in 1 patient
`Ts
`This initial evaluation of the safety and efficacy of autologous HER2-CAR
`lipase elevation and pneumonitis in another patient. The remaining
`CMV bispecific T cells in patients with progressive GBM shows that
`were ALT/ASTelevation (n = 2), colitis (n = 1), and uveitis ( and
`infusions are safe and that cells could persist for up to 12 weeks in the
`Responses have been observed in MEL and RCC pts. Additional safety. ns:
`peripheral blood. Clinical benefit was observed in 33% of patients setting
`preliminary efficacy data will be available for presentation. Gonclus!
`the stage for studies that combine HER2-CAR CMV T ceils with other
`Pembrolizumab and low-dose {P| combination therapy was consider? sed
`immunomodulatory approaches to enhancetheir expansion and anti-GBM
`have an acceptable safety profile in this initial safety run-in period.
`sage
`an"
`activity. Clinical trial information: NCTO1109095.
`on these results, we have initiated a protocol-specified, single-armOy
`sion cohort to further evaluate the safety,
`tolerability, and Prorein
`efficacy of this combination in adva
`vical tria
`tion: NCTO2089685.
`nced MELpts. Clinic
`
`3010
`
`Poster Discussion Session; Displayed in Poster Session (Board #336),
`Sat, 8:00 AM-11:30 AM, Discussed in Poster Discussion Session,
`Sat, 3:00 PM-4:15 PM
`
`Preliminary safety and activity of nivolumab and its combination with
`ipilimumab in recurrent glioblastoma (GBM): CHECKMATE-143. First
`Author; John H. Sampson, Duke University Medical Center, Durham, NC
`Background: GBM has a grim prognosis despite current first-line therapies.
`{mmune checkpoint inhibitors have shown antitumoractivity in both solid
`tumors and preclinical glioma models. This study evaluates the safety/
`tolerability of the checkpoint inhibitors nivolumab (NIVO) and ipilimumab
`(IPI) in patients (pts) with a first recurrence of GBM. Methods: Pts were
`randomized to NIVO 3 mg/kg Q2W or NIVO 1 mp/kg +
`IPI 3 mg/kg
`(NIVO+IPI) Q3W followed by NIVO 3 mg/kg Q2W. Eligible pts had first
`recurrenceof primary GBM, no prior bevacizumab treatment and KPS =70,
`The primary endpoint was safety/tolerability. This analysis reports the
`preliminary experience after all pts had the opportunity to,complete 2=6
`months (mo)of follow-up after first dose. Results: 20 pts were treated, 10 in
`each arm. Al! pts had prior surgical resection, radiation, and temozolomide.
`Median age was 57 years (range: 37-73), KPS=90 (n==13), 80 (n=2) and
`70 (n=5), Median time from first GBM diagnosis was 9 mo. The median
`numberof doses (range) received in NIVO arm was 6 (3-23). In NIVO+IPI,
`pts received 3 (2-8) doses of NIVO and 2 (2-4) of IP!. Drug-related adverse
`events (AE) in 23 pts were fatigue (n=3) and nausea (n=3) with NIVO and
`fatigue (n = 8), diarrhea (n = 7), AST and lipase increased (n = 5 each),
`vomiting and ALT increased (n=4 each), and amylase increased, head-
`ache, hyperthyroidism, nausea and maculo-papular rash (n=3 each) with
`NIVO+IPI, All NIVO AEs were grade 1 or 2. Eight (80%) NIVO+IP! pts had
`grade 3 or 4 AEs. Drug-related AEs leading to discontinuation occurred only
`in NIVO+IPI pts (n = 5; 50%), including colitis, cholecystitis, diabetic
`ketoacidosis, confusion, and increasedlipase. There were no drug-related
`deaths. Among 20 treated pts, OS at 6 mo. was 75%, including 7/10 NIVO
`pts (70%) and 8/10 NIVO+IPI pts (80%). ORR, PFS, and biomarker
`analysis are being evaluated. Conclusions: Thisis the first randomized study
`to report the safety/tolerability of checkpoint inhibitors in GBM. The AE
`profile of NIVO + IPI was consistent with studies in other tumors. OS at 6
`mo.
`is encouraging relative to comparable historical controls. Updated
`safety, efficacy, and biomarkerdata including on-treatment histopathology
`will be presented. Clinical trial information: NCTO2017717.
`
`3011
`
`.
`.
`.
`37)
`Poster Discussion Session; Displayed in Poster Session (Board tet
`Sat, 8:00 AM-11:30 AM, Discussed in Poster Discussion se pM
`Sat, 3:00 PMA
`Safety andefficacy of MEDI4736,ananti-PD-L1 antibody,in patien'® ot
`a squamous cell carcinoma of the head and neck (SCCHN) rrrcancel
`cohort. First Author: Neil Howard Segal, Memorial Sloan Kettering
`Center, New York, NY
`piM)
`:
`Background: Outcomesare poorfor atients (pts) with recurrentimetastatic( ters
`SCCHN,and new treatments are heeded An seine phase I/II, multe of
`open-label study (NCTO1693562) is evaluating the safety and ef D-
`and
`MEDI4736 (M), a human IgGl mAb that blocks PD-L1 binding to PUging
`CD80with high affinity and selectivity, in multiple solid tumor typeste with
`SCCHN. PD-L1 is expressed in SCCHN tumors and may be assoclath of 0
`responseto anti-PD-L1 treatment, Methods: Pts with R/M SCCHN, an tered 'V
`or 1, withoutprior anti-PD-1/PD-L1 exposureareeligible. M is admin's”
`oon
`every 2 weeks at 10 mg/kg for 12 months. Retreatment is permite g the
`Progression after 12 months. PD-L1 expression is assessed by! u ently,
`Ventana SP263 clone. Prior documented HPV status is collected at stu Yjude
`Responseis based oninvestigator assessment per RECISTv1.1. Data reviously
`represent a larger population with more mature follow up than Pies: Asal
`reported (Fury M, et al. Poster presented al ESMO 2014, 988PD). Rese, ol
`31 Oct 2014, 62 pts (mean age 58 years [range 24-96]; 86% mariaa™
`current/prior smokers; ECOG 0/1: 38%/62%; HPV pos/neg/unk:
`odian ot
`21%), with a medianof3 prior systemic treatments (1-10), received 4 ine most
`6 doses (1-26). Drug-related AEs were observed in 60% of pts: tz?
`frequent were fatigue (11%), diarrhea, (8%), and nausea (7%) GrFatigues
`related AEs were reported in 7%of pts: rash (2 pts), and increased
`tin ation
`and tumorinflammation (1 pt each), No drug-related AEs led to discon ots wert
`or death. No colitis or grade = 3 pneumonitis was observed. Overall, 9
`25% in
`evaluable for response with = 24 weeks of follow up; ORR was 12 spo se
`PD-L1+pts), and DCR at 24 weeks was 16%(25%in PD-L1+ pts). Rey+ to
`are ongoing in 5/6 respondingpts, with response durations ranging fronusions:
`43+ weeks. Median duration of response has not been reached. Corb an
`With more mature follow up, the safety profile of Min SCCHN is managercr ar
`consistent with previous reports. Responses are durable; ORR ang
`on
`higherin POLL + pts.A registration programis underwayin pts withformato”
`and
`in combination wi
`ali
`ab.
`Clinical
`trla
`NCToleGaeen
`th tremelimumab. Ctinic
`
`
`This material may be protected by Copyright law (Title 17 U.S. Code)
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