JOURNAL OF>
`CLINICAL
`ONCOLOGY
`
`ASC®)
`
`May 30-June 3 ah
`McCormick Place
`
`heey
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`Chicago,IL
`
`Genome & Co. v. Univ. of Chicago
`PGR2019-00002
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`UNIV. CHICAGO EX. 2051
`
`lume 32, Issue 15S, Part| of II
`
`3
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`May 20, 2014
`
`Official Journal of the
`Uta(otal(TAAL edCeOLb
`
`Journal ofclinical oncology : official journal of the
`American Society of Clinical Oncology.
`v.32, no.15, suppl. pt.1 (2014)
`General Collection
`W1 JOS894H
`
`aa
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`YY erlerr
`
`2014 ASCO Annual Meeting Proceedings
`
`x
`
`PROPERTY OF THE
`
`# > | NATIONAL
`,
`MEEBICINE
`
`;
`
`1
`
`RY OF
`
`50th Annual Meeti
`
`

`

`50th
`
`Annual Meeting of the
`American Society of Clinical Oncology
`May 30-June 3, 2014
`
`Chicago, Illinois
`2014 Annual Meeting ProceedingsPart|
`(a supplement to the Journalof Clinical Oncology)
`
`
`
`Copyright 2014 American Society of Clinical Oncology
`
`

`

`Editor: Michael A. Carducci, MD
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`Managing Editor: Amy Hindman
`Editorial Coordinator: Devon Carter
`Production Manager: Donna Dottellis
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`eS
`ae
`eS
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`
`
`CONTENTS —
`
`Special Award Lecture Abstracts ......
`
`1s
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`3s
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`5s
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`48s
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`84s
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`114s
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`142s
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`179s
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`213s
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`255s
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`296s
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`continued on following page
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`
`
`Journal ofClintetl Qiealogy ASSN 0732-183N) is published 36 umesa year, three times monthly, by the American Society of Clinical Oncology, 2318 Mill Road, Suite 800,
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`2014 ASCO ANNUAL MEETING PROCEEDINGS
`
`scccccccecaavauueravauausanscacnensecsussscsesecsisnse:seesssssenseseseeneteseenenansenees
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`dessenengneeeeeeeceseseeasaneetes
`
`Saeeeeeeseeseees dacsaeeecesssersseneensenes
`
`
`
`
`
`uses
`
`Plenary (Abstracts LBA1~ LBA) -occcccsccseccssssssssssssssesessseceseeceraeesssteessnneseny
`Breast Cancer-HER2/ER
`Scheduled presentations (AbstractS 500 ~ TPS672) csccssessessceceseeneeseeeeeore
`Breast Cancer-Triple-Negative/Cytotoxics/Local Therapy
`
`Scheduled presentations (Abstracts 1000% - TPS1149) wo..eeeeeeees
`Cancer Prevention/Epidemiology
`Scheduled presentations (Abstracts 1500 - TPS161B) ...c.ssecssccssssssessesseeseenencnessssesseenessaseasensnaserensenesenanenec sages
`Central Nervous System Tumors
`Scheduled presentations (Abstracts 2000 - TPS2112) .....s-ssesssssssssseeneseerssseessenseresnssesteseneeseeserassnesnensensaceacaranens
`Developmental! Therapeutics—Clinical Pharmacology and Experimental Therapeutics
`Scheduled presentations (Abstracts 2500 - TPS2647) ...csssssssrseseeseesreseneeeessarerentrseaeserssseseananentessensenenenes
`Developmental Therapeutics—Immunotherapy
`Scheduled presentations (AbstractS 3000 - TPS3134) ...cccsccescssnssseseccensesesseneseneesseetnersessessersnapesensnneecnerensreeat
`Gastrointestinal (Colorectal) Cancer
`Scheduled presentations (AbstractS 3500 - TPS3667) ...cesesssssseccssssserersesesscssnssteseteessersenensssnaesenneetseriens
`Gastrointestinal (Noncolorectal) Cancer
`Scheduled presentations (Abstracts 4000 ~ TPS4163) occ cscssssssssssecsessescecssesseersssneseenesise
`Genitourinary (Nonprostate) Cancer
`Scheduled presentations (Abstracts 4500 - TPS4607) ooo.ceccsssssccescescssscesensreeeeeeenees
`
`

`

`
`
`Genitourinary (Prostate) Cancer
`Scheduled presentations (AbstractS 5000 - TPS5111) oecsserrseeernsveseecensenssene settatteneees Jensueseersneneeenseseseanes
`Gynecologic Cancer
`Scheduled presentations (Abstracts LBA5500 ~ TPS5632) -reeresesesscnsetennesseerenenencnenenennssenneneserivaisensentsseneas
`
`Head and Neck Cancer
`Scheduled presentations (Abstracts GOOO ~ TPSG106) ...essesssasssseecesesssnescssenessessesserestensenerseseaseussaeseraneeerenengnd
`
`Health Services Research
`Scheduled presentations (Abstracts 6500 ~ TPS6639) venice eeeenenercsnneaenersenscascrtesesabevcnecasunnenssessoenrnerens
`Leukemia, Myelodysplasia, and Transplantation
`Scheduled presentations (Abstracts 7002 - TPS712Z8) o..ccccceeecsterceetsesstenineineccnsseesieacesenneseneetenenatuneentenpens
`Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
`Scheduled presentations (Abstracts 7500 ~ TPS7612Z) v.ecessesecensensersenrnssrsneeneeces Sen caenenedenneanesvenreenes Jentceeereraneoe
`Lung Cancer—Non-Small Cell Metastatic
`Scheduled presentations (Abstracts 8000 ~ 8135) wc ieceeccesteensseoneoseeesteuernuersnesnerenees Seeesesevege des teseeeeseeerseees
`Lymphoma and Plasma Cell Disorders
`Scheduled presentations (Abstracts 8500 - TPS8630) .......ee deeeeeseueaenasasouacepervennecsuagsnuneasaensteaeusssescesnnne nesses
`
`Melanoma/Skin Cancers
`Scheduled presentations (Abstracts LBAQOOO% ~ TPS9121) oo. eeseseessseesreseessueveneseesaeueseressnousversaeensasessuaneeeeees
`
`Patient and Survivor Care
`
`Scheduled presentations (Abstracts LBAQ500% ~ TPS9G6GA4) 0...eececeeeenesceeeeeee Vunoseavannusvavertveeseseaqeaanverseeties
`
`Pediatric Oncology
`Scheduled presentations (Abstracts 10000 - TPS10095) ......ceeceeseese peeecese deebenecuenaeeaneeneeveeenenerseeentuaueataneeseamnes
`Sarcoma
`
`Scheduled presentations (Abstracts 10500 - TPS10604) oo... cceteeeerneneeee duvvecesescecuesasssqueessecereneeesereeaeensnnns
`
`Tumor Biology
`Scheduled presentations (Abstracts 11000 - TPS11136) 0.0...Lecuebecedeedennueneesseceeetteveevenuerseveuecsensaseseeseneetenenereente
`
`Author Index oo... cece ce cc ccscusesvecneseevavsusaursesssavsassavatgssuesssssssuvsevausavseratvisrecasensseessans decnuesuceessucanseseusenves
`
`323s
`
`351s
`
`384s
`
`410s
`
`445s
`
`477s
`
`506s
`
`539s
`
`571s
`
`602s
`
`644s
`
`668s
`
`695s
`
`730s
`
`
`
`— wwwjcoorg
`
`TenetrcpoegeReAAMOSMTPRArememer
`
`

`

`American Society of Clinical Oncology
`50th Annual Meeting
`
`2014 Abstracts
`
`The Plenary Sessio
`
`Descriptions of Scientific Sessions
`Plenary Session
`n includes abstracts selected by the Scientific Program Committee as having
`practice-changing findings of the highest scientific merit.
`Oral Abstract Sessions
`Oral Abstract Sessionsinclude 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 discussionsof the findings from the abstracts.
`Clinical Science Symposia
`orum for science in oncology, combining didactic lectures ona
`Clinical Science Symposia provide a f
`specific topic with the presentationof abstracts. Experts in the field serve as discussants to place
`d critically discuss the conclusions in terms of their applicability
`studies in the appropriate context an
`to clinical practice.
`
`Poster Highlights Sessions
`s feature selected abstractsof clinical research in poster format. The
`Poster Highlights Session
`posters are grouped by topic and are on display for a specified time with opportunities for networking,
`followed by a discussion session in which experts provide commentary on the research findings.
`General Poster Sessions
`abstracts of clinical research in poster format. The posters
`General Poster Sessions include selected
`are grouped by topic and are on display fora specified time. Trials in Progress abstract presentations
`n each track, and are designedto facilitate awareness of open, ongoingclinical
`are presented withi
`trials of any phase.
`
`Publication-Only Abstracts
`selected to be published online in conjunction with the Annual
`Publication-only abstracts were
`Meeting, but not to be presented at the Meeting.
`
`acts are citable to this Journal of Clinical Oncology supplement.
`All presented and publication-only abstr
`les, please see the Letter from the Editor.
`For citation examp
`ins abstracts selected by the ASCO Scientific Program Committee for
`This publication conta
`al Meeting. Abstracts selectedfor 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 numberfor scheduled
`presentations. To determine the jocation 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.
`The deadline for abstract submission for the 2015 Annual Meetingis
`Tuesday, February 3, 2015, at 11:59 PM (EST).
`
`

`

`
`
` This material may be protected by Copyright law (Title 17 U.S. Code)
`
`Lung Cancer—Non-Small Cell Metastatic
`
`511s
`
`8020_—s—Poster Highlights Session (Board #34), Tue, 8:00 AM-11:00 AM and
`8021% Poster Highlights Session (Board #35), Tue, 8:00 AM-11:00 AM and
`11:30 AM-12:45 PM
`11:30 AM-12:45 PM
`Clinical activity and biomarkers of MEDI4736,an anti-PD-L1 antibody, in
`patients with NSCLC, Presenting Author: Julie R. Brahmer, The Sidney
`Kimmel! Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
`Background: Lungcancer is the leading cause of cancer death in both men
`and women. PD-L1 is upregulated in NSCLC and maybe associated with a
`poor prognosis. MEDI4736 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 (NCTO1693562) is evalu-
`ating the safety and efficacy of MEDI4736 administered IV 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-related response criteria (irRC)
`in escalation and
`RECISTv1.1 in expansion. Results: As of Jan 17, 2014, 13 NSCLCptsin
`dose escalation (median age 65 yrs; 40-76), all PS O-1, with a median of 4
`prior treatments, received a median of 7 doses (1-25) of MEDI4736 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 fed 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; 4/13 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 NSCLCpts in total. Preliminary clinical activity
`has been observed with acceptable safety, no = grade 3 pneumonitis, and
`no apparentdifferences in toxicity between treatment-naive vs pretreated
`pts. Assessment of clinical activity by PD-L1 expression, underlying
`mutation, smoking history, and line of therapy patient-reported outcomesis
`ongoing. Conclusions: The preliminary safety and durable clinical efficacy
`profile of MEDI4736 in NSCLC supports continued clinical development;
`AEs are manageable, even in highly pretreated pts. Recruitment continues
`and development of MEDI4736 in NSCLC as monotherapyand in combina-
`tion is ongoing.Clinical trial information: NCTO1693562.
`
`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, Los Angeles, CA
`Background: This Phase | study evaluated the safety,
`tolerability, and
`clinical activity of MK-3475, a selective anti-PD-1 antibody that blocks the
`interaction between programmed death-1 (PD-1) on T-celis and PD-L1 and
`PD-L2 on tumorcells 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 (Q2W) or 3 weeks (Q3W). Some pts with tumors without
`PD-L1 expression who had received =2 prior lines of therapy were treated
`with MK-3475 at 10 mg/kg Q2W. At least
`1 measurable tumor lesion,
`ECOG performancestatus of 0-1, adequate organ function, and new tumor
`biopsy <60 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 tumorstaining. 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 casesof drug-related grade 3/4
`pneumonitis. The: preliminary ORR (confirmed & unconfirmed by irRC/
`RECIST)in all pts was 15%/21% (16%/24% for pts with PD-L1 expressing
`tumors [19%/31% 10 mp/kg Q2W, 15%/22% 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 datasetwill 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 robustantitumoractivity in previously-treated pts with progressive
`locally advanced or metastatic NSCLC that expressed PD-L1. Clinical trial
`information: NCTO1295827.
`
`8023_Poster Highlights Session (Board #37), Tue, 8:00 AM-11:00 AM and
`8022_—Poster Highlights Session (Board #36), Tue, 8:00 AM-11:00 AM and
`11:30 AM-12:45 PM
`11:30 AM-12:45 PM
`
`Safety and response with nivolumab (anti-PD-1; BMS-936558, ONO-
`Nivolumab (anti-PD-1; BMS-936558, ONO-4538)andipilimumab in first-line
`NSCLC:Interim phase| results. PresentingAuthor: Scott Joseph Antonia, H. Lee
`4538)plus erlotinib in patients (pts) with epidermal growth factor receptor
`Moffitt Cancer Center & Research Institute, Tampa, FL
`mutant (EGFR MT) advanced NSCLC. Presenting Author: Naiyer A. Rizvi,
`Background: Nivolumab, a fully human 'gG4 programmed death-1 (PD-1)
`Memorial Sloan-Kettering Cancer Center, New York, NY
`immune checkpoint
`inhibitor antibody, and ipilimumab, an IgGl CTLA-4
`Background: Erlotinib is FDA-approved for thefirst-line treatment of EGFR
`checkpointreceptorblocking antibody, have shownactivity in advanced NSCLC;
`clinical data in melanoma showed improved responses and a manageable safety
`MT NSCLC, with a median progressionfree survival (PFS) of 10.4 months.
`profile when combined. Wereport interim results from a phase| study evaluating
`Nivolumab, a fully human igG4 programmed death-1 (PD-1) immune
`first-line nivolumab + ipitimumab (N+1) in advanced NSCLCpatients (pts).
`checkpoint inhibitor antibody, demonstrated encouraging safety and sur-
`Methods: Chemotherapy-naive pts (1=46) with squamous(sq) or non-sq NSCLC
`vival outcomes as monotherapy in advanced NSCLC pts. Preclinical data
`received the 3 + 1 mg/kg or 1 + 3 mg/kg combination dose IV Q3Wfor 4 cycles
`followed by nivolumab 3 mg/kg IV Q2W until progression/unacceptable toxicity.
`support EGFR pathwayactivation of PD-L1 expression and immune escape
`Objective response rate (ORR; RECIST 1.1) was evaluated overall and by
`in EGFR driven lung tumors.Interim results from a phase| study evaluating
`baseline tumor PD-L1 status (Dako immunohistochemistry assay). After an
`nivolumab + erlotinib in an EGFR MT advanced NSCLC cohort are
`amendment, a 1 + 1 mg/kg cohort was added (n=30, data immature at Dec
`reported. Methods: Stage IIIB/IV EGFR MT chemotherapy-naive NSCLC pts
`2013 analysis). Results: In the 4 cohorts with =4 monthsfollow up, any-grade
`(EGFR TKI naive or progression post prior TKI therapy) received nivolumab
`treatment-related adverse events (managed with protocol algorithms) were
`reported in 39 pts (85%; grade 3-4 in 22 pts [48%]) and led to discontinuation
`3 mg/kg IV Q2W + erlotinib 150 mg PO daily until progression/
`in 16 pts. Treatment-related deaths (n=3) were due to respiratory failure,
`unacceptable toxicity. Objective response rate (ORR) and PFS were
`bronchopulmonary hemorrhage and toxic epidermal necrolysis. Responses
`evaluated by RECIST 1.1. Results: All pts (n=21) began study treatment
`occurred in all 4 cohorts (Table); overall ORR” was 22% (median duration of
`210 months prior to data analysis; only 1 pt was EGFR TKI naive.
`response [mDOR] not reached [NR]) and stable disease (SD)33% (range 13 -
`34.1+ wks); 2 pts exhibited unconventional “immune related”
`responses. In 29
`Any-grade treatment-related AEs were reported in all 21 pts; treatment-
`evaluable tumor samples from the study, ORR did not correlate with PD-L1
`related grade 3-4 AEs (4 pts) were increased AST (n=2) or ALT (n=1),
`status. Conclusions: These interim data in pts with advanced NSCLC suggest that
`weight decrease and diarrhea (1 pt each); 2 pts discontinued due to
`a nivolumab + ipilimumab immunotherapy regimen ts feasible and demon-
`treatment-related AEs (grade 3 AST increase and grade 2 nephritis). No
`strates antitumoractivity in both PD-L1+ and PD-L1- pts. Safety will be further
`pneumonitis (any grade) was observed. ORR was 19% (4/21 pts) and 24 wk
`assessed at the 1 + 1 mg/kg dose. The recommended combination dosefor
`phase II/III evaluation has not been determined. Clinical
`trial
`information:
`PFS rate was 47%; median duration of response (DOR) was not reached
`NCTO1454102,
`(range 6.1+ to 27.1+ wks). Of
`the 20 pts with acquired erlotinib
`
`N1+130N1+13 N3 +401 N3 +11
`
`resistance, 3 (15%) achievedpartial response (PR, all ongoing; DOR 6.1+,
`Sq
`Non-sq
`Sq
`Non-sq
`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+, 31.14,
`7
`15
`8
`16
`35.9, 52.7 and 53 wks), and 1 pt had an unconventional “immune
`1(14)
`1(7)
`2 (25)
`2(13)
`1(14)
`2 (13)
`3 (38)
`4 (25)
`related” response (ongoing), with 46% reduction in target lesions after
`3(14)
`progression in non-target lesions. The EGFR TK!-naive pt achieved PR with
`3(19)
`4 (50)
`6 (40)
`2 (29)
`SD, n(%)
`DOR 24.3+ wks (ongoing). Conclusions: These interim results suggest that
`mDOR(Kaplan-Meier)? NR(9+) NR(21+) 17(12,21) NR(24+, 25+)
`nivolumab + erlotinib may provide durable clinical benefit and an accept-
`wk (range)
`able safety profile in TKI refractory, EGFR MT advanced NSCLC, supporting
`
`
`Ongoing responders,* 1(100)=1(100) 0 2 (100)
`
`n(%)
`further evaluation of nivolumab in pts with EGFR MT NSCLC. Additional
`follow up will be presented. Clinical trial information: NCTO1454102.
`
`* Confirmed OR only. ° Confirmed + unconfirmed OR.
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`ORR,” n(%)
`
`7 (29)
`
`