JOURNAL OF
`SAINI(One
`()NCOLOGY
`
`2048 ae
`
`Volume 33,Issue 15S, Part | of Il
`
`May20, 2015
`
`Official Journal of the
`American Society of Clinical Oncology
`
`Journal of clinical oncology : official journal of the
`meen Societyof Clinical Oncology.
`.335,
`no.15, suppl. pt.1 (2015)
`General Collection
`W1 JO5894H
`
`* 2015 ASCO Annual Meeting neeen
`
`SVM)Mercelate)
`May 29-June2, 2015
`McCormick Place
`Chicago,IL
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`Editor: Michael A. Carducci, MD
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`Supplement to May 20, 2015
`
`Ufa)85-9289ismap eeann
`CLINICAL
`
`ONBOLOGY
`
`CONTENTS
`
`2015 ASCO ANNUAL MEETING PROCEEDINGS
`Special Award Lecture Abstracts
`Plenary Session
`35
`(Abstracts LBAI-| BAA)
`Pathways Clinical Science Symposia
`(Abstracts LBA100- LBA109)
`Global Oncology Symposium
`(Abstract 200)
`Breast Cancer-HER2/ER
`Scheduledpresentations (Abstracts 500 - TPS642)
`Breast Cancer-Triple-Negative/Cytotoxics/Local Therapy
`Scheduled presentations (Abstracts 1000 - TPS1113)
`Cancer Prevention, Genetics, and Epidemiology
`735
`Scheduled presentations (Abstracts 1500-1592)
`Central Nervous System Tumors
`Scheduled presentations (Abstracts 2000 - TPS2081)
`Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
`Scheduled presentations (Abstracts 2500 - TPS2624)
`Developmental Therapeutics—Immunotherapy
`148s
`Scheduled presentations (Abstracts 3000-TPS3106)
`
`.
`
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`This material may be protected by Copyright law (Title 17 U.S. Code)
`
`
`400s
`
`Lung Cancer-Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
`
`7500
`
`Oral Abstract Session, Sat, 3:00 PM-6:00 PM
`
`Bevacizumab 15mg/kg plus cisplatin-pemetrexed (CP) triplet versus CP
`doublet in Malignant Pleural Mesothelioma (MPM): Results of the IFCT-
`GFPC-0701 MAPS randomized phase 3 trial. First Author: Gerard Zaleman,
`Caen Univ Hosp, Caen, France
`Background: (MPM median overall survival (OS) did not exceed 13 months
`with pemetrexed-platinum doublet, with virtually no surviving patients at 5
`years. Vascular endothelial growth factor is a potent mitogen for MPM cells.
`Methods:
`In this French multicenter randomized phase 3 trial, eligible
`patients had unresectable, histologically proved MPM, age < 76, no prior
`chemo, PS 0-2, no thrombosis, nor bleeding. Randomized patients (1:1)
`received pem 500 mg/m*, CDDP 75 mg/m®at D1, with (arm B) or without
`bevacizumab (arm A), 15 mg/kg Q21D, for 6 cycles. Arm B non-progressive
`patients received bevacizumab maintenance therapy until progression or
`toxicity. Primary endpoint was OS. 445 patients were to be randomized,
`and 385 events observed, to show a significant OS improvement, with 80%
`statistical power, 5% a-risk. Results: From Feb, 2008 to Jan. 2014, 448
`patients were included in 73 centers. Males: 75.4%, median age: 65.7
`years (range 34.7-75.9), PS 0-1: 96.7%. The IDMC recommended a
`secondinterimanalysis after 85% of events. Qn 01-Jan-2015, the duration
`since last news was < 30 days in 105 out of 106 still
`living patients.
`Overall survival was significantly longer in the experimental arm (median:
`18.8 months, 95%Cl[15.9-22.6] vs. 16.1 months, 95%CI(14.0-17.9] for
`the reference arm, (adj.HR = 0.76, 95%CI[0.61; 0.94], p = 0.012). With
`only 46/448 non-progressive patients at the date of analysis, median PFS
`was 9.6 months, 95%CI[8.5-10.6] in bevacizumab arm vs. 7.5 months,
`95%CI[6.8-8.1] (adj.HR = 0.62, 95%CI[0.50-0.75], p < 0.0001). G3-4
`hematological toxicities did not significantly differ in the two arms (49.5%
`vs. 47.3%). Significantly more G3 proteinuria (0.0 vs. 3.1%), G3 hyperten-
`sion (0.0 vs. 23%), G3-4 arterial thrombotic events (0.0 vs. 2.7%) were
`observed in bevacizumab arm, QOL and exploratory biomarkersstudies will
`be also presented at
`time of
`the meeting. Conclusions: Bevacizumab
`addition to pemetrexed/cis-platin provides a significantly longer survival in
`pts with MPM, with acceptable toxicity, making this triplet a new treatment
`paradigm. Clinical trial information: NCTO0651456.
`
`Oral Abstract Session, Sat, 3:00 PM-6:00 PM
`7502
`Pembrolizumab (MK-3475) in patients (pts) with extensive-stage small cell
`lung cancer (SCLC): Preliminary safety and efficacy results from KEYNOTE-
`028. First Author: Patrick Alexander Ott, Dana-Farber Cancer Institute,
`Boston, MA
`Background: Treatment options for pts with SCLC that progresses on
`platinum-based chemotherapy are limited. Pembrolizumab, an anti-PD-1
`monoclonal antibody designed to block the interaction between PD-1 and
`its ligands PD-L1 and PD-L2, has shown antitumor activity in multiple
`advanced malignancies, including non-small cell lung cancer. We assessed
`the safety and efficacy of pembrolizumab in pts with PD-L1* SCLC.
`Methods: KEYNOTE-028 (ClinicalTrials.gov, NCTO2054806) is an ongoing
`multicohort, phase Ib study of pembrolizumab in pts with PD-L1'
`advanced solid tumors. Keyeligibility criteria for the SCLC cohort include:
`confirmed, measurable disease; PD-L1 expression in = 1% of cells in
`tumor nests or PD-L1" bands in stroma as assessed by IHC at a central
`laboratory; failure of standard therapy; and absenceof autoimmune disease
`or interstitial lung disease. Pembrolizumab 10 mg/kgis given every 2 wk for
`up to 2 y or until confirmed progression or unacceptable toxicity. Primary
`end points are safety, tolerability, and response assessed per RECIST v1.1
`by investigator review every 8 wk for the first 6 mo and every 12 wk
`thereafter, Results: Of the 135 pts with SCLC screened, 37 (27%) had
`PD-L1 tumors. Seventeen pts were enrolled from March 2014 through
`January 2015 (59% men; median age, 62 y; 59% ECOGPS1). One pt was
`misenrolled and did not receive pembrolizumab.All 16 treated pts received
`prior platinum and etoposide. 9 pts (53%) experienced a drug-related AE
`(DRAE); only 1 pt had a grade = 3 DRAE. There were no treatment-related
`deaths or discontinuations due to DRAEs, Four of 16 (25%) evaluable pts
`had a partial response. One (7%) pt had stable disease, resulting in a
`disease control rate of 31%. Six (37%) pts had progressive disease as their
`best response, and 5 pts had no assessment at
`the time of analysis.
`Responses are durable, with all responders on treatment for 16+ wks with
`ongoing response. Conclusions: Pembrolizumab is generally well tolerated
`and has promising antitumor activity in pts with PD-L1" SCLC who have
`progressedonprior platinum-based therapy. Enrollment in the SCLC cohort
`of KEYNOTE-028is ongoing.Clinical trial information: NCTO2054806.
`
`Oral Abstract Session, Sat, 3:00 PM-6:00 PM
`7501
`Phase III trial (NGRO15) with NGR-hTNF plus best investigator choice
`(BIC) versus placebo plus BIC in previously treated patients with advanced
`malignant pleural mesothelioma (MPM). First Author: Rabab M. Gaafar,
`National Cancer Institute, Cairo University, Cairo, Egypt
`Background: Currently, there are no standard options for MPM patients who
`failed a pemetrexed-based chemotherapy (CT). NGR-hTNF, a tumor-
`targeted antivascular agent, displays antitumor activity through a vessel
`normalization that improves intratumor CT uptake and T-cell
`infiltration.
`Methods: MPM patients who progressed onor after a front-line pemetrexed-
`based regimen, stratified for performance status (PS) and CT agent, were
`randomly assigned to receive weekly NGR-hTNF 0.8 wg/m* (arm A; n =
`200) or placebo (arm B; n = 200), both given with BIC (gemcitabine ([G],
`vinorelbine [V], doxorubicin [D] or supportive care). Primary endpoint was
`overall survival (OS). Hypothesis testing: hazard ratio (HR) = 0.72, 1-8 =
`0.80, « = 0,05. Results: Baseline characteristics were balanced between
`arms (A vs B): median age (65 vs 67 years); men (76% vs 74%); PS = 1
`(72% vs 69%); nonepithelial histology (15% vs 19%); poor EORTC score
`(30%vs 23%); prior treatment-free interval (TFI) < median of 4.8 months
`(47% vs 53%). Investigator-selected CT (n = 381, 95%): G 55%, V 42%,
`D 3%. Patients completing six CT cycles: 41% vs 32% (p = 0.08). Most
`common grade 3/4 toxicity: neutropenia (17% vs 19%) and fatigue (5% vs
`8%). After a median follow-up of 18.9 months, OS did not differ
`significantly between arms in ITT analysis (median 8.4 vs 7.9 months; HR
`= 0.94 p = 0.61), By predefined OS analyses, there was a significant
`interaction only between treatment group and TFI (p = 0.008).
`In 198
`patients with TFl shorter than 4.8 months afterfirst-line therapy, median
`OS for NGR-hTNF vs placebo was 9.0 vs 6.3 months and 1-year OS was
`39% vs 23%, respectively (HR = 0.69 p = 0.02; stratified HR = 0.65 p =
`0.01), By CT agent, median OS for NGR-hTNF plus G vs placebo plus G was
`9.0 vs 6.2 months and for NGR-hTNFplus V vs placebo plus V was 9.7 vs
`6.9 months. A significant treatment-by-TFI interaction was also observed
`for PFS (p = 0.009), with 6-month rates in the short TF! subset of 25% for
`NGR-hTNF and 12%for placebo (HR = 0.71 p = 0.03). Conclusions:
`Though the primary endpoint was not met, OS and PFS benefit reported
`with NGR-hTNF plus CT in patients with short TFl deserves a confirmatory
`first-line phaseIII trial. Clinical trial information: NCTO1098266.
`
`Oral Abstract Session, Sat, 3:00 PM-6:00 PM
`7503
`Phase1/1! study of nivolumab with or without ipilimumabfor treatmentof
`recurrent small cell lung cancer (SCLC): CA209-032.First Author: Scott
`Joseph Antonia, Moffitt Cancer Center, Tampa, FL
`Background: Patients (pts) with SCLC respond to initial platinum (PLT)
`based chemotherapy (CT), but rapidly progress. Combined blockade of
`PD-1 and CTLA-4 immune checkpoint pathways has anti-tumor activity
`with a manageable safety profile. Nivolumab (NIVO)is a fully human IgG4
`PD-1 immune checkpoint inhibitor approved in the US & Japan. Interim
`safety and efficacy of NIVO +\- ipilimumab (IPI), a CTLA-4 checkpoint
`inhibitor, in pretreated SCLC pts are reported. Methads: Pts who were PLT
`sensitive or refractory and had progressive disease were enrolled regardless
`of tumor PD-L1 status or number of prior CT regimens. This open-label
`study randomized pts to NIVO 3 mg/kg IV Q2W or NIVO+IPI (1 + 1 mg/kg,
`1 + 3 mg/kg or 3 + 1 mg/kg) IV Q3W for 4 cycles followed by NIVO 3 mg/kg
`Q2W. Primary objective was overall response rate (ORR). Other objectives
`were safety, PFS, OS and biomarkeranalysis. Results: Seventy-five pts were
`enrolled (NIVO, n = 40; NIVO+IPI, n = 35); 59% had = 2 prior regimens.
`Drug-related adverse events (DrAEs)
`in = 10% were fatigue (18%),
`diarrhea (13%), nausea (10%), and decreased appetite (10%) with NIVO;
`and fatigue (29%), diarrhea (17%), pruritus (14%), nausea, endocrine
`disorders and rash (11% each) with NIVO+IPI. Gr 3/4 DrAE in = 5%
`included diarrhea and rash (6% each; NIVO+IPI). Drug-related pneumoni-
`tis occurred in 2 pts (1 per arm). One pt experienced a drug-related SAE of
`myasthenia gravis on study which was fatal. Of 40 evaluable NIVO pts,
`partial response (PR) was seen in 6, 15% (duration of ongoing responses
`[DOR] 80-251+ days); stable disease (SD) in 9, 22.5%; and progressive
`disease (PD) in 25, 62.5%. In 20 evaluable NIVO+/PI pts, 1 had complete
`response (CR), 5% (DOR 322+ days); 4 had a PR, 20% (DOR 41-83+
`days); 6 had SD, 30%, and 9 had PD, 45%. In the NIVO+/PI arm, 12 pts
`had not reached first tumor assessment and 3 were not evaluable. Nine pts
`(23%) continue treatment with NIVO and 19 (54%) with NIVO+IPI.
`Conclusions:
`In this PD-L1 unselected SCLC population with progression
`post-PLT, NIVO alone or combined with |PI was tolerable. ORR was 15%
`(NIVO) and 25% (NIVO+IPI) for evaluable pts; durable responses were
`noted. Updated safety, clinical activity and biomarker analysis will be
`presented. Clinical trial information: NCT1928394.
`
`