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`ASCO Meeting Library
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`Antitumor Activity of the Anti-PD-1 Antibody Pembrolizumab in Biomarker-
`Unselected Patients with R/M Head and Neck Cancer: Preliminary Results from
`KEYNOTE-012 Expansion Cohort
`Presented Monday,June 1, 2015
`
`signin CQ ?)
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`Addto Collection @
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`Abstract
`6 Video @ slides
`
`Authors:
`TanguyY. Seiwert, Robert |. Haddad, Shilpa Gupta, Ranee Mehra, Makoto Tahara, Raanan
`Berger, Se-Hoon Lee, Barbara Burtness, Dung T. Le, Karl Heath, Amy Blum, Marisa Dolled-Filhart,
`Kenneth Emancipator, Kumudu Pathiraja, Jonathan D. Cheng, Laura Q. Chow: The University of
`Chicago, Chicago, IL; Dana-Farber CancerInstitute, Boston, MA; H. Lee Moffitt Cancer Center
`and Research Institute, Tampa...
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`First Author: ceeaD
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`Meeting:
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`Session
`Type:
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`2015 ASCO
`Annual Meeti
`eee
`Oral Abstract
`Session
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`AbstractDisclosures
`.
`Background:
`Pembrolizumab (MK-3475)is a humanized monoclonal antibody that blocks interaction of PD-1
`[=|
`Head and Neck
`withits ligands, PD-L1 and PD-L2, thereby promotingactivity of tumor-specific effectorT cells.
`ia)
`Cancer
`KEYNOTE 012 (NCTO1848834) had previously demonstratedclinical activity of pembrolizumab
`fe)
`LeAsoos
`Abstract#:
`10 mg/kg every 2 weeks in patients (pts) with recurrent/metastatic SCCHN enriched for PD-L1-
`positive tumors with a response rate of 20%. We now report on the larger SCCHN expansion
`
`cohort of KEYNOTE 012,irrespective of biomarker status using a 3-weekly fixed dose. Clinical Trial§=—NCTO1848834
`Registry
`Number:
`
`aes "
`Track:
`
`centane Neck
`Head and Neck
`cee
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`Methods:
`Pts with advanced SCCHN irrespective of PD-L1 expression or HPV status received a fixed dose
`of 200 mg pembrolizumab,intravenously, every 3 weeks. Pts were evaluated every 8 weeks with
`radiographic imaging. The primary end point was overall response rate (ORR) perinvestigator
`assessment (RECI|ST 1.1). Secondary objectives included progression-free survival (PFS) and
`overall survival (OS). Adverse events (AEs) were assessed according to CTCAE v4. PD-L1 was
`assessed retrospectively by immunohistochemistry.
`
`Results:
`132 pts with recurrent/metastatic SCCHN were enrolled. Mean (SD) age was 58.9 (9.7) years;
`83.3% were male; 56.8% had 2 2 lines of therapy for recurrent disease. 73/132 pts (55.3%)
`remain on treatment. Out of 132 treated pts, 99 pts were available for this preliminary efficacy
`analysis with a post-baseline scan or discontinued therapy prior to the scan dueto clinical
`progression or AE. ORR(confirmed and unconfirmed) per RECIST 1.1 was 18.2% (95% Cl, 11.1-
`27.2) with 18 partial responses and 31.3% with stable disease. Biomarkeranalysis is ongoing
`and results will be presented. Drug-related AEs of any grade occurred in 47% ofall enrolled pts,
`and drug-related grade = 3 AEs occurredin 7.6%. The mast common drug-related AEs ( = 5%) of
`any grade were fatigue (12.1%), decreased appetite (6.8%), pyrexia (6.1%), and rash (5.3%).
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`Conclusions:
`
`Pembrolizumab givenat a fixed dose of 200 mg every 3 weeks was well tolerated and
`demonstrated a clinically meaningful ORR of 18.2% in pts with recurrent/metastatic SCCHN.
`Clinicaltrial information: NCT01848834
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`Subtrack:
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`ceeton:
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`20'5Gurel
`ebstr LEAGOOS)
`Head and neck squamous cell
`Geren)
`Outcome assessment
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`Drug safety
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`Advanced disease
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`Programmed deathligand 1
`Biomarkers.
`
`Late breaking abstracts
`2015 Annual Meeting
`Proceedings Notices
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`Genome & Co. v. Univ. of Chicago, PGR2019-00002
`UNIV. CHICAGO EX. 2045
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