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`Phase lrll Safety and Antiturncir Activity of Nivoiumab in Patients with Advanced Hepatocellular Carcinoma
`[HCC]: WEB-040
`i Presented Saturday. May 30. 2015
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` 6 VideoG Abstract @ Slides
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`Authors:
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`Anthony EL EIIKhoueiry. ignacio Melero. Todd 5. Crocenzi, Theodore Hobart Welling Thomas Cheung vau. Winnie
`Yen, Akhll Chopra. Joseph Grossc, leln Lang. Jeffrey Anderson, Christine Mane Dela Cruz, Bruno Sangro: University
`of Southern Calliomia Norris Comprehensive Cancer Center, Los Angeles. Cit Clinica Universidad de Navarra and
`CIBERend, Pamplona. Spain: Frmidence Cancer Center. Pordand....
`View More-l
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`flhslracl Discldslles
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`Background:
`Overelioresslon of PD-Ll In HCC has a poor prognosis. Safety and dreilrnlnary antlturnor efficacy of niwlu man. a
`fully human :36: monoclonal antibody PD-t Inhibitor. was evaluated In a multiple ascending-dose. phase lrll stud}r
`in patients (ms) with HCC.
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`Medmls:
`Fits wltn Histologitaily confirmed advanced HCC with Child-Pugh (E P] score 5 B? and progressive disease [90; on.
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`intolerant of. 0r refusing sorai‘enio were enrolled. Dose escalation occurred in parallel cohorts based on etiology.
`no act-fire hepatitisvfrus in-‘eCtion or viruSAim’eCLN HCC nits. Pts received nivoiurnao DJ - 10 marks. intravenously
`for up to two years. The primary endpoint was safety. Secondary endpoints Included antltumor activity using
`rni-‘iECIST criteria, pharmacokinetlcs. and immundgenltity.
`Shesuitst
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`The Study has enrolled 41 pts with a CD score of 5 (n I 35) or 6 (n = 6). e036 score of!) {n * 26) or i tn “51.18%
`with extrahepatjc metastasis andror portal vein invasion, and Hill with prior sorafenib use. Eighteen DE. remain
`on study. and 23 discontinued treatment due to PD in 117}, complete response (CR: n i 2]. drug-related adverse
`events iAEs' n = 2) and nondrug-reiated AEs (n . 2:. Drug-related AEs ofany grade occurred In 29 ptst?1%: 17%
`grade 3rd). with z 10% of pits experiencing aspartate amlnptransrerase {ASTJ increase and rash (each 1W1}, alanine
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`emlnotransferaseifilm and lipase increase {each 1596}. and arm-lase Increase [1296]. Grade 3 and 4 AB 2 5% were
`A'ST increase [12%].ALT increase (10%] and lipase increase (5%}. A dose-limiting toxicity occurred In an uninfected
`at at 10 W no maximum tolerated dose was defined in any cohort Response was evaluabie in 39 p612 Cl!
`i596] and "I partial responses [PR: 1896!. Response duration was 14- I‘i'+ months for CR 4 l-B+ months for PR. and
`1.5—1?“ months for Stable disease (SD). Overall survival {05} rate a! 6 months Is 7296.
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`conclusions:
`Niuoiumal: has a manageable AE profile and produced durable responses across all close levels and HCC cohorts
`With a favorable almond-i 05 rate. Updated safety. ar-tIturricir activity. and diurnal-Ker data wilt be presented.
`Clinical trial Information: NCI'DIESSBTB
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`Genome & Co. v. Univ. of Chicago, PGR2019-00002
`UNIV. CHICAGO EX. 2044
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