Journal ArticleDOI
Phase I/II safety and antitumor activity of nivolumab in patients with advanced hepatocellular carcinoma (HCC): CA209-040.
Anthony B. El-Khoueiry,Ignacio Melero,Todd S. Crocenzi,Theodore H. Welling,Thomas Yau,Winnie Yeo,Akhil Chopra,Joseph F. Grosso,Lixin Lang,Jeffrey Anderson,Christine Dela Cruz,Bruno Sangro +11 more
Reads0
Chats0
TLDR
Nivolumab has a manageable AE profile and produced durable responses across all dose levels and HCC cohorts, with a favorable 6-month OS rate.Abstract:
LBA101 Background: Overexpression of PD-L1 in HCC has a poor prognosis. Safety and preliminary antitumor efficacy of nivolumab, a fully human IgG4 monoclonal antibody PD-1 inhibitor, was evaluated in a multiple ascending-dose, phase I/II study in patients (pts) with HCC. Methods: Pts with histologically confirmed advanced HCC with Child-Pugh (CP) score ≤ B7 and progressive disease (PD) on, intolerant of, or refusing sorafenib were enrolled. Dose escalation occurred in parallel cohorts based on etiology: no active hepatitis virus infection or virus-infected HCC pts. Pts received nivolumab 0.1 – 10 mg/kg intravenously for up to two years. The primary endpoint was safety. Secondary endpoints included antitumor activity using mRECIST criteria, pharmacokinetics, and immunogenicity. Results: The study has enrolled 41 pts with a CP score of 5 (n = 35) or 6 (n = 6), ECOG score of 0 (n = 26) or 1 (n = 15), 73% with extrahepatic metastasis and/or portal vein invasion, and 77% with prior sorafenib use. Eighteen pts ...read more
Citations
More filters
Journal ArticleDOI
Mechanism-driven biomarkers to guide immune checkpoint blockade in cancer therapy
TL;DR: This work discusses biomarkers for anti-PD1 therapy based on immunological, genetic and virological criteria and suggests mechanism-based insights from such studies may guide the design of synergistic treatment combinations based on immune checkpoint blockade.
Journal ArticleDOI
Evidence-Based Diagnosis, Staging, and Treatment of Patients With Hepatocellular Carcinoma.
TL;DR: Studies now aim to identify molecular markers and imaging techniques that can detect patients with HCC at earlier stages and better predict their survival time and response to treatment.
Journal ArticleDOI
Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies
Jarushka Naidoo,David B. Page,Bob T. Li,L. C. Connell,Katja Schindler,Mario E. Lacouture,Mario E. Lacouture,Michael A. Postow,Michael A. Postow,Jedd D. Wolchok,Jedd D. Wolchok +10 more
TL;DR: Clinical studies investigating single-agent anti-PD-1/PD-L1 therapy and trials of combination approaches with other standard anticancer therapies, in multiple tumor types are reviewed and the key adverse events reported in these studies are summarized.
Journal ArticleDOI
Management of immune checkpoint blockade dysimmune toxicities: a collaborative position paper
Stéphane Champiat,Stéphane Champiat,Olivier Lambotte,Emmanuel Barreau,Rakiba Belkhir,Amandine Berdelou,Franck Carbonnel,Cécile Cauquil,Philippe Chanson,Philippe Chanson,Michael Collins,Antoine Durrbach,Stéphane Ederhy,S. Feuillet,Hélène François,Julien Lazarovici,J. Le Pavec,J. Le Pavec,E. De Martin,Christine Mateus,Jean-Marie Michot,Didier Samuel,Jean-Charles Soria,Jean-Charles Soria,Caroline Robert,Alexander M.M. Eggermont,Aurélien Marabelle,Aurélien Marabelle +27 more
TL;DR: Practical guidelines are proposed for the oncologist to help in the clinical care of patients under ICB immunotherapy, which can become life-threatening if not anticipated and managed appropriately.
Journal ArticleDOI
Liver Cancer Cell of Origin, Molecular Class, and Effects on Patient Prognosis
Daniela Sia,Augusto Villanueva,Scott L. Friedman,Josep M. Llovet,Josep M. Llovet,Josep M. Llovet +5 more
TL;DR: Proposals of the cell of origin of liver tumorigenesis are reviewed and the classes of liver cancer based on molecular features are clarified and how they affect patient prognosis are clarified.
Related Papers (5)
Sorafenib in Advanced Hepatocellular Carcinoma
Josep M. Llovet,Sergio Ricci,Vincenzo Mazzaferro,Philip Hilgard,Edward Gane,Jean-Frédéric Blanc,André Cosme de Oliveira,Armando Santoro,Jean-Luc Raoul,Alejandro Forner,Myron Schwartz,Camillo Porta,Stefan Zeuzem,Luigi Bolondi,Tim F. Greten,Peter R. Galle,Jean Francois Seitz,Ivan Borbath,Dieter Häussinger,Tom Giannaris,Minghua Shan,M. Moscovici,D. Voliotis,Jordi Bruix +23 more
Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial.
PD-1 Blockade in Tumors with Mismatch-Repair Deficiency
Dung T. Le,Jennifer N. Uram,Hao Wang,Bjarne Bartlett,Holly Kemberling,Aleksandra Eyring,Andrew D. Skora,Brandon Luber,Nilofer S. Azad,Daniel A. Laheru,Barbara A. Biedrzycki,Ross C. Donehower,Atif Zaheer,George A. Fisher,Todd S. Crocenzi,James J. Lee,Steven M. Duffy,Richard M. Goldberg,Richard M. Goldberg,Albert de la Chapelle,Albert de la Chapelle,Minori Koshiji,Feriyl Bhaijee,Thomas Huebner,Ralph H. Hruban,Laura D. Wood,Nathan Cuka,Drew M. Pardoll,Nickolas Papadopoulos,Kenneth W. Kinzler,Shibin Zhou,Toby C. Cornish,Janis M. Taube,Robert A. Anders,James R. Eshleman,Bert Vogelstein,Luis A. Diaz +36 more
Improved Survival with Ipilimumab in Patients with Metastatic Melanoma.
F. Stephen Hodi,Steven J. O'Day,David F. McDermott,R. W. Weber,Jeffrey A. Sosman,John B. A. G. Haanen,Rene Gonzalez,Caroline Robert,Dirk Schadendorf,Jessica C. Hassel,Wallace Akerley,Alfons J.M. van den Eertwegh,Jose Lutzky,Paul Lorigan,Julia Vaubel,Gerald P. Linette,David W. Hogg,Christian H. Ottensmeier,Céleste Lebbé,Christian Peschel,Ian Quirt,Joseph I. Clark,Jedd D. Wolchok,Jeffrey S. Weber,Jason Tian,Michael Yellin,Geoffrey M. Nichol,Axel Hoos,Walter J. Urba +28 more
Safety, activity, and immune correlates of anti-PD-1 antibody in cancer.
Suzanne L. Topalian,F. Stephen Hodi,Julie R. Brahmer,Scott N. Gettinger,David Smith,David F. McDermott,John D. Powderly,Richard D. Carvajal,Jeffrey A. Sosman,Michael B. Atkins,Philip D. Leming,David R. Spigel,Scott J. Antonia,Leora Horn,Charles G. Drake,Drew M. Pardoll,Lieping Chen,William H. Sharfman,Robert A. Anders,Janis M. Taube,Tracee L. McMiller,Haiying Xu,Alan J. Korman,Maria Jure-Kunkel,Shruti Agrawal,Dan McDonald,Georgia Kollia,Ashok Kumar Gupta,Jon M. Wigginton,Mario Sznol +29 more