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20 results on '"I. Lowy"'

1. FP04.03 Clinical Benefit of First-Line Cemiplimab in Patients with Locally Advanced NSCLC: Subgroup Analysis from EMPOWER-Lung 1

Author

M. Gogishvili, Frank Seebach, P. Rietschel, S. Lee, Igor Bondarenko, Mahmut Gumus, D. Bentsion, Jennifer McGinniss, Giuseppe Gullo, Virote Sriuranpong, O. Gladkov, Irfan Cicin, Sadettin Kilickap, Philip Clingan, I. Lowy, Naiyer A. Rizvi, Ahmet Sezer, Mustafa Ozguroglu, Jean-Francois Pouliot, and Haci Mehmet Turk

Subjects
Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Lung, business.industry, First line, Locally advanced, Subgroup analysis, medicine.anatomical_structure, Internal medicine, medicine, In patient, business
Published
2021

2. LBA52 EMPOWER-Lung 1: Phase III first-line (1L) cemiplimab monotherapy vs platinum-doublet chemotherapy (chemo) in advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%

Author

M. Gogishvili, I. Lowy, Siyu Li, P. Rietschel, Haci Mehmet Turk, Irfan Cicin, Naiyer A. Rizvi, I. Bondarenko, Mahmut Gumus, D. Bentsion, Oleg Gladkov, Sadettin Kilickap, Giuseppe Gullo, Philip Clingan, Virote Sriuranpong, S. Lee, Ahmet Sezer, and Mustafa Ozguroglu

Subjects
Chemotherapy, Lung, biology, business.industry, First line, medicine.medical_treatment, chemistry.chemical_element, non-small cell lung cancer (NSCLC), Hematology, medicine.disease, Programmed cell death ligand 1, medicine.anatomical_structure, Oncology, chemistry, PD-L1, medicine, biology.protein, Cancer research, Platinum, business
Published
2020

3. Impact of Prior Lines of Systemic Therapy (PST) on the Efficacy Of Cemiplimab, a Human Monoclonal Anti–PD-1, in Patients (PTS) with Advanced Cutaneous Squamous Cell Carcinoma (CSCC)

Author

Dirk Schadendorf, Annette M. Lim, Karl D. Lewis, Leonel Hernandez-Aya, Jocelyn Booth, Matthew G. Fury, I. Lowy, Jigar Desai, Axel Hauschild, Alexander Guminski, Nikhil I. Khushalani, Zhen Chen, Danny Rischin, Anne Lynn S. Chang, Siyu Li, Elizabeth Stankevich, Brett G.M. Hughes, Michael R. Migden, and Chrysalyne D. Schmults

Subjects
medicine.drug_class, business.industry, medicine.medical_treatment, Phases of clinical research, Hematology, Monoclonal antibody, medicine.disease, Chemotherapy regimen, Cytokine release syndrome, Oncology, Monoclonal, medicine, Cancer research, Progression-free survival, business, Adverse effect, Neoadjuvant therapy
Published
2019

4. 115P Survival data from EMPOWER-Lung 4: Phase II study of cemiplimab plus ipilimumab in the second-line (2L) treatment of advanced non-small cell lung cancer (NSCLC)

Author

Yvonne Summers, J. De Castro Carpeno, Hwa Ryeon Kim, P. Rietschel, S. Lee, M. Majem Tarruella, M. Cobo, Y. Xu, Byoung Yong Shim, C.A. Thomas, C-H. Chiu, I. Lowy, and Jeong Seon Ryu

Subjects
Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Lung, business.industry, Phases of clinical research, non-small cell lung cancer (NSCLC), Ipilimumab, medicine.disease, Survival data, Second line, medicine.anatomical_structure, Internal medicine, Medicine, business, medicine.drug
Published
2021

5. 1269P EMPOWER-lung 4: Phase II, randomized, open-label high dose or standard dose cemiplimab alone/plus ipilimumab in the second-line treatment of advanced non-small cell lung cancer (NSCLC)

Author

I. Lowy, C.A. Thomas, C-H. Chiu, M. Cobo, M. Majem Tarruella, P. Rietschel, H.R. Kim, Y. Xu, Jeong Seon Ryu, J. De Castro Carpeno, S. Lee, Yvonne Summers, and Byoung-Yong Shim

Subjects
Oncology, medicine.medical_specialty, Lung, Second line treatment, business.industry, non-small cell lung cancer (NSCLC), Ipilimumab, Hematology, medicine.disease, medicine.anatomical_structure, Internal medicine, Medicine, Open label, business, medicine.drug
Published
2020

6. Phase II study of 2 dosing regimens of cemiplimab, a human monoclonal anti–PD-1, in metastatic cutaneous squamous cell carcinoma (mCSCC)

Author

Anne Lynn S. Chang, Axel Hauschild, Jessica L. Geiger, Alexander Guminski, Nikhil I. Khushalani, Matthew G. Fury, Chrysalyne D. Schmults, Siyu Li, Thomas Eigentler, Dirk Schadendorf, Annette M. Lim, Anna C. Pavlick, Claas Ulrich, Michael R. Migden, Brett G.M. Hughes, Lara Dunn, I. Lowy, Danny Rischin, and Elizabeth Stankevich

Subjects
business.industry, medicine.medical_treatment, Cancer, Phases of clinical research, Hematology, medicine.disease, Radiation therapy, Oncology, Pharmacokinetics, Response Evaluation Criteria in Solid Tumors, Monoclonal, Cancer research, Medicine, Dosing, business, Adverse effect
Published
2019

7. Cemiplimab, a human PD-1 monoclonal antibody, in patients (pts) with recurrent or metastatic cervical cancer: Interim data from phase I cohorts

Author

Matthew G. Fury, Daniel C. Cho, Melissa Mathias, Irene Brana, Antonio González-Martín, I. Lowy, M. Gil-Martin, Kyriakos P. Papadopoulos, Gerald Steven Falchook, A. Weise, M. Feng, J.Y. Hou, Aung Naing, Salma K. Jabbour, Kathleen N. Moore, Danny Rischin, Jingjin Li, Joaquina Baranda, and Silvia C. Formenti

Subjects
Oncology, medicine.medical_specialty, medicine.drug_class, business.industry, Hematology, Monoclonal antibody, 03 medical and health sciences, 0302 clinical medicine, Interim, Internal medicine, 030220 oncology & carcinogenesis, medicine, In patient, 030212 general & internal medicine, business, Metastatic cervical cancer
Published
2018

8. P2.01-26 EMPOWER-Lung 3: Phase 3 Study of Combinations of Cemiplimab and Chemotherapy in First-Line Treatment of Advanced NSCLC

Author

M. Gogishvili, T. Makharadze, P. Rietschel, H. Chen, P. Snodgrass, N. Mobashery, S. Lee, I. Lowy, and M. Navarro

Subjects
Pulmonary and Respiratory Medicine, Oncology, Chemotherapy, medicine.medical_specialty, Lung, business.industry, medicine.medical_treatment, Phases of clinical research, First line treatment, medicine.anatomical_structure, Internal medicine, Medicine, business
Published
2019

9. A phase III, randomised, double-blind study of adjuvant cemiplimab versus placebo post-surgery and radiation in patients with high-risk cutaneous squamous cell carcinoma (CSCC)

Author

Matthew G. Fury, I. Lowy, Danny Rischin, Elizabeth Stankevich, Sandro V. Porceddu, Hyunsil Han, and Siyu Li

Subjects
medicine.medical_specialty, Randomization, business.industry, medicine.medical_treatment, Perineural invasion, Hematology, medicine.disease, Placebo, Oncology, Internal medicine, Adjuvant therapy, Medicine, Risk factor, Skin cancer, Stage (cooking), business, Adjuvant
Abstract

Background CSCC is the second most common skin cancer. While the surgical cure rate for CSCC is > 95%, a proportion of pts are considered to have high-risk for recurrence as assessed by immune status, primary disease stage, extent of nodal involvement, presence of extracapsular extension, and prior treatment. Post-operative RT is recommended for pts with high-risk features, but relapse with locoregional recurrence or distant metastases may still occur. This study evaluates the efficacy of cemiplimab, a human anti–PD-1 monoclonal antibody, as an adjuvant therapy for pts with CSCC with high-risk features, after surgery and RT. Trial design This randomised, placebo-controlled, double-blind, multicentre, Phase III study will evaluate cemiplimab as an adjuvant treatment for pts with high-risk CSCC, based on surgical and clinicopathologic findings, who have completed surgery and post-operative RT. Immunocompromised pts were excluded. The trial will enrol 412 pts from about 100 sites in North America, Europe, and Asia-Pacific regions. Pts with at least one of the following high-risk features are eligible: a) nodal disease with extracapsular extension b) in-transit metastases c) T4 lesion d) perineural invasion and e) recurrent CSCC with at least one other risk factor. In Part 1 (blinded), pts will be randomised 1:1 to receive 350 mg cemiplimab or placebo intravenously every 3 weeks (Q3W) for up to 48 weeks. In optional Part 2 (unblinded), pts in the placebo arm who experience disease recurrence or pts in the cemiplimab arm who experience disease recurrence ≥3 months after completion of 48-week treatment in Part 1 will be eligible to receive open-label 350 mg Q3W cemiplimab for up to 96 weeks. Key objectives are to compare disease-free survival (primary) as well as overall survival, freedom from locoregional relapse, and distant relapse (secondary) of adjuvant cemiplimab vs placebo in pts with high-risk CSCC. Editorial acknowledgement Medical writing support and typesetting was provided by Bu Reinen of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi. Legal entity responsible for the study Regeneron Pharmaceuticals, Inc., and Sanofi. Funding Regeneron Pharmaceuticals, Inc., and Sanofi. Disclosure D. Rischin: Research grant / Funding (institution), Non-remunerated activity/ies: Regeneron Pharmaceuticals, Inc.; Research grant / Funding (institution), Non-remunerated activity/ies: GSK; Research grant / Funding (institution), Travel / Accommodation / Expenses, Non-remunerated activity/ies: Merck; Research grant / Funding (institution), Non-remunerated activity/ies: Bristol-Myers Squibb; Research grant / Funding (institution): Roche. M.G. Fury: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. I. Lowy: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. E. Stankevich: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. S. Li: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. H. Han: Full / Part-time employment: Regeneron Pharmaceuticals, Inc. S.V. Porceddu: Advisory / Consultancy, Travel / Accommodation / Expenses: Merck Serono; Advisory / Consultancy, Travel / Accommodation / Expenses: Merck Sharp & Dohme; Advisory / Consultancy: UpToDate; Advisory / Consultancy: Oral Oncology.

Published
2019

10. P2.01-01 Cemiplimab, a Human PD-1 Monoclonal Antibody, Versus Chemotherapy in First-Line Treatment of Advanced NSCLC with PD-L1 ≥50%

Author

Sadettin Kilickap, I. Lowy, A. Lowczak, Mahmut Gumus, Philip Clingan, Ahmet Sezer, D. Bentsion, S. Lee, M. Gogishvili, Naiyer A. Rizvi, O. Gladkov, Virote Sriuranpong, Siyu Li, P. Rietschel, P. Snodgrass, and M. Navarro

Subjects
Pulmonary and Respiratory Medicine, Chemotherapy, biology, business.industry, medicine.drug_class, medicine.medical_treatment, Anti pd 1, Monoclonal antibody, First line treatment, Oncology, PD-L1, biology.protein, Cancer research, Medicine, business
Published
2019

11. Pharmacokinetic (PK) analysis of weight-based and fixed dose cemiplimab in patients (pts) with advanced malignancies

Author

Anne Paccaly, Matthew G. Fury, I. Lowy, Michael R. Migden, John D. Davis, Ronda Rippley, Feng Yang, Kyriakos P. Papadopoulos, Elizabeth Stankevich, and Danny Rischin

Subjects
0301 basic medicine, education.field_of_study, medicine.medical_specialty, business.industry, Population, Locally advanced, Stock options, Hematology, Fixed dose, Clinical trial, 03 medical and health sciences, Regimen, 030104 developmental biology, 0302 clinical medicine, Oncology, 030220 oncology & carcinogenesis, Family medicine, Medicine, In patient, education, business, Weight based dosing
Abstract

Background Cemiplimab (cemiplimab-rwlc in the US), a human monoclonal anti–PD-1 antibody, has shown substantial antitumour activity in pts with advanced malignancies and is FDA-approved for pts with advanced (metastatic or locally advanced) cutaneous squamous cell carcinoma (CSCC). We sought to compare weight-based and fixed dosing regimens of cemiplimab in pts with advanced malignancies. Methods This PK analysis included 505 pts with advanced tumours, including 135 pts with advanced CSCC, from phase I and phase II studies of cemiplimab (NCT02383212 and NCT02760498, respectively). Pts received either weight-based doses of cemiplimab (1, 3, 10 mg/kg every 2 weeks [Q2W] and 3 mg/kg every 3 weeks [Q3W]) or a fixed dose regimen (200 mg Q2W). This analysis pooled data from 10,935 PK samples including 2,023 samples from pts with advanced CSCC, to predict the Q3W fixed dose regiment with equivalent cemiplimab exposure as the recommended Phase II dose (3 mg/kg Q2W) using a 2compartment population PK (PopPK) model incorporating covariates that improved goodness-of-fit statistics. The selected fixed dose regimen was confirmed by PK data of the regimen in pts with advanced CSCC from the phase II trial. Results In the phase I study, dose-proportional kinetics were observed over the 1 to 10 mg/kg Q2W dose range. The 350 mg Q3W fixed dose regimen was selected based on PopPK model simulations as it provided similar cemiplimab exposure to 3 mg/kg Q2W at steady state (ss) over a 6-week (6wk) treatment period (e.g. mean AUC6wk, ss [coefficient of variation (CV)]: 3,800 [37.2%] and 3,710 [35.9%] mg*day/mL for 350 mg Q3W and 3 mg/kg Q2W, respectively). The observed exposures in patients with advanced CSCC in the phase II trial receiving 350 mg Q3W cemiplimab were comparable to the simulated exposures. In addition, the observed exposures at ss were similar between 3 mg/kg Q2W and 350 mg Q3W. Conclusions The results from PopPK simulations support the use of a 350 mg Q3W fixed dose regimen, with similar cemiplimab exposure to a weight-based 3 mg/kg Q2W regimen, in pts with advanced malignancies. Clinical trial identification NCT02383212 and NCT02760498. Editorial acknowledgement Bu Reinen of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi. Legal entity responsible for the study Regeneron Pharmaceuticals, Inc., and Sanofi. Funding Regeneron Pharmaceuticals, Inc., and Sanofi. Disclosure M.R. Migden: Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Regeneron Pharmaceuticals, Inc.; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Genentech; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Eli Lilly; Honoraria (self), Travel / Accommodation / Expenses: Sun Pharma. A. Paccaly: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. K.P. Papadopoulos: Research grant / Funding (institution): Regeneron Pharmaceuticals, Inc.; Research grant / Funding (institution): Merck; Research grant / Funding (institution): MedImmune; Research grant / Funding (institution): Merck KGaA; Research grant / Funding (institution): Mabspace Biosciences. F. Yang: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. J.D. Davis: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. R. Rippley: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. I. Lowy: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. M.G. Fury: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. E. Stankevich: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. D. Rischin: Research grant / Funding (institution), Non-remunerated activity/ies: Regeneron Pharmaceuticals, Inc.; Research grant / Funding (institution), Non-remunerated activity/ies: GSK; Research grant / Funding (institution), Travel / Accommodation / Expenses, Non-remunerated activity/ies: Merck; Research grant / Funding (institution), Non-remunerated activity/ies: Bristol-Myers Squibb; Research grant / Funding (institution): Roche.

Published
2019

12. GOG 3016/ENGOT-cx9: An open-label, multi-national, randomized, phase III trial of cemiplimab, an anti-PD-1, versus investigator's choice (IC) chemotherapy in ≥ second-line recurrent or metastatic cervical cancer

Author

Edwin A. Alvarez, Melissa Mathias, Ignace Vergote, Stephanie Lheureux, Ana Oaknin, I. Lowy, M. Feng, Bradley J. Monk, Matthew G. Fury, Alessandro D. Santin, Danny Rischin, Krishnansu S. Tewari, and Stephanie Gaillard

Subjects
Oncology, medicine.medical_specialty, Chemotherapy, business.industry, medicine.medical_treatment, Anti pd 1, Hematology, Second line, Multi national, Internal medicine, medicine, Open label, business, Metastatic cervical cancer
Published
2018

13. Cemiplimab, a human monoclonal anti-PD-1, in patients (pts) with advanced or metastatic hepatocellular carcinoma (HCC): Data from an expansion cohort in a phase I study

Author

Elizabeth Stankevich, Nelson S. Yee, Kyriakos P. Papadopoulos, Jingjin Li, Marka R. Crittenden, Victor Moreno, Irene Brana, Safi Shahda, Glenn Kroog, Michael J. Pishvaian, Matthew G. Fury, Silvia C. Formenti, Melissa Mathias, R. Al-Rajabi, Glen J. Weiss, M. Feng, I. Lowy, M. Gil-Martin, and Gerald Steven Falchook

Subjects
0301 basic medicine, Brachial Plexus Neuritis, Oncology, medicine.medical_specialty, business.industry, Anti pd 1, Phases of clinical research, Hematology, Phase i study, 03 medical and health sciences, 030104 developmental biology, Internal medicine, Cohort, Monoclonal, medicine, In patient, Metastatic hepatocellular carcinoma, business
Published
2018

14. Cemiplimab, a human monoclonal anti-PD-1, plus radiotherapy (RT) in advanced non-small cell lung cancer (NSCLC): Results from a phase I expansion cohort (EC 2)

Author

Tracey Rowlands, I. Lowy, Lee S. Rosen, P. Lopez Criado, M. Feng, M. Gil-Martin, Elizabeth Stankevich, Melissa Lynne Johnson, P. Rietschel, Kosalai Kal Mohan, V. Moreno, Donald W. Northfelt, P. Garrido Lopez, Jingjin Li, Raid Aljumaily, Marka R. Crittenden, Matthew G. Fury, Salma K. Jabbour, and A. Hervás Morón

Subjects
business.industry, medicine.medical_treatment, Anti pd 1, non-small cell lung cancer (NSCLC), Hematology, medicine.disease, 030226 pharmacology & pharmacy, Radiation therapy, 03 medical and health sciences, 0302 clinical medicine, Oncology, 030220 oncology & carcinogenesis, Cohort, Monoclonal, medicine, Cancer research, business
Published
2018

15. MA04.01 Cemiplimab, a Human Monoclonal Anti-PD-1, Alone or in Combination with Radiotherapy: Phase 1 NSCLC Expansion Cohorts

Author

V. Moreno, M.P. Lopez-Criado, Raid Aljumaily, Emiliano Calvo, Jingjin Li, M. Feng, Melissa Lynne Johnson, Lee S. Rosen, Donald W. Northfelt, P. Rietschel, Kosalai Kal Mohan, M. Gil-Martin, A. Hervás Morón, Pilar Garrido, Matthew G. Fury, Marka R. Crittenden, Elizabeth Stankevich, Salma K. Jabbour, I. Lowy, and Kyri Papadopoulos

Subjects
0301 basic medicine, Pulmonary and Respiratory Medicine, business.industry, medicine.medical_treatment, Anti pd 1, Radiation therapy, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Oncology, 030220 oncology & carcinogenesis, Phase (matter), Monoclonal, Cancer research, Medicine, business
Published
2018

16. Phase I study of cemiplimab, a human monoclonal anti-PD-1, in patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC): Longer follow-up efficacy and safety data

Author

Hani M. Babiker, M. Gil-Martin, Emiliano Calvo, Elizabeth Stankevich, I. Lowy, Howard Safran, April K.S. Salama, Kyriakos P. Papadopoulos, Melissa Mathias, Antonio González-Martín, Jiaxin Niu, Taofeek K. Owonikoko, Jingjin Li, K. Kal Mohan, Victor Moreno, Daruka Mahadevan, Matthew G. Fury, and Raid Aljumaily

Subjects
Cutaneous squamous cell carcinoma, Oncology, business.industry, Monoclonal, Anti pd 1, Locally advanced, Cancer research, Medicine, In patient, Hematology, business, Phase i study
Published
2018

17. Phase I expansion cohort results of cemiplimab, a human PD-1 monoclonal antibody, in combination with radiotherapy (RT), cyclophosphamide and GM-CSF, in patients (pts) with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC)

Author

Matthew G. Fury, Jingjin Li, A. Hervás Morón, Victor Moreno, P. Garrido Lopez, Irene Brana, Melissa Mathias, M. Feng, Silvia C. Formenti, Daruka Mahadevan, Kosalai Kal Mohan, Jordi Giralt, Emiliano Calvo, Marka R. Crittenden, Danny Rischin, Elizabeth Stankevich, Hani M. Babiker, Kyriakos P. Papadopoulos, Taofeek K. Owonikoko, and I. Lowy

Subjects
Oncology, medicine.medical_specialty, Cyclophosphamide, medicine.drug_class, business.industry, medicine.medical_treatment, Hematology, Monoclonal antibody, medicine.disease, Head and neck squamous-cell carcinoma, Radiation therapy, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Cohort, medicine, In patient, business, 030217 neurology & neurosurgery, medicine.drug
Published
2018

18. REGN2810, a fully human programmed death protein 1 (PD-1) monoclonal antibody for unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC): Updated follow-up of patients treated in a phase I study

Author

Matthew G. Fury, Kyriakos P. Papadopoulos, Howard Safran, Chetachi Emeremni, Elizabeth Stankevich, Nelson S. Yee, I. Lowy, and Melissa Lynne Johnson

Subjects
Cutaneous squamous cell carcinoma, medicine.drug_class, business.industry, medicine, Locally advanced, Cancer research, Dermatology, Monoclonal antibody, business, Phase i study, Programmed death
Published
2018

19. Survival Analysis of a Randomized Phase III Trial Comparing Androgen Deprivation Therapy (ADT) Plus Docetaxel Versus ADT Alone in Hormone-Sensitive Metastatic Prostate Cancer (GETUG-AFU 15/0403)

Author

S. Xiong, J. D. Wesley, F. Rolland, S. Chan, Bradley C. Carthon, L. G. Garcia, M. Fenner, Linda Sharp, Frank Priou, R. Morales-Barrera, W. Gerritsen, Bernhard J. Eigl, M. Tod, A.J.M. van den Eertwegh, Lawrence Fong, D. Baertschi, Arnoud J. Templeton, J.N. Graff, J. Morote, C. G. O'Bryan-Tear, Mert Basaran, S. Dixit, L. Mourey, J.P. Fusco, James B. Trager, C. Arbayo, Z. Peng, E. Solsona, D. D. Tsao-Wei, David P. Dearnaley, M. Hirmand, G. Procopio, M. Hancock, E. Verzoni, Eric Winquist, L. Shen, A. Sella, R. Tang, E. Ileana, J. A. Rinck, J.-G. Judde, B. Mellado, J. Simko, Martin E. Gleave, A. G. Caamano, Maha Hussain, Shaw Ling Wang, V. Ortega, L. Nicacio, Omar Esteban Carranza, D. G. Power, Frances P. Stewart, L. Bourre, Lawrence Karsh, B. Bennett, R. van Gool, S. Moran, M. Schulze, G. C. Cedermark, B. Esterni, Sophie D. Fosså, R. N. Dass, Guru Sonpavde, Anthony M. Joshua, B. A. Blumenstein, Christophe Massard, Andre Deeke Sasse, C. Suarez, D. Hawes, M. Marin-Aguilera, J. Lackey, M. Sharma, V. Pasov, J. T. Dalton, G. Velasco, G. Liu, J. Li, M. I. Murdock, D. Rathkopf, P. Vrignaud, R. Strebel, F. de Braud, Karim Fizazi, P. Raina, Linda Zinoli, V. De Angelis, A. J. Lloyd, B. Laguerre, S. Hitier, F. Vazquez, L. Zubiri, G. Maier, H. Lannert, M. A. Johnston, Stéphane Oudard, S.J. Hotte, X. Zhou, Nancy A. Dawson, Michael E. Cox, S. Donegani, M. Sisani, Jeffrey R. Gingrich, J. M. Ferrero, C. Papandreou, J. B. Whitmore, R. Sands, Q. Wang, Matthew R. Smith, C. Theodore, P. Perrin, P. M. Hoff, C. S.-L. Thibault, J.S. de Bono, J. Droz, Steinbjørn Hansen, M. A. Morgan, John M. Corman, P. Tryon, M. Climent, S. Berry, C. W. M. Reuter, A. Ozcimen, G. De Castro, T. Sella, G. Geiges, I. Kocak, U. Anido, Y. Hao, N. Bedini, Tanya B. Dorff, María E. Zudaire, David Smith, S. Li, Mansoor N. Saleh, M. Junqueira, I. Krakowski, Nadeem A. Sheikh, G. Sanchez-Olle, Raymond S. McDermott, G. Deplanque, Marianna de Camargo Cancela, L. Bellardita, W. Ye, R. Valdagni, J. Pinski, Nina Tunariu, C. Cavaliere, T. Devries, Silke Gillessen, Vasileios J. Assikis, Christopher J. Logothetis, K. Staudacher, A. Bahl, G. Chodak, R. Wei, Pasquale Rescigno, T. Shahid, M. Taplin, L. Ahrlund-Richter, Chadi Nabhan, N. Batista, Simon J. Hall, A. Heidenreich, Deborah Mukherji, Kim N. Chi, S. Zanetta, Ethan Basch, C. Kim, M. Haggman, Kurt Miller, S. Crowe, L. G. Fonseca, M. Nister, V. Grunwald, David I. Quinn, P. Cabrera, J. Wong, Peter F.A. Mulders, Noah M. Hahn, E. Levesque, W. Liu, Chris Parker, I. Gil-Aldea, I. Testa, Shahneen Sandhu, F. Ricci, N. Sacks, J. E. Brown, Eric J. Small, A. Ganser, C. Pezaro, S. Boccardo, E. Small, C. V. Morales, R. P. Taylor, Przemyslaw Twardowski, W. R. Clark, L. M. A. Aparicio, David Olmos, D. E. Castellano, Phillip Parente, R. Delva, A. Sanchez, Michael L. Meyers, A. Ruffion, P. Gascon, J. R. Gingerich, U. Harmenberg, D. Pouessel, Joshi J. Alumkal, L. Reyno, M. Spencer, S. Neibart, C. Korn, M. Habibian, Hazem I. Assi, J. Sarantopoulos, J. Charpentier, J. Squire, Christian Rothermundt, J. Versluis, G. Liskovsky, Saskia J. A. M. Santegoets, Maria Jose Lechuga, A. Hamzaj, E. Arevalo, Andrew J. Armstrong, Steven M. Larson, V. Naini, F. Kueppers, H. Ozen, R. Barroso-Sousa, C.J. Amling, Andrea L. Harzstark, L. Puglia, S. Bracarda, S. Le Moulec, S. Hubay, S. V. Liu, A. Horchani, L. Lui, F. Joly Lobbedez, S. Del Buono, S. Basu, N. Tiftik, D. Nicolle, P. de Souza, G. Freyer, T. Magnani, E. Benaim, E. Y. Yu, V. Yvonnet, N. Rozumna-Martynyuk, S. Salvi, P. Samper, M. S. N. M. Sharial, R. Salvioni, J. G. Gandhi, O. Terekhov, Elizabeth Eisenhauer, G. Gravis, I. Bodrogi, J. Lin, I. N. Boyko, B. Zhang, Patricia Martin, S. Kovel, Eleni Efstathiou, A. Cross, S. Villa, Cora N. Sternberg, Vivian Weinberg, M. Soulie, J. Zou, M. Wilbaux, David B. Agus, Yohann Loriot, C. Goessl, A. Stam, I. De Torres, D. W. Davis, M. Hjelm-Eriksson, P. Federico, J. E. Garcia-Vargas, M. Gedamke, Philip W. Kantoff, A. Petremolo, F. Marrocolo, B. Perez-Valderrama, G. Mordenti, X. Maldonado, P. Hamberg, Roberto Pili, M. Doherty, K. Hege, Pier Vitale Nuzzo, Winald R. Gerritsen, D. P. Petrylak, L. Ji, O. A. Sartor, Leonard G. Gomella, Sumanta K. Pal, J. Bruce, Scott North, Mario A. Eisenberger, Robert E. Coleman, Diletta Bianchini, E. Henin, Michael A. Carducci, A. G. Omlin, S. De Placido, A. Liede, J. Good, A. Hartford, Richard Cathomas, Anna C. Ferrari, S. S. Sridhar, Alessandra Rubagotti, A. C. R. Chaves, P. Sieber, L. O. Reis, D. Lin, A. Arican, Y. Zhang, O. Nordle, J. Tito, G. Bhattacharyya, V. Melnikova, N. Aucoin, P. W. Price, Susan Ellard, P. Beuzeboc, K. Noonan, A. A. Ranade, M. W. Frohlich, B. Anand, K. Buyukafsar, William R. Berry, Mitchell S. Steiner, D. Raghavan, Daniel J. George, C. D. L. Piedra, Gregory R. Pond, F. Acosta, A. O. Sartor, A. Yildirim, G. Di Lorenzo, Thomas W. Griffin, P. M. Parikh, Harry Comber, Matthew D. Galsky, A. J. Armstrong, J. M. Fitzpatrick, M. Legrier, J. R. Piulats, Neal D. Shore, Walter M. Stadler, J. Powers, R. J. Amato, S. O'Reilly, G. B. Kanaka, M. Girard, N. Nicolai, D. Maillet, C. Piatek, Robert H. Getzenberg, Dana E. Rathkopf, J. Eymard, E. C. Alvarez, S. Wong, H. Kurt, Elisabeth I. Heath, R. C. Winterhalder, T. Zoubir, A. Tagliapietra, I. N. Hernandez, Oliver Sartor, H. Malhotra, Amir Goldkorn, E. J. Leonard, J. M. Wolff, Ronald F. Tutrone, Charles S. Cleeland, Q. Perez, A. Ulyanov, Christopher Sweeney, Mustafa Ozguroglu, Jolanda Paolini, I. Lowy, Ignacio Gil-Bazo, C. Dzik, Fred Saad, William Oh, L. Skoog, S. Stagni, Emmanuel S. Antonarakis, Maria J. Ribal, C. L. Nourani, E. Chow-Maneval, J-P. Machiels, K. Anderes, Shannon Matheny, T. de La Motte Rouge, A. Ata, Celestia S. Higano, Malcolm David Mason, Heather Haynes, L. Sengelov, M. Poupon, S. Nilsson, K. Jelaca-Maxwell, R. A. Stephenson, Thian Kheoh, Howard I. Scher, S. Groshen, P. Schellhammer, Y. Pawitan, C. Li, C. D'Aniello, A. Olsson, Michael Pollak, T. Harding, I. Latorzeff, Ralph J. Hauke, Arturo Molina, Paul N. Mainwaring, J. J. Lozano, F. McDonnell, B. You, R. B. Sims, P. Carroll, Z. I. Malik, Joan Carles, Ainhoa Castillo, D. T. Castro, M.D. Michaelson, T.D. de Gruijl, Joaquim Bellmunt, N. Houede, Manisha Singh, A. Guillot, A. M. Cassidy, Charles J. Ryan, E. Esteban, M. Truini, Laurence Albiges, C. Buonerba, O. Gunther, G. Forsberg, Bryan Selby, Paul G. Corn, B. A. Wood, J. K. Singh, Michael J. Morris, J. Biswas, M. Gross Goupil, Francesco Boccardo, W. de Schultz, P. Czaykowski, Nicholas J. Vogelzang, M. Y. Teo, P. Afzal, and Gerhardt Attard

Subjects
medicine.medical_specialty, Genitourinary system, business.industry, Standard treatment, Hazard ratio, Urology, Hematology, medicine.disease, Androgen deprivation therapy, Prostate cancer, medicine.anatomical_structure, Oncology, Docetaxel, Prostate, medicine, Clinical endpoint, business, medicine.drug
Abstract

Background Androgen deprivation therapy (ADT) is the standard treatment of hormone-sensitive metastatic prostate cancer (HSMPC). We performed a phase III multicentre trial to compare ADT alone with ADT plus docetaxel (D) in HNMPC. Methods Patients (pts) with HSMPC were randomly assigned to either arm A (ADT + D: 75mg/m q3w, up to 9 cycles) or arm B (ADT). The primary endpoint was overall survival (OS). The planned number of pts was 378 to detect an improvement in OS with a hazard ratio (HR) of 0.62, a power of 80% and an alpha risk of 0.05 (two-sided test). Secondary endpoints were biological progression-free survival (PFS) and clinical PFS. Data on toxicity and quality of life have been previously presented. Results From October 2004 to December 2008, 385pts were included. Baseline characteristics were well balanced between the two arms. Median age was 63 years (43-84), median PSA was 26.4 ng/ml (0.1-11900), Gleason score was ≥ 8 in 57%. Prognostic classification was as follows: good prognosis (49%), intermediate (29%) and poor (22%). The majority of pts had metastases at the time of diagnosis (72%), 28% developed metastases after local treatment failure. Median number of D cycles was 8 (range 0-9). The median follow-up was 50 months (mo) [95%CI: 49-54]. At 6 mo, a higher PSA response (≥ 50%) in arm A (94% vs 85%, p = 0.0096) and a higher PSA progression (≥ 25%) in arm B (10% vs 1%, p = 0.0015) were observed. Biological PFS was significantly longer in arm A: 22.9 vs 12.9 mo, HR; 0.72 [95%CI: 0.57-0.91] (p = 0.005). Clinical PFS was increase in arm A: 23.46 vs 15.44 mo, HR: 0.75 [95CI: 0.59-0.94] (0.015). OS was not significantly different (median: 58.9 mo in arm A and 54.2 mo in arm B, HR: 1.01 [95%CI: 0.75-1.36]. The median OS for each prognostic group was 69.1 [95%CI: 60.9-NR], 46.5 [95%CI: 37.7-NR] and 36.6 [95%CI9: 28.5-58.9] mo respectively in the good, intermediate, and poor prognosis groups (p = 0.001), with no difference between the two arms. At the cut-off time, 65% of pts from the ADT arm had received docetaxel since they developed castrate-resistant prostate cancer. Conclusion Combining docetaxel and ADT improves PFS over ADT alone in pts with HSMPC. However, no difference in OS was observed between the two arms. Disclosure G. Gravis: I have expert testimony to disclose: Sanofi Aventis, uncompensated. K. Fizazi: Participation to advisory boards and speaker for Sanofi-Aventis. F. Joly Lobbedez: advisory board/board of directors position: Sanofi, Roche, Pfizer, Novartis, Ferring; compensated consultant relationship: Roche, Novartis; honoraria: Sanofi, Roche, Pfizer, Novartis, Ferring, Ipsen,Takeda; travel remuneration: ASCO by Novartis, ESMO by Janssen. S. Oudard: I have an advisory relationship and honoraria to disclose: Pfizer Oncology, Bayer-Schering Pharma, Hoffman La Roche, Glaxo SmithKline, Novartis Pharma, Sanofi Aventis. D. Pouessel: Consultant role and honoraria: Sanofi, P. Beuzeboc: Presentations: Avantis, All other authors have declared no conflicts of interest.

Published
2012

20. Phase I study of a neutralizing monoclonal anti-CTLA4 antibody (MDX-010) in patients with relapse of malignancy after allogeneic hematopoietic stem cell transplantation

Author

A. Bashey, B. Medina, R.-K. Zhong, J.-H. Zhou, E. Carrier, J. Castro, P. Holman, T.A. Lane, C. Sun, I. Lowy, S. Corringham, R. Soiffer, J. Mason, and E.D. Ball

Subjects
Transplantation, biology, business.industry, medicine.medical_treatment, Hematopoietic stem cell transplantation, Hematology, Malignancy, medicine.disease, Phase i study, Monoclonal, medicine, Cancer research, biology.protein, In patient, Anti ctla4, Antibody, business
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