About this Medicine article

Phase I Study of Single-Agent Anti–Programmed Death-1 (MDX-1106) in Refractory Solid Tumors: Safety, Clinical Activity, Pharmacodynamics, and Immunologic Correlates by Julie R. Brahmer; Charles G. Drake; Ira Wollner; John D. Powderly; Joel Picus; William H. Sharfman; Elizabeth Stankevich; Alice Pons; Theresa M. Salay; Tracee L. McMiller; Marta M. Gilson; Changyu Wang; Mark Selby; Janis M. Taube; Robert Anders; Lieping Chen; Alan J. Korman; Drew M. Pardoll; Israel Lowy; Suzanne L. Topalian is a Medicine article available to read on EtoBox.

## Purpose Programmed death-1 (PD-1), an inhibitory receptor expressed on activated T cells, may suppress antitumor immunity. This phase I study sought to determine the safety and tolerability of anti–PD-1 blockade in patients with treatment-refractory solid tumors and to preliminarily assess antitumor activity, pharmacodynamics, and immunologic correlates. ## Patients and Methods Thirty-nine patients with advanced metastatic melanoma, colorectal cancer (CRC), castrate-resistant prostate cancer, non–small-cell lung cancer (NSCLC), or renal cell carcinoma (RCC) received a single intravenous infusion of anti–PD-1 (MDX-1106) in dose-escalating six-patient cohorts at 0.3, 1, 3, or 10 mg/kg, followed by a 15-patient expansion cohort at 10 mg/kg. Patients with evidence of clinical benefit at 3 months were eligible for repeated therapy. ## Results Anti–PD-1 was well tolerated: one serious adverse event, inflammatory colitis, was observed in a patient with melanoma who received five doses at 1 mg/kg. One durable complete response (CRC) and two partial responses (PRs; melanoma, RCC) were seen. Two additional patients (melanoma, NSCLC) had significant lesional tumor regressions not meeting P

Author

Julie R. Brahmer; Charles G. Drake; Ira Wollner; John D. Powderly; Joel Picus; William H. Sharfman; Elizabeth Stankevich; Alice Pons; Theresa M. Salay; Tracee L. McMiller; Marta M. Gilson; Changyu Wang; Mark Selby; Janis M. Taube; Robert Anders; Lieping Chen; Alan J. Korman; Drew M. Pardoll; Israel Lowy; Suzanne L. Topalian

Publisher

American Society of Clinical Oncology; American Society of Clinical Oncology (ASCO) (ISSN 0732-183X)

Published

2010

Language

EN

Field

Medicine (Health Sciences)