OSI Pharmaceuticals completes enrollment in Phase III clinical trial of Tarceva

Apr 26 2010

OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that it has completed enrollment in the RADIANT study, a Phase III clinical trial testing Tarceva^® (erlotinib) as an adjuvant therapy in patients with Stage IB-IIIA non-small cell lung cancer (NSCLC) who have undergone surgery and have EGFR-positive tumors. RADIANT is an international, randomized, double-blinded, placebo-controlled Phase III study that has reached its enrollment goal of 945 patients. The primary objective of the study is to determine whether the targeted therapy Tarceva prolongs disease-free survival when given as an adjuvant therapy. This is defined as a cancer treatment that is given after the primary treatment, which is typically surgery or surgery and chemotherapy in this group of NSCLC patients, to lower the risk of the cancer coming back.

“The study has received considerable interest from both investigators and patients and we look forward to the potential for interim results in 2012 and final results in 2013-2014.”

"We believe an oral therapy like Tarceva can be a valuable addition to the treatment paradigm by extending the disease-free survival of patients with Stage Ib-IIIa NSCLC," said Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "The study has received considerable interest from both investigators and patients and we look forward to the potential for interim results in 2012 and final results in 2013-2014."