• 5/17/2005
  • Orlando, FL
  • press release
  • Business Wire (www.businesswire.com)

OSI Pharmaceuticals provided a second informational update summarizing highlights from presentations on Tarceva(TM) (erlotinib) made at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO) being held from May 14-17 in Orlando, Fla. The presentations included data from two separate single-arm Phase II studies of monotherapy Tarceva in chemotherapy-naive or front-line non-small cell lung cancer patients. Both studies indicated encouraging indications of anti-tumor activity for monotherapy Tarceva in this setting. Another presentation based on data from the BR.21 study concluded that patients on Tarceva had slower deterioration of their disease-related symptoms of cough, dyspnea and pain and that these differences were clinically and statistically significant. Encouraging indications of anti-tumor activity were also reported in several Phase II studies outside of NSCLC including combination therapy data for Tarceva with Avastin in renal cell carcinoma, Tarceva with chemotherapy in head and neck cancer and monotherapy use of Tarceva in colorectal and hepatocellular cancer.

Highlights included:

Phase II Study of Combination Cisplatin, Docetaxel and Erlotinib in Patients with Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) – E.S. Kim (Abstract #5546)

Encouraging preliminary data was presented from an ongoing Phase II trial combining Tarceva with cisplatinum and docetaxel in HNSCC. Results were reported for the 22 patients evaluable for response. Complete response was reported in 3 patients (13 percent), partial response was reported in 14 patients (64 percent) and 4 patients (18 percent) were reported having stable disease. Responses were documented using RECIST. No unanticipated toxicities were evident from the combination. One patient experienced grade 4 febrile neutropenia and 6 patients had grade 3 neutropenia and 15 patients had rash grade 1/2 rash and grade 3 rash was reported for 1 patient. The trial continues to accrue patients.

About Tarceva

Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, which is one of the factors critical to cell growth in non-small cell lung cancer (NSCLC) and other solid tumors. HER1, also known as EGFR, is a component of the HER signaling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which may block tumor cell growth. Tarceva is the only HER1/EGFR-targeted therapy proven to significantly prolong survival in second-line NSCLC as a single agent.

Tarceva was approved by the FDA in November 2004 and is an oral tablet indicated for daily administration for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. Results from two earlier large, randomized, placebo-controlled clinical trials in first-line advanced NSCLC patients showed no clinical benefit with concurrent administration of Tarceva with doublet platinum-based chemotherapy (carboplatin and paclitaxel or gemcitabine and cisplatin) and its use is not recommended in that setting.

Additional early-stage trials of Tarceva are being conducted in other solid tumors. In April 2005, OSI submitted a supplemental New Drug Application (sNDA) with the FDA for use of Tarceva plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received any previous treatment. Tarceva is the only EGFR therapy proven to significantly prolong survival in first-line locally advanced or metastatic pancreatic cancer in combination with gemcitabine.