Preliminary data of BIBW 2992 in head and neck cancer, NSCLC to be presented at ASCO 2010

Boehringer Ingelheim will announce preliminary data in the areas of head and neck cancer and non-small cell lung cancer (NSCLC) for one of the company's investigational compounds, BIBW 2992. These data will be presented at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) annual meeting in Chicago.  BIBW 2992 is an orally-administered small molecule under development that irreversibly inhibits the epidermal growth factor receptor (EGFR/HER1) and human epidermal receptor 2 (HER2) tyrosine kinases.

BIBW 2992 data in head and neck cancer

New data will report preliminary best response analysis for 74/109 patients from an ongoing Phase 2 study of 124 patients with metastatic or recurrent  squamous cell carcinoma of the head and neck (SCCHN) who did not respond to platinum-containing therapy.  In this study, patients were initially randomly assigned to either BIBW 2992 or cetuximab. Twenty-two percent of the 34 patients receiving BIBW 2992 experienced reduction in tumor size (measured as partial response), compared to 13 percent of the 40 patients receiving cetuximab. Preliminary safety analyses revealed diarrhea and skin-related adverse events as the most common adverse events associated with BIBW 2992.

"Metastatic head and neck cancer has a very poor prognosis, and patients are in desperate need for new treatment options," says Tanguy Y. Seiwert, M.D., lead investigator of the trial, University of Chicago Medical Center. "These findings, while preliminary, are encouraging and warrant further investigation of BIBW 2992 in head and neck cancer."

BIBW 2992 data in NSCLC

In LUX-Lung 2, a Phase 2 study, 444 patients with advanced adenocarcinoma of the lung who were untreated or progressed after one course of chemotherapy were tested for common EGFR mutations. Of the patients who tested positive for EGFR mutations, 129 patients received treatment with BIBW 2992. The overall response rates (primary endpoint) for patients with the common EGFR mutations deletion 19 and L858R were 62 percent and 52 percent, respectively.  Median progression-free survival (secondary endpoint) was estimated to be 12 months for the overall group. The most common drug-related adverse events were diarrhea and rash (reported in 95% for each), with 18 percent and 19 percent of patients experiencing grade 3 symptom severity, respectively.

LUX-Lung 2 is part of the comprehensive LUX-Lung clinical trial program evaluating BIBW 2992 in various patient populations, all with NSCLC. This LUX-Lung trial program currently comprises five trials.

"Boehringer Ingelheim is using scientific advances to develop a range of targeted therapies in areas of medical need, including various solid tumors and hematological cancers," said Dr. Andree Amelsberg, Executive Director and Medical Leader Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. "We are pleased with the preliminary results of these Phase 2 studies, which support continued development of BIBW 2992 as a potential new treatment option for head and neck cancer and non-small cell lung cancer."