Possible breakthrough drug in lung cancer

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Interim Phase II data from the LUX-Lung 2 study suggest BIBW 2992 has anti-tumor activity in advanced, second-line, non-small cell lung cancer (NSCLC) patients who have epidermal growth factor receptor (EGFR) mutations.

"Lung cancer kills more people than any other cancer.3 The LUX-Lung 1 and 2 studies represent an opportunity to investigate BIBW 2992 across a range of different patient populations," said Dr. Manfred Haehl, corporate senior vice president, Medicine, Boehringer Ingelheim. "The preliminary data from the LUX-Lung 2 study suggests that BIBW 2992 may have activity in the second-line setting among NSCLC patients with EGFR mutations, which is encouraging news".

BIBW 2992 is an orally-administered, irreversible dual inhibitor of the epidermal growth factor receptor (EGFR) and human epithelial receptor 2 (HER2) tyrosine kinases.1 It is the first irreversible EGFR-TKI (tyrosine kinase inhibitor) to reach Phase III for third/fourth-line NSCLC.

In the emerging era of personalized cancer medicine, Boehringer Ingelheim is one of the first companies to prospectively identify appropriate patients for clinical trials based on biomarkers. As part of the LUX-Lung clinical development program, Boehringer Ingelheim is evaluating BIBW 2992 in NSCLC patients who test positive for EGFR activating mutations.

"It is well documented that 'activating' mutations that arise in the tyrosine kinase (TK) domain of the EGFR gene are linked to an increased sensitivity to first generation EGFR TKIs.6,7,8 The majority of patients who initially respond to EGFR TKIs such as gefitinib or erlotinib will eventually develop resistance, often through gaining another mutation, such as the so-called T790M resistance mutation,"9,10 said Dr. Haehl.

Detailed Findings from LUX-Lung 2.

To date, 409 NSCLC patients have been screened in the LUX-Lung 2 study and 104 patients with EGFR mutations have started therapy with BIBW 2992 once daily. Preliminary data will be presented at ASCO for the first 73 second-line patients, all of whom had previously received one regimen of chemotherapy. Sixty-seven patients are evaluable for response.

Interim data show:.

• 64% of patients (43/67) taking BIBW 2992 in the second-line setting experienced a partial response (75% among patients with deletion 19 and 66% in patients with L858R mutations)
• 31% (21/67) of patients taking BIBW 2992 in the second-line setting experienced stable disease
• Median progression-free survival (PFS) in second-line setting is 10.2 months
• The most common related adverse events were diarrhea and skin-related disorders in 86% and 89% of patients respectively [16% and 18% being grade 3 respectively]
• 37 patients had dose reduction and 4 patients discontinued therapy due to adverse events

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Posted by: Scott    Source