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Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009
Date:5/14/2009

rkers. 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.(5)

"It is well documented that 'activating' mutations that arise in the tyrosine kinase (TK) domain of the EGFR gene are associated with 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:(2)

To date, 409 NSCLC patients have been screened in the LUX-Lung 2 study and 104 patients with EGFR mutations have started treatment 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:(1)

  • 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 treatment due to adverse events

Findings from LUX-Lung 1

In addition, preliminary data on t
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SOURCE Boehringer Ingelheim
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