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news.Boehringer Ingelheim is set to present its investigational compound BIBW 2992 LUX-Lung 2 trial data at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, 4-8 June 2010.
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LUX-Lung 2 is part of the comprehensive LUX-Lung clinical trial programme. Currently, the clinical trial programme comprises more than ten trials conducted across the globe. LUX-Lung 2 is a Phase II trial evaluating BIBW 2992 in NSCLC patients with EGFR mutations, either treatment naïve or after first line chemotherapy.
BIBW 2992 is a small molecule targeting the epidermal growth factor receptor (EGFR/HER1) and human epidermal receptor 2 (HER2) receptor tyrosine kinase. The compound works distinctively by irreversibly binding to the receptor – unlike available treatments in this class.
The LUX-Lung 2 trial data, accepted by ASCO for presentation, showed that BIBW 2992 shrinked tumours in 22% of patients with head and neck cancer (measured as partial response), compared to 13% of those receiving cetuximab.
Boehringer Ingelheim said that the new data on BIBW 2992 reaffirmed its anti-tumour activity in non-small-cell lung cancer (NSCLC) patients with EGFR mutations.
The data showed that the majority of patients (61%) with common EGFR mutations (deletion 19 and L858R) have significant tumour shrinkage (measured as partial response) when treated with BIBW 2992 as assessed by independent review. Patients with common mutations taking BIBW 2992 have a long time to progression (median of approximately 14 months) and a long survival (median of 2 years).
Tanguy Seiwert, lead investigator of the trial at University of Chicago Medical Center, said: “The results for BIBW-2992 are potentially quite meaningful for patients diagnosed with head and neck cancer since the data support that this novel, irreversible EGFR/erbB2 compound appears to be at least as effective as cetuximab with a comparable safety profile.
“Recurrent head and neck cancer carries a very poor prognosis, and this is truly the first time that an oral EGFR targeting agent has shown this level of activity in head and neck cancer. At this advanced stage patients with head and neck cancer have few treatment options, and BIBW 2992 could potentially provide a much needed alternative treatment option.”
James Yang of National Taiwan University Hospital and investigator of the LUX-Lung 2 clinical trial, said: “These results are exciting, as they affirm BIBW 2992’s marked and durable anti-tumour activity in NSCLC patients with EGFR mutations.”