Enrolment Started For LUX-Lung 1 Study Oncology Research Programme

Main Category: Lung Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 02 Jun 2008 - 4:00 PDT

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Boehringer Ingelheim is making progress in its oncology research programme, particularly in the most common form of lung cancer, non-small cell lung cancer (NSCLC).

The first pivotal study for BIBW 2992 has now begun patient enrolment. The LUX-Lung 1 study is a randomized, double-blind phase IIb/III study. It will aim to determine the efficacy of BIBW 2992 plus best supportive care (BSC) compared to placebo plus BSC. This trial is conducted in lung cancer patients in whom the first-generation treatments erlotinib or gefitinib have failed, both The FDA's Fast Track programme will facilitate the development programme and expedite the review of new treatments that demonstrate the potential to address an unmet medical need in serious or lifethreatening diseases. The Fast Track designation also means data may be submitted on a rolling basis.

Preliminary findings from LUX-Lung 2 study reported

Promising results from another study from the BIBW 2992* LUX-Lung trial programme have been reported at ASCO (abstract 8026)1. In LUX-Lung 2, a high rate of disease control (87.5%) and a promising overall response rate (50%) were reported as preliminary findings from this ongoing phase II study.

NSCLC patients in this study had previously been treated with chemotherapy and they all have lung cancer with activating EGFR mutations1.

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.

In a poster discussion session, the study lead author, Dr Chih-Hsin James Yang from the National Taiwan University Hospital, Taipei, Taiwan, presented the results from 24 patients, on behalf of Taiwan and US investigators. These patients had been treated for at least four weeks with BIBW 2992, at a dose of 50 mg per day and were evaluable for response1.

This ongoing study examines how effective this irreversible dual inhibitor of EGFR and HER2 kinases would be in patients who have activating EGFR mutations. The preliminary findings suggest that BIBW 2992 is effective in patients with advanced NSCLC who have activating mutations, including some with mutations which are relatively resistant to reversible EGFR TKIs.

To date, Dr Yang and his colleagues have screened 174 patients and detected activating EGFR mutations in 64 of these patients1. The primary endpoint of the study is Objective Response Rate (according to RECIST criteria).

- Objective Response Rate was 50%: 12 out of 24 patients achieved a partial response (PR: defined as tumour shrinkage of 30% or more), including in one patient with brain metastases - Disease Control Rate (PR + stable disease) was 87.5%: 21 out of 24 patients achieved either stable disease or a PR

- 17 out of 24 patients currently remain on treatment. So far, the longest duration of treatment with BIBW 2992 is eight months

- Of note, PRs were observed in two patients with two different mutations (G719S/S768I and L861Q) which are relatively resistant to reversible EGFR TKIs in patients studied to date

- Five patients have progressed following initial disease control

- The authors suggest that BIBW 2992 is well tolerated and the most common side effects observed included diarrhoea and skin rash

*BIBW 2992 (Tovok™) and BIBF 1120 (Vargatef™) are investigational agents. Their efficacy and safety have not yet been fully established.

‡BIBW 2992 is a novel representative of the new generation of tyrosine kinase inhibitors. It is an irreversible inhibitor of both EGFR and HER2 kinases5. BIBF 1120 is a novel triple angiokinase inhibitor that simultaneously inhibits vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs) and fibroblast growth factor receptors (FGFRs)6

Boehringer Ingelheim ranks among the world's leading pharmaceutical companies, focusing on prescription medicines, consumer health care, and chemicals.

http://www.boehringer-ingelheim.com

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