Date: 2016-06-07
Type of
information: Presentation of results at a congress
phase: 1-2
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: BergenBio (Norway)
Product: BGB324 and erlotinib
Action
mechanism:
- AXL inhibitor/receptor tyrosine kinase inhibitor/epidermal growth factor receptor tyrosine kinase inhibitor/EGFR tyrosine kinase inhibitor (EGFR.
- BGB324 is a highly selective, oral AXL inhibitor that blocks the epithelial-mesenchymal transition, which is a key driver of metastasis and drug-resistance.
- Erlotinib (Tarceva®) is an EGFR tyrosine kinase inhibitor.
Disease: non-small cell lung cancer
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This phase 1-2 multi-center open-label study is evaluating BGB324 in combination with erlotinib in patients with Stage IIIb or Stage IV non-small cell lung cancer. (NCT02424617)
Latest
news:
- • On June 7, 2016, BerGenBio announced that clinical data from BGB324, a first-in-class selective Axl kinase inhibitor, was presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (abstract). The data demonstrated the clinical activity, tolerability and unique mechanism-of-action of BGB324 in patients with acute myeloid leukemia and myelodysplastic syndrome. The presented data demonstrate that BGB324 can be safely administered for prolonged periods at doses that inhibit Axl activation and exhibit anti-leukemic activity, and therefore could be a potential treatment option for patients with acute myeloid leukemia and myelodysplastic syndrome. A dose escalation study was performed to identify the recommended Phase 2 dose of BGB324 in patients with previously treated AML or high risk MDS. Three daily maintenance dose levels (100mg, 200mg and 300mg) were explored. Twenty patients with AML and four patients with MDS were treated; seven patients remain on treatment.
- The data demonstrated encouraging signals of anti-leukemic activity. One AML patient reported complete remission, with incomplete blood count recovery at five months; another patient reported partial remission demonstrated by clearance of circulating leukemic blasts accompanied by peripheral blood count recovery for more than three months. Two of the four MDS patients showed objective responses. A further six patients in the study showed disease stabilisation for more than four months. Complete inhibition of Axl activation and signal transduction was demonstrated in leukaemia cells from patient bone marrow samples, validating the unique mechanism-of-action of BGB324. Reversible mild or moderate gastrointestinal disorders were the most common observed adverse events. These occurred mostly during the loading dose period and resolved during chronic dosing.
- • On June 10, 2015, BerGenBio announces that its multi-centre open label Phase 1b trial (BGBC004) of BGB324, a selective inhibitor of Axl, in patients with Stage IIIb and Stage IV non-small cell lung cancer (NSCLC) in erlotinib-sensitive and refractory patients who have an activating EGFR mutation, is now underway at the University of Texas MD Anderson Cancer Center, Houston, Oncology Partners, Houston, and at UT Southwestern Medical Center, Dallas, Texas, USA. This multi-centre trial, which will enrol 66 patients, is designed to: determine the maximum dose of BGB324 that can be safely administered in combination with erlotinib; identify the recommended Phase 2 dose of BGB324; and evaluate the safety, pharmacokinetics and clinical activity of BGB324 in combination with erlotinib. BergenBio is looking forward to reporting results later in 2015.
Is
general: Yes
