Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

4004 - Update on the randomised Phase Ib/II study of the selective small molecule AXL inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Cytotoxic Therapy;  Clinical Research;  Immunotherapy

Tumour Site

Melanoma

Presenters

Cornelia Schuster

Citation

Annals of Oncology (2018) 29 (suppl_8): viii442-viii466. 10.1093/annonc/mdy289

Authors

C. Schuster1, G. Gausdal2, B.T. Gjertsen3, J. Lorens4, O. Straume5

Author affiliations

  • 1 Department Of Clinical Science, Centre For Cancer Biomarkers, University of Bergen, 5021 - Bergen/NO
  • 2 Bergenbio Asa, BerGenBio ASA, 5021 - Bergen/NO
  • 3 Department Of Internal Medicine, Helse Bergen Haukeland University Hospital, 5021 - Bergen/NO
  • 4 Department Of Biomedicine, Centre For Cancer Biomarkers, University of Bergen, 5021 - Bergen/NO
  • 5 Oncology And Medical Physics, Haukeland Universitetssykehus, 5021 - Bergen/NO
More

Resources

Abstract 4004

Background

Upregulation of the receptor tyrosine kinase AXL has been linked with both minor treatment effect of PD-1 blockade and acquired resistance to BRAF inhibitors in melanoma. Bemcentinib is a first-in-class orally bioavailable selective inhibitor of AXL which is currently investigated in several phase II clinical trials. BGBIL006 (NCT02872259) is an open label phase Ib/II trial designed to explore whether combination with bemcentinib improves overall response rates to standard of care therapies in patients (pts) with metastatic melanoma (MM).

Methods

Dose escalation of bemcentinib in combination with 150mg twice daily/2mg daily dabrafenib/trametinib (D/T) in newly diagnosed, BRAF+, MM with high tumour load followed a 3 + 3 design (part 1). In part 2, pts were randomised 2:1 to receive D/T or pembro +/- bemcentinib at RP2D, respectively, based on mutation status and tumour load. Pts were allowed to switch D/T with pembrolizumab and vice versa upon progression (part 3). Tumour responses were assessed per investigator using RECIST v1.1. Plasma protein biomarker levels were measured using the DiscoveryMap v3.3 panel (Myriad RBM) in pts pre-dose and at C2D1.

Results

In part 1, 6 pts were enrolled first line (age 34-71, LDH > 1 x ULN 50%). There was 1 dose limiting toxicity (G3 rash) and an RP2D of bemcentinib in combination with D/T of 200mg daily bemcentinib with full dose D/T was confirmed. As of 2 May 18, a further 17 pts have been enrolled into part 2 of the study and four had progressed to part 3. Grade 3 treatment-related adverse events (AEs) were observed in 7 pts (30%). No G4 AEs or treatment related deaths occurred. Biomarkers candidates predicting treatment benefit were explored. Pre/post treatment changes of soluble proteins will be presented.

Conclusions

Bemcentinib RP2D (200 mg daily) is well tolerated in combination with both D/T and pembro without increased toxicity compared to either therapeutic approach alone. Further investigation of safety and efficacy as well as biomarker candidates is ongoing.

Clinical trial identification

NCT02872259.

Legal entity responsible for the study

Department for Oncology and Medical Physics, Haukeland University Hospital Bergen.

Funding

KLINBFORSK governmental funding.

Editorial Acknowledgement

Disclosure

G. Gausdal: Employee: BerGenBio. B.T. Gjertsen: Stock/ownership: Alden Cancer Therapy II, Kinn Therapeutics AS. J. Lorens: Ownership: BerGenBio ASA. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.