CCBIO presence at the 9th World Congress of Melanoma

Results and analysis of the BGB324 study

The clinical trial of BGB324 in combination with either MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA® in advanced melanoma, was presented at the 9th World Congress of Melanoma. Dr. Oddbjørn Straume, consultant oncologist at Haukeland University Hospital and CCBIO PI, presented the results and analysis from this dose-finding part of the study (NCT02872259) in a poster at the 9th World Congress of Melanoma. The poster was entitled: A Phase Ib/II randomised study of BGB324 in combination with pembrolizumab or dabrafenib/trametinib in patients with advanced melanoma. The presentation introduced the trial design and study background as well as presented safety data of metastatic melanoma patients treated to date.

Dr. Straume reported that the recommended Phase 2 dose (RP2D) of BGB324 in combination with trametinib and dabrafenib had been established. In addition, he presented early data demonstrating that BGB324 is well tolerated in combination with either dabrafenib and trametinib or pembrolizumab.

Patient recruitment in all three arms of the Phase 2 study is ongoing and seeks to demonstrate safety and efficacy of BGB324 in combination with pembrolizumab or dabrafenib and trametinib in the first-line and second line setting. The clinical study is recruiting well at four sites in Norway and reports a favorable safety profile. A parallel biomarker study is ongoing in collaboration with MIT and Harvard Medical School.

Dr Straume commented: "Although novel immune- and targeted therapies show high initial response rates they are curtailed by the development of treatment resistance. Combination strategies therefore are being widely explored to further improve patient outcomes. Axl is a combination target of particularly high interest as it has been shown to be a key driver of resistance in melanoma to both anti-PD-1 therapy and MAP kinase inhibitors as well as playing a role in anti-tumor immune suppression. BGB324 is the most advanced selective Axl inhibitor in clinical development. It is very encouraging to see that BGB324 thus far has been tolerated well in patients with metastatic melanoma and I look forward to continue enrolling patients into the randomised arms of the study."

Also see international news headline in the Asco Post: Axl Inhibitor BGB324 in Combination With Trametinib Plus Dabrafenib or Pembrolizumab in Advanced Melanoma

TERT promoter mutations and protein expression

PhD Candidate Emilia Hugdahl in Professor Lars A. Akslen's group was presenting a poster of her work on concordancy and prognostic value of TERT promoter mutations and TERT protein expression in matched primary and metastatic melanoma tumors, which was recently accepted for publication in the British Journal of Cancer.

As a novel finding, her work demonstrates a high degree of discordancy of TERT mutation status between primary and metastatic lesions, with the majority of discordant cases being TERT mutation negative in metastases. This might indicate that TERT promoter mutation is not required for further progression at the stage of loco-regional metastasis.

Emilia Hugdahl's PhD project at CCBIO is focusing on prognostic factors in primary and matched metastatic melanoma tumors.