Array BioPharma Announces Publication of Phase 3 Data of Melanoma Treatment

Edward Kim  |

Although much less common than basal cell and squamous cell skin cancers. melanoma is more dangerous because of the higher likelihood of metastasis, according to the American Cancer Society. There are about 200,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have mutations to the BRAF (B-RAF, one of a family of rapidly accelerated fibrosarcoma kinases) gene, a key target in the treatment of metastatic melanoma.

Array BioPharma (Nasdaq: ARRY) announced that detailed results of its pivotal Phase 3 trial for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma were published in The Lancet Oncology. In the analysis of the primary endpoint, the median progression-free survival (mPFS) for patients treated with the combination of encorafenib, 450 mg daily, plus binimetinib, 45 mg twice daily was 14.9 months versus 7.3 months for patients treated with vemurafenib, 960 mg twice daily [hazard ratio (HR) 0.54, 95% confidence interval (CI) 0.41–0.71, p<0.0001].

In February 2018, Array announced that this combination treatment demonstrated median overall survival of 33.6 months compared to 16.9 months for patients treated with vemurafenib alone (HR 0.61, 95% CI 0.47-0.79, p <0.001). The hazard ratio describes the relative risk of the complication based on comparison of event rates, while the confidence interval is a precision measurement indicating the range of values that is likely to include the true population value.

Encorafenib is a late-stage small molecule BRAF inhibitor and binimetinib is a late-stage small molecule MEK (mitogen-activated extracellular signal-regulated kinase) inhibitor, both of which target key enzymes in the mitogen-activated protein kinase (MAPK) signaling pathway. MAPKs are involved in a variety of fundamental cellular processes such as proliferation, differentiation, motility, stress response, apoptosis (cell death) and survival.

Source: Array BioPharma, March 12, 2018.

The manuscript entitled "Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial," was published online on March 21, 2018. Array had previously announced top line results from this study in September 2016.

A median progression-free survival of nearly 15 months with the combination of encorafenib and binimetinib is clinically meaningful for patients with advanced BRAF-mutant metastatic melanoma. Further, a median overall survival of 33.6 months, compared to 16.9 months with vemurafenib monotherapy... further supplements the published data and shows that the combination of encorafenib and binimetinib may become a promising new therapy for patients with advanced BRAF-mutant metastatic melanoma.

- Keith T. Flaherty, MD, Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital Cancer Center; Professor of Medicine, Harvard Medical School.

The FDA is currently reviewing the New Drug Applications to support use of the combination of encorafenib and binimetinib for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma and has set a PDUFA target action date of June 30, 2018 for both applications. In addition, the European Medicines Agency, the Swiss Medicines Agency and the Australian Therapeutic Goods Administration are each reviewing the Marketing Authorization Applications for encorafenib and binimetinib.

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Source: Array BioPharma, March 12, 2018.


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