PFS doubles! Melanoma combination therapy is expected to be approved in the first half of the year

PFS doubles! Melanoma combination therapy is expected to be approved in the first half of the year

March 23, 2018 Source: WuXi PharmaTech

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Array BioPharma today announced that detailed results of the key phase 3 COLUMBUS trial for patients with advanced BRAF mutations, unresectable or metastatic melanoma, were published in The Lancet Oncology. The study showed that patients receiving biimetinib and encorafenib combination therapy had significantly longer progression-free survival (PFS) compared with patients receiving vemurafenib alone.

Metastatic melanoma is a serious life-threatening skin cancer. Only about 20% of patients diagnosed with advanced cancer can survive for more than 5 years. There are approximately 200,000 new cases of melanoma in the world each year, and about half of them have BRAF mutations, which is a key target for the treatment of metastatic melanoma.

MEK and BRAF are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Studies have shown that this pathway controls several key cellular activities including proliferation, differentiation, survival, and angiogenesis. Abnormal protein activation occurs in many cancers, such as melanoma, colorectal cancer, and thyroid cancer. Binimetinib and encorafenib are small molecule inhibitors of MEK and BRAF, respectively, which are expected to inhibit both types of proteins and thus control disease.

â–²Binimetinib's molecular structure (Source: By Vaccinationist (PubChem) [Public domain or Public domain], via Wikimedia Commons)

The COLUMBUS trial (NCT01909453) is a two-part, international, randomized, open-label, phase 3 clinical trial designed to assess the safety and efficacy of binimetinib and encorafenib combination therapy compared to vemurafenib or encorafenib alone. The study was conducted in 921 patients with BRAF V600 mutations leading to unresectable or metastatic melanoma. The results of the COLUMBUS Part 1 study showed that COMBO450 (450 mg encorafenib once daily and 45 mg binimetinib twice daily) significantly prolonged PFS in patients with advanced BRAF mutant melanoma. The PFS increased from 7.3 months using vemurafenib to 14.9 months (HR 0.54, 95% CI: 0.41-0.71, P < 0.001). The purpose of the COLUMBUS Part 2 study was to evaluate the role of binimetinib in combination therapy. The median PFS for patients treated with COMBO300 (300 mg encorafenib once daily and 45 mg binimetinib twice daily) was 12.9 months, compared with 9.2 months for patients receiving a single dose of encorafenib (HR 0.77, 95). %CI: 0.61-0.97, p=0.029).

â–² Encorafenib's molecular structure (Source: By Vaccinationist (Own work) [Public domain], via Wikimedia Commons)

Dr. Kema T. Flaherty, MD, professor of medicine at Harvard Medical School, said: "For patients with advanced BRAF mutant metastatic melanoma, the median progression-free survival of nearly 15 months with encorafenib and binimetinib combination therapy is clinically significant. The secondary endpoint data not included in this paper, the median overall survival was recently published at 33.6 months, compared with 16.9 months for vemurafenib alone (HR 0.61, 95% CI 0.47-0.79, p < 0.001). These data show that For patients with advanced BRAF mutant metastatic melanoma, the combination of encorafenib and binimetinib may be promising new therapies."

The US FDA is currently reviewing the new drug application (NDA) for combination therapy for the treatment of patients with advanced, unresectable or metastatic melanoma of BRAF mutation, which is expected to be returned by June 30, 2018. In addition, the European Medicines Agency (EMA), the Swiss Medicines Agency and the Australian Therapeutic Goods Administration are reviewing the marketing authorization application for this combination therapy.

We expect this new drug to pass the review and bring hope to patients with metastatic melanoma.

Reference materials:

[1] Array BioPharma Announces Publication of Detailed Phase 3 COLUMBUS Trial Data of Encorafenib and Binimetinib in Melanoma Patients in The Lancet Oncology

[2] WuXi PharmaTech - Array BioPharma Melanoma New Therapy COMBO450 Submits FDA Application

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