GSK melanoma drugs beat rival in new study
pharmafile | July 18, 2014 | News story | Sales and Marketing | GSK, Roche, Tafinlar, Yervoy, Zelboraf, mekinist, melanoma
GlaxoSmithKline’s new combination melanoma treatment has bested Roche’s established oncology drug Zelboraf when treating patients with the deadliest form of skin cancer.
This was proved in a new Phase III study of GSK’s MEK inhibitor Mekinist (trametinib) in combination with its BRAF inhibitor Tafinlar (dabrafenib) in a head-to-head with rival pill Zelboraf (vemurafenib), made by Roche.
The trial was looking at its effects in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma – GSK said their combination was so effective that an independent monitoring body said the study should be stopped early.
This recommendation was based on an interim analysis that showed the overall survival (OS) benefit for the GSK drugs compared to Zelboraf was impressive enough to have patients switch over to the combination therapy, thereby stopping the study.
GSK is currently only releasing the headline data and further details of how much OS was increased in the 700 patients will be published later this year.
Dr Rafael Amado, head of oncology R&D at GSK, says: “[These] headline results for the combination of dabrafenib and trametinib add to the body of evidence our Phase III programme has provided thus far, which we hope will more fully characterise the efficacy and safety profile of this combination for patients with BRAF V600-mutant metastatic melanoma.
“We will continue to analyse this data versus vemurafenib over the coming months and look forward to sharing these with the scientific community once the analysis is complete.”
Although good news for GSK now, it is arguably better news for Swiss major Novartis. This is because in April the firm announced that it would be buying a majority stake in much of GSK’s oncology pipeline, which includes both Mekinist and Tafinlar.
Analysts have predicted peak annual sales for Mekinist and Tafinlar to reach around £1.5 billion ($2.4 billion) by 2020.
Growing market
Roche’s Zelboraf was the first in a new class of BRAF inhibitors to be approved for melanoma back in 2011, and is currently only approved as a singular treatment.
GSK’s BRAF inhibitor Tafinlar gained approval much later in 2013 but unlike Roche, GSK secured approval for a combination approach with both Tafinlar and Mekinist earlier this year.
As the latest data suggests, this combination therapy is proving more efficacious for BRAF patients when compared to using Zelboraf alone.
But Roche has been working on one of its own combination therapies. In fortuitous timing new top-line data revealed this week showed its investigational MEK inhibitor cobimetinib, used in combination with Zelboraf, helped advanced BRAF patients live ‘significantly longer’ without their disease worsening when compared to those using Zelboraf alone.
Any approval is still some way off and it is important to note that whilst these data are encouraging, they only show an increase progression-free survival (PFS). In contrast, the latest data from GSK shows its drugs can actually increase OS, which is the golden endpoint in all oncology trials, and one more important to cancer doctors than PFS.
All of these medicines will, however, need to compete with Bristol-Myers Squibb’s cancer vaccine Yervoy (ipilimumab), which was the first of the new generation of melanoma drugs to be approved by the FDA in early 2011.
This treatment is expected to reach blockbuster sales and can potentially treat all forms of melanoma, as it ‘teaches’ the body’s immune system to combat cancer.
It was also the first of the new generation of melanoma drugs to prove an increase in OS and has yielded impressive sales as it marches toward its predicted peak annual revenue of $1.5 billion.
Ben Adams
Related Content
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
GSK shares results from phase 3 trial for gonorrhoea treatment
GSK has announced positive results from its phase 3 EAGLE-1 trial for gepotidacin, a potential …
GSK’s meningococcal vaccine candidate accepted for FDA review
GSK has announced that the US Food and Drug Administration (FDA) has accepted for review …
