pharmafileSeptember 12, 2017
In a perfect example of the competitive nature of the pharmaceutical industry, just as one company posted success in one particular area, another company was forced to reveal its failure in the same patient group. The area is the treatment of BRAF V600 mutation-positive melanoma, and the two rival companies are Roche and Novartis.
Novartis combination treatment, using Tafinlar and Mekinist, revealed a 53% reduction in the risk of death or recurrence in patients against placebo treatment. While Roche’s treatment, Zelboraf, failed to hit its primary endpoint of significantly reducing the risk of recurrence.
The treatments were being used after patients had undergone surgery to remove tumours and possessed a genetic mutation called BRAF. The BRAF mutation is exhibited in approximately half of patients with melanoma.
It represents another success in the area for Novartis, with the combination treatment gaining ground in the market. The treatments brought in sales of $672 million for the company in sales in 2016. The two drugs were acquired as part of an asset swap deal with GSK back in early 2015.
"While surgery is a curative option for most patients with localized melanoma, there is a need for improved standard of care therapies for patients - especially for stage III disease, which carries a higher risk of relapse and death following resection," said Vas Narasimhan, Global Head Drug Development and Chief Medical Officer, Novartis. "The COMBI-AD data results address a significant unmet need in patients with stage III melanoma. We look forward to discussing the results with regulatory authorities worldwide."
For Roche, it represents a worrying sign for its drug that brought in sales of just $224 million last year, in figures that have continued to fall since 2014. Although the company was able to release some positive news from the data, noting that there was a 46% reduce rate of recurrence risk in earlier stage patients (IIC-IIIB).
"While results in people with stage IIIC melanoma were not what we had hoped, the reduction in the risk of recurrence in people with stage IIC-IIIB disease is encouraging and suggests Zelboraf may play a role in this earlier setting," said Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development.
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