Roche: two drugs fail in late-stage trials.

(CercleFinance.com) - A Roche drug has failed to help people with completely resected, BRAF V600 mutation-positive melanoma in a late-stage clinical trial, the Swiss drugmaker said on Monday.


A phase III study, which was designed to investigate the efficacy and safety of Zelboraf, did not meet its primary endpoint of significantly reducing the risk of recurrence in patients with stage IIIC melanoma.

People in the second cohort of the trial had a median disease-free survival of 23.1 months with Zelboraf, compared to 15.4 months with placebo.

While a 46% reduction in recurrence risk was observed in stage IIC-IIIB patients of the first cohort, the results cannot be formally tested for significance due to the pre-specified statistical design of the study, Roche said.

Melanoma is a less common, but more aggressive and deadlier form of skin cancer.

Roche also said last Friday that the primary endpoint has not been met in a phase III study evaluating the safety and efficacy of lampalizumab, an investigational medicine for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD).

After these results, Roche shares were down 0.8% at 242.6 Swiss francs on Monday morning, underperforming the European drugs sector, which is up 0.4%.

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