Novartis Posts a Win, Remains Standard of Care.


Novartis posts a win, Roche a flop in skin cancer trials. “This is somewhat sad, as a clinician, since there’s definitely a clinical benefit here.” Mekinist and Tafinlar were initially developed by GlaxoSmithKline but were acquired by Novartis as part of a complex asset swap between the two companies. Novartis isn’t alone with successful results in melanoma. Bristol-Myers Squibb reported information with its immunotherapy drug Opdivo, which isn’t restricted to use in patients with BRAF mutant tumors.

Their earnings combined stays less than half of the drugs of Novartis while Roche in 2015 began pairing Zelboraf with Cotellic against melanoma to counter mixes like Novartis’s who have become standard of care. The findings imply Novartis is currently gaining the upper hand in expanding the use against advanced, high-risk skin cancer for which there’s a risk of the potentially deadly tumors emerging elsewhere on the body of its combination therapy.

ZURICH/MADRID (Reuters) – Swiss drug maker Novartis notched a trial win because of its drug cocktail against skin cancer on Monday, while a rival treatment from Roche with slipping sales failed in a separate study with a similar patient group.

By contrast, Roche’s Zelboraf earnings plummeted to 213 million Swiss francs ($224 million) in 2016, down around a fifth from their 2014 levels. Mekinist and Tafinlar have been reaping $672 million in sales in 2016, compared to $453 million the prior year.

All the medicines were tested in melanoma patients who had a mutation called BRAF, which makes them likely to react to the cancer pills and had undergone surgery to cut out tumors. Patients with BRAF mutations constitute around half of their melanoma population.

For instance, the separate cohort of patients with less severe stage IIC to IIIB melanoma of its trial saw their risk of disease cut by 46 percent. “These are the best results ever revealed for an adjuvant (post-surgery) treatment in phase III melanomas,” stated Axel Hauschild of the University of Kiel, Germany, one of the primary researchers on the Novartis trial. “These are practice-changing outcomes.” Roche, which began its trial of Zelboraf in patients who had undergone operation before it had approval, said it was disappointed, but said the news was not exclusively dour.

The mix of Mekinist and Tafinlar of Novartis slashed at the risk of death or melanoma returning by 53 percent versus placebo in patients with stage III disease, according to data released at the European Society for Medical Oncology congress in Madrid.

Novartis Jeff Legos said the company hoped to submit the combination for regulatory approval in the adjuvant setting by the year’s end. Giving the medicines can have side effects and around a quarter of patients on the Novartis combination had to stop treatment due to adverse events.

The findings from colleagues and Hauschild were published online in the New England Journal of Medicine. Although it seemed to be effective in people who have earlier-stage melanoma, the endpoint of disease-free survival did not improve in patients with disease that is similar. Buechele said he would explore the information . The company does not plan any studies in the adjuvant setting with Cotellic and Zelboraf.