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Roche's Kadcyla fails in gastric cancer trial

Results are a major blow to the firm's ambition of expanding the indications for its breast cancer drug

Roche's hopes of expanding the use of its breast cancer drug Kadcyla into a treatment for stomach cancer have been dashed by disappointing trial results.

Kadcyla (trastuzumab emtansine) - an antibody-drug conjugate (ADC) that links the antibody in Roche's Herceptin to a cytotoxic molecule - was unable to show a benefit as a second-line treatment for HER2-positive advanced gastric cancer in the study.

The trial - called GATSBY - was comparing Kadcyla to standard taxane therapy for this form of stomach cancer, which is estimated to account for around 10%-20% of all gastric cancer cases.

The trial is particularly disappointing as Kadcyla parent Herceptin has previously been shown to be effective in HER2-positive gastric cancer, and has been approved for this use for several years. Roche has previously said that it hoped to file for approval of Kadcyla in this indication next year.

Roche has just reported third-quarter financial results which reveal Kadcyla sales of CFH 558m ($574m) in the first nine months of the year, a 57% increase on the same period of 2014 with particularly strong growth in Europe thanks to recent launches in France, Italy and Spain.

Despite the strong uptake, the drug has run into some challenges that have limited its growth. For example, in the UK it was rejected by the National Institute for Health and Care Excellence (NICE) on the grounds of cost, and was also recently culled from the list of drugs available under the Cancer Drugs Fund (CDF).

The results in gastric cancer are disappointing but are not expected to be a major blow to Kadcyla's prospects, however, as the drug remains in three registration trials that could expand its use into early breast cancer and is also in a Phase II trial in HER2-positive non-small cell lung cancer (NSCLC).

All told, Roche recorded a 6% increase in revenues in the third quarter to CHF 11.9bn, and raised its forecast for the full year. The company now expects revenues to rise in the mid-single-digit percentage range in 2015.

Among its best-performing products were breast cancer therapy Perjeta (pertuzumab), up 66% to CHF 1.04bn in the nine-month period, and this in turn helped boost sales of Herceptin by 10% to CHF 4.88bn as the two drugs are administered in combination.

“With sales continuing to grow strongly, we are raising our outlook for the full year," said Roche chief executive Severin Schwann, who also pointed to the positive newsflow coming from the firm's product pipeline.

"This includes data on our cancer immunotherapy medicine atezolizumab in bladder and lung cancer and, in particular, strong data on ocrelizumab in both relapsing and primary progressive forms of multiple sclerosis."

Article by
Phil Taylor

23rd October 2015

From: Research



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