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ASCO conference: Roche scraps plans to develop breast cancer drug on weak data

Roche Holding AG said it is dropping plans to develop cancer drug taselisib after its combination with a hormone therapy to treat certain breast cancer patients did not produce significant benefit and had serious side effects in a late stage study.

"The magnitude of benefit observed in the Sandpiper [trial] isn't as strong as we had hoped for and, given the challenging difficult safety profile of this combination and the current clinical landscape, Roche will not be pursuing a regulatory filing for taselisib," it said in a statement emailed to S&P Global Market Intelligence.

The Swiss drugmaker evaluated the experimental medicine combined with AstraZeneca PLC's Faslodex, or fulvestrant, in a phase 3 trial of 516 breast cancer patients whose disease growth was due to the hormone estrogen, had grown to nearby tissue or other parts of the body and had a mutation in the PIK3CA gene.

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Results from the phase 3 Sandpiper trial, which were presented at the 2018 American Society of Clinical Oncology meeting, showed patients on the combination lived without the disease worsening for a median of 7.4 months, versus 5.4 months for patients who received the hormone therapy and a placebo.

The taselisib and Faslodex combination also led to an increase in side effects, which included diarrhea, high blood sugar and inflammation in the colon, mouth and lips.

The side effects caused 17% of the patients to drop the combination regimen, compared to only 2% dropping treatment in the placebo group, Roche said in its ASCO presentation.

"HR-positive, HER2-negative metastatic breast cancer is an area where there has been notable progress in the last few years and more treatment options are now available to patients, which is great news," Roche said in its emailed statement.

In a previous phase 2 study, named Lorelei, the drug's combination with letrozole, also a hormone therapy, was shown to reduce tumor size in patients with early breast cancer with the PIK3CA mutation.

The 2018 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from all over the world, with more than 2,500 study abstracts to be presented on-site and an additional 3,350 abstracts to be published online.