Novartis' bid to widen Afinitor's breast cancer reach falls short in PhIII

Novartis' ($NVS) Afinitor already boasts an indication in advanced HR-positive, HER2-negative breast cancer, and the pharma giant was hoping to double up by adding a nod for HER2-positive advanced breast cancer. But no such luck: On Friday, the drugmaker announced its treatment had come up short in a Phase III trial.

In a study of 719 patients with locally advanced or metastatic HER2-positive cancer, Afinitor combined with Roche's ($RHHBY) Herceptin plus paclitaxel prolonged progression-free survival by 15 months, a span just half a month longer than the Herceptin/paclitaxel combo plus placebo produced.

And while Afinitor performed better in a subgroup of HR-negative, HER2-positive women, lengthening progression-free survival by 7.2 months over the placebo cocktail, the results didn't demonstrate statistical significance, Novartis said.

While HER2-positive breast cancer patients make up about 20% of the wider advanced breast cancer patient pool, Novartis was quick to point out that Afinitor already has the biggie under its belt. Its HR-positive, HER2-negative indication accounts for about 70% of all invasive breast cancers globally, leading some analysts to predict an extra $1.5 billion in sales when it snagged the FDA OK back in 2012.

And that was just one of several label expansions Novartis has tallied since Afinitor first made its debut in early 2009. First approved for kidney cancers, the drug has since racked up indications in pancreatic cancer, rare childhood brain tumors, and benign tumors caused by tuberous sclerosis in addition to breast cancer. And that's led to sizable yearly sales leaps for the med, which most recently grew by 66% to hit $1.3 billion for 2013.

But it hasn't all been a walk in the park for the hard-charging therapy. Last September, investigators announced Afinitor had failed to outperform placebo in improving survival rates among liver cancer patients. And the Basel-based pharma has run into setbacks with the U.K.'s cost watchdogs, too, who have refused to clear the drug's breast cancer indication.

- read the release

Special Reports: Top 20 orphan drugs by 2018 - Afinitor | Top 15 Drug Launch Superstars - Afinitor - Novartis | The top 10 pharma companies by 2013 revenue - Novartis

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