Combos, Results

Roche’s ‘success’ with its big Perjeta/Herceptin PhIII falls flat at ASCO, but it’s a boost for Puma

Sandra Horning

CHICAGO — Roche heralded a success for its closely-watched combination breast cancer study of Perjeta and Herceptin at ASCO on Monday, but once the data came into focus there didn’t seem to be much to cheer about at the pharma giant.

The two drugs together performed better than Herceptin alone in improving patients’ odds of preventing a recurrence of the disease — by a margin of 0.9%. After three years of therapy the score was 94.1% survival in the combo arm with a 93.2% score for Herceptin.

“The goal of adjuvant treatment is to help each person with cancer have the best chance of a cure, and we come closer to this goal with each advance,” said Sandra Horning, chief medical officer and head of global product development. “In the APHINITY study, the Perjeta-based regimen improved upon the high bar set by Herceptin in people with HER2-positive early breast cancer. We look forward to working with global health authorities to bring this treatment option to patients.”

The new cocktail approach will cost significantly more than Herceptin alone, and that won’t sit well with payers. Roche had been hoping to shore up its blockbuster Herceptin franchise as that drug faces biosimilar competition.

The big winner in all this? Puma Biotech, which saw its shares $PBYI shoot up 18% Monday morning.

Their new drug neratinib demonstrated a 34% reduction in the risk of recurrence or death. It takes a leap to do these kinds of cross-trial analyses that drive drug developers a tad crazy now and then, but Wall Street analysts were quick to give Puma a thumbs up, particularly after it just handily won an FDA panel vote endorsing an approval.


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RAPS Regulatory Convergence 2017