Results

Roche shares spike as PhIII breast cancer combo with Perjeta scores a success, Puma takes a beating

Sandra Horning

Roche scored a big win for its cancer franchise today, reporting that a key Phase III trial adding Perjeta to Herceptin and chemotherapy outperformed the two older standards alone in reducing the risk of death or relapse for early-stage breast cancer patients after surgery. Analysts crowed that the clinical victory signals a major advance for Roche, likely adding billions to its megablockbuster oncology franchise.

Shares of Roche jumped as much as 7% on Thursday morning, a rare spike for a Big Pharma like Roche.

Herceptin has played a huge role in combating HER2-positive breast cancer. But Roche is now facing generic competition on that front that could seriously erode sales. Adding Perjeta to their combo will make it a much tougher franchise to compete against.

Tim Anderson, who expects to see Perjeta worldwide sales double to more than $4 billion in the next five years, wants to see the data at ASCO. “Without full details of the data, however, some degree of hand-wringing will likely continue, in terms of just how big the clinical benefit is likely to be,” he added.

That message was not lost on investors in Puma $PBYI. The biotech has been testing a combination of neratinib and chemo against the standard Herceptin matchup in breast cancer. And while it has produced positive data, neratinib is also linked closely with severe diarrhea.

“Following this morning’s…positive top-line data in APHINITY, barring any unlikely and unexpected surprises when the full data are presented (most likely at ASCO), the commercial opportunity for neratinib in the extended adjuvant setting should be considered as eliminated,” noted RBC’s Simos Simeonidis.

Puma’s shares tanked this morning, plunging 23% in pre-market trading.

The data from Roche’s APHINITY study will have to wait for an upcoming conference, but analysts say that they’re looking for a several point improvement in the percentage of women in this study whose breast cancer did not return within three years, beating a standard combo that already has scored a very high success rate in stopping cancer.

“These results from the positive APHINITY study represent an important addition to the body of data for Perjeta in the treatment of people with HER2-positive early breast cancer,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “We look forward to discussing these adjuvant results with global regulatory authorities.”

Gunter von Minckwitz, MD, study coordinator from the Breast International Group and academic study partners, added:

“APHINITY provides yet another example of the importance of industry-academic collaborations and their value in advancing cancer care for people affected by this challenging disease.”



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