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J&J prostate cancer advances may bode ill for Pfizer

June 6, 2017

Big, impressive results for Johnson & Johnson’s Zytiga, premiering this past weekend at the American Society of Clinical Oncology’s annual meeting, could mean everything to men who get a common type of cancer.

But for Pfizer Inc. PFE, -0.88% and already-uneven sales of its Xtandi, the new research could represent more bumps ahead.

Both drugs are treatments for prostate cancer, which is the most common cancer in men after skin cancer, according to the American Cancer Society. About one in seven men will be diagnosed with prostate cancer during their lifetime.

The drug that is approved first could have a significant commercial advantage. Two recent trials will likely set Johnson & Johnson’s JNJ, +0.47%  Zytiga up for just that benefit, said Leerink analyst Geoffrey Porges.

 

Zytiga is currently used with the immunosuppressant drug prednisone for men whose prostate cancer is castration-resistant, meaning the cancer worsens even after treatments lower the body’s testosterone and the cancer has spread elsewhere in the body.

But an approval for Zytiga with another therapy in newly-diagnosed metastatic prostate cancer is probably around the corner, Porges said.

“Given the exceptional results, the combination is likely to be rapidly adopted as soon as reimbursement is available,” Porges said. Some patients — about 10% to 15% — may not be able to tolerate Zytiga, but “otherwise Xtandi will be pushed to ‘the back of the bus’ in terms of the treatment sequence.”

Pfizer told MarketWatch that it is “very confident” in Xtandi’s potential, and noted that it is the standard of care for advanced prostate cancer.

“We believe the greatest future growth opportunity for Xtandi is potentially broadening the indication towards earlier non-metastatic lines of prostate cancer therapy,” a spokesperson said, adding that the company has two late-stage trials running in non-metastatic prostate cancers and a late-stage trial in early metastatic hormone-sensitive prostate cancer.

Xtandi was considered a key motivation for the drugmaker’s $14 billion acquisition of biotech Medivation last summer, but sales stumbled in the latest quarter, with an executive at the company admitting that it was performing below expectations in the U.S.

 

The drug is also set to lose exclusivity in the next year or two, said Porges, which will allow competition from other products.

More recently, a study looking at whether patients whose cancer progressed after initially responding to Xtandi would benefit from combining it with Zytiga had disappointing results.

Meanwhile, at the same cancer conference, the new Zytiga results dazzled scientists and Wall Street analysts.

The drug had especially promising results in one large trial.

Adding Zytiga could result in a 37% relative survival improvement compared with the standard of care, the trial found, along with big decreases in the chance of relapsing and chance of serious bone complications.

“This study result, with the huge overall survival benefit and improvement in failure-free survival and time to skeletal events, establishes the Zytiga + [a hormone therapy called androgen deprivation therapy (ADT)] combination as the new standard of care for men starting long-term ADT for metastatic or recurrent prostate cancer,” said Porges. Treatment in this setting would be longer-term, he said.

 

Another big trial showed the drug could have major benefits for patients who have been newly diagnosed with high-risk prostate cancers.

So much so that “these consistent and robust findings led the presenter, and the discussant at the plenary session, to declare that Zytiga plus ADT should be the new standard of care for newly diagnosed or presenting metastatic castrate sensitive prostate cancer,” Porges said.

The results could provide a large boost to Johnson & Johnson, since “whichever medicine is used second will generate one-third or less of the revenue of the drug used in the first position,” Porges said.

Plus, research comparing the two drugs directly showed some, but not enough, evidence supporting Xtandi as the better treatment.

A mid-stage clinical trial that enrolled 200 patients compared the two drugs head-to-head in metastatic castration-resistant prostate cancer and found Xtandi seemed more effective, but other clinical measures did not show improvement, Porges said.

http://on.mktw.net/2sAzVuY

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