Results

J&J’s stellar prostate cancer data signals the likelihood of a broader market approval, as Pfizer rival struggles

CHICAGO — J&J will be looking to expand its blockbuster market for Zytiga (abiraterone) after posting stellar data at ASCO showing that the drug combined with standard hormone therapy registered a major improvement in progression-free survival among newly diagnosed patients with metastatic prostate cancer.

The LATITUDE study data demonstrated that the combination therapy delivered an average stretch of 33 months without the disease worsening, compared to 14.8 months for standard hormone therapy. Zytiga plus prednisone in combination with ADT decreased the risk of progression or death by 53% compared to placebo plus ADT in patients with mHNPC. And while overall survival was not reached yet for the Zytiga combo, the comparison arm came in at 34.7 months.

J&J $JNJ has been duking it out with Pfizer’s Xtandi — recently acquired in the $14 billion Medivation deal — in the area of prostate cancer, where both drugs are credited with a major improvement in the standard of care for prostate cancer.

The progress for J&J will likely be viewed as Pfizer’s loss. The pharma giant has posted shrinking sales for Xtandi since it completed the buyout. And its follow-on data hasn’t been good.

Karim Fizazi, University Paris-Sud

Late last year Pfizer and its partners at Astellas conceded that Xtandi combined with Zytiga and prednisone failed to bend the curve on progression-free survival for chemo-naïve patients whose disease had progressed following treatment with Xtandi, compared with a group of patients treated with Zytiga and prednisone alone. The investigators had been looking for a rationale to continue treatment with Xtandi, which would have expanded its blockbuster market even further.

Said J&J’s principal investigator Dr. Karim Fizazi:

This is important new information, as not all patients respond well to the current standard of care. LATITUDE suggests that abiraterone acetate plus prednisone, in combination with androgen deprivation therapy, can offer a new and much-needed option for patients with high-risk newly diagnosed mHNPC.


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