Encouraging Data on Pharmacyclics/J&J Drug - Analyst Blog

Pharmacyclics Inc. PCYC announced encouraging data on oncology drug Imbruvica (ibrutinib) from a phase III study (RESONATE: n=391). The study was evaluating Pharmacyclics' Imbruvica (ibrutinib) versus GlaxoSmithKline GSK and Genmab's Arzerra (ofatumumab) in patients suffering from relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The patients were treated at least once before for the disease which affects predominantly elderly people.

Results from the multi-center, international, open-label, randomized study, which was published in an online first edition of the New England Journal of Medicine, revealed that treatment with Imbruvica caused patients to live longer without the disease worsening compared to those in the Arzerra arm. Data revealed a 78% reduction in risk of progression or death in patients treated with Imbruvica compared to those being treated with Arzerra. The overall response rate was also found to be favorable in the Imbruvica arm.

We note that the RESONATE study was stopped early following the recommendation of an independent Data Monitoring Committee (DMC) as it had already met the trial's primary and a key secondary endpoint of progression-free survival and overall survival, respectively.

Pharmacyclics and partner Johnson & Johnson JNJ gained accelerated approval from the U.S. Food and Drug Administration (FDA) for Imbruvica in the previously treated CLL indication in Feb 2014. Full approval was sought in April for the same indication on the basis of data from the RESONATE study. Gaining the FDA nod, as far as full approval for the indication is concerned, should be a mere formality for the partners given the highly impressive data from the RESONATE study.

We remind investors that Imbruvica was approved by the FDA in Nov 2013 as a monotherapy for treating patients suffering from mantle cell lymphoma (MCL). The drug has been approved to treat MCL patients who have been treated at least once for the disease. The drug is being studied for other oncology indications as well. We expect investor focus to remain on updates regarding Imbruvica, going forward.

Pharmacyclics carries a Zacks Rank #3 (Hold). Gilead Sciences GILD is an example of a better-ranked stock in the healthcare sector with a Zacks Rank #1 (Strong Buy).