Shares of Pharmacyclics, Inc. ($PCYC) are on the run Tuesday after and Independent Data Monitoring Committee said that a Phase III trial of Imbruvica (ibrutinib) should be stopped early because it has already hit its primary and secondary endpoints.
The company’s RESONATE study was measuring survival rates of patients treated with Imbruvica versus ofatumumab, a drug sold by GlaxoSmithKline ($GSK) under the brand name Arzerra. Pharmacyclics said that the pill Imbruvica demonstrated a statistically significant improvement in its primary endpoint of progression-free survival in patients with refractory chronic lymphocytic leukemia or small lymphocytic leukemia.
The drug also hit its secondary endpoint of improving overall survival rates in the trial, which included 391 patients at more than 70 sites in 10 countries. Ibrutinib is one of only a handful of drugs that have garnered the vaunted “breakthrough therapy” designation of the U.S. Food and Drug Administration that was put into effect late in 2012. The drug acts by inhibiting BTK, a kinase enzyme that plays a key role in B cell maturation.
The independent review committee recommended that patients in the ofatumumab arm of the trial be allowed to switch to Imbruvica if they choose.
Pharmacyclics added that it is now it discussions with the FDA about the next step towards regulatory approval. In the same fold, Imbruvica co-developer Janssen Pharmaceuticals, a division of Johnson & Johnson ($JNJ), is speaking with the European Medicines Agency about advancing Imbruvica towards commercialization.
In November, the FDA approved Imbruvica for mantle-cell lymphoma (MCL), but did not respond to the portion of the application that sought approval of the drug from chronic lymphocytic leukemia, or CLL as it is called. The approval of Imbruvica for mantle-cell lymphoma puts the drug in competition with Takeda Pharmaceuticals’ Velcade and Celgene’s ($CELG) Revlimid. None of the drugs are cheap, including Pharmacyclics pricing Imbruvica for MCL at roughly $130,000 per year in the U.S.
"I am tremendously proud of the accomplishment of the Pharmacyclics team for their effort and execution as well as the collaboration with the clinical sites toward this high quality study. This collaboration resulted in expeditious enrollment, and rapid data collection and analysis," said Dr. Maria Fardis, Chief of Oncology Operations and Alliances at Pharmacyclics in a statement today.
Shares of PCYC leapt ahead by more than 18 percent on the day at $124.67 in mid-afternoon trading. Shares of JNJ are also climbing, up 2.3 percent at $94.50.
It’s a nice move for Pharmacyclic shares, but trails that of Epizyme ($EPZM), which has galloped ahead more than 70 percent in Tuesday action after announcing that it has collected $29 million in milestone payments for developments with its cancer drugs.
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