Six percent of patients in the ponatinib study developed pancreatitis, inflammation of the pancreas, although no patients withdrew from the study due to the side effect. Four patients, all with advanced CML and other medical complications, died during the study and may have been related to ponatinib, researchers said.
After 10 months of follow-up, 70% of chronic lymphocytic leukemia patients responded to a low-dose of PCI-32765. That's an increase from a 48% response rate reported last spring.
Patients treated with a higher dose of PCI-32765 reported a 44% response rate after a shorter 6.5 months of follow up.All patients enrolled in the PCI-32765 study have CLL that is no longer responding to currently approved treatments. "This is a potentially transforming drug for CLL," said Dr. John Byrd, professor of hematology and oncology at Ohio State University and an investigator in the PCI-32765 study. On Thursday, Pharmacyclics licensed PCI-32765 to Johnson & Johnson for $150 million upfront and as much as $825 million in future development milestones. PCI-32765 is a pill designed to block the production of an enzyme known as Bruton's tyrosine kinase that is responsible for the unchecked or cancerous growth of B-cells. YM Biosciences (YMI) will be presented highly anticipated data on its myelofibrosis drug CYT387 during a Monday night poster session starting at 9 pm ET. "Several key opinion leaders we spoke with said they believe '387's anemia benefits are real, even though they do not expect it to be quite as robust as previous results and do not have a scientific explanation for these effects," writes Wells Fargo biotech analyst Brian Abrahams. Sally Church, a cancer drug consultant who co-writes the popular Biotech Strategy Blog, tweeted last might, "Going to call it and say we won't see Hb [hemoglobin] increase with $YMI in tomorrow's #ash11 poster. Storm in a teacup." Researchers presented updated results from a pivotal study of Incyte's (INCY) recently approved myelofibrosis drug Jakafi showing a statistically significant, 50% reduction in the risk of death. However, given that the survival benefit was derived from a retrospective look at the data, it was unclear whether Incyte would be able to convince regulators to include the new claim in Jakafi's label. --Written by Adam Feuerstein in Boston.
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