A late stage study on Johnson and Johnson’s and AbbVie’s Imbruvica showed a reduction in the risk of death and disease progression as opposed to chemotherapy in leukemia patients who had previously remained untreated. This has helped set the stage for the anti-cancer drug’s expanded approval.
A total of 269 patients aged 65 and older with chronic lymphocytic leukemia (CLL) were tested, as Imbruvica decreased death risk by an impressive 85 percent, as compared with chlorambucil chemotherapy. Three patients died in the Imbruvica group, as to 17 patients in the chemotherapy group. Currently, Imbruvica is approved to treat CLL patients who had received one therapy prior to the medication.
“If you move this drug into previously untreated patients, it looks even better than what we’ve seen before,” said lead author Dr. Jan Burger in a statement. He and his team will present the data at the next American Society of Hematology meeting in Orlando.
The main variable of the research was median PFS, or progression-free survival – this is the time it took for the cancer to worsen in half of each group’s patients. For the chemotherapy group, median PFS was 18.9 months, while the Imbruvica group had not yet reached this level. After a year and a half, 90 percent of Imbruvica patients had not experienced disease progression.
“In every measurable way it is so clearly better (than chemotherapy) that the data argue for supporting approval,” added Burger in reference to Imbruvica’s efficacy. Both J&J and AbbVie are hoping for a decision from federal regulators by the first quarter of 2016.
Results of the study were published this week in the New England Journal of Medicine.