publication date: Jan. 2, 2015

Phase II Imbruvica Trial Shows 47% of MCL Patients Alive at 27-Month Median Follow-up


A phase II trial of Imbruvica showed that more than 30 percent of treated relapsed/refractory mantle cell lymphoma patients remained progression-free after two years with no new or unexpected adverse events occurring during that time. Forty-seven percent of the 111 patients treated were still living at the 27-month median follow-up.

The data were presented at the annual meeting of the American Society of Hematology. A separate phase II study presented at the annual meeting evaluated a combination of Imbruvica and rituximab in relapsed/refractory MCL patients.

In the first trial, patients received Imbruvica once daily until disease progression or unacceptable toxicity. While the median treatment duration in the trial was 8.3 months, 46 percent of patients received treatment for more than one year and 20% continued on treatment in the extension trial for more than two years.

At 24 months, 31 percent of patients remained progression-free and 47 percent remained alive. The median overall survival was 22.5 months and the median progression-free survival was 13 months. Investigators observed a 67 percent overall response rate, which was the primary endpoint of the trial, and 23 percent of patients experienced a complete response. The median response time was 1.9 months and the median duration of response was 17.5 months. Patients were allowed to continue treatment through a long-term extension trial.

Data from the follow-up analysis were consistent with earlier results from the trial, which served as the basis for the November 2013 FDA approval of Imbruvica for the treatment of patients with MCL who have received at least one prior therapy. Accelerated approval was granted for this indication based on … Continue reading CCL Dec – Phase II Imbruvica Trial Shows 47% of MCL Patients Alive at 27-Month Median Follow-up

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