Lymphoma Drug Shows Improved Survival
Treatment with Imbruvica found to improve overall response rate.
New results during a phase 3 clinical trial indicates progress in the treatment of mantle cell lymphoma (MCL) with Ibrutinib (Imbruvica).
MCL comes from B cells, a type of white blood cell that originates in the bone marrow. The median survival rate is only 3 to 4 years and this new trial drug has shown some promise.
Imbruvica was found to significantly prolong progression-free survival (PFS), while improving overall response rates compared with temsirolimus.
The results of the trial showed 57% of patients had reduced risk of disease progression or death after a 20 month median follow-up (HR 0.43 [95% CI, 0.32-0.58; P<0.0001]). When looking at the data, researchers found that the median PFS for patients who were treated with Imbruvica was 14.6 months, while PFS for patients treated with temisirolimus was 6.2 months.
Imbruvica also had a significantly higher ORR compared with temsirolimus when assessed by independent review (72% vs. 40%, respectively; difference 31.­5% [95% CI, 20­.5—42.­5]; p<0­0001). Of the 26 patients administered Imbruvica, about 19% had a complete response (CR), while 2 patients administered temsirolimus had a CR of 1%.
However, the duration of patients taking Imbruvica was 4 times longer than patients on temsiroliums (14.4 months vs. 3 months). The median overall survival was not reached with Imbruvica when compared with the 21.3 months with temsirolimus (HR, 0.76; [95% CI, 0.53-1.09).
"MCL patients typically achieve only short-term remissions with conventional therapies, so the positive results seen with Imbruvica in this Phase 3 trial are particularly striking," said study investigator Simon Rule, MD. "As clinicians, we strive to ensure our patients receive safe and effective treatment options. The RAY data show Imbruvica was associated with an improved risk-benefit profile compared to temsirolimus."
It was found that 7% of Imbruvica patients and 26% of temsirolimus patients ended treatment due to adverse events. After a 20-month median follow up, it was found that 42% of patients in the Imbruvica group and 45% of patients in the temsirolimus group died.