A phase III trial demonstrated a 37 percent improvement in progression-free survival when using the investigational compound LBH589 (panobinostat) in combination with bortezomib and dexamethasone compared to treatment with the same regimen with placebo in patients with relapsed or relapsed and refractory multiple myeloma.
The trial, PANORAMA-1, met its primary endpoint (HR=0.63 [95% CI: 0.52 to 0.76]; p<0.0001). The results were presented at the annual meeting of the American Society of Clinical Oncology in Chicago.
In the LBH589 arm, there was a 4-month prolongation of median PFS: 12 months compared to 8 months in the placebo arm. The effect of LBH589 was observed across all patient subgroups.
The findings also showed that adding LBH589 to bortezomib and dexamethasone led to a significant increase in higher quality responses compared to standard-of-care therapy alone, as evidenced by a nearly two-fold increase in complete/near complete response rates: 28 percent compared to 16 percent, respectively (p=0.00006).
PANORAMA-1 is a randomized, double-blind, global registration trial to evaluate LBH589 in combination with bortezomib and dexamethasone against bortezomib and dexamethasone alone in patients with relapsed or relapsed and refractory multiple myeloma who failed on at least one prior treatment. The study of 768 patients took place in 215 clinical trial sites worldwide. Data for overall survival, a secondary endpoint, are not yet mature. Other secondary endpoints include overall response rate, duration of response and safety.
LBH589, a pan-deacetylase inhibitor, potentially provides a novel mechanism of action to treat multiple myeloma and works by blocking a key class of cancer cell enzymes, which ultimately leads to cellular stress and death of these cells.
In May, LBH589 was granted priority review by FDA and additional global regulatory submissions are underway, according to the drug’s sponsor, Novartis.
