Multiple myeloma occurs in roughly 1-5 of every 100,000 people.
The results, which were released at the 20th Congress of the European Hematology Association, are from a subgroup analysis that included 147 patients enrolled in the phase 3 PANobinostat ORAl in Multiple MyelomA (PANORAMA)-1 trial.
Panobinostat combined with bortezomib and dexamethasone in multiple myeloma patients who had received ≥2 prior lines of therapy, including bortezomib and an immunomodulatory drug (IMiD), had a 7.8-month longer median progression-free survival (PFS) than patients who received placebo plus bortezomib and dexamethasone.
Panobinostat is a potent pan-deacetylase inhibitor that targets aberrations in multiple myeloma biology, including epigenetics and protein metabolism.
Dr. Hermann Einsele, director of the Medical Clinic at University of Wurzberg in Germany, and colleagues elsewhere analyzed outcomes in patients enrolled in the PANORAMA-1 study based on prior treatment characteristics, including receipt of prior IMiDs; bortezomib plus IMiDs; and bortezomib plus IMiDs and ≥ 2 prior lines of therapy.
'Unmet medical need' for new multiple myeloma treatments
"While proteasome inhibitors and IMIDs have significantly improved outcomes for multiple myeloma patients over the last decade, the disease is still incurable," Dr. Einsele observed. "As a result, there is an unmet medical need for agents with a new mode of action in patients who are relapsed and/or refractory."
The PANORAMA-1 study met its primary endpoint (P
The subanalysis found that the median PFS increased to 12.5 months in patients who had received ≥2 prior regimens, including bortezomib and an IMiD, and were randomized to the panobinostat arm compared with 4.7 months in patients assigned to placebo (hazard ratio=0.47 [95% confidence interval (CI), 0.31-0.72]).
Compared to the placebo arm, treatment with the panobinostat combination also resulted in an increase in complete/near complete response rates (21.9% vs. 8.1%) and overall response rate (58.9% vs. 39.2%).
In a subgroup previously treated with an IMiD, the different in median PFS benefit was 4.9 months in favor of the combination therapy.
In a subgroup previously treated with bortezomib and an IMiD, the difference in median PFS benefit was 4.8 months favoring combination therapy.
Overall, the safety profile for each subgroup was similar to that of the overall population.
"Together, these data identify the subgroup of patients with relapsed or relapsed and refractory [multiple myeloma] who benefits most with panobinostat-bortezomib-dexamethasone," Dr. Einsele said. "The findings support the recent [Food and Drug Administration] approval of the panobinostat combination in [multiple myeloma] patients who received ≥2 prior regimens, including IMiDs and bortezomib."
Multiple myeloma occurs in roughly 1-5 of every 100,000 people worldwide.
The PANORAMA-1 study was conducted at 215 centers in 34 countries.