Panobinostat Dosing Regimens With SQ Bortezomib/Dexamethasone in Resistant Myeloma
Posted: Friday, February 12, 2021
Results of an open-label phase II trial investigating the activity and safety of three different dosing regimens of oral panobinostat, in combination with subcutaneous (SQ) bortezomib and oral dexamethasone for patients with resistant multiple myeloma, indicated that the higher weekly dosages provided the best overall response. However, the lowest weekly dosage was best tolerated. Paul G. Richardson, MD, of Dana-Farber Cancer Institute, Boston, and colleagues reported their findings in The Lancet Oncology.
In the PANORAMA 3 study, between 2016 and 2019, 248 adult patients in 21 countries were randomly assigned to a panobinostat regimen of either 20 mg three times weekly (group A), 20 mg twice weekly (group B), or 10 mg three times weekly (group C). All patients had an Eastern Cooperative Oncology Group performance status of up to 2 and had received one to four previous lines of therapy, including an immunomodulatory agent. All study drugs were administered in 21-day cycles, with the primary endpoint of the overall response rate after eight treatment cycles, but the study was not designed for statistical comparisons.
With a median duration of follow-up across all treatment groups of 14.7 months, the team found that the overall response rates were 62.2%, 65.1%, and 50.6% in groups A, B, and C, respectively. Serious adverse events occurred in a little more than half of the patients (42 of 78) in group A and a little less than half (40 of 83 and 35 of 83) of the patients in groups B and C, respectively. Although 14 deaths occurred across the groups during the study, none were deemed related to the study treatment.
Of note, wrote Dr. Richardson and co-investigators, is that “the safety profile of panobinostat 20 mg three times weekly was more favorable than in previous trials of this regimen with intravenous bortezomib, suggesting that subcutaneous bortezomib improves the tolerability of the panobinostat plus bortezomib plus dexamethasone regimen.”
Disclosure: The study authors’ disclosure information can be found at thelancet.com.
