What schedule of panobinostat with subcutaneous bortezomib and dexamethasone tablets is effective for patients with relapsed and refractory multiple myeloma?

This study evaluated the treatment schedule for panobinostat (Farydak) tablets combines with subcutaneous (injections under the skin) bortezomib (Velcade) and dexamethasone (Ozurdex) tablets in patients with relapsed/refractory (R/R) multiple myeloma (MM). The study found that 20mg of panobinostat should be given twice – three times a week in this combination.

MM is a type of blood cancer. A high number of patients with MM relapse (the tumor grows after treatment) or are resistant to therapy (refractory). A standard treatment for R/R MM is bortezomib in combination with dexamethasone (Vd regimen). New, more effective therapies that can be used in combination with the Vd regimen are being developed.

Panobinostat targets tumor cells to prevent their growth and cause the tumor cells to die. While panobinostat is approved for the treatment of patients with MM in combination with Vd, the dose that should be used, and how often it should be given is not yet clear.

This study included 241 patients with R/R MM. The patients had previously been given 1-4 types of treatment. Patients were split into three treatment groups based on the type of panobinostat treatment they received. All patients were also given the Vd regimen. Group 1 (79 patients) were given 20mg of panobinostat 3 times a week. Group 2 (82 patients) had 20mg of panobinostat 2 times a week. Group 3 (80 patients) received 10mg of panobinostat 3 times a week. The average follow-up time was 14.7 months.

62.2% of patients in group 1, 67.5% in group 2, and 53% in group 3 showed a response to treatment. Patients in group 1 responded after an average of 1 month. Patients in group 2 responded after 2 months and those in group 3 after 3 months on average.

After 1 year, 53% of group 1 and 51% of group 2 were estimated to be alive without progression of MM. This was compared to 33% in group 3. 

Patients in all groups had similar side effects. 54% of patients in group 1, 48% in group 2, and 44% in group 3 had a serious side effect. The most common side effect was pneumonia. 

This study showed that patients with R/R MM who were given 20 mg panobinostat twice/three times a week + Vd regimen had a good response to therapy.

The study could not compare how effective the different treatment schedules were between groups. The rate of survival of patients without progression of their disease has not yet been calculated. The number of patients aged over 75 was low. This made it difficult to understand the impact of panobinostat on older patients. This study was funded by Novartis Pharmaceuticals who manufactures panobinostat.