Here is a study I didn’t write much about from ASCO last month.. Presented by Dr. Jóse San Miguel of Hospital Universitario de Salamanca, Spain, the study revealed data examining VELCADE in combination with the novel agent panobinostat. The open-label, multi-center, dose-escalation study presented the following results for 38 evaluable patients:
• Responses were observed in 68% (26) of patients; responses were also seen in 62% of VELCADE refractory patients
• Additional patients are being enrolled in cohort 3 to confirm MTD of VELCADE at 1.3 mg/m2 in combination with panobinostat at 20mg
Patients were randomized to five cohorts to receive VELCADE at doses ranging from 1.0 – 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21-day cycle and panobinostat at doses ranging from 10 – 25 mg on days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle. Dexamethasone at a dose of 20 mg was given to patients on the day of and day after VELCADE treatment at the discretion of the investigator. Common adverse events include diarrhea, nausea, pyrexia, fatigue and asthenia. DLTs were observed in cohorts 2, 4 and 5 and included neutropenia, thrombocytopenia, TCP, asthenia and dizziness.
Please note the first bulleted point: “responses were also seen in 62% of VELCADE refractory patients.” It is early, but that is pretty impressive. Studies featuring panobinostat as a single agent against myeloma have been disappointing. But combine it with Velcade or Revlimid and BAM! positive results soar! More evidence drug combo’s are the wave of our future as multiple myeloma patients.
Feel good and keep smiling! Pat