What have Pomalyst clinical studies shown?
Pomalyst® (pomalidomide, Celgene) was granted approval by the US Food and Drug Administration based on the results of a Phase II trial that evaluated Pomalyst alone and in combination with low-dose dexamethasone. The study included 221 patients with relapsed myeloma who had received an average of 5 previous therapies, were refractory to their last myeloma therapy, and had received both Velcade® (bortezomib, Takeda Oncology) and Revlimid® (lenalidomide, Celgene).
- This study showed that 33% of patients receiving the combination and 18% of patients receiving Pomalyst alone achieved a partial response or better.
- The responses lasted a median of 8.3 months in the combination group and 10.7 months in the Pomalyst group.
- On average, the overall survival was 16.5 months in the combination group and 13.6 months in the Pomalyst group. This is longer than what has historically been seen in patients in whom currently approved novel therapies have failed.
- Pomalyst-low-dose-dexamethasone was just as effective in patients who had received Revlimid as part of their last treatment and whose myeloma no longer responded to Revlimid or both Revlimid and Velcade.
The combination of Pomalyst and low-dose dexamethasone was compared to high-dose dexamethasone in a Phase III trial with 455 patients with refractory myeloma who had failed therapy with both Velcade and Revlimid, given either alone or in combination.
- This study showed that patients receiving the combination of Pomalyst plus low-dose dexamethasone lived significantly longer than those receiving high dose dexamethasone (12.4 months versus 8 months).
- Overall responses rates were 24% with Pomalyst and low-dose dexamethasone versus 4% with high-dose dexamethasone alone.
- On average, time without progression of myeloma was 3.6 months with Pomalyst and low-dose dexamethasone versus 1.8 months with high-dose dexamethasone alone.
- The combination was effective in patients with high-risk myeloma and those who previously received Revlimid.
Pomalyst-low-dose dexamethasone is listed as one of several preferred regimens for previously treated myeloma in current treatment guidelines.
Results of several early-stage trials have evaluated the addition of a third agent to Pomalyst-dex in relapsed and/or refractory myeloma. For example:
- Results of a randomized Phase II trial that enrolled 80 patients who no longer responded to Revlimid showed that adding cyclophosphamide improved the overall response rate and time without progression over that seen with Pomalyst-low-dose dex.
- Preliminary results of a small Phase II trial of the combination of Pomalyst-low-dose dex and Keytruda® (pembrolizumab, Merck), a type of immunotherapy known as a checkpoint inhibitor, showed early evidence of deep, durable responses, including in patients with high-risk disease.
- Preliminary results of an ongoing multicenter Phase 1b study showed that the combination of Darzalex and Pomalyst-dex resulted in a high 71% overall response rate in heavily pretreated patients.
How is Pomalyst currently being studied in myeloma?
Pomalyst is being evaluated in a number of ongoing clinical trials in relapsed and/or refractory myeloma, including two Phase III trials.
- The combination of Pomalyst, Velcade, and low-dose dexamethasone is being compared to Velcade-low-dose dex in relapsed or refractory myeloma.
- Pomalyst-low-dose dex is being evaluated in combination with Keytruda in relapsed and/or refractory myeloma.