Contributions
Abstract: PB2155
Type: Publication Only
Background
Pomalidomide is a 2nd generation immunomodulatory drug that has been approved for the treatment of patients who progress after prior treatment with proteasome inhibitor and lenalidomide. Experience with pomalidomide in Asian patients is very limited to date.
Aims
We aim to study the efficacy and toxicity of Pd in Asian patients with relapse or refractory myeloma and if the additional of cyclophosphamide can elevate response in suboptimal responders to Pd.
Methods
We conducted a prospective Phase 2 trial of pomalidomide (4mg daily for 21 days every 4 weeks) plus dexamethasone (40mg once weekly) in myeloma patients who have relapsed after prior bortezomib and are refractory to lenalidomide Asia (NCT02158702). If there was less than a minimal response after three cycles of Pd, including progression within three cycles, cyclophosphamide 300mg/m2 (day 1, 8, 15) can be added. This report presents data available up till the data cut-off date of 17 Jan 2018.
Results
One hundred and thirty patients have available base line information and safety data. At the cut-off date, 51% of the patients have either progressed or died. Cohort has typical disease characteristics of relapse MM. Median prior line of treatment is 3. 81% of patients experienced adverse events (AEs) of any grade (27% of episodes grade 3 or higher), with 67% of these episodes related to the study drugs. 71.5% of patients experienced serious AEs (SAEs) of any grade (72% of episodes grade 3 or higher), with 32% of these episodes related to the study drugs. Almost all grade 3 or higher events were related to cytopenias and infections. Only 1 patient experienced each of the following AEs: grade 3 peripheral neuropathy, venous thromboembolism or grade 3 renal impairment. 45 patients have died, 22 from disease progression, 10 from sepsis or pneumonia, and 4 from cardiac events.The median follow-up of the whole group is 9.2 months. The median progression free survival (PFS) (N=119) was 10.2 months. Those treated with only Pd (n=81) have a median PFS of 9.2 months. Patients on Pcd (n= 38) had a median PFS of 11.37 months. Achievement of a partial response (PR) or better was significantly associated with improved PFS. There was no significant difference in PFS by age, number of prior lines of treatment, or the presence of high-risk genetics. Overall median OS was 18.4 months. For those treated with Pd, the median OS was 18.4 months whereas it is not yet reached for those on Pcd. One hundred and two patients have data for response assessment. Fifty-three (52%) achieved a ≥PR response with 1 achieving CR and 1 stringent CR. The median duration of response was 11.7 months for those who had achieved a ≥PR. If minimal response was included, the response rates would be 87%. For those on Pd (N=64), 58% achieve ≥PR. Thirty-eight patients had cyclophosphamide added due to suboptimal response after three cycles of Pd, 16 (42%) of these achieve ≥PR. In these patients the median duration of response is 13.5 months.
Conclusion
This is the first prospective report of the efficacy and safety of Pd in Asian patients with RRMM. Our results compare favorably with previously published data from the US and Europe. In patients with suboptimal response, the addition of cyclophosphamide upgraded responses, rendering survivals comparable to those Pd-responsive patients. A randomized Phase 3 study conducted by the AMN comparing Pcd to Pd has commenced enrolment recently.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Clinical Trial, Myeloma, Relapse, Treatment
Abstract: PB2155
Type: Publication Only
Background
Pomalidomide is a 2nd generation immunomodulatory drug that has been approved for the treatment of patients who progress after prior treatment with proteasome inhibitor and lenalidomide. Experience with pomalidomide in Asian patients is very limited to date.
Aims
We aim to study the efficacy and toxicity of Pd in Asian patients with relapse or refractory myeloma and if the additional of cyclophosphamide can elevate response in suboptimal responders to Pd.
Methods
We conducted a prospective Phase 2 trial of pomalidomide (4mg daily for 21 days every 4 weeks) plus dexamethasone (40mg once weekly) in myeloma patients who have relapsed after prior bortezomib and are refractory to lenalidomide Asia (NCT02158702). If there was less than a minimal response after three cycles of Pd, including progression within three cycles, cyclophosphamide 300mg/m2 (day 1, 8, 15) can be added. This report presents data available up till the data cut-off date of 17 Jan 2018.
Results
One hundred and thirty patients have available base line information and safety data. At the cut-off date, 51% of the patients have either progressed or died. Cohort has typical disease characteristics of relapse MM. Median prior line of treatment is 3. 81% of patients experienced adverse events (AEs) of any grade (27% of episodes grade 3 or higher), with 67% of these episodes related to the study drugs. 71.5% of patients experienced serious AEs (SAEs) of any grade (72% of episodes grade 3 or higher), with 32% of these episodes related to the study drugs. Almost all grade 3 or higher events were related to cytopenias and infections. Only 1 patient experienced each of the following AEs: grade 3 peripheral neuropathy, venous thromboembolism or grade 3 renal impairment. 45 patients have died, 22 from disease progression, 10 from sepsis or pneumonia, and 4 from cardiac events.The median follow-up of the whole group is 9.2 months. The median progression free survival (PFS) (N=119) was 10.2 months. Those treated with only Pd (n=81) have a median PFS of 9.2 months. Patients on Pcd (n= 38) had a median PFS of 11.37 months. Achievement of a partial response (PR) or better was significantly associated with improved PFS. There was no significant difference in PFS by age, number of prior lines of treatment, or the presence of high-risk genetics. Overall median OS was 18.4 months. For those treated with Pd, the median OS was 18.4 months whereas it is not yet reached for those on Pcd. One hundred and two patients have data for response assessment. Fifty-three (52%) achieved a ≥PR response with 1 achieving CR and 1 stringent CR. The median duration of response was 11.7 months for those who had achieved a ≥PR. If minimal response was included, the response rates would be 87%. For those on Pd (N=64), 58% achieve ≥PR. Thirty-eight patients had cyclophosphamide added due to suboptimal response after three cycles of Pd, 16 (42%) of these achieve ≥PR. In these patients the median duration of response is 13.5 months.
Conclusion
This is the first prospective report of the efficacy and safety of Pd in Asian patients with RRMM. Our results compare favorably with previously published data from the US and Europe. In patients with suboptimal response, the addition of cyclophosphamide upgraded responses, rendering survivals comparable to those Pd-responsive patients. A randomized Phase 3 study conducted by the AMN comparing Pcd to Pd has commenced enrolment recently.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Clinical Trial, Myeloma, Relapse, Treatment