OVERALL RESPONSE RATE OF PATIENTS WITH REFRACTORY MULTIPLE MYELOMA TREATED WITH POMALIDOMIDE AND LOW DOSE DEXAMETHASONE AFTER LENALIDOMIDE FAILURE: INTERIM RESULTS OF THE POSEIDON STUDY
(Abstract release date: 05/19/16)
EHA Library. Dechow T. 06/09/16; 132853; E1304
Prof. Dr. Tobias Dechow
Contributions
Contributions
Abstract
Abstract: E1304
Type: Eposter Presentation
Background
The management of patients with primary refractory or relapsed and refractory multiple myeloma (RRMM) who failed lenalidomide and bortezomib treatment poses a clinical challenge. Prognosis for these patients is poor. The pivotal MM-003 trial demonstrated a benefit of the oral regimen pomalidomide (POM) in combination with low dose dexamethasone (LoDEX) for RRMM patients who had failed lenalidomide and bortezomib treatment. With a median follow-up of 10 months, POM + LoDEX showed an overall response rate (ORR; ≥ partial response [PR]) of 31 % vs. 10 % (p<0.001), a significantly longer progression-free survival (PFS) and a significant improvement in overall survival (OS) compared to high-dose DEX. Efficacy of POM + LoDEX was consistent across various age groups and tolerability was unaffected by age.
Aims
POSEIDON is a non-interventional, prospective, multicenter study designed to further evaluate effectiveness (ORR, PFS, OS) and safety of POM + LoDEX in routine clinical practice. It is carried out in 55 private practices and outpatient clinics in Germany.
Methods
Transplant-ineligible patients with RRMM who have received at least two prior lines of therapy including both lenalidomide and bortezomib, and who have demonstrated disease progression or were refractory to their last line of treatment could be enrolled. Patients received POM + LoDEX according to SmPC and were treated until disease progression or the development of unacceptable toxicity. At enrollment, patients were prospectively assigned to two subgroups with regard to lenalidomide in the preceding treatment line (subgroup A) or no lenalidomide in the preceding treatment line (subgroup B). The interim analysis was based on the modified intention-to-treat population including all patients who received at least one dose of POM.
Results
At data cut-off for this interim analysis (December 1st, 2015), 138 patients have been enrolled; 126 patients were evaluable with a median follow-up of 6.9 months. 66 and 60 patients were assigned to subgroup A and subgroup B, respectively. Median age was 74 years (range 46-87) with 49 % and 43 % of patients > 75 years of age in subgroups A and B, respectively. 59 % were male. The median time from diagnosis was 4.8 years (range 0.4-18.2). Median number of prior treatment lines was n = 3 (range 2-9), with n = 2 in subgroup A (range 2-9), and n = 4 in subgroup B, respectively (range 2-9). For the 99 patients (55 patients in subgroup A, 44 patients in subgroup B) who received POM + LoDEX and had at least one response evaluation documented at data cut-off, the ORR was 26 % in subgroup A and 52 % in subgroup B, respectively. Additionally, 13 % (subgroup A) and 9 % (subgroup B) of these patients achieved a minor response. The most common ≥ grade 3 adverse events were leukopenia (10 %) and anemia (7 %), respiratory tract infections (10 %) and vascular disorders (3 %).
Conclusion
The results of this interim analysis confirm the beneficial effectiveness and safety of POM + LoDEX in heavily pretreated RRMM patients in a real-life setting. Even lenalidomide and bortezomib refractory patients with lenalidomide in the preceding treatment line and heavily pretreated patients > 75 years of age do benefit from POM + LoDEX treatment. The interim data of the non-interventional POSEIDON study are encouraging and highlight the potential clinical value of POM + LoDEX in these poor prognosis patients.
Session topic: E-poster
Keyword(s): Clinical data, Imids, Multiple myeloma, Therapy
Type: Eposter Presentation
Background
The management of patients with primary refractory or relapsed and refractory multiple myeloma (RRMM) who failed lenalidomide and bortezomib treatment poses a clinical challenge. Prognosis for these patients is poor. The pivotal MM-003 trial demonstrated a benefit of the oral regimen pomalidomide (POM) in combination with low dose dexamethasone (LoDEX) for RRMM patients who had failed lenalidomide and bortezomib treatment. With a median follow-up of 10 months, POM + LoDEX showed an overall response rate (ORR; ≥ partial response [PR]) of 31 % vs. 10 % (p<0.001), a significantly longer progression-free survival (PFS) and a significant improvement in overall survival (OS) compared to high-dose DEX. Efficacy of POM + LoDEX was consistent across various age groups and tolerability was unaffected by age.
Aims
POSEIDON is a non-interventional, prospective, multicenter study designed to further evaluate effectiveness (ORR, PFS, OS) and safety of POM + LoDEX in routine clinical practice. It is carried out in 55 private practices and outpatient clinics in Germany.
Methods
Transplant-ineligible patients with RRMM who have received at least two prior lines of therapy including both lenalidomide and bortezomib, and who have demonstrated disease progression or were refractory to their last line of treatment could be enrolled. Patients received POM + LoDEX according to SmPC and were treated until disease progression or the development of unacceptable toxicity. At enrollment, patients were prospectively assigned to two subgroups with regard to lenalidomide in the preceding treatment line (subgroup A) or no lenalidomide in the preceding treatment line (subgroup B). The interim analysis was based on the modified intention-to-treat population including all patients who received at least one dose of POM.
Results
At data cut-off for this interim analysis (December 1st, 2015), 138 patients have been enrolled; 126 patients were evaluable with a median follow-up of 6.9 months. 66 and 60 patients were assigned to subgroup A and subgroup B, respectively. Median age was 74 years (range 46-87) with 49 % and 43 % of patients > 75 years of age in subgroups A and B, respectively. 59 % were male. The median time from diagnosis was 4.8 years (range 0.4-18.2). Median number of prior treatment lines was n = 3 (range 2-9), with n = 2 in subgroup A (range 2-9), and n = 4 in subgroup B, respectively (range 2-9). For the 99 patients (55 patients in subgroup A, 44 patients in subgroup B) who received POM + LoDEX and had at least one response evaluation documented at data cut-off, the ORR was 26 % in subgroup A and 52 % in subgroup B, respectively. Additionally, 13 % (subgroup A) and 9 % (subgroup B) of these patients achieved a minor response. The most common ≥ grade 3 adverse events were leukopenia (10 %) and anemia (7 %), respiratory tract infections (10 %) and vascular disorders (3 %).
Conclusion
The results of this interim analysis confirm the beneficial effectiveness and safety of POM + LoDEX in heavily pretreated RRMM patients in a real-life setting. Even lenalidomide and bortezomib refractory patients with lenalidomide in the preceding treatment line and heavily pretreated patients > 75 years of age do benefit from POM + LoDEX treatment. The interim data of the non-interventional POSEIDON study are encouraging and highlight the potential clinical value of POM + LoDEX in these poor prognosis patients.
Session topic: E-poster
Keyword(s): Clinical data, Imids, Multiple myeloma, Therapy
Abstract: E1304
Type: Eposter Presentation
Background
The management of patients with primary refractory or relapsed and refractory multiple myeloma (RRMM) who failed lenalidomide and bortezomib treatment poses a clinical challenge. Prognosis for these patients is poor. The pivotal MM-003 trial demonstrated a benefit of the oral regimen pomalidomide (POM) in combination with low dose dexamethasone (LoDEX) for RRMM patients who had failed lenalidomide and bortezomib treatment. With a median follow-up of 10 months, POM + LoDEX showed an overall response rate (ORR; ≥ partial response [PR]) of 31 % vs. 10 % (p<0.001), a significantly longer progression-free survival (PFS) and a significant improvement in overall survival (OS) compared to high-dose DEX. Efficacy of POM + LoDEX was consistent across various age groups and tolerability was unaffected by age.
Aims
POSEIDON is a non-interventional, prospective, multicenter study designed to further evaluate effectiveness (ORR, PFS, OS) and safety of POM + LoDEX in routine clinical practice. It is carried out in 55 private practices and outpatient clinics in Germany.
Methods
Transplant-ineligible patients with RRMM who have received at least two prior lines of therapy including both lenalidomide and bortezomib, and who have demonstrated disease progression or were refractory to their last line of treatment could be enrolled. Patients received POM + LoDEX according to SmPC and were treated until disease progression or the development of unacceptable toxicity. At enrollment, patients were prospectively assigned to two subgroups with regard to lenalidomide in the preceding treatment line (subgroup A) or no lenalidomide in the preceding treatment line (subgroup B). The interim analysis was based on the modified intention-to-treat population including all patients who received at least one dose of POM.
Results
At data cut-off for this interim analysis (December 1st, 2015), 138 patients have been enrolled; 126 patients were evaluable with a median follow-up of 6.9 months. 66 and 60 patients were assigned to subgroup A and subgroup B, respectively. Median age was 74 years (range 46-87) with 49 % and 43 % of patients > 75 years of age in subgroups A and B, respectively. 59 % were male. The median time from diagnosis was 4.8 years (range 0.4-18.2). Median number of prior treatment lines was n = 3 (range 2-9), with n = 2 in subgroup A (range 2-9), and n = 4 in subgroup B, respectively (range 2-9). For the 99 patients (55 patients in subgroup A, 44 patients in subgroup B) who received POM + LoDEX and had at least one response evaluation documented at data cut-off, the ORR was 26 % in subgroup A and 52 % in subgroup B, respectively. Additionally, 13 % (subgroup A) and 9 % (subgroup B) of these patients achieved a minor response. The most common ≥ grade 3 adverse events were leukopenia (10 %) and anemia (7 %), respiratory tract infections (10 %) and vascular disorders (3 %).
Conclusion
The results of this interim analysis confirm the beneficial effectiveness and safety of POM + LoDEX in heavily pretreated RRMM patients in a real-life setting. Even lenalidomide and bortezomib refractory patients with lenalidomide in the preceding treatment line and heavily pretreated patients > 75 years of age do benefit from POM + LoDEX treatment. The interim data of the non-interventional POSEIDON study are encouraging and highlight the potential clinical value of POM + LoDEX in these poor prognosis patients.
Session topic: E-poster
Keyword(s): Clinical data, Imids, Multiple myeloma, Therapy
Type: Eposter Presentation
Background
The management of patients with primary refractory or relapsed and refractory multiple myeloma (RRMM) who failed lenalidomide and bortezomib treatment poses a clinical challenge. Prognosis for these patients is poor. The pivotal MM-003 trial demonstrated a benefit of the oral regimen pomalidomide (POM) in combination with low dose dexamethasone (LoDEX) for RRMM patients who had failed lenalidomide and bortezomib treatment. With a median follow-up of 10 months, POM + LoDEX showed an overall response rate (ORR; ≥ partial response [PR]) of 31 % vs. 10 % (p<0.001), a significantly longer progression-free survival (PFS) and a significant improvement in overall survival (OS) compared to high-dose DEX. Efficacy of POM + LoDEX was consistent across various age groups and tolerability was unaffected by age.
Aims
POSEIDON is a non-interventional, prospective, multicenter study designed to further evaluate effectiveness (ORR, PFS, OS) and safety of POM + LoDEX in routine clinical practice. It is carried out in 55 private practices and outpatient clinics in Germany.
Methods
Transplant-ineligible patients with RRMM who have received at least two prior lines of therapy including both lenalidomide and bortezomib, and who have demonstrated disease progression or were refractory to their last line of treatment could be enrolled. Patients received POM + LoDEX according to SmPC and were treated until disease progression or the development of unacceptable toxicity. At enrollment, patients were prospectively assigned to two subgroups with regard to lenalidomide in the preceding treatment line (subgroup A) or no lenalidomide in the preceding treatment line (subgroup B). The interim analysis was based on the modified intention-to-treat population including all patients who received at least one dose of POM.
Results
At data cut-off for this interim analysis (December 1st, 2015), 138 patients have been enrolled; 126 patients were evaluable with a median follow-up of 6.9 months. 66 and 60 patients were assigned to subgroup A and subgroup B, respectively. Median age was 74 years (range 46-87) with 49 % and 43 % of patients > 75 years of age in subgroups A and B, respectively. 59 % were male. The median time from diagnosis was 4.8 years (range 0.4-18.2). Median number of prior treatment lines was n = 3 (range 2-9), with n = 2 in subgroup A (range 2-9), and n = 4 in subgroup B, respectively (range 2-9). For the 99 patients (55 patients in subgroup A, 44 patients in subgroup B) who received POM + LoDEX and had at least one response evaluation documented at data cut-off, the ORR was 26 % in subgroup A and 52 % in subgroup B, respectively. Additionally, 13 % (subgroup A) and 9 % (subgroup B) of these patients achieved a minor response. The most common ≥ grade 3 adverse events were leukopenia (10 %) and anemia (7 %), respiratory tract infections (10 %) and vascular disorders (3 %).
Conclusion
The results of this interim analysis confirm the beneficial effectiveness and safety of POM + LoDEX in heavily pretreated RRMM patients in a real-life setting. Even lenalidomide and bortezomib refractory patients with lenalidomide in the preceding treatment line and heavily pretreated patients > 75 years of age do benefit from POM + LoDEX treatment. The interim data of the non-interventional POSEIDON study are encouraging and highlight the potential clinical value of POM + LoDEX in these poor prognosis patients.
Session topic: E-poster
Keyword(s): Clinical data, Imids, Multiple myeloma, Therapy
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