THE STRATUS TRIAL (MM-010): ANALYSIS OF THE ITALIAN SUBGROUP OF PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA TREATED WITH POMALIDOMIDE PLUS LOW-DOSE DEXAMETHASONE
(Abstract release date: 05/19/16)
EHA Library. Cavo M. 06/09/16; 134881; PB1981
Prof. Michele Cavo
Contributions
Contributions
Abstract
Abstract: PB1981
Type: Publication Only
Background
There are few treatment (Tx) options and overall survival (OS) is short for patient (pts) with relapsed/refractory multiple myeloma (RRMM) who have failed or progressed on Tx with agents such as lenalidomide (LEN) and bortezomib (BORT) (Kumar et al, Leukemia, 2012). Pomalidomide (POM), a distinct immunomodulatory agent with tumoricidal and immunoregulatory effects, plus low-dose dexamethasone (LoDEX) is approved in the United States and European Union (EU) for the Tx of pts with RRMM who have had ≥ 2 prior Tx, including LEN and a proteasome inhibitor (BORT in the EU). Tx with POM + LoDEX has shown statistically greater survival benefits than Tx with high-dose DEX (San Miguel et al, Lancet Oncol, 2013) or POM alone (Richardson et al, Blood, 2014). POM + LoDEX has also demonstrated high overall response rates (ORRs) in pts with RRMM in the STRATUS trial (MM-010), a single-arm, open-label phase 3b study being conducted in 19 countries across Europe, with Italian pts constituting the largest national subset (Dimopoulos et al, EHA 2015).
Aims
To examine the efficacy and safety of POM + LoDEX in the Italian population of the STRATUS trial.
Methods
Pts with RRMM (progressive disease [PD] on or within 60 days of last prior Tx) who had experienced Tx failure with BORT and LEN, had received adequate prior alkylator therapy, and provided informed consent were eligible. Pts received POM 4 mg on days 1-21 of a 28-day cycle in combination with DEX 40 mg (20 mg for pts aged > 75 yrs) on days 1, 8, 15, and 22. Thromboprophylaxis was required for all pts. Pts were treated until PD or unacceptable toxicity. Primary endpoint was safety.
Results
In the 219 pts enrolled in Italy, median age was 67 yrs (range, 42-84 yrs), 55% were male, and 37% of pts were International Staging System stage III. The median time since diagnosis was 5.5 yrs. Patients were heavily pretreated, with a median of 4 prior anti-myeloma regimens (range, 2-11), and most pts were refractory to LEN (95%), BORT (82%), or both LEN and BORT (78%). As of May 4, 2015, 2 pts (1%) were not treated, 54 pts (25%) were still on Tx, and 163 pts (74%) had discontinued. The most common reasons for discontinuation were disease progression (50%), death (10%), and adverse events (AEs; 5%). After a median follow-up of 11.3 mos, in the intention-to-treat population, the ORR was 37.9% (range, 31.4% - 44.7%), the median duration of response was 6.8 mos (95% CI, 4.9-10.8 mos), median progression-free survival (PFS) was 5.2 mos (95% CI, 4.4-6.4 mos), and median OS was 12.0 mos (95% CI, 10.6-15.2 mos). The most frequent grade 3/4 treatment-emergent AEs were neutropenia (56.7%), anemia (25.8%), thrombocytopenia (23.5%), and pneumonia (12.4%). Grade 3/4 venous thromboembolism (deep vein thrombosis and pulmonary embolism) and peripheral neuropathy was infrequent (2.3% and 0%, respectively). AEs led to dose reductions or interruptions of POM in 23.0% and 71.0% of pts, respectively, and the median relative dose intensity for POM was 0.90.
Conclusion
POM + LoDEX was active in this study subgroup, which was representative of the heavily pretreated MM-010 population. Efficacy outcomes, including PFS and OS, were consistent with those seen in previous trials. POM + LoDEX treatment was well tolerated, and no new safety signals were observed. AEs were appropriately managed, and discontinuations due to AEs were infrequent. This study confirms that POM + LoDEX is effective in patients with advanced RRMM, including those who have experienced failure of prior Tx with BORT and/or LEN.
Session topic: E-poster
Type: Publication Only
Background
There are few treatment (Tx) options and overall survival (OS) is short for patient (pts) with relapsed/refractory multiple myeloma (RRMM) who have failed or progressed on Tx with agents such as lenalidomide (LEN) and bortezomib (BORT) (Kumar et al, Leukemia, 2012). Pomalidomide (POM), a distinct immunomodulatory agent with tumoricidal and immunoregulatory effects, plus low-dose dexamethasone (LoDEX) is approved in the United States and European Union (EU) for the Tx of pts with RRMM who have had ≥ 2 prior Tx, including LEN and a proteasome inhibitor (BORT in the EU). Tx with POM + LoDEX has shown statistically greater survival benefits than Tx with high-dose DEX (San Miguel et al, Lancet Oncol, 2013) or POM alone (Richardson et al, Blood, 2014). POM + LoDEX has also demonstrated high overall response rates (ORRs) in pts with RRMM in the STRATUS trial (MM-010), a single-arm, open-label phase 3b study being conducted in 19 countries across Europe, with Italian pts constituting the largest national subset (Dimopoulos et al, EHA 2015).
Aims
To examine the efficacy and safety of POM + LoDEX in the Italian population of the STRATUS trial.
Methods
Pts with RRMM (progressive disease [PD] on or within 60 days of last prior Tx) who had experienced Tx failure with BORT and LEN, had received adequate prior alkylator therapy, and provided informed consent were eligible. Pts received POM 4 mg on days 1-21 of a 28-day cycle in combination with DEX 40 mg (20 mg for pts aged > 75 yrs) on days 1, 8, 15, and 22. Thromboprophylaxis was required for all pts. Pts were treated until PD or unacceptable toxicity. Primary endpoint was safety.
Results
In the 219 pts enrolled in Italy, median age was 67 yrs (range, 42-84 yrs), 55% were male, and 37% of pts were International Staging System stage III. The median time since diagnosis was 5.5 yrs. Patients were heavily pretreated, with a median of 4 prior anti-myeloma regimens (range, 2-11), and most pts were refractory to LEN (95%), BORT (82%), or both LEN and BORT (78%). As of May 4, 2015, 2 pts (1%) were not treated, 54 pts (25%) were still on Tx, and 163 pts (74%) had discontinued. The most common reasons for discontinuation were disease progression (50%), death (10%), and adverse events (AEs; 5%). After a median follow-up of 11.3 mos, in the intention-to-treat population, the ORR was 37.9% (range, 31.4% - 44.7%), the median duration of response was 6.8 mos (95% CI, 4.9-10.8 mos), median progression-free survival (PFS) was 5.2 mos (95% CI, 4.4-6.4 mos), and median OS was 12.0 mos (95% CI, 10.6-15.2 mos). The most frequent grade 3/4 treatment-emergent AEs were neutropenia (56.7%), anemia (25.8%), thrombocytopenia (23.5%), and pneumonia (12.4%). Grade 3/4 venous thromboembolism (deep vein thrombosis and pulmonary embolism) and peripheral neuropathy was infrequent (2.3% and 0%, respectively). AEs led to dose reductions or interruptions of POM in 23.0% and 71.0% of pts, respectively, and the median relative dose intensity for POM was 0.90.
Conclusion
POM + LoDEX was active in this study subgroup, which was representative of the heavily pretreated MM-010 population. Efficacy outcomes, including PFS and OS, were consistent with those seen in previous trials. POM + LoDEX treatment was well tolerated, and no new safety signals were observed. AEs were appropriately managed, and discontinuations due to AEs were infrequent. This study confirms that POM + LoDEX is effective in patients with advanced RRMM, including those who have experienced failure of prior Tx with BORT and/or LEN.
Session topic: E-poster
Abstract: PB1981
Type: Publication Only
Background
There are few treatment (Tx) options and overall survival (OS) is short for patient (pts) with relapsed/refractory multiple myeloma (RRMM) who have failed or progressed on Tx with agents such as lenalidomide (LEN) and bortezomib (BORT) (Kumar et al, Leukemia, 2012). Pomalidomide (POM), a distinct immunomodulatory agent with tumoricidal and immunoregulatory effects, plus low-dose dexamethasone (LoDEX) is approved in the United States and European Union (EU) for the Tx of pts with RRMM who have had ≥ 2 prior Tx, including LEN and a proteasome inhibitor (BORT in the EU). Tx with POM + LoDEX has shown statistically greater survival benefits than Tx with high-dose DEX (San Miguel et al, Lancet Oncol, 2013) or POM alone (Richardson et al, Blood, 2014). POM + LoDEX has also demonstrated high overall response rates (ORRs) in pts with RRMM in the STRATUS trial (MM-010), a single-arm, open-label phase 3b study being conducted in 19 countries across Europe, with Italian pts constituting the largest national subset (Dimopoulos et al, EHA 2015).
Aims
To examine the efficacy and safety of POM + LoDEX in the Italian population of the STRATUS trial.
Methods
Pts with RRMM (progressive disease [PD] on or within 60 days of last prior Tx) who had experienced Tx failure with BORT and LEN, had received adequate prior alkylator therapy, and provided informed consent were eligible. Pts received POM 4 mg on days 1-21 of a 28-day cycle in combination with DEX 40 mg (20 mg for pts aged > 75 yrs) on days 1, 8, 15, and 22. Thromboprophylaxis was required for all pts. Pts were treated until PD or unacceptable toxicity. Primary endpoint was safety.
Results
In the 219 pts enrolled in Italy, median age was 67 yrs (range, 42-84 yrs), 55% were male, and 37% of pts were International Staging System stage III. The median time since diagnosis was 5.5 yrs. Patients were heavily pretreated, with a median of 4 prior anti-myeloma regimens (range, 2-11), and most pts were refractory to LEN (95%), BORT (82%), or both LEN and BORT (78%). As of May 4, 2015, 2 pts (1%) were not treated, 54 pts (25%) were still on Tx, and 163 pts (74%) had discontinued. The most common reasons for discontinuation were disease progression (50%), death (10%), and adverse events (AEs; 5%). After a median follow-up of 11.3 mos, in the intention-to-treat population, the ORR was 37.9% (range, 31.4% - 44.7%), the median duration of response was 6.8 mos (95% CI, 4.9-10.8 mos), median progression-free survival (PFS) was 5.2 mos (95% CI, 4.4-6.4 mos), and median OS was 12.0 mos (95% CI, 10.6-15.2 mos). The most frequent grade 3/4 treatment-emergent AEs were neutropenia (56.7%), anemia (25.8%), thrombocytopenia (23.5%), and pneumonia (12.4%). Grade 3/4 venous thromboembolism (deep vein thrombosis and pulmonary embolism) and peripheral neuropathy was infrequent (2.3% and 0%, respectively). AEs led to dose reductions or interruptions of POM in 23.0% and 71.0% of pts, respectively, and the median relative dose intensity for POM was 0.90.
Conclusion
POM + LoDEX was active in this study subgroup, which was representative of the heavily pretreated MM-010 population. Efficacy outcomes, including PFS and OS, were consistent with those seen in previous trials. POM + LoDEX treatment was well tolerated, and no new safety signals were observed. AEs were appropriately managed, and discontinuations due to AEs were infrequent. This study confirms that POM + LoDEX is effective in patients with advanced RRMM, including those who have experienced failure of prior Tx with BORT and/or LEN.
Session topic: E-poster
Type: Publication Only
Background
There are few treatment (Tx) options and overall survival (OS) is short for patient (pts) with relapsed/refractory multiple myeloma (RRMM) who have failed or progressed on Tx with agents such as lenalidomide (LEN) and bortezomib (BORT) (Kumar et al, Leukemia, 2012). Pomalidomide (POM), a distinct immunomodulatory agent with tumoricidal and immunoregulatory effects, plus low-dose dexamethasone (LoDEX) is approved in the United States and European Union (EU) for the Tx of pts with RRMM who have had ≥ 2 prior Tx, including LEN and a proteasome inhibitor (BORT in the EU). Tx with POM + LoDEX has shown statistically greater survival benefits than Tx with high-dose DEX (San Miguel et al, Lancet Oncol, 2013) or POM alone (Richardson et al, Blood, 2014). POM + LoDEX has also demonstrated high overall response rates (ORRs) in pts with RRMM in the STRATUS trial (MM-010), a single-arm, open-label phase 3b study being conducted in 19 countries across Europe, with Italian pts constituting the largest national subset (Dimopoulos et al, EHA 2015).
Aims
To examine the efficacy and safety of POM + LoDEX in the Italian population of the STRATUS trial.
Methods
Pts with RRMM (progressive disease [PD] on or within 60 days of last prior Tx) who had experienced Tx failure with BORT and LEN, had received adequate prior alkylator therapy, and provided informed consent were eligible. Pts received POM 4 mg on days 1-21 of a 28-day cycle in combination with DEX 40 mg (20 mg for pts aged > 75 yrs) on days 1, 8, 15, and 22. Thromboprophylaxis was required for all pts. Pts were treated until PD or unacceptable toxicity. Primary endpoint was safety.
Results
In the 219 pts enrolled in Italy, median age was 67 yrs (range, 42-84 yrs), 55% were male, and 37% of pts were International Staging System stage III. The median time since diagnosis was 5.5 yrs. Patients were heavily pretreated, with a median of 4 prior anti-myeloma regimens (range, 2-11), and most pts were refractory to LEN (95%), BORT (82%), or both LEN and BORT (78%). As of May 4, 2015, 2 pts (1%) were not treated, 54 pts (25%) were still on Tx, and 163 pts (74%) had discontinued. The most common reasons for discontinuation were disease progression (50%), death (10%), and adverse events (AEs; 5%). After a median follow-up of 11.3 mos, in the intention-to-treat population, the ORR was 37.9% (range, 31.4% - 44.7%), the median duration of response was 6.8 mos (95% CI, 4.9-10.8 mos), median progression-free survival (PFS) was 5.2 mos (95% CI, 4.4-6.4 mos), and median OS was 12.0 mos (95% CI, 10.6-15.2 mos). The most frequent grade 3/4 treatment-emergent AEs were neutropenia (56.7%), anemia (25.8%), thrombocytopenia (23.5%), and pneumonia (12.4%). Grade 3/4 venous thromboembolism (deep vein thrombosis and pulmonary embolism) and peripheral neuropathy was infrequent (2.3% and 0%, respectively). AEs led to dose reductions or interruptions of POM in 23.0% and 71.0% of pts, respectively, and the median relative dose intensity for POM was 0.90.
Conclusion
POM + LoDEX was active in this study subgroup, which was representative of the heavily pretreated MM-010 population. Efficacy outcomes, including PFS and OS, were consistent with those seen in previous trials. POM + LoDEX treatment was well tolerated, and no new safety signals were observed. AEs were appropriately managed, and discontinuations due to AEs were infrequent. This study confirms that POM + LoDEX is effective in patients with advanced RRMM, including those who have experienced failure of prior Tx with BORT and/or LEN.
Session topic: E-poster
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