OPTIMISMM SUBANALYSIS: POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE AFTER 1 PRIOR LINE OF THERAPY IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA BY AGE, PRIOR TRANSPLANT, AND HIGH-RISK CYTOGENETICS
Author(s): ,
Meletios Dimopoulos
Affiliations:
National and Kapodistrian University of Athens,Athens,Greece
,
Katja Weisel
Affiliations:
Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology,University Medical Center Hamburg-Eppendorf,Hamburg,Germany
,
Philippe Moreau
Affiliations:
University Hospital Hôtel-Dieu,Nantes,France
,
Larry D Anderson Jr
Affiliations:
University of Texas Southwestern Medical Center,Dallas,United States
,
Darrell White
Affiliations:
Dalhousie University and Queen Elizabeth II Health Sciences Centre,Halifax,Canada
,
Jesus San Miguel
Affiliations:
Clinica Universidad de Navarra, CIMA, IDISNA,Pamplona,Spain
,
Pieter Sonneveld
Affiliations:
Erasmus MC Cancer Institute,Rotterdam,Netherlands
,
Monika Engelhardt
Affiliations:
Universitätsklinikum Freiburg,Freiburg,Germany
,
Matthew Jenner
Affiliations:
Southampton General Hospital,Southampton,United Kingdom
,
Alessandro Corso
Affiliations:
Policlinico San Matteo Universita Di Pavia,Pavia,Italy
,
Jan Dürig
Affiliations:
University Hospital Essen,Essen,Germany
,
Michel Pavic
Affiliations:
Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Centre de Recherche Clinique Etienne-Le Bel (CRCELB) Hopital Fleurimont,Sherbrooke,Canada
,
Morten Salomo
Affiliations:
Copenhagen University Hospital, Rigshospitalet,Kobenhavn,Denmark
,
Eva Casal
Affiliations:
Brisol-Myers Squibb,Summit,United States
,
Ruiyun Jiang
Affiliations:
Brisol-Myers Squibb,Summit,United States
,
Shankar Srinivasan
Affiliations:
Brisol-Myers Squibb,Summit,United States
,
Tuong Nguyen
Affiliations:
Brisol-Myers Squibb,Summit,United States
,
Tsvetan Biyukov
Affiliations:
Celgene International Sàrl, a Bristol-Myers Squibb Company,Boudry,Switzerland
,
Teresa Peluso
Affiliations:
Celgene International Sàrl, a Bristol-Myers Squibb Company,Boudry,Switzerland
Paul Richardson
Affiliations:
Department of Medical Oncology ,Jerome Lipper Multiple Myeloma Center,Dana-Farber Cancer Institute, Harvard Medical School,Boston,United States
EHA Library. Dimopoulos M. 06/12/20; 294874; EP957
Prof. Dr. Meletios Dimopoulos
Prof. Dr. Meletios Dimopoulos
Contributions
Abstract

Abstract: EP957

Type: e-Poster

Presentation during EHA25: All e-Poster presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

Background
Lenalidomide (LEN) is a standard treatment (Tx) for newly diagnosed multiple myeloma, regardless of patient (pt) age and transplant eligibility, and pts are routinely treated with LEN until disease progression. Pts who have exhausted the benefit of LEN at first relapse are a growing population in need of effective Tx options. Pomalidomide (POM), bortezomib (BORT), and dexamethasone (DEX; PVd) was recently approved in the European Union and other countries for use after 1 prior Tx (including LEN) in pts with relapsed or refractory multiple myeloma (RRMM) on the basis of data from the phase 3 OPTIMISMM trial (NCT01734928). An analysis of pts at first relapse demonstrated that PVd significantly improved progression-free survival (PFS) vs Vd (median, 20.7 vs 11.6 mos; hazard ratio = 0.54 [95% CI, 0.36-0.82]; P = .0027).

Aims
To report the efficacy and safety of PVd by age, prior stem cell transplant (SCT) status, and presence of high-risk cytogenetic abnormalities (HR CAs; defined as del[17p], t[4;14], or t[14;16]) in pts treated after 1 prior line of therapy (LOT).

Methods
Pts received PVd or Vd (1:1) in 21-day cycles (Cs). POM 4 mg/d was given on d 1-14 (PVd arm only); BORT 1.3 mg/m2 was given on d 1, 4, 8, and 11 of C 1-8 and on d 1 and 8 of C 9+; and DEX 20 mg/d (10 mg/d for pts aged > 75 yrs) was given on the days of and after BORT. Key eligibility criteria included ≥ 2 cycles of prior LEN; LEN-refractory pts were allowed. PFS was the primary endpoint. All pts provided informed consent.

Results
226 of 559 pts (40%) enrolled in OPTIMISMM had 1 prior LOT: 100 pts aged ≤ 65 yrs (49 PVd, 51 Vd) and 126 aged > 65 yrs (62 PVd, 64 Vd). In pts aged ≤ 65 yrs (PVd vs Vd), 55.1% vs 51.0% were LEN refractory and 83.7% vs 72.5% had prior BORT. In pts aged > 65 yrs, 59.7% vs 60.9% were LEN refractory and 41.9% vs 46.9% had prior BORT.

After 1 prior LOT, PVd significantly improved PFS in pts aged ≤ 65 yrs (median, 22.0 vs 13.1 mos; P = .0258) and those aged > 65 yrs (median, 17.6 vs 9.9 mos; P = .0369) vs Vd (Table); data cutoff was 26 October 2017. The overall response rate (ORR) was also significantly higher with PVd vs Vd across all age groups. The rate of ≥ very good partial response (VGPR) was 65.3% vs 17.6% in pts aged ≤ 65 yrs and 58.1% vs 26.6% in pts aged > 65 yrs. Improvements in PFS and ORR with PVd vs Vd were also observed in pts with or without prior SCT and in pts with HR CAs (Table). Pts with HR CAs had a median PFS of 14.7 mos with PVd (n = 18) vs 9.9 mos with Vd (n = 14).

The most common grade 3/4 treatment-emergent adverse events with PVd vs Vd were neutropenia (49.0% vs 6.3%), infections (30.6% vs 14.6%), and thrombocytopenia (26.5% vs 18.8%) in pts aged ≤ 65 yrs and neutropenia (25.8% vs 12.9%), infections (27.4% vs 16.1%), and thrombocytopenia (14.5% vs 22.6%) in pts aged > 65 yrs.

Conclusion
In pts with LEN-pretreated RRMM at first relapse, PVd reduced the risk of progression or death by 51% in pts aged ≤ 65 yrs and by 43% in those > 65 yrs vs Vd and led to significantly improved ORR and deeper responses. Similar outcomes were observed in pts regardless of prior SCT. Although the analysis is limited by the number of pts, the high ORR and depth of response seen with PVd in pts with HR CAs are promising. The safety of PVd in the pt subgroups was consistent with the known profiles of POM, BORT, and DEX. The findings from this analysis continue to support the use of PVd after first relapse in pts previously treated with LEN, regardless of age, prior SCT status, and presence of HR CAs.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Multiple myeloma, Refractory, Relapse

Abstract: EP957

Type: e-Poster

Presentation during EHA25: All e-Poster presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

Background
Lenalidomide (LEN) is a standard treatment (Tx) for newly diagnosed multiple myeloma, regardless of patient (pt) age and transplant eligibility, and pts are routinely treated with LEN until disease progression. Pts who have exhausted the benefit of LEN at first relapse are a growing population in need of effective Tx options. Pomalidomide (POM), bortezomib (BORT), and dexamethasone (DEX; PVd) was recently approved in the European Union and other countries for use after 1 prior Tx (including LEN) in pts with relapsed or refractory multiple myeloma (RRMM) on the basis of data from the phase 3 OPTIMISMM trial (NCT01734928). An analysis of pts at first relapse demonstrated that PVd significantly improved progression-free survival (PFS) vs Vd (median, 20.7 vs 11.6 mos; hazard ratio = 0.54 [95% CI, 0.36-0.82]; P = .0027).

Aims
To report the efficacy and safety of PVd by age, prior stem cell transplant (SCT) status, and presence of high-risk cytogenetic abnormalities (HR CAs; defined as del[17p], t[4;14], or t[14;16]) in pts treated after 1 prior line of therapy (LOT).

Methods
Pts received PVd or Vd (1:1) in 21-day cycles (Cs). POM 4 mg/d was given on d 1-14 (PVd arm only); BORT 1.3 mg/m2 was given on d 1, 4, 8, and 11 of C 1-8 and on d 1 and 8 of C 9+; and DEX 20 mg/d (10 mg/d for pts aged > 75 yrs) was given on the days of and after BORT. Key eligibility criteria included ≥ 2 cycles of prior LEN; LEN-refractory pts were allowed. PFS was the primary endpoint. All pts provided informed consent.

Results
226 of 559 pts (40%) enrolled in OPTIMISMM had 1 prior LOT: 100 pts aged ≤ 65 yrs (49 PVd, 51 Vd) and 126 aged > 65 yrs (62 PVd, 64 Vd). In pts aged ≤ 65 yrs (PVd vs Vd), 55.1% vs 51.0% were LEN refractory and 83.7% vs 72.5% had prior BORT. In pts aged > 65 yrs, 59.7% vs 60.9% were LEN refractory and 41.9% vs 46.9% had prior BORT.

After 1 prior LOT, PVd significantly improved PFS in pts aged ≤ 65 yrs (median, 22.0 vs 13.1 mos; P = .0258) and those aged > 65 yrs (median, 17.6 vs 9.9 mos; P = .0369) vs Vd (Table); data cutoff was 26 October 2017. The overall response rate (ORR) was also significantly higher with PVd vs Vd across all age groups. The rate of ≥ very good partial response (VGPR) was 65.3% vs 17.6% in pts aged ≤ 65 yrs and 58.1% vs 26.6% in pts aged > 65 yrs. Improvements in PFS and ORR with PVd vs Vd were also observed in pts with or without prior SCT and in pts with HR CAs (Table). Pts with HR CAs had a median PFS of 14.7 mos with PVd (n = 18) vs 9.9 mos with Vd (n = 14).

The most common grade 3/4 treatment-emergent adverse events with PVd vs Vd were neutropenia (49.0% vs 6.3%), infections (30.6% vs 14.6%), and thrombocytopenia (26.5% vs 18.8%) in pts aged ≤ 65 yrs and neutropenia (25.8% vs 12.9%), infections (27.4% vs 16.1%), and thrombocytopenia (14.5% vs 22.6%) in pts aged > 65 yrs.

Conclusion
In pts with LEN-pretreated RRMM at first relapse, PVd reduced the risk of progression or death by 51% in pts aged ≤ 65 yrs and by 43% in those > 65 yrs vs Vd and led to significantly improved ORR and deeper responses. Similar outcomes were observed in pts regardless of prior SCT. Although the analysis is limited by the number of pts, the high ORR and depth of response seen with PVd in pts with HR CAs are promising. The safety of PVd in the pt subgroups was consistent with the known profiles of POM, BORT, and DEX. The findings from this analysis continue to support the use of PVd after first relapse in pts previously treated with LEN, regardless of age, prior SCT status, and presence of HR CAs.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Multiple myeloma, Refractory, Relapse

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