Contributions
Abstract: S772
Type: Oral Presentation
Presentation during EHA22: On Sunday, June 25, 2017 from 08:45 - 09:00
Location: Hall A
Background
Novel targeted agents are emerging for B-cell malignancies, but few studies have safely combined these agents. Ublituximab (UTX) is a novel glycoengineered mAb targeting a unique epitope on the CD20 antigen. TGR-1202 is a next generation, once daily, PI3Kδ inhibitor, demonstrating a favorable safety profile compared to prior inhibitors, including in long-term follow up (Burris, 2016).
Aims
This Ph 1 trial evaluates the safety/efficacy of the triplet combination of a novel anti-CD20 mAb + PI3Kδ + BTK inhibitor (ibrutinib) in pts with B-cell malignancies.
Methods
Eligible pts had CLL or rel/ref NHL w/o limit to prior therapies, including those ref to prior PI3Kδ or BTK inhibitors. UTX dosed on D 1, 8, 15 of C 1, D 1 of C 2-6, and C 9 & 12. TGR-1202 dose escalated (400/600/800mg QD), ibrutinib dosed at 420mg (CLL) or 560mg (NHL), both on C1D1.
Results
Subtype | N | CR | PR | ORR |
CLL/SLL | 19 | 3 | 16 | 100% |
FL/MZL | 7 | 2 | 4 | 86% |
DLBCL | 6 | 0 | 1 | 17% |
MCL | 4 | 1 | 3 | 100% |
Conclusion
This is the first known triplet combination of an anti-CD20 mAb + PI3Kδ + BTK inhibitor. The combination of UTX, TGR-1202, and ibrutinib has been well tolerated with activity observed across heavily pre-treated and high-risk B-cell malignancies. Expansion cohorts at the highest dose (800mg TGR-1202 + full dose ibrutinib) are underway. Future trials for the triplet are warranted.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): CD20, B cell, PI3K
Abstract: S772
Type: Oral Presentation
Presentation during EHA22: On Sunday, June 25, 2017 from 08:45 - 09:00
Location: Hall A
Background
Novel targeted agents are emerging for B-cell malignancies, but few studies have safely combined these agents. Ublituximab (UTX) is a novel glycoengineered mAb targeting a unique epitope on the CD20 antigen. TGR-1202 is a next generation, once daily, PI3Kδ inhibitor, demonstrating a favorable safety profile compared to prior inhibitors, including in long-term follow up (Burris, 2016).
Aims
This Ph 1 trial evaluates the safety/efficacy of the triplet combination of a novel anti-CD20 mAb + PI3Kδ + BTK inhibitor (ibrutinib) in pts with B-cell malignancies.
Methods
Eligible pts had CLL or rel/ref NHL w/o limit to prior therapies, including those ref to prior PI3Kδ or BTK inhibitors. UTX dosed on D 1, 8, 15 of C 1, D 1 of C 2-6, and C 9 & 12. TGR-1202 dose escalated (400/600/800mg QD), ibrutinib dosed at 420mg (CLL) or 560mg (NHL), both on C1D1.
Results
Subtype | N | CR | PR | ORR |
CLL/SLL | 19 | 3 | 16 | 100% |
FL/MZL | 7 | 2 | 4 | 86% |
DLBCL | 6 | 0 | 1 | 17% |
MCL | 4 | 1 | 3 | 100% |
Conclusion
This is the first known triplet combination of an anti-CD20 mAb + PI3Kδ + BTK inhibitor. The combination of UTX, TGR-1202, and ibrutinib has been well tolerated with activity observed across heavily pre-treated and high-risk B-cell malignancies. Expansion cohorts at the highest dose (800mg TGR-1202 + full dose ibrutinib) are underway. Future trials for the triplet are warranted.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): CD20, B cell, PI3K