1. BRIGHT: 5-Yr Follow-up of First-line BR vs R-CHOP/R-CVP in Pts With iNHL or MCL
CCO Independent Conference Highlights* of the 2017 ASCO Annual Meeting; June 2-6, 2017; Chicago, Illinois
*Clinical Care Options (CCO) is an independent medical education organization that provides conference coverage and other unique educational programs for healthcare professionals
BR, bendamustine/rituximab; iNHL, indolent non-Hodgkin lymphoma; MCL, mantle cell lymphoma; R-CHOP, rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone; R-CVP, rituximab plus cyclophosphamide/vincristine/prednisone.
This activity is supported by educational grants from AbbVie, Amgen, AstraZeneca, Celgene Corporation, Genentech, Halozyme, Incyte, and Merck & Co., Inc.

2. First-line BR vs R-CHOP/R-CVP in iNHL or MCL: Background
BRIGHT: randomized, open-label phase III noninferiority study of BR vs R-CHOP or R-CVP in treatment-naive pts with iNHL or MCL
BR noninferior to R-CHOP/R-CVP for CR (primary endpoint; 31% vs 25%; P = .0225)[1]
ORR for BR vs R-CHOP/R-CVP: 97% vs 91% (P = .0102)[1]
Incidence of vomiting, nausea, drug hypersensitivity increased with BR; peripheral neuropathy/paresthesia, alopecia, constipation increased with R- CHOP/R-CVP (all P < .05)[1]
Improved QoL with BR vs R-CHOP/R-CVP[2]
Current analysis reports results from 5-yr follow-up study[3]
BR, bendamustine/rituximab; iNHL, indolent non-Hodgkin lymphoma; MCL, mantle cell lymphoma; QoL, quality of life; R-CHOP, rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone; R-CVP, rituximab plus cyclophosphamide/vincristine/prednisone.
1. Flinn IW, et al. Blood. 2014;123: Burke JM, et al. Clin Lymphoma Myeloma Leuk. 2016;16: e1. 3. Flinn I, et al. ASCO Abstract 7500.
Slide credit: clinicaloptions.com

3. BRIGHT 5-Yr Follow-up: Study Design
Preassignment by investigator
Bendamustine 90 mg/m2 IV Days 1-2
+ Rituximab 375 mg/m2 IV Day 1
(28-day cycles)
Bendamustine or
R-CHOP
R-CHOP standard dosing
(21-day cycles)
Treatment-naive pts with iNHL or MCL
(N = 447)
5-yr follow-up
Bendamustine 90 mg/m2 IV Days 1-2
+ Rituximab 375 mg/m2 IV Day 1
(28-day cycles)
Bendamustine or
R-CVP
R-CVP standard dosing
(21-day cycles)
BR, bendamustine/rituximab; DoR, duration of response; EFS, event-free survival; iNHL, indolent non-Hodgkin lymphoma; MCL, mantle cell lymphoma; R-CHOP, rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone; R-CVP, rituximab plus cyclophosphamide/vincristine/prednisone.
All regimens, including BR, given for 6 cycles with option to increase to 8 cycles at investigator discretion.
R-CHOP: R 375 mg/m2 IV Day 1; C 750 mg/m2 IV Day 1; D 50 mg/m2 IV Day 1; V 1.4 mg/m2 IV Day 1; P 100 mg PO Days 1-5.
R-CVP: R 375 mg/m2 IV Day 1; C 750 or 1000 mg/m2 IV Day 1; V 1.4 mg/m2 IV Day 1; P 100 mg PO Days 1-5.
Investigator-assessed time-to-event endpoints: PFS, EFS, DoR, OS
Stratified by preassigned treatment, lymphoma type
Slide credit: clinicaloptions.com
Flinn I, et al. ASCO Abstract Standard dosing in slidenotes.

4. BRIGHT 5-Yr Follow-up: Pt Disposition
R-CHOP/R-CVP
Randomized (ITT),* n
224
223
Treated (safety population), n
221
215
Evaluable (primary endpoint), n
213
206
Completed ≥ 6 cycles of treatment, n
203
196
Received rituximab maintenance, % 43 45
Second-line treatment, %
Bendamustine regimen†
Other 22 3 8 11 34 12 4 17
BR, bendamustine/rituximab; ITT, intent to treat; R-CHOP, rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone; R-CVP, rituximab plus cyclophosphamide/vincristine/prednisone.
*Population included in time-to-event analyses.
†Mostly BR.
Slide credit: clinicaloptions.com
Flinn I, et al. ASCO Abstract 7500.

5. BRIGHT 5-Yr Follow-up: PFS
1.0
0.9
0.8
0.7
0.6
0.5
PFS
0.4
0.3
5-Yr Rate, % (95% CI):
65.5 ( ) vs 55.8 ( )
HR: 0.61 (95% CI: ; P = .0025)
0.2 BR
R-CHOP/R-CVP
0.1
BR, bendamustine/rituximab; MCL, mantle cell lymphoma; R-CHOP, rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone; R-CVP, rituximab plus cyclophosphamide/vincristine/prednisone. 2 4 6 8 10 12 18 24 30 36 42 48 54 60 66 72
Mos
Pts at Risk, n BR
R-CHOP/R-CVP
224
223
218
205
122 94
37 11
0 0
BR associated with significantly increased PFS in overall pt population (P = .0025) and in subgroup analyses in pts with MCL and when BR compared with R-CVP (both P < .05); similar trends seen in pts with iNHL and when BR compared with R-CHOP
Slide credit: clinicaloptions.com
Flinn I, et al. ASCO Abstract Reproduced with permission.

6. BRIGHT 5-Yr Follow-up: PFS by Lymphoma Type
iNHL
MCL
1.0
1.0
0.9
0.9
0.8
0.8
0.7
0.7
0.6
0.6
0.5
0.5 BR
R-CHOP/R-CVP BR
R-CHOP/R-CVP
PFS
PFS
0.4
0.4
0.3
0.3
0.2
0.2
5-Yr Rate, %: 70.3 vs 62.0
HR: 0.70 (95% CI: ; P = .0582)
5-Yr Rate, %: 39.7 vs 14.2
HR: 0.40 (95% CI: ; P = .0035)
BR, bendamustine/rituximab; iNHL, indolent non-Hodgkin lymphoma; MCL, mantle cell lymphoma; R-CHOP, rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone; R-CVP, rituximab plus cyclophosphamide/vincristine/prednisone.
0.1
0.1 2 4 6 8 10 12 18 24 30 36 42 48 54 60 66 72 2 4 6 8 10 12 18 24 30 36 42 48 54 60 66 72
Mos
Mos
Slide credit: clinicaloptions.com
Flinn I, et al. ASCO Abstract Reproduced with permission.

7. BRIGHT 5-Yr Follow-up: DoR
Population*
5-Yr DoR, % (95% CI)
HR (95% CI)
P Value BR
R-CHOP/R-CVP
All pts
65.5 ( )
56.9 ( )
0.66 ( )
.0134
Pts with iNHL
70.5 ( )
62.4 ( )
0.73 ( )
.1051
Pts with MCL
39.7 ( )
15.9 ( )
0.47 ( )
.0231
*Pts at risk, n (BR vs R-CHOP/R-CVP): all: 209 vs 194; iNHL: 173 vs 167; MCL: 36 vs 27.
BR associated with significantly increased DoR in overall pt population and pts with MCL in subgroup analysis (P < .05)
BR, bendamustine/rituximab; DoR, duration of response; iNHL, indolent non-Hodgkin lymphoma; MCL, mantle cell lymphoma; R-CHOP, rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone; R-CVP, rituximab plus cyclophosphamide/vincristine/prednisone.
Slide credit: clinicaloptions.com
Flinn I, et al. ASCO Abstract 7500.

8. BRIGHT 5-Yr Follow-up: OS, EFS
Population
5-Yr OS, % (95% CI)
HR (95% CI)
P Value BR
(n = 224)
R-CHOP/R-CVP
(n = 223)
All pts
81.6 ( )
85.0 ( )
1.15 ( )
.5461
Treatment allocation had no significant effect on OS in overall pt population or pt subgroups
BR associated with significantly increased EFS in overall pt population and pts with MCL in subgroup analysis (P < .05)
BR had higher rate of secondary malignancy vs R-CHOP/R-CVP (19% vs 11%; P = .022); however, with NHL and nonmelanoma skin cancer excluded, difference becomes nonsignificant (10% vs 6%; P = .133)
BR, bendamustine/rituximab; EFS, event-free survival; MCL, mantle cell lymphoma; NHL, non-Hodgkin lymphoma; R-CHOP, rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone; R-CVP, rituximab plus cyclophosphamide/vincristine/prednisone.
Slide credit: clinicaloptions.com
Flinn I, et al. ASCO Abstract 7500.

9. Conclusions In treatment-naive pts with iNHL or MCL, first-line BR:
Significantly increased 5-yr PFS, DoR, and EFS vs R-CHOP/R-CVP in overall pt population and MCL subgroup
PFS benefit greater in BR vs R-CVP comparison
Associated with increased risk of secondary malignancy vs R-CHOP/R-CVP
Treatment allocation had no significant effect on 5-yr OS
BR, bendamustine/rituximab; DoR, duration of response; EFS, event-free survival; iNHL, indolent non-Hodgkin lymphoma; MCL, mantle cell lymphoma; R-CHOP, rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone; R-CVP, rituximab plus cyclophosphamide/vincristine/prednisone.
Slide credit: clinicaloptions.com
Flinn I, et al. ASCO Abstract 7500.
Slide credit: clinicaloptions.com

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