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ARTICLE - MAIC in 3L+ FL M.J. Maurer et al. Table 3. Sensitivity analyses of matching-adjusted indirect comparison weighting scenarios in LEO CReWE cohort.
Scenario
N
ESS
MAIC weighted ORR (95% CI)
MAIC weighted CR (95% CI)
MAIC weighted PFS12 (95% CI)
Unweighted analysis
202
-
77.6 (70.9-83.2)
57.8 (50.5-64.8)
65.0 (58.6-72.2)
Primary MAIC analysis
202
127
73.0 (65.3-79.5)
52.9 (44.8-60.7)
59.5 (51.0-69.3)
Change trial I/E criteria application
1
No trial I/E criteria
357
297
73.7 (68.2-78.6)
56.0 (50.1-61.8)
63.1 (57.3-69.5)
2
LEO clinician trial I/E criteria
217
172
74.1 (67.0-80.2)
54.6 (47.1-61.9)
64.7 (57.3-73.0)
Change matching variables
3
Add gender
202
128
72.9 (65.2-79.5)
52.3 (44.3-60.2)
59.2 (50.8-69.1)
4
Add stage
190
116
70.6 (62.4-77.7)
52.0 (43.6-60.3)
59.5 (50.7-69.8)
5
Add ECOG PS
183
114
73.6 (65.5-80.4)
52.7 (44.2-61.0)
62.1 (53.2-72.5)
6
Add FLIPI
188
117
69.3 (61.0-76.5)
49.1 (40.8-57.4)
56.5 (47.8-66.8)
7
Add bulky disease
191
120
70.4 (62.4-77.4)
52.8 (44.6-60.8)
55.6 (47.0-65.9)
8
Substitute refractory to prior line
203
132
71.7 (64.1-78.4)
51.1 (43.2-59.0)
58.4 (50.1-68.1)
9
Substitute POD24 to any 1L
201
127
74.4 (66.9-80.8)
53.3 (45.3-61.1)
59.9 (51.4-69.7)
10
Dichotomize prior LOT
202
133
66.7 (58.7-73.9)
50.6 (42.6-58.6)
55.3 (47.0-64.9)
Change selection of index therapy
11
Random line
202
85
71.5 (63.1-78.8)
41.7 (33.4-50.5)
54.1 (43.8-66.8)
12
First eligible line
202
20
49.4 (36.5-62.5)
34.8 (23.0-48.5)
34.4 (21.2-55.8)
13
Last eligible line
202
126
73.7 (66.1-80.2)
53.1 (45.1-61.0)
61.5 (53.1-71.3)
N: number; MAIC: matching-adjusted indirect comparison; ESS: effective sample size; CI: confidence interval; POD24: progression of disease in 24 months; 1L: first-line; LOT: line of therapy; ORR: overall response rate; CR: complete response; PFS12: progression-free survival at 12 months; I/E: inclusion / exclusion; ECOG PS: Eastern Cooperative Oncology Group Performance Status; FLIPI: Follicular Lymphoma Interna- tional Prognostic Index.
with R/R FL respond favorably to therapy, albeit of lim- ited duration. These data suggest that the encouraging response rates observed in this novel class of bispe- cific therapy in a heavily pre-treated population yield similar PFS to our comparison cohort with the current study follow-up. Although the methodology utilized in this analysis has limitations relative to a randomized clinical trial, it helps to provide comparative context for clinical outcomes and patterns of care. Differences in response and progression assessment methodology should be taken into consideration when making direct comparisons between clinical trials and observational cohorts of patients treated in routine clinical practice. Development of a set of best practices by clinical expert consensus for these types of comparative effectiveness analyses in the R/R FL space may be beneficial for more consistency in future studies. Comprehensive data that include safety, tolerability, quality of life, as well as ef- ficacy, should be considered when evaluating treatment options for patients with R/R FL.
Disclosures
MJM declares advisory board (Adaptive Biotechnologies, AstraZeneca, GenMab); consulting (BMS); research funding (Genmab, Genentech/Roche, BMS); spouse employment and
stock (Exact Sciences). CC declares research funding (Se- curaBio, Genmab, Gilead, Genentech, Inc.). MCL declares re- search funding (Genentech, Genmab). TMH declares research funding (Genentech, Sorrento); consulting or advisory role (Eli Lilly & Co., Morphosys, Incyte, Biegene, Loxo Oncology); data monitoring committee (Seagen, Tess Therapeutics, Eli Lilly & Co.). ISL declares current employment (Univer- sity of Miami); honoraria (Adaptive); consulting or advisory role (LRF); research funding (NCI); provided compensation teaching (Kyowa Kirin). YW declares research funding (Incyte, InnoCare, LOXO Oncology, Eli Lilly, MorphoSys, Novartis, Ge- nentech, Genmab); advisory board (Eli Lilly, LOXO Oncology, TG Therapeutics, Incyte, InnoCare, Kite, Jansen, BeiGene); consultancy (Innocare, AbbVie); honorarium (Kite). LJN de- clares research funding (BMS, Caribou Biosciences, Epizyme, Genentech, Gilead/Kite, Genmab, Janssen, IGM Biosciences, Novartis, Takeda); honoraria (Abbvie, ADC Therapeutics, BMS, Caribou Biosciences, Epizyme, Genentech/Roche, Gilead/ Kite, Genmab, Incyte, Janssen, MEI, Novartis, Takeda); DSMC (Genentech/Roche, MEI, Takeda, Denovo). CS declares current employment (University of Iowa); honoraria (Iowa Oncology Society, Curio Science); consulting or advisory role (Pfizer, GSK). DC declares research funding (Janssen, Epizyme, BMS, MorphoSys). PM declares consulting or advisory role (Abbvie, AztraZeneca, Beigene, BMS, Daiichi, Genentech, Janssen). JBC
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