Introduction. These patients benefit less from conventional chemotherapy than patients identified as MMR proficient or microsatellite stable 3-5

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1 Nivolumb + Ipilimumb Combintion in Ptients With DNA Mismtch Repir-Deficient/Microstellite Instbility-High Metsttic Colorectl Cncer: First Report of the Full Cohort From CheckMte-142 Abstrct 553 André T, Lonrdi S, Wong M, Lenz H-J, Gelsomino F, Agliett M, Morse M, Vn Cutsem E, McDermott R, Hill AG, Swyer MB, Hendlisz A, Neyns B, Svrcek M, Moss RA, Ledeine J-M, Co ZA, Kmble S, Kopetz S, Overmn MJ

2 Introduction Approximtely 4% of ptients with mcrc hve deficiency in the DNA mismtch repir system (dmmr) tht leds to high microstellite instbility (MSI-H) 1,2 These ptients benefit less from conventionl chemotherpy thn ptients identified s MMR proficient or microstellite stble 3-5 Nivolumb demonstrted durble responses, sustined disese control, nd encourging survivl in ptients with dmmr/msi-h mcrc in the monotherpy cohort of CheckMte Nivolumb nd ipilimumb ct synergisticlly to promote T-cell ntitumor ctivity; therefore, combintion therpy could further improve results 7-9 Presented here re nlyses from the nivolumb + ipilimumb combintion therpy cohort of CheckMte-142, which is the lrgest single-study report of combintion immune checkpoint inhibitors in ptients with dmmr/msi-h mcrc mcrc, metsttic colorectl cncer 1. Le DT, et l. Science 217;357(6349(: Koopmn M, et l. Br J Cncer 29;1(2): Venderbosch S, et l. Clin Cncer Res 214;2(2: Tougeron D, et l. Ann Oncol 217;28(suppl 5). Abstrct 533P. 5. Lenz H, et l. J Clin Oncol 217;35(suppl): Abstrct Overmn MJ, et l. Lncet Oncol 217;18(9): Diz LA, et l. Ann Oncol. 217;28(suppl 5). Abstrct 386P. 8. Antoni SJ, et l. Lncet Oncol 216;17(7): Lrkin J, et l. N Engl J Med 215;373(1): Presented André T, et l. by: J Prof Clin Oncol. Thierry 218;36(suppl André 4S): Abstrct

3 Histologiclly confirmed metsttic or recurrent CRC dmmr/msi-h per locl lbortory 1 prior line of therpy CheckMte-142 Study Design Combintion cohort Monotherpy cohort Phse II Nonrndomized Study Nivolumb 3 mg/kg + ipilimumb 1 mg/kg Q3W (4 doses nd then nivolumb 3 mg/kg Q2W) Nivolumb 3 mg/kg Q2W Primry endpoint: ORR per investigtor ssessment (RECIST v1.1) Other key endpoints: ORR per BICR, DCR, b DOR, PFS, OS, nd sfety Medin follow-up in the combintion therpy cohort (N = 119) ws 13.4 months (rnge, 9-25) c Results of the monotherpy cohort (N = 74) with similr medin follow-up of 13.4 months (rnge, 1-32) re lso presented 1,c Enrollment ws stggered with dditionl ptients being enrolled if 7 of the first 19 centrlly confirmed MSI-H ptients hd confirmed response (CR or PR). CheckMte-142 monotherpy nd combintion therpy cohorts were not rndomized or designed for forml comprison. b Ptients with CR, PR, or SD for 12 weeks. c Defined here s the time from first dose to dt cutoff. BICR, blinded independed centrl review; CR, complete response; DCR, disese control rte; DOR, durtion of response; ORR, overll response rte; OS, overll survivl; PFS, progression-free survivl 1. Overmn MJ, et l. Lncet Oncol. 217;18(9): André T, et l. J Clin Oncol. 218;36(suppl 4S): Abstrct 553. Overmn MJ, et l. J Clin Oncol. 218 Jn 2. [Epub hed of print]. 3

4 Bseline Chrcteristics Nivolumb + Ipilimumb N = 119 Medin ge (rnge), yers 58. (21-88) Mle, n (%) 7 (59) ECOG performnce sttus, n (%) 54 (45) 1 65 (55) Disese stge t dignosis, n (%) I-III IV Tumor PD-L1 expression t bseline, n (%) 1% <1% Unknown Muttion sttus, n (%) BRAF/KRAS wildtype BRAF muttion KRAS muttion Unknown Clinicl history of Lynch syndrome, n (%) b Yes No Unknown 66 (55) 53 (45) 26 (22) 65 (55) 28 (24) 31 (26) 29 (24) 44 (37) 15 (13) 35 (29) 31 (26) 53 (45) All ptients hd stge IV disese t study entry. b Bsed on the clinicl records of the ptients t sites in countries where this reporting ws permitted (excluded Itly). Presented André T, et l. by: J Prof Clin Oncol. Thierry 218;36(suppl André 4S): Abstrct 553. Overmn MJ, et l. J Clin Oncol. 218 Jn 2. [Epub hed of print]. 4

5 Prior lines of therpy, n (%) Prior Therpies Nivolumb + Ipilimumb N = (23) 43 (36) 48 (4) Prior therpies received, n (%) Fluoropyrimidine b Oxlipltin Irinotecn VEGF inhibitors c EGFR inhibitors d Regorfenib Trifluridine/tipircil Other chemotherpy Other experimentl drugs 118 (99) 111 (93) 87 (73) 68 (57) 35 (29) 11 (9) 2 (2) 8 (7) 3 (3) 76% of ptients received 2 prior lines of therpy 69% received 3 prior chemotherpies including fluoropyrimidine, oxlipltin, nd irinotecn EGFR, epiderml growth fctor receptor; VEGF, vsculr endothelil growth fctor One ptient hd received no prior lines of therpy. b Included fluorourcil nd cpecitbine. c Included bevcizumb, flibercept, nd rmucirumb. d Included cetuximb nd pnitumumb. Presented André T, et l. by: J Prof Clin Oncol. Thierry 218;36(suppl André 4S): Abstrct 553. Overmn MJ, et l. J Clin Oncol. 218 Jn 2. [Epub hed of print]. 5

6 Exposure nd Disposition Nivolumb + Ipilimumb N = 119 Medin number of doses, (rnge) Nivolumb Ipilimumb 24 (1 55) 4 (1 4) Continuing tretment, n (%) 75 (63) Discontinued tretment, n (%) 44 (37) Resons for tretment discontinution, n (%) Disese progression AE relted to study drug AE unrelted to study drug Other 23 (19) 16 (13) 2 (2) 3 (3) Other resons included loss to follow-up, deth, nd ptient did not present for restging (n = 1 for ech). AE, dverse event Presented André T, et l. by: J Prof Clin Oncol. Thierry 218;36(suppl André 4S): Abstrct 553. Overmn MJ, et l. J Clin Oncol. 218 Jn 2. [Epub hed of print]. 6

7 Investigtor-Assessed Response nd Disese Control Nivolumb + Ipilimumb N = Nivolumb N = 74 1,c Ptients, % ORR (95% CI): 55% (45.2, 63.8) 3 5 DCR b ws 8% (95% CI: 71.5, 86.6) with combintion therpy ORR (95% CI): 31% (2.8, 42.9) CR PR SD PD Unknown Medin follow-up ws 13.4 months (rnge, 9-25). b Disese control ws defined s ptients with CR, PR, or SD for 12 weeks. Presented André T, et l. by: J Prof Clin Oncol. Thierry 218;36(suppl André 4S): Abstrct 553. Overmn MJ, et l. J Clin Oncol. 218 Jn 2. [Epub hed of print]. 7

8 Investigtor-Assessed Response nd Disese Control Nivolumb + Ipilimumb N = Nivolumb N = 74 1,c Ptients, % ORR (95% CI): 55% (45.2, 63.8) ORR (95% CI): 31% (2.8, 42.9) CR PR SD PD Unknown DCR b ws 8% (95% CI: 71.5, 86.6) with combintion therpy nd 69% (57.1, 79.2) with monotherpy 1,d Combintion therpy provided numericlly higher ORR, including CRs, nd DCR reltive to monotherpy during similr follow-up period d Medin follow-up ws 13.4 months (rnge, 9-25). b Disese control ws defined s ptients with CR, PR, or SD for 12 weeks. c Medin follow-up ws 13.4 months (rnge, 1 32). d CheckMte-142 monotherpy nd combintion therpy cohorts were not rndomized or designed for forml comprison. 1. Overmn MJ et l. Lncet Oncol. 217;18(9): Presented André T, et l. by: J Prof Clin Oncol. Thierry 218;36(suppl André 4S): Abstrct 553. Overmn MJ, et l. J Clin Oncol. 218 Jn 2. [Epub hed of print]. 8

9 Best Reduction in Trget Lesions 1 Nivolumb + Ipilimumb Best Reduction From Bseline in Trget Lesion Size, % Confirmed response per investigtor ssessment * * * * * % of ptients hd reduction in tumor burden from bseline with combintion therpy Evluble ptients per investigtor ssessment. André T, et l. J Clin Oncol. 218;36(suppl 4S): Abstrct

10 Chrcteriztion of Response Nivolumb + Ipilimumb Medin time to response ws 2.8 months (rnge, 1-14) Responses were durble: Responders (n = 65) On tretment Off tretment First response Ongoing response Censored Deth Medin DOR ws not reched 94% of responders hd ongoing responses t dt cutoff 83% of responders hd responses lsting 6 months Response per investigtor ssessment. Weeks André T, et l. J Clin Oncol. 218;36(suppl 4S): Abstrct 553. Overmn MJ, et l. J Clin Oncol. 218 Jn 2. [Epub hed of print]. 1

11 Response nd Disese Control in Ptient Subsets Nivolumb + Ipilimumb (N = 119) n ORR DCR b Tumor PD-L1 expression, n (%) 1% (54) 2 (77) <1% (52) 51 (78) BRAF/KRAS muttion sttus, n (%) Wildtype (55) 24 (77) BRAF mutnt (55) 23 (79) KRAS mutnt (57) 37 (84) Clinicl history of Lynch syndrome, n (%) c Yes (71) 3 (86) No (48) 25 (81) Responses were observed irrespective of tumor PD-L1 expression, BRAF or KRAS muttionl sttus, or clinicl history of Lynch syndrome Per investigtor ssessment. b Ptients with CR, PR, or SD for 12 weeks. c Bsed on the clinicl records of the ptients t sites in countries where this reporting ws permitted (excluded Itly). Presented André T, et l. by: J Prof Clin Oncol. Thierry 218;36(suppl André 4S): Abstrct 553. Overmn MJ, et l. J Clin Oncol. 218 Jn 2. [Epub hed of print]. 11

12 No. t Risk Progression-Free Survivl, % c Progression-Free nd Overll Survivl Nivolumb + ipilimumb Nivolumb Nivolumb + ipilimumb,b Months Nivolumb 1,e,f 9-month rte (95% CI), % 76 (67., 82.7) 54 (41.5, 64.5) 12-month rte (95% CI), % 71 (61.4, 78.7) 5 (38.1, 61.4) 27 3 Nivolumb + ipilimumb Nivolumb With similr follow-up, combintion therpy provided improved PFS nd OS reltive to monotherpy,e,f Overll Survivl, % Nivolumb + ipilimumb Nivolumb Nivolumb + ipilimumb,d Months Nivolumb 1,e,f 9-month rte (95% CI), % 87 (8., 92.2) 78 (66.2, 85.7) 12-month rte (95% CI), % 85 (77., 9.2) 73 (61.5, 82.1) Medin follow-up ws 13.4 months (rnge, 9-25). b Medin PFS ws not reched (95% CI, not estimble). c PFS per investigtor ssessment. d Medin OS ws not reched (95% CI, 18., not estimble). e Medin follow-up ws 13.4 months (rnge, 1-32). f CheckMte-142 monotherpy nd combintion therpy cohorts were not rndomized or designed for forml comprison. 1. Overmn MJ, et l. Lncet Oncol. 217;18(9): André T, et l. J Clin Oncol. 218;36(suppl 4S): Abstrct 553. Overmn MJ, et l. J Clin Oncol. 218 Jn 2. [Epub hed of print]. 12

13 4 Ptient-Reported Outcomes EORTC QLQ-C3 globl helth sttus/qol Nivolumb + Ipilimumb 3 EQ-5D VAS Lest Squres Men Chnge From Bseline (95% CI) Better Worse Weeks * * P<.5; P< Ptient no Sttisticlly significnt nd cliniclly meningful improvements were chieved in key ptientreported outcomes, with improvements mintined for extended periods while on tretment Better Worse Weeks * P<.5; P< EORTC, Europen Orgnistion for Reserch nd Tretment of Cncer; QoL, qulity of life; VAS, visul nlogue scle Chnges in men scores over time were nlyzed using liner mixed models djusted for bseline score. Chnges from bseline of 1 points (EORTC QLQ-C3) nd 7 points (EQ-5D VAS) were regrded s cliniclly meningful. 1,2 1. Osob D, et l. J Clin Oncol 1998;16(1): Pickrd AS, et l. Helth Qul Life Outcomes 27;5:7. André T, et l. J Clin Oncol. 218;36(suppl 4S): Abstrct 553. Overmn MJ, et l. J Clin Oncol. 218 Jn 2. [Epub hed of print]. 13

14 Sfety Summry Ptients, n (%) Nivolumb + Ipilimumb N = 119 Any Grde Grde 3-4 Any TRAE 87 (73) 38 (32) Any serious TRAE 27 (23) 24 (2) Any TRAE leding to discontinution 15 (13) 12 (1) TRAEs reported in >1% of ptients Dirrhe 26 (22) 2 (2) Ftigue 21 (18) 2 (2) Pruritus 2 (17) 2 (2) Pyrexi 18 (15) Incresed AST 17 (14) 9 (8) Hypothyroidism 16 (13) 1 (1) Nuse 15 (13) 1 (1) Incresed ALT 14 (12) 8 (7) Rsh 13 (11) 2 (2) Hyperthyroidism 13 (11) No new sfety signls or tretmentrelted deths were reported Ptients who discontinued tretment due to study drug-relted AE (n = 16) hd n ORR (63%) consistent with the overll popultion For combintion therpy reltive to monotherpy: 1,b,c,d Any-grde TRAEs (73%; 7%) were comprble Grde 3-4 TRAEs (32%; 2%) were cceptble TRAEs leding to discontinution (13%; 7%) were modest ALT, lnine minotrnsferse; AST, sprtte minotrnsferse; TRAE, tretment-relted dverse event. Autoimmune heptitis nd cute kidney injury were the only TRAEs tht led to discontinution in >1 ptient (2% ech). b Combintion: medin follow-up, 13.4 months (rnge, 9-25). c Monotherpy: medin follow-up, 13.4 months (rnge, 1-32). d CheckMte-142 monotherpy nd combintion therpy cohorts were not rndomized or designed for forml comprison. 1. Overmn MJ et l. Lncet Oncol. 217;18(9): André T, et l. J Clin Oncol. 218;36(suppl 4S): Abstrct 553. Overmn MJ, et l. J Clin Oncol. 218 Jn 2. [Epub hed of print]. 14

15 Conclusions Nivolumb + ipilimumb provided durble clinicl benefit in previously treted ptients with dmmr/msi-h mcrc, of whom 76% hd received 2 prior lines of therpy High ORR (55%) nd durble responses (medin DOR not reched) High rte of disese control (8%) for 12 weeks Encourging survivl (medin PFS nd OS not reched; 85% of ptients live t 1 yer) Sfety ws mngeble with low (13%) rte of discontinution due to TRAEs Meningful improvements were observed in key ptient-reported outcomes Indirect comprisons in this nonrndomized phse II study (CheckMte-142) suggest tht nivolumb + ipilimumb provides numericlly higher ORR, PFS, nd OS rtes t 1 yer reltive to nivolumb monotherpy with fvorble benefit-risk profile Nivolumb + ipilimumb represents promising new tretment option for ptients with previously treted dmmr/msi-h mcrc André T, et l. J Clin Oncol. 218;36(suppl 4S): Abstrct 553. Overmn MJ, et l. J Clin Oncol. 218 Jn 2. [Epub hed of print]. 15

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