Efficacy of Pembrolizumab in Patients With Advanced Melanoma With Stable Brain Metastases at Baseline: A Pooled Retrospective Analysis

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1 Efficcy of Pembrolizumb in Ptients With Advnced Melnom With Stble Brin Metstses t Bseline: A Pooled Retrospective Anlysis Abstrct 1248PD Hmid O, Ribs A, Dud A, Butler MO, Crlino MS, Hwu WJ, Long GV, Ancell K, Hodi FS, Khushlni NI, Blnk CU, Loqui C, Lin J, Krepler C, Diede SJ, nd Robert C

2 Pembrolizumb in Advnced Melnom Over 25% of ptients with metsttic melnom hve brin metstsis t dignosis Prognosis is poor, with medin overll survivl (OS) of 6 months following dignosis 1-3 Pembrolizumb nd nivolumb (PD-1 inhibitors), nd nivolumb + ipilimumb (CTLA-4 inhibitor), re effective for the tretment of dvnced melnom 4-6 However, phse III trils excluded ptients with ctive brin metstsis Checkpoint inhibitors hve demonstrted efficcy in ptients with melnom nd untreted nd/or ctive brin metstsis in phse II trils 7-9 Intrcrnil response rtes of 20%-55% Fvorble outcomes hve been reported with nivolumb + ipilimumb (46%-55%) 8,9 ; however, not ll ptients re suitble for or hve ccess to nivolumb + ipilimumb 1. Cgney DN, et l. Neuro-Oncology. 2017;19(11): Dvies MA, et l. Cncer. 2011;117(8): Fife KM, et l. J Clin Oncol. 2004;22(7): Robert C, et l. N Engl J Med. 2015;372(4): Robert C, et l. N Engl J Med. 2015;372(26): Lrkin J, et l. N Engl J Med. 2015;373(1): Goldberg SB, et l. Lncet Oncol. 2016;17(7): Long GV, et l. Lncet Oncol. 2018;19(5): Twbi HA, et l. N Engl J Med. 2018;379(8):

3 Trils Study Overview Pembrolizumb Tretment Regimens KEYNOTE-001: Pembrolizumb in ptients with progressive, loclly dvnced/metsttic melnom (phse I) 1 Dt cutoff: Sept 1, 2017 N = 135 received pembrolizumb 2 mg/kg q 3 w 10 mg/kg q 2 w 10 mg/kg q 3 w KEYNOTE-002: Pembrolizumb vs chemotherpy in ptients with dvnced melnom (phse II RCT) 2 Dt cutoff: My 30, 2018 N = 361 received pembrolizumb 2 mg/kg q 3 w 10 mg/kg q 3 w KEYNOTE-006: Sfety & efficcy of 2 dosing schedules of pembrolizumb vs ipilimumb in ptients with dvnced melnom (phse III RCT) 3 Dt cutoff: Dec 4, 2017 N = 556 received pembrolizumb 10 mg/kg q 2 w 10 mg/kg q 3 w Ptients in ll 3 trils hd no ctive CNS metstsis Retrospective, pooled nlysis b compring the efficcy nd sfety profile of pembrolizumb monotherpy in ptients with dvnced melnom cross 3 clinicl trils 1 3 in ptients with versus without brin metstsis t bseline Ptients with previously treted brin metstsis were included if they were stble, there ws no evidence of new enlrging brin metstses, nd ptients hd not received systemic steroids for 2 weeks. b Given similr efficcy profiles, results for dose groups were pooled. CNS, centrl nervous system; RCT, rndomized clinicl tril 1. Hmid O, et l. N Engl J Med. 2013;369(2): Ribs A, et l. Lncet Oncol. 2015;16(8): Robert C, et l. N Engl J Med. 2015;372(26):

4 Eligibility Criteri Study KEYNOTE-001 KEYNOTE-002 KEYNOTE-006 -Relted Inclusion Criteri Cliniclly stble for 4 weeks before study entry No evidence of new or enlrging brin metstsis Off steroids for 7 dys before first dose of pembro Inctive (without evidence of progression by CT/MRI) 4 weeks before plnned study strt On 10 mg/dy prednisone or equivlent for 2 weeks prior to plnned study strt Stble (without evidence of progression by MRI 4 weeks before study strt) No evidence of new or enlrging brin metstses Off systemic steroids for 2 weeks before study strt CT/MRI, computed tomogrphy/mgnetic resonnce imging; pembro, pembrolizumb

5 Bseline Demogrphics nd Disese Chrcteristics Chrcteristic Age, yers, medin (rnge) Stble Brin Metstsis (n = 157) No Brin Metstsis (n = 1404) 56.0 (20-84) 62.0 (15-94) Mle, n (%) 98 (62.4) 852 (60.7) ECOG PS, n (%) 0 97 (61.8) 922 (65.7) 1 60 (38.2) 479 (34.1) Missing 0 3 (0.2) LDH, n (%) Norml 89 (56.7) 873 (62.2) Elevted 66 (42.0) 510 (36.3) Missing 2 (1.3) 21 (1.5) Chrcteristic Metstsis stge t study entry, b n (%) Stble Brin Metstsis (n = 157) No Brin Metstsis (n = 1404) M (2.1) M1 1 (0.6) c 9 (0.6) M1 1 (0.6) c 125 (8.9) M1b 2 (1.3) c 228 (16.2) M1c 153 (97.5) 1013 (72.2) Defined s 1.1 upper limit of norml. b Per Americn Joint Committee on Cncer (AJCC) (7 th edition). c Metstsis stging error. Dt cutoff: KN001 Sep 1, 2017; KN002 My ; KN006 Dec 4, ECOG PS, Estern Coopertive Oncology Group performnce sttus; LDH, lctte dehydrogense 1. Edge SB, et l. AJCC Cncer Stging Mnul. Seventh ed. New York, NJ, United Sttes: Springer; 2010.

6 Bseline Demogrphics nd Disese Chrcteristics (Cont d) Chrcteristic BRAF sttus Stble Brin Metstsis (n = 157) No Brin Metstsis (n = 1404) Mutnt 59 (37.6) 373 (26.6) Wildtype 97 (61.8) 1020 (72.6) Unknown 1 (0.6) 11 (0.8) PD-L1 sttus PD-L (58.6) 754 (53.7) PD-L1 21 (13.4) 239 (17.0) Unknown/missing 44 (28.0) 411 (29.3) Chrcteristic Prior lines of therpy, n (%) Stble Brin Metstsis (n = 157) No Brin Metstsis (n = 1404) 0 9 (5.7) 191 (13.6) 1 44 (28.0) 441 (31.4) 2 38 (24.2) 282 (20.1) 3 42 (26.8) 191 (13.6) Missing 24 (15.3) 299 (21.3) Dt cutoff: KN001 Sep 1, 2017; KN002 My ; KN006 Dec 4, 2017.

7 Drug Exposure nd Follow-Up Tretment durtion medin, months (rnge) Pembrolizumb doses medin, n (rnge) Follow-up durtion medin, months (rnge) Ptients With Stble Bseline Ptients Without Bseline 5.4 ( ) 5.1 (0-66.9) 9 (1-99) 9 (1-122) 23.4 ( ) 23.1 ( ) Dt cutoff: KN001 Sep 1, 2017; KN002 My ; KN006 Dec 4, 2017.

8 Sites of Progression Site, n (%) Stble Bseline (n = 45) No Bseline (n = 416) Lymph node 34 (75.6) 284 (68.3) Lung 34 (75.6) 269 (64.7) Brin 27 (60.0) 39 (9.4) Liver 21 (46.7) 228 (68.3) Skin 12 (26.7) 97 (23.3) Bone 5 (11.1) 66 (15.9) Other 30 (66.7) 329 (79.1) Among ptients who experienced progressive disese. Dt cutoff: KN001 Sep 1, 2017; KN002 My ; KN006 Dec 4, 2017.

9 Best Overll Response by Investigtor Assessment n (%) Best overll response, n (%) Stble Bseline (n = 157) No Bseline (n = 1404) Complete response (CR) 19 (12.1) 191 (13.6) Prtil response (PR) 41 (26.1) 350 (24.9) Stble disese (SD) 37 (23.6) 321 (22.9) Progressive disese (PD) 45 (28.7) 416 (29.6) NonCR/nonPD 0 0 Not evluble/not ssessed 15 (9.6) 126 (9.0) ORR (CR+PR), n (%) [95% CI] 60 (38.2) [30.6 to 46.3] 541 (38.5) [36.0 to 41.1] Difference in ORR, % (95% CI) 0.3 (-7.9 to 8.0); P =.469 DCR (CR+PR+SD+nonCR/nonPD) 97 (61.8) 862 (61.4) DCR, disese control rte Dt cutoff: KN001 Sep 1, 2017; KN002 My ; KN006 Dec 4, 2017.

10 Response Durtion nd Time to Response in Ptients With or Without Bseline Stble brin metstsis t bseline (N = 157) No stble brin metstsis t bseline (N = 1404) TTR, Medin Months (Rnge) DoR, Medin Months (Rnge) 2.8 (2.6 to 19.3) NR (1.9+ to 57.9+) 2.8 (0.5 to 49.6) NR (1.0+ to 66.3+) Responders, % Time, Months Ptients who chieved prtil or complete response by investigtor ssessment. Dt cutoff: KN001 Sep 1, 2017; KN002 My ; KN006 Dec 4, DoR, durtion of response; TTR, time to response

11 PFS in Ptients With or Without Bseline Stble brin metstsis t bseline (N = 157) No stble brin metstsis t bseline (N = 1404) Events, n (%) 113 (72.0) 5.9 (5.3 to 11.9) 1059 (75.4) 6.8 (5.7 to 8.3) Medin PFS, Months (95% CI) HR (95% CI) P Vlue b 1.04 (0.86 to 1.26).6622 PFS, % Time, Months Bsed on Cox regression model with tretment s covrite; b One-sided P-vlue bsed on log-rnk test. Dt cutoff: KN001 Sep 1, 2017; KN002 My ; KN006 Dec 4, 2017.

12 OS in Ptients With or Without Bseline Stble brin metstsis t bseline (N = 157) No stble brin metstsis t bseline (N = 1404) Events, n (%) Medin PFS, Months (95% CI) HR (95% CI) P Vlue b 96 (61.1) 23.6 (16.4 to 42.2) 881 (62.7) 22.9 (20.4 to 25.9) 1.02 (0.83 to 1.26).579 OS, % Time, Months Bsed on Cox regression model with brin metstsis s covrite; b One-sided P-vlue bsed on log-rnk test. Dt cutoff: KN001 Sep 1, 2017; KN002 My ; KN006 Dec 4, 2017.

13 Response by Investigtor Assessment in Ptients by Bseline LDH Level Norml LDH Stble Bseline (n = 89) No Bseline (n = 873) Elevted LDH b Stble Bseline (n = 66) No Bseline (n = 510) ORR, n (%) 48 (53.9) 400 (45.8) CR, n (%) 17 (19.1) 148 (17.0) PR, n (%) 31 (34.8) 252 (28.9) SD, n (%) 19 (21.3) 226 (25.9) PD, n (%) 20 (22.5) 219 (25.1) Medin (rnge) TTR, months Medin (rnge) DoR, months 2.8 ( ) 2.8 ( ) NR (1.9+ to 57.9+) NR (1.4+ to 63.5+) ORR, n (%) 48 (53.9) 400 (45.8) CR, n (%) 17 (19.1) 148 (17.0) PR, n (%) 31 (34.8) 252 (28.9) SD, n (%) 19 (21.3) 226 (25.9) PD, n (%) 20 (22.5) 219 (25.1) Medin (rnge) TTR, months Medin (rnge) DoR, months 2.8 ( ) 2.8 ( ) NR (1.9+ to 57.9+) NR (1.4+ to 63.5+) From the Kpln-Meier method for censored dt. b Elevted LDH defined s 1.1 X upper limit of norml. Dt cutoff: KN001 Sep 1, 2017; KN002 My ; KN006 Dec 4, 2017.

14 PFS nd OS by Investigtor Assessment in Ptients by Bseline LDH Level Norml LDH Stble Bseline (n = 89) No Bseline (n = 873) Events, n (%) 55 (61.8) 612 (70.1) Medin PFS, months (95% CI) 24-month PFS rte (95% CI) 18.5 ( ) 11.2 ( ) 44.6 ( ) 37.7 ( ) Events, n (%) 43 (48.3) 475 (54.4) Medin OS, months (95% CI) 55.8 (32.0-NR) 37.9 ( ) 24-month OS rte, (95% CI) 66.1 ( ) 60.3 ( ) Elevted LDH b Stble Bseline (n = 66) No Bseline (n = 510) Events, n (%) 57 (86.4) 429 (84.1) Medin PFS, months (95% CI) 24-month PFS rte (95% CI) 2.8 ( ) 3.2 ( ) 13.3 ( ) 19.4 ( ) Events, n (%) 53 (80.3) 389 (76.3) Medin OS, months (95% CI) 7.1 ( ) 10.3 ( ) 24-month OS rte (95% CI), 25.4 ( ) 30.2 ( ) From the Kpln-Meier method for censored dt. b Elevted LDH defined s 1.1 X upper limit of norml. Dt cutoff: KN001 Sep 1, 2017; KN002 My ; KN006 Dec 4, 2017.

15 N (%) Adverse Events Stble Bseline Metstsis (n = 157) No Bseline (n = 1404) AE, ny grde 153 (97.5) 1381 (98.4) Tretment-relted AE (TRAE), ny grde 122 (77.7) 1139 (81.1) Discontinution due to TRAE 14 (8.9) 115 (8.2) Deth due to TRAE 0 2 (0.1) Immune-medited AE, ny grde 40 (25.5) 368 (26.2) Nervous-system AE, ny grde 91 (58.0) 628 (44.7) Nervous-system AE, grde (12.1) 70 (5.0) Nervous-system TRAE, ny grde 31 (19.7) 222 (15.8) Nervous-system TRAE, grde (3.2) 10 (0.7) Excluding infusion rections. Dt cutoff: KN001 Sep 1, 2017; KN002 My ; KN006 Dec 4, AE, dverse event; TRAE, tretment-relted AE

16 Conclusions In this pooled retrospective nlysis of 1561 ptients treted with pembrolizumb in KEYNOTE-001, KEYNOTE-002, nd KEYNOTE-006, overll efficcy nd sfety were similr in ptients with or without brin metstsis t bseline In ptients who hd PD, progression occurred in the brin more often in ptients with stble brin metstsis t bseline versus those without brin metstsis Apprent differences in efficcy prmeters mong ptients by bseline LDH level, with or without brin metstsis t bseline, need to be investigted in dequtely powered nd prospective studies These dt suggest tht pembrolizumb is sfe, efficcious tretment for dvnced melnom in ptients with or without previously treted nd stble brin metstsis t bseline

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