Page 1 (0s)
VİDEO 1: Çalışma künyesi, dizaynı, sonlanım noktaları ve hasta başlangıç özellikleri.
Page 2 (8s)
Rugo MK-3475 KN355 FA ESMO 2021. KEYNOTE-355: Metastatik Üçlü Negatif Meme Kanserinin Birinci Basamak Tedavisinde Plasebo + Kemoterapiye Karşı Pembrolizumab + Kemoterapinin Değerlendirildiği Randomize, Çift Kör, Faz 3 Çalışmanın Final Sonuçları.
Page 3 (1m 23s)
Key Eligibility Criteria • Age 218 years • Central determination of TNBC and PD-LI expressiona • Previously untreated locally recurrent inoperable or metastatic TNBC • De novo metastasis or completion of treatment with curative intent 26 months prior to first disease recurrence • ECOG performance status 0 or 1 • Life expectancy 212 weeks from randomization • Adequate organ function • No systemic steroids • No active CNS metastases • No active autoimmune disease Pembrolizumabb + Chemotherapyc Progressive diseasee/cessation of study therapy Placebod + Chemotherapyc Stratification Factors: • Chemotherapy on study (taxane or gemcitabine-carboplatin) • PD-LI tumor expression (CPS 21 or CPS <1) • Prior treatment with same class chemotherapy in the neoadjuvant or adjuvant setting (yes or no).
Page 4 (2m 35s)
Rugo MK-3475 KN355 FA ESMO 2021. Çalışma Sonlanım Noktaları.
Page 5 (3m 8s)
Rugo MK-3475 KN355 FA ESMO 2021. Başlangıç Özellikleri: ITT.
Page 6 (3m 45s)
Video 2: Etkinlik sonuçları: OS and PFS.
Page 7 (3m 52s)
90 80 70 60 50 20 10 o No. at risk 220 103 100 : 34.0% 40 e 30 : 58.3% : 44.7% Pembro + Chemo Placebo + Chemo nIN 155/220 84/103 Events 70.5% 81.6% (95% Cl) 0.73 (0.55-0.95) P-value (one-sided) 0.0093a 1 48 .20/0 23.0 months 16.1 months 3 214 98 6 193 91 9 171 77 12 154 66 15 139 55 18 127 46 21 116 39 24 27 30 33 Time, months 36 73 39 17 42 43 12 45 31 8 48 6 51 2 54 105 35 91 30 84 25 78 22.
Page 8 (4m 36s)
90 80 70 60 50 30 20 10 o No. at risk 425 211 100 1 37.7% : 29.5% 40 : 48.4% : 41.40/0 Pembro + Chemo Placebo + Chemo n/N 336/425 1771211 Events 79.1% 83.9% HR (95% Cl) 0.86 (0.72-1.04) p-value (one-sided) 0.0563a 17.6 months 16.0 months 3 406 200 6 365 187 9 308 163 12 271 133 15 236 110 18 204 87 21 175 71 24 27 30 33 Time, months 36 99 39 39 80 30 42 38 15 45 60 21 48 21 10 51 3 2 54 159 62 137 54 120 47 108 40.
Page 9 (5m 15s)
90 80 60 50 20 10 o No. at risk 566 281 100 47.8% : 41.8% : 35.5% : 30.4% 40 30 Pembro + Chemo Placebo + Chemo niN 460/566 238/281 Events 81.3% 84.7% (95% Cl) 0.89 (0.76-1.05) 17.2 months 15.5 months 3 539 267 6 486 246 9 415 209 12 363 174 15 309 144 18 269 117 21 226 97 24 27 30 33 Time, months 36 124 50 39 94 38 42 69 18 45 42 25 48 22 12 51 4 3 54 200 85 174 73 153 62 137 54.
Page 10 (5m 52s)
Median OS (mo) Subgroup Overall PD-LI CPS cutoff of 1 CPS 21 CPS PD-LI cps cutoff of 10 cps 210 CPS PD-LI cps cutoff of 20 CPS 220 cps 0.0 0.5 847 636 211 323 524 204 643 1.5 Pembro + Chemo 17.2 17.6 16.2 23.0 14.7 24.0 15,9 Placebo + Chemo 15.5 16.0 14.7 16.1 15.2 15.6 15.5 Hazard Ratio for Death (95%) 0.89 (0.76 to 1.05) 0.86 (0.72 to 1.04) 0.97 (0.72 to 1.32) 0.71 (0.54 to 0.93) 1.04 (0.85 to 1.26) 0.72 (0.51 to 1.01) 0.96 (0.80 to 1.14) 1.0 Hazard Ratio (95% Cl) Favors Pembro + Chemo Favors Placebo + Chemo.
Page 11 (7m 0s)
100 39.1% 23.0% ¯¯¯¯¯¯¯¯¯ 5.6 months 51 54 5648 44 41 38 32 24 17 52 44 423836343227 19 13 1' 10 100 31.7% 19.4% 29.3% 20.8% 9.7 months 7.6 months 5.6 months 42 45 48 10 0369 12 15 18 21 2427 3033 36 3942 4548 51 54 Time, months No. at risk 220173122 95 63 103 80 41 30 18 15 12 11 70 10 0369 No. at risk 10 12 15 18 212427303336 Time, months 7.5 months 5.6 months 0 3 6 9 12 15 1821242730333639424548 5154 Time, months 4 4 6 3 o 1 o 8 8 6 42531520214294 72 60 211 158 81 512820 17 14 14 12 10 7 39 5 5 6 3 1 o 0 o 0 No. at risk 56640826018311684 7063 51 474441 35 26 17 6 28121410868 n 29232020 17 15 15 11 8 74 o 2 o o.
Page 12 (8m 6s)
Video 3: Etkinlik sonuçları: ORR, DCR ve DoR.
Page 13 (8m 13s)
Pembro + Chemo o Partial Response Complete Response Placebo + Chemo Partial Response Complete Response 70 60 50 40 o 30 20 10 N = 220 N = 103 N = 425 N = 211 N = 566 N = 281.
Page 14 (8m 37s)
PD-LI CPS 210 PD-LI CPS 21 80 65.0% 70 60 50 40 30 20 10 N = 220 54.4% N = 103 80 70 60 50 40 30 20 10 58.6% 53.6% Pembro + Chemo Placebo + Chemo ITT 80 70 56.0% 60 50 40 30 20 10 N = 425 N = 211 N = 566 51.2% N = 281.
Page 15 (9m 1s)
100 100 55.5% 46.8% 37.9% 29.6% 0 70 40 10 036 No. at risk 116 106 82 42 39 36 33 26 23 15 13 39 36 18 16 42 3923 9 61 12 15 18 21 24 27 3033 36 3942 45 48 51 Time, months 10 036 No. at risk 9 12 15 18 21 2427 303336 39 42 45 48 51 Time, months 100 10 036 No. at risk 46.1% 33.3% 9 12 15 18 21 24273033 48 51 Time, months 49 16 14 13 43 9 9 8 32 7 6 5 4 4 8 4 3 o 0 o 0 191 17212487 67 57 82 74 412720 51 18 12 11 10 9 30 7 26 6 5 5 9 4 1 3 0 0 23120915210581 64 5847 4239 3329 20 16 104 95 50 3526 21 15 14 12 11 9 8 6 5 9 4 3 0.
Page 16 (10m 0s)
Video 4: Yan etkiler.
Page 17 (10m 7s)
100 90 80 70 60 50 40 30 20 10 49. I 45.9 38.1 All Treatment-Related Any grade Grade 3-5 Led to death Led to discontinuation of any drug 41.3 39.3 33.1 Pembro + Chemo (N = 562) 96.3% 68.1% 0.40/oa 18.3% 33.5 28.6 Placebo + Chemo (N = 281) 95.0% 66.9% 0.0% 11.00/0 29.9 Grade 1-2 23 Pembro + Chemo Placebo + Chemo 26.3 22.4 20.5 16.4.
Page 18 (10m 49s)
Placebo + Chemo (N = 281) All Immune-Mediated Any grade Grade 3-5 Led to death 12 10 ö 1.8 20 18 16 14 8 6 4 2 15.8 3.2 Pembro + Chemo (N = 562) 26.5% 5.3% 0.0% 2.8% 2.5 6.4% 0.0% 0.0% 0.0% 1.4 cP Grade 1-2 23 Led to discontinuation of any drug 4.3 1.1 o Pembro + Chemo Placebo + Chemo 1.8 0.4.