Evidenzprofil_Cemiplimab mono Erstlinie NSCLC Stadium III oder IV

Lungenkarzinom · Version 5.1

Cemiplimab (Neues Anwendungsgebiet: nicht-kleinzelliges Lungenkarzinom, Erstlinie)
Wirkstoff Cemiplimab Handelsname Libtayo
Pharmazeutischer Unternehmer Sanofi-Aventis Deutschland GmbH Beschlussdatum 20.01.2022
Anwendungsgebiet nicht-kleinzelliges Lungenkarzinom
Population/ZVT Titel Mortalität Morbidiät QoL Sicherheit Zusatznutzen
A Erwachsene mit lokal fortgeschrittenem NSCLC, die keine Kandidaten für eine definitive Radiochemotherapie sind, oder mit metastasiertem NSCLC, das PD-L1 in ≥ 50 % der Tumorzellen exprimiert und ohne EGFR-, ALK- oder ROS1-Aberrationen; Erstlinientherapie n.b.

Es liegen keine bewertbaren Daten vor

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Es liegen keine bewertbaren Daten vor

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 ist nicht belegt
ZVT Pembrolizumab
↑↑/↓↓: positiver/negativer statistisch signifkanter Effekt, hohe Aussagesicherheit; ↑/↓: positiver/negativer statistisch signifkanter Effekt, niedrige oder unklare Aussagesicherheit; ↔: kein signifikanter/relevanter Unterschied; ↓: n.b.: nicht bewertbar; Ø: keine Daten

A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer (NCT03088540)
Short Name Design Population Intervention Comparator Outcomes
EMPOWER-Lung1
R2810-ONC-1624, 2016-004407-31		 Randomized, Crossover Assignment, Phase 3 Open Label study Treatment-naive with Stage 3-4 and ECOG 0-1 Carcinoma，Non-Small-Cell Lung Cemiplimab (N=283)1 Standard-of-care chemotherapy (N=280)2
  1. Primary: Overall survival
  2. Primary: Progression-free survival
  3. Secondary: Objective response rates
  4. Secondary: Duration of response
  5. Secondary: Change in EORTC QLQ-C30
  6. Secondary: Change in EORTC QLQ-LC13
  7. Secondary: Adverse Events
  8. Secondary: Serious Adverse Events
  9. Secondary: Deaths
Levels of Evidence
GRADE ⊕⊕⊕⊖a We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
a: Open Label Study

Outcome Cemiplimab
N=283		 Standard-of-care chemotherapy
N=280		 Effect Estimate GRADE
Modul 4 der Nutzenbewertung von Cemiplimab (Libtayo®): Sanofi-Aventis Deutschland GmbH 2021. Modul 4 der Nutzenbewertung von Cemiplimab (Libtayo®). *
Dichotomous Outcomes
OS - Time To Event N=283 [17.9; ] N=280 14.2 [11.2; 17.5] HR 0.566 [0.418; 0.767]; p=0.0002 ⊕⊕⊕⊖
Gender
female N=35 17.7 [9.5; ] N=49 [11.2; ] HR 1.198 [0.544; 2.637]; p=0.6553
male N=248 [18.7; ] N=231 13.3 [10.2; 17.1] HR 0.499 [0.358; 0.693]; p<0.0001
PFS - Time To Event1 N=283 8.2 [6.1; 8.8] N=280 5.7 [4.5; 6.2] HR 0.541 [0.433; 0.675]; p<0.0001 ⊕⊕⊖⊖a
Age
<65 N=157 8.4 [5.2; 12.7] N=147 5.7 [4.2; 6.2] HR 0.513 [0.38; 0.694]; p<0.0001
≥65 N=126 7.4 [4.5; 10.4] N=133 6.0 [4.3; 6.2] HR 0.621 [0.448; 0.861]; p=0.0042
Gender
female N=35 8.2 [2.3; 13.4] N=49 6.4 [4.2; 8.3] HR 0.825 [0.459; 1.482]; p=0.5198
male N=248 7.0 [6.1; 8.8] N=231 5.2 [4.3; 6.1] HR 0.509 [0.4; 0.646]; p<0.0001
DOR - Time To Event1 N=283 16.7 [12.5; 22.8] N=280 6.0 [4.3; 6.5] HR 0.223 [0.131; 0.379]; p<0.0001 ⊕⊕⊕⊖
EORTC QLQ-C30 (Fatigue) - TTC N=283 6.31 [3.22; ] N=280 2.63 [1.84; 3.29] HR 0.66 [0.516; 0.843]; p=0.0009 ⊕⊕⊖⊖b
Age
<65 N=157 13.14 [5.62; ] N=147 1.84 [1.35; 2.83] HR 0.499 [0.356; 0.698]; p<0.0001
≥65 N=126 3.19 [1.68; ] N=133 3.71 [2.33; 4.83] HR 0.922 [0.644; 1.321]; p=0.6596
EORTC QLQ-C30 (Pain) - TTC N=283 13.14 [11.83; 26.51] N=280 5.36 [3.42; ] HR 0.746 [0.561; 0.993]; p=0.0445 ⊕⊕⊖⊖b
Age
<65 N=157 26.51 [13.14; 26.51] N=147 4.34 [2.43; ] HR 0.562 [0.379; 0.834]; p=0.0042
≥65 N=126 9.23 [3.48; ] N=133 12.29 [3.48; ] HR 1.094 [0.725; 1.65]; p=0.6691
EORTC QLQ-C30 (Nausea) - TTC N=283 [13.83; ] N=280 3.02 [2.23; ] HR 0.458 [0.343; 0.613]; p<0.0001 ⊕⊕⊖⊖b
ECOG-PS
0 N=77 [13.83; ] N=75 2.23 [1.71; 4.6] HR 0.279 [0.154; 0.504]; p<0.0001
1 N=206 [9.72; ] N=205 3.55 [2.33; ] HR 0.552 [0.395; 0.772]; p=0.0005
Histology
Non-squamous epithelium N=161 [; ] N=159 2.50 [1.84; ] HR 0.401 [0.271; 0.594]; p<0.0001
Squamous epithelium N=122 [9.17; ] N=121 3.65 [2.33; ] HR 0.553 [0.357; 0.858]; p=0.0082
EORTC QLQ-C30 (Dyspnea) - TTC N=283 [16.1; ] N=280 [4.83; ] HR 0.837 [0.611; 1.147]; p=0.2674 ⊕⊕⊖⊖b
Region
Asia N=31 [1.45; ] N=29 5.09 [1.41; ] HR 0.879 [0.407; 1.899]; p=0.7431
Europe N=215 [16.1; ] N=216 [4.63; ] HR 0.695 [0.472; 1.023]; p=0.0652
Rest of the World N=37 1.64 [0.79; ] N=35 [0.99; ] HR 1.848 [0.834; 4.081]; p=0.1285
EORTC QLQ-C30 (Insomnia) - TTC N=283 20.30 [16.1; ] N=280 7.95 [4.99; ] HR 0.875 [0.648; 1.181]; p=0.3823 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Lack of Appetite) - TTC N=283 16.00 [13.14; ] N=280 4.34 [2.79; ] HR 0.573 [0.428; 0.768]; p=0.0002 ⊕⊕⊖⊖b
Age
<65 N=157 [13.14; ] N=147 2.99 [2.33; ] HR 0.477 [0.322; 0.708]; p=0.0002
≥65 N=126 [5.65; ] N=133 7.92 [2.73; ] HR 0.744 [0.486; 1.139]; p=0.1732
ECOG-PS
0 N=77 13.14 [5.55; 16] N=75 [2.1; ] HR 0.787 [0.457; 1.357]; p=0.3894
1 N=206 [9.76; ] N=205 3.65 [2.6; 7.95] HR 0.517 [0.367; 0.73]; p=0.0002
Gender
female N=35 9.17 [3.19; ] N=49 7.95 [2.04; ] HR 0.849 [0.409; 1.766]; p=0.6623
male N=248 [16; ] N=231 4.07 [2.79; ] HR 0.553 [0.404; 0.758]; p=0.0002
Parentage
not white N=40 [9.72; ] N=40 1.95 [0.79; 7.92] HR 0.313 [0.143; 0.685]; p=0.0037
white N=243 16.00 [9.76; ] N=240 4.37 [2.83; ] HR 0.656 [0.478; 0.899]; p=0.0087
Region
Asia N=31 [9.72; ] N=29 1.97 [0.79; 7.92] HR 0.323 [0.133; 0.787]; p=0.0129
Europe N=215 16.00 [9.17; ] N=216 [2.96; ] HR 0.68 [0.488; 0.947]; p=0.0225
Rest of the World N=37 [; ] N=35 2.33 [1.54; ] HR 0.381 [0.154; 0.941]; p=0.0365
EORTC QLQ-C30 (Constipation) - TTC N=283 [; ] N=280 [6.24; ] HR 0.658 [0.475; 0.912]; p=0.0120 ⊕⊕⊖⊖b
Gender
female N=35 13.14 [3.19; ] N=49 [7.62; ] HR 1.016 [0.434; 2.378]; p=0.9702
male N=248 [; ] N=231 7.66 [4.57; ] HR 0.607 [0.427; 0.864]; p=0.0056
Parentage
not white N=40 11.73 [3.42; ] N=40 1.91 [1.28; ] HR 0.43 [0.208; 0.889]; p=0.0227
white N=243 [; ] N=240 [7.62; ] HR 0.714 [0.495; 1.03]; p=0.0716
Region
Asia N=31 11.73 [11.73; ] N=29 1.64 [0.79; ] HR 0.329 [0.139; 0.781]; p=0.0118
Europe N=215 [; ] N=216 7.66 [6.24; ] HR 0.798 [0.54; 1.179]; p=0.2569
Rest of the World N=37 [3.12; ] N=35 2.43 [1.45; ] HR 0.436 [0.18; 1.057]; p=0.0662
EORTC QLQ-C30 (Diarrhea) - TTC N=283 [14.36; ] N=280 13.24 [13.24; ] HR 0.9 [0.624; 1.298]; p=0.5738 ⊕⊕⊖⊖b
Gender
female N=35 11.89 [9.17; ] N=49 [; ] HR 2.816 [0.846; 9.372]; p=0.0915
male N=248 [14.36; ] N=231 13.24 [7.89; ] HR 0.771 [0.525; 1.133]; p=0.1848
Parentage
not white N=40 12.75 [5.55; ] N=40 [13.24; ] HR 1.853 [0.745; 4.61]; p=0.1847
white N=243 [14.36; ] N=240 [7.89; ] HR 0.802 [0.537; 1.197]; p=0.2797
EORTC QLQ-LC13 (Pain in other parts) - TTC N=283 20.30 [13.14; ] N=280 [5.36; ] HR 0.911 [0.668; 1.243]; p=0.5566 ⊕⊕⊖⊖b
EORTC QLQ-LC13 (Pain in arm or shoulder) - TTC N=283 [; ] N=280 [; ] HR 0.876 [0.641; 1.198]; p=0.4082 ⊕⊕⊖⊖b
EORTC QLQ-LC13 (Pain in chest) - TTC N=283 [; ] N=280 [6.44; ] HR 0.592 [0.421; 0.833]; p=0.0027 ⊕⊕⊖⊖b
ECOG-PS
0 N=77 [; ] N=75 [2.86; ] HR 0.393 [0.201; 0.77]; p=0.0065
1 N=206 [; ] N=205 [6.44; ] HR 0.693 [0.464; 1.034]; p=0.0722
Gender
female N=35 13.86 [5.62; 13.86] N=49 6.44 [2.14; ] HR 0.372 [0.153; 0.901]; p=0.0286
male N=248 [; ] N=231 [4.86; ] HR 0.661 [0.455; 0.96]; p=0.0299
Histology
Non-squamous epithelium N=161 [; ] N=159 [4.14; ] HR 0.36 [0.219; 0.592]; p<0.0001
Squamous epithelium N=122 [; ] N=121 [; ] HR 0.992 [0.606; 1.626]; p=0.9758
Parentage
not white N=40 [; ] N=40 4.86 [2.79; ] HR 0.266 [0.101; 0.699]; p=0.0072
white N=243 [; ] N=240 [6.44; ] HR 0.677 [0.468; 0.979]; p=0.0381
Region
Asia N=31 [; ] N=29 4.86 [2.43; ] HR 0.411 [0.149; 1.13]; p=0.0848
Europe N=215 [; ] N=216 [; ] HR 0.777 [0.519; 1.164]; p=0.2217
Rest of the World N=37 [; ] N=35 2.14 [0.82; 3.19] HR 0.199 [0.078; 0.511]; p=0.0008
EORTC QLQ-LC13 (Alopcia) - TTC N=283 [; ] N=280 2.14 [1.45; 2.83] HR 0.182 [0.128; 0.259]; p<0.0001 ⊕⊕⊖⊖b
ECOG-PS
0 N=77 [; ] N=75 3.22 [0.92; ] HR 0.117 [0.048; 0.285]; p<0.0001
1 N=206 [18.04; ] N=205 1.84 [1.45; 2.46] HR 0.207 [0.141; 0.303]; p<0.0001
Gender
female N=35 [2.43; ] N=49 1.61 [1.45; 3.48] HR 0.38 [0.188; 0.768]; p=0.0070
male N=248 [18.04; ] N=231 2.17 [1.45; 3.22] HR 0.162 [0.108; 0.243]; p<0.0001
Histology
Non-squamous epithelium N=161 [; ] N=159 2.83 [2.04; ] HR 0.321 [0.209; 0.494]; p<0.0001
Squamous epithelium N=122 [18.04; ] N=121 1.38 [0.79; 1.45] HR 0.081 [0.043; 0.155]; p<0.0001
Parentage
not white N=40 [2.73; ] N=40 4.40 [1.61; ] HR 0.565 [0.261; 1.22]; p=0.1461
white N=243 [18.04; ] N=240 1.68 [1.41; 2.46] HR 0.148 [0.099; 0.221]; p<0.0001
Region
Asia N=31 [; ] N=29 [1.61; ] HR 0.509 [0.197; 1.319]; p=0.1648
Europe N=215 [18.04; ] N=216 1.51 [1.38; 2.3] HR 0.146 [0.097; 0.221]; p<0.001
Rest of the World N=37 [7.66; ] N=35 2.99 [1.58; ] HR 0.344 [0.126; 0.943]; p=0.0380
EORTC QLQ-LC13 (Peripheral neuropathy) - TTC N=283 20.50 [15.97; ] N=280 4.17 [2.79; 2.95] HR 0.463 [0.345; 0.621]; p<0.0001 ⊕⊕⊖⊖b
Age
<65 N=157 [; ] N=147 3.65 [2.6; 6.01] HR 0.393 [0.258; 0.597]; p<0.0001
≥65 N=126 15.97 [6.24; ] N=133 4.34 [2.23; 6.05] HR 0.563 [0.371; 0.853]; p=0.0068
Histology
Non-squamous epithelium N=161 20.50 [7.62; ] N=159 5.95 [3.55; ] HR 0.554 [0.372; 0.825]; p=0.0036
Squamous epithelium N=122 [; ] N=121 2.63 [2.1; 4.17] HR 0.373 [0.241; 0.579]; p<0.0001
Parentage
not white N=40 20.50 [2.1; 20.5] N=40 4.17 [2.23; ] HR 0.957 [0.472; 1.94]; p=0.9028
white N=243 [15.97; ] N=240 3.65 [2.63; 5.95] HR 0.396 [0.285; 0.549]; p<0.0001
Region
Asia N=31 20.50 [2.1; 20.5] N=29 3.48 [1.61; ] HR 0.752 [0.348; 1.628]; p=0.4699
Europe N=215 [15.97; ] N=216 4.17 [2.76; 5.95] HR 0.383 [0.268; 0.546]; p<0.0001
Rest of the World N=37 6.51 [2.17; ] N=35 6.05 [2.1; 8.18] HR 0.808 [0.378; 1.729]; p=0.5834
EORTC QLQ-LC13 (Sore mouth) - TTC N=283 [20.07; ] N=280 [; ] HR 0.607 [0.403; 0.913]; p=0.0165 ⊕⊕⊖⊖b
Region
Asia N=31 [; ] N=29 3.12 [1.45; ] HR 0.394 [0.157; 0.989]; p=0.0472
Europe N=215 [16.13; ] N=216 [; ] HR 0.744 [0.441; 1.255]; p=0.2682
Rest of the World N=37 [; ] N=35 6.05 [2.3; ] HR 0.372 [0.134; 1.034]; p=0.0580
EORTC QLQ-LC13 (Dyspnea) - TTC N=283 5.65 [2.63; 9.69] N=280 3.48 [2.79; 4.99] HR 0.943 [0.732; 1.215]; p=0.6515 ⊕⊕⊖⊖b
EORTC QLQ-LC13 (Haemoptysis) - TTC N=283 [; ] N=280 [; ] HR 0.773 [0.493; 1.21]; p=0.2595 ⊕⊕⊖⊖b
Gender
female N=35 [9.03; ] N=49 [; ] HR 2.634 [0.669; 10.366]; p=0.1658
male N=248 [; ] N=231 [; ] HR 0.653 [0.406; 1.052]; p=0.0801
Parentage
not white N=40 [; ] N=40 [4.37; ] HR 0.384 [0.144; 1.025]; p=0.0561
white N=243 [; ] N=240 [; ] HR 0.959 [0.576; 1.596]; p=0.8718
EORTC QLQ-LC13 (Coughing) - TTC N=283 16.10 [9.76; ] N=280 [8.18; ] HR 1.057 [0.762; 1.468]; p=0.7393 ⊕⊕⊖⊖b
Histology
Non-squamous epithelium N=161 9.76 [9.69; ] N=159 [8.18; ] HR 1.254 [0.828; 1.899]; p=0.2843
Squamous epithelium N=122 18.04 [14.06; ] N=121 [; ] HR 0.777 [0.452; 1.337]; p=0.3623
EORTC QLQ-LC13 (Dysphagia) - TTC N=283 [; ] N=280 [7.95; ] HR 0.726 [0.475; 1.11]; p=0.1395 ⊕⊕⊖⊖b
Parentage
not white N=40 [; ] N=40 4.21 [2.14; ] HR 0.389 [0.166; 0.913]; p=0.0301
white N=243 [; ] N=240 [; ] HR 0.878 [0.535; 1.443]; p=0.6082
Region
Asia N=31 [; ] N=29 [2.14; ] HR 0.374 [0.13; 1.077]; p=0.0684
Europe N=215 [; ] N=216 [; ] HR 0.998 [0.569; 1.751]; p=0.9954
Rest of the World N=37 11.79 [3.75; ] N=35 4.37 [2.07; ] HR 0.57 [0.247; 1.313]; p=0.1868
ORR - TuDD1 N=283 111 (39.22%) N=280 57 (20.36%) RR 1.93 [1.466; 2.532]; p<0.0001 ⊕⊕⊕⊖
EORTC QLQ-C30 (Physical Function) - TTC N=283 13.14 [9.69; ] N=280 3.78 [2.76; ] HR 0.528 [0.399; 0.699]; p<0.0001 ⊕⊕⊖⊖b
Gender
female N=35 5.65 [1.54; 13.14] N=49 [2.63; ] HR 1.195 [0.618; 2.311]; p=0.5968
male N=248 16.10 [12.52; ] N=231 3.78 [2.6; 4.63] HR 0.468 [0.345; 0.636]; p<0.0001
Histology
Non-squamous epithelium N=161 12.68 [9.69; ] N=159 4.24 [2.63; ] HR 0.672 [0.47; 0.96]; p=0.0292
Squamous epithelium N=122 [8.44; ] N=121 3.02 [2.5; 4.63] HR 0.371 [0.234; 0.587]; p<0.0001
EORTC QLQ-C30 (Role Function) - TTC N=283 13.14 [5.72; ] N=280 3.19 [2.23; 4.34] HR 0.666 [0.511; 0.868]; p=0.0027 ⊕⊕⊖⊖b
ECOG-PS
0 N=77 5.72 [2.83; 16] N=75 4.14 [2.04; 8.44] HR 0.757 [0.456; 1.257]; p=0.2818
1 N=206 14.29 [12.52; ] N=205 2.63 [2.17; 4.24] HR 0.625 [0.458; 0.854]; p=0.0032
EORTC QLQ-C30 (Emotional Function) - TTC N=283 [; ] N=280 8.44 [4.67; ] HR 0.584 [0.422; 0.808]; p=0.0012 ⊕⊕⊖⊖b
Age
<65 N=157 [; ] N=147 [3.52; ] HR 0.498 [0.317; 0.782]; p=0.0025
≥65 N=126 [8.84; ] N=133 5.26 [4.63; ] HR 0.745 [0.474; 1.173]; p=0.2044
ECOG-PS
0 N=77 [; ] N=75 4.67 [3.12; 8.44] HR 0.364 [0.195; 0.679]; p=0.0015
1 N=206 [14.03; ] N=205 [4.86; ] HR 0.714 [0.489; 1.043]; p=0.0817
Parentage
not white N=40 [11.73; ] N=40 3.19 [1.94; ] HR 0.351 [0.148; 0.83]; p=0.0172
white N=243 [; ] N=240 8.44 [4.67; ] HR 0.654 [0.462; 0.925]; p=0.0164
EORTC QLQ-C30 (Cognitive Function) - TTC N=283 10.61 [7.66; ] N=280 3.91 [2.92; 5.62] HR 0.645 [0.489; 0.851]; p=0.0019 ⊕⊕⊖⊖b
EORTC QLQ-C30 (Social Function) - TTC N=283 11.96 [6.57; 24.87] N=280 3.52 [2.23; 4.57] HR 0.603 [0.463; 0.785]; p=0.0002 ⊕⊕⊖⊖b
Gender
female N=35 3.38 [1.54; 13.14] N=49 3.68 [1.31; ] HR 1.005 [0.543; 1.863]; p=0.9866
male N=248 12.22 [8.61; 24.87] N=231 3.48 [2.23; 4.57] HR 0.566 [0.423; 0.757]; p=0.0001
EORTC QLQ-C30 (Global Health Status) - TTC N=283 9.89 [5.62; ] N=280 4.34 [3.06; 8.18] HR 0.773 [0.59; 1.014]; p=0.0625 ⊕⊕⊖⊖b
AE (Any) - TTE N=355 0.82 [0.72; 1.25] N=342 0.26 [0.26; 0.33] HR 0.509 [0.434; 0.598]; p<0.0001 ⊕⊕⊕⊖
Region
Asia N=39 0.30 [0.13; 0.53] N=37 0.23 [0.1; 0.33] HR 0.678 [0.43; 1.097]; p=0.1156
Europe N=274 1.28 [0.82; 1.45] N=268 0.30 [0.26; 0.46] HR 0.47 [0.391; 0.564]; p<0.0001
Rest of the World N=42 0.56 [0.33; 0.72] N=37 0.20 [0.1; 0.36] HR 0.759 [0.475; 1.211]; p=0.2469
AE (CTCAE ≥3) - TTE N=355 22.51 [14.32; ] N=342 7.10 [3.48; 8.38] HR 0.511 [0.403; 0.647]; p<0.0001 ⊕⊕⊕⊖
ECOG-PS
0 N=96 [; ] N=92 7.69 [2.69; ] HR 0.391 [0.241; 0.633]; p=0.0001
1 N=259 20.17 [11.7; ] N=250 7.10 [3.48; 8.41] HR 0.586 [0.447; 0.77]; p=0.0001
AE-Disc (Any) - TTE N=355 [; ] N=342 [; ] HR 1.097 [0.546; 2.206]; p=0.7940 ⊕⊕⊕⊖
ECOG-PS
0 N=96 [; ] N=92 [; ] HR 0.281 [0.052; 1.52]; p=0.1407
1 N=259 [23.16; ] N=250 [; ] HR 1.562 [0.691; 3.533]; p=0.2841
SAE (Any) - TTE N=355 23.16 [20.17; ] N=342 16.72 [16.72; ] HR 0.764 [0.57; 1.025]; p=0.0726 ⊕⊕⊕⊖
Outcome Cemiplimab
N=283		 Indirekter Vergleich: Pembrolizumab (KEYNOTE 024)
N=154		 Effect Estimate GRADE
Modul 4 der Nutzenbewertung von Cemiplimab (Libtayo®): Sanofi-Aventis Deutschland GmbH 2021. Modul 4 der Nutzenbewertung von Cemiplimab (Libtayo®). **
Dichotomous Outcomes
OS - Time To Event N=283 N=154 HR 0.94 [0.58; 1.54] ⊕⊕⊕⊕
PFS - Time To Event N=283 N=154 HR 1.08 [0.74; 1.58] ⊕⊕⊖⊖a
EORTC QLQ-C30 (Fatigue) - TTC N=283 N=154 HR 0.93 [0.62; 1.39] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Pain) - TTC N=283 N=154 HR 1.04 [0.66; 1.62] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Nausea) - TTC N=283 N=154 HR 1.17 [0.7; 1.97] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Dyspnea) - TTC N=283 N=154 HR 1.33 [0.79; 2.23] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Insomnia) - TTC N=283 N=154 HR 1.25 [0.77; 2.03] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Lack of Appetite) - TTC N=283 N=154 HR 1.02 [0.62; 1.68] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Constipation) - TTC N=283 N=154 HR 1.34 [0.8; 2.24] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Diarrhea) - TTC N=283 N=154 HR 1.43 [0.79; 2.58] ⊕⊖⊖⊖c,b
EORTC QLQ-LC13 (Pain in other parts) - TTC N=283 N=154 HR 1.01 [0.63; 1.62] ⊕⊖⊖⊖c,b
EORTC QLQ-LC13 (Pain in arm or shoulder) - TTC N=283 N=154 HR 0.79 [0.46; 1.36] ⊕⊖⊖⊖c,b
EORTC QLQ-LC13 (Pain in chest) - TTC N=283 N=154 HR 0.95 [0.52; 1.74] ⊕⊖⊖⊖c,b
EORTC QLQ-LC13 (Alopcia) - TTC N=283 N=154 HR 2.02 [0.99; 4.1] ⊕⊖⊖⊖c,b
EORTC QLQ-LC13 (Peripheral neuropathy) - TTC N=283 N=154 HR 0.94 [0.58; 1.55] ⊕⊖⊖⊖c,b
EORTC QLQ-LC13 (Dysphagia) - TTC N=283 N=154 HR 1.65 [0.84; 3.24] ⊕⊖⊖⊖c,b
EORTC QLQ-LC13 (Sore mouth) - TTC N=283 N=154 HR 1.84 [0.97; 3.5] ⊕⊖⊖⊖c,b
EORTC QLQ-LC13 (Dyspnea) - TTC N=283 N=154 HR 1.07 [0.7; 1.65] ⊕⊖⊖⊖c,b
EORTC QLQ-LC13 (Haemoptysis) - TTC N=283 N=154 HR 1.31 [0.53; 3.23] ⊕⊖⊖⊖c,b
EORTC QLQ-LC13 (Dysphagia) - TTC N=283 N=154 HR 1.41 [0.83; 2.39] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Physical Function) - TTC N=283 N=154 HR 0.93 [0.6; 1.44] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Role Function) - TTC N=283 N=154 HR 1.07 [0.69; 1.66] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Emotional Function) - TTC N=283 N=154 HR 0.82 [0.47; 1.43] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Cognitive Function) - TTC N=283 N=154 HR 0.76 [0.48; 1.2] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Social Function) - TTC N=283 N=154 HR 1.23 [0.79; 1.92] ⊕⊖⊖⊖c,b
EORTC QLQ-C30 (Global Health Status) - TTC N=283 N=154 HR 1.19 [0.76; 1.87] ⊕⊖⊖⊖c,b
AE (Any) - TTE N=283 N=154 HR 0.78 [0.58; 1.04] ⊕⊕⊖⊖b
AE (CTCAE ≥3) - TTE N=283 N=154 HR 1.04 [0.71; 1.53] ⊕⊕⊖⊖b
AE-Disc (Any) - TTE N=283 N=154 HR 1.83 [0.69; 4.82] ⊕⊕⊖⊖b
SAE (Any) - TTE N=283 N=154 HR 0.76 [0.49; 1.2] ⊕⊕⊖⊖b
*Database cutoff: 27.02.2020
**Database cutoff: not reported
1: ICR analysis
a: Missing individual analysis of combined endpoint componenets (progression); b: Incomplete observation for potentially informative reasons; c: Decreasing response rate in course of study
AE: Adverse Events; AE-Disc: Adverse Events Leading to Treatment Discontinuation; Alopcia: Alopcia; Any: Any Grade; Cognitive Function: Cognitive Function; Constipation: Constipation; Coughing: Coughing; CTCAE ≥3: Common Terminology Criteria for Adverse Events, Grade ≥3; Diarrhea: Diarrhea; DOR: Duration Of Response; Dysphagia: Dysphagia; Dyspnea: Dyspnea; Emotional Function: Emotional Function; EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; EORTC QLQ-LC13: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 Module; Fatigue: Fatigue; Global Health Status: Global Health Status; Haemoptysis: Haemoptysis; Insomnia: Insomnia; Lack of Appetite: Lack of Appetite; MCID: Minimal Clinically Important Difference; Nausea: Nausea; ORR: Objective Response Rate; OS: Overall Survival; Pain: Pain; Pain in arm or shoulder: Pain in arm or shoulder; Pain in chest: Pain in chest; Pain in other parts: Pain in other parts; Peripheral neuropathy: Peripheral neuropathy; PFS: Progression-Free Survival; Physical Function: Physical Function; Role Function: Role Function; SAE: Serious Adverse Events; Social Function: Social Function; Sore mouth: Sore mouth; TTC: Time To Change ; TTE: Time To Event ; TuDD: Time to Definitive Deterioration