natgillin/translations-raw huggingface dataset:
Hjælpestoffer: L-histidin, L-histidin-hydrochloridmonohydrat, saccharose, polysorbat 80, vand til injektionsvæsker. 
Excipients: L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80, water for injections.
3. kvartal 2021 
3Q 2021
EU/1/15/1024/001 (1 hætteglas) 
EU/1/15/1024/001 (1 vial)
Nefritis forekom hos 22 (0,4%) patienter, som fik pembrolizumab som monoterapi, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 5 (0,1%), 14 (0,2%) og 1 (< 0,1%) patienter. 
Nephritis occurred in 22 (0.4%) patients, including Grade 2, 3 or 4 cases in 5 (0.1%), 14 (0.2%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab as monotherapy.
Pembrolizumab 10 mg/kg hver 3. uge 
Pembrolizumab 10 mg/kg every 3 weeks
Pembrolizumab 200 mg hver 3. uge n=154 
Pembrolizumab 200 mg every 3 weeks n=154
denne tabel for RCCpatienter i behandling med pembrolizumab i kombination med axitinib og med forhøjede leverenzymer. 
NOTE: for RCC patients treated with pembrolizumab in combination with axitinib with liver enzyme elevations, see dosing guidelines following this table.
Kortikosteroider skal administreres ved bivirkninger ≥ grad 2 (initialdosis 1-2 mg/kg/dag prednison eller ækvivalent hermed efterfulgt af langsom udtrapning); pembrolizumab skal pauseres ved grad 2-pneumonitis og seponeres permanent ved grad 3-, grad 4- eller tilbagevendende grad 2-pneumonitis (se pkt. 
Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper); pembrolizumab should be withheld for Grade 2 pneumonitis, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 pneumonitis (see section 4.2).
De primære resultatmål var OS og PFS (BICR-vurdering i henhold til RECIST 1.1). 
The primary efficacy outcome measures were OS and PFS (assessed by BICR according to RECIST 1.1).
* BICR-vurdering i henhold til RECIST version 1.1 
* Assessed by BICR using RECIST 1.1
KEYTRUDA er ikke undersøgt hos patienter med svært nedsat nyrefunktion (se pkt. 
KEYTRUDA has not been studied in patients with severe renal impairment (see sections 4.4 and 5.2).
• Cetuximab 400 mg/m2 støddosis og herefter 250 mg/m2 en gang ugentligt, carboplatin AUC 
(n=99), or cetuximab 400 mg/m2 loading dose and then 250 mg/m2 once weekly (n=71).
Objektiv responsrate ORR % (95% CI) Komplet respons % Partielt respons % Responsvarighed Median i måneder (interval) 
Objective response rate ORR % (95% CI) Complete response % Partial response % Response Duration Median in months (range)
PFS-rate i måned 24 (95% CI) 
OS rate at 24 months HR (95% CI)
Pembrolizumab 10 mg/kg hver 2. uge n=279 
Pembrolizumab 10 mg/kg every 2 weeks n=279
EU/1/15/1024/002 (1 hætteglas) 
EU/1/15/1024/002 (1 vial)
Antal i risikogruppe Pembrolizumab + kemo: Standard: 
Number at Risk Pembrolizumab + Chemo:
Kortikosteroider skal administreres ved bivirkninger ≥ grad 2 (initialdosis 1-2 mg/kg/dag prednison eller ækvivalent hermed efterfulgt af langsom udtrapning), og på basis af sværhedsgraden af kreatininstigningen skal behandlingen med pembrolizumab pauseres ved grad 2-nefritis og seponeres permanent ved grad 3- eller 4-nefritis (se pkt. 
Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper) and, based on severity of creatinine elevations, pembrolizumab should be withheld for Grade 2, and permanently discontinued for Grade 3 or Grade 4 nephritis (see section 4.2).
Behandlingsarm PFS-rate i måned 12 PFS-rate i måned 18 HR (95% CI) p-værdi Pembrolizumab + Axitinib 60% 
Treatment arm PFS rate at 12 months PFS rate at 18 months HR (95% CI) p-value Pembrolizumab + Axitinib 60%
20,1% med forhøjet ALAT; 13,2% med forhøjet ASAT; 10,8% med nedsat lymfocyttal; 8,9% med forhøjet glucose; 7,8% med nedsat natrium; 6,4% med nedsat fosfat; 6,2% med forhøjet kalium; 4,3% med forhøjet kreatinin; 3,6% med nedsat kalium; 2,1% med forhøjet bilirubin; 2,1% med nedsat hæmoglobin; 1,7% med forhøjet alkalisk fosfatase; 1,5% med forhøjet INR (protrombintid); 1,4% med nedsat leukocyttal; 1,4% med nedsat trombocyttal; 1,2% med forlænget aktiveret partiel tromboplastintid 
In patients treated with pembrolizumab in combination with axitinib, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 20.1% for ALT increased, 13.2% for AST increased, 10.8% for lymphocytes decreased, 8.9% for glucose increased, 7.8% for sodium decreased, 6.4% for phosphate decreased, 6.2% for potassium increased, 4.3% for creatinine increased, 3.6% for potassium decreased, 2.1% for bilirubin increased, 2.1% for haemoglobin decreased, 1.7% for alkaline phosphatase increased, 1.5% for prothrombin INR increased, 1.4% for leukocytes decreased, 1.4% for platelets decreased, 1.2% for activated partial thromboplastin time prolonged, 1.2% for neutrophils decreased, 1.2% for sodium increased, 0.7% for calcium decreased, 0.7% for calcium increased, 0.5% for albumin decreased, and 0.2% for glucose decreased.
Colitis er rapporteret hos patienter, der fik pembrolizumab (se pkt. 
Colitis has been reported in patients receiving pembrolizumab (see section 4.8).
- Øvrige indholdsstoffer: L-histidin, L-histidin-hydrochloridmonohydrat, saccharose, polysorbat 80 og vand til injektionsvæsker. 
The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80 and water for injections.
Pembrolizumab 10 mg/kg hver 3. uge n=277 
Pembrolizumab 10 mg/kg every 3 weeks n=277
Et hætteglas med pulver indeholder 50 mg pembrolizumab. 
One vial of powder contains 50 mg of pembrolizumab.
Tabel 24: Effektresultater for pembrolizumab som monoterapi i KEYNOTE-048 med PD-L1ekspression (CPS ≥ 1) 
Table 24: Efficacy results for pembrolizumab as monotherapy in KEYNOTE-048 with PD-L1 expression (CPS ≥ 1)
1. kvartal 2021 
1Q 2021
Kortikosteroider skal administreres ved bivirkninger ≥ grad 2 (initialdosis 1-2 mg/kg/dag prednison eller ækvivalent hermed efterfulgt af langsom udtrapning); pembrolizumab skal pauseres ved grad 2- eller grad 3-colitis og seponeres permanent ved grad 4-colitis (se pkt. 
Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper); pembrolizumab should be withheld for Grade 2 or Grade 3 colitis, and permanently discontinued for Grade 4 colitis (see section 4.2).
Patienterne blev randomiseret i forholdet 1:1 til en af følgende behandlingsarme: 
Patients were randomised (1:1) to one of the following treatment arms:
- Øvrige indholdsstoffer: L-histidin, L-histidin-hydrochloridmonohydrat, saccharose og polysorbat 80. 
The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose and polysorbate 80.
Pembrolizumab 200 mg hver 3. uge n=64 
Pembrolizumab 200 mg every 3 weeks n=64
* Inkluderer patienter uden målbar sygdom ved baseline ved uafhængig radiologisk gennemgang † IRO = Integrated Radiology and Oncology vurdering i henhold til RECIST 1.1 ‡ Baseret på stabil sygdom eller bedre som bedste respons § Baseret på patienter med bekræftet respons ved uafhængig gennemgang, startende fra den dato, hvor respons blev registreret første gang; n=23 for ipilimumab-erfarne patienter; n=18 for ipilimumab-naive patienter ¶ Baseret på Kaplan-Meier-estimering 
Based on patients with a confirmed response by independent review, starting from the date the response was first recorded; n=23 for patients previously treated with ipilimumab; n=18 for patients naïve to treatment with ipilimumab Based on Kaplan-Meier estimation
Behandlingsarm OS-rate i måned 12 OS-rate i måned 18 HR (95% CI) p-værdi Pembrolizumab + Axitinib 90% 
Treatment arm OS rate at 12 months OS rate at 18 months HR (95% CI) p-value Pembrolizumab + Axitinib 90%
(n=279) eller 3. uge (n=277) eller ipilimumab 3 mg/kg hver 3. uge (n=278). 
Patients were randomised (1:1:1) to receive pembrolizumab 10 mg/kg every 2 (n=279) or 3 weeks (n=277) or ipilimumab 3 mg/kg every 3 weeks (n=278).
Det primære resultatmål var ORR baseret på BICR i henhold til RECIST version 1.1. 
The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1.
Se produktresuméet for de samtidigt administrerede lægemidler ved anvendelse i kombinationsbehandling. 
For use in combination, see the SmPC for the concomitant therapies.
Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) - problemer med skjoldbruskkirtlen - nedsat appetit - hovedpine; ændret smagssans - højt blodtryk - kortåndethed; hoste; hæshed - diarré; mavesmerter; kvalme; opkastning; forstoppelse - blærer eller udslæt på håndflader eller fodsåler; hududslæt; kløe - træthedsfølelse; usædvanlig træthed eller svaghed; feber - forhøjede leverenzymværdier i blodet; unormale prøveresultater for nyrefunktion - smerter i muskler og knogler; ledsmerter eller muskelsmerter, smerter eller ømhed; smerter i arme eller ben. 
Very common (may affect more than 1 in 10 people) - thyroid gland problems - feeling less hungry - headache; change in your sense of taste - high blood pressure - shortness of breath; cough; hoarseness - diarrhoea; stomach pain; nausea; vomiting; constipation - blisters or rash on palms of hands or soles of feet; skin rash; itching - feeling tired; unusual tiredness or weakness; fever - increased liver enzyme levels in the blood; abnormal kidney function test - pain in the muscles and bones; joint or muscle pain, aches or tenderness; pain in arms or legs
* Hazard ratio (pembrolizumab sammenlignet med kemoterapi) baseret på den stratificerede Cox proportional hazard-model Baseret på stratificeret log rank-test 
* Hazard ratio (pembrolizumab compared to chemotherapy) based on the stratified Cox proportional hazard model Based on stratified Log rank test
Pembrolizumab 2 mg/kg hver 3. uge 
Pembrolizumab 2 mg/kg every 3 weeks
Behandlingsarm 12 måneders OS-rate HR (95% CI) p-værdi Pembrolizumab 
Treatment arm OS rate at 12 months HR (95% CI) p-value Pembrolizumab
Figur 5: Kaplan-Meier-kurve for progressionsfri overlevelse i hver behandlingsarm i KEYNOTE-024 (intent to treat-population) 
Figure 5: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-024 (intent to treat population)
• en bestemt type hoved-halskræft kaldet planocellulært hoved-hals karcinom 
• a kind of head and neck cancer called head and neck squamous cell carcinoma
Figur 1: Kaplan-Meier-kurve for samlet overlevelse i hver behandlingsarm i KEYNOTE-006 (intent to treat-population) 
Figure 1: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-006 (intent to treat population)
Antal (%) patienter med hændelse HR* (95% CI) p-værdi 
Number (%) of patients with event Hazard ratio* (95% CI) p-Value
HR* (95% CI) p-værdi 
Hazard ratio* (95% CI) p-Value
Pembrolizumab 200 mg hver 3. uge n=270 
Pembrolizumab 200 mg every 3 weeks n=270
Pembrolizumab 10 mg/kg hver 2. uge: 
Pembrolizumab 10 mg/kg every 2 weeks:
Pembrolizumab 200 mg hver 3. uge n=210 
Pembrolizumab 200 mg every 3 weeks n=210
Nefritis er rapporteret hos patienter, der fik pembrolizumab (se pkt. 
Nephritis has been reported in patients receiving pembrolizumab (see section 4.8).
Figur 3: Kaplan-Meier-kurve for progressionsfri overlevelse i hver behandlingsarm i KEYNOTE-002 (intent to treat-population) 
Figure 3: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-002 (intent to treat population)
- muskelsmerter eller muskelømhed; ledsmerter med hævelser; smerter i arme eller ben - inflammation i nyrerne; pludseligt opstået nyreskade - kuldegysninger; influenzalignende sygdom - forhøjet indhold af kalcium i blodet; forhøjede leverenzymværdier i blodet. 
itchy skin; hair loss - inflammation of the liver - muscle pain, aches or tenderness; joint or muscle pain with swelling; inflammation of the sheath that surrounds tendons - sudden kidney damage; inflammation of the kidneys - swelling; flu-like illness; chills - increased calcium in the blood; increased liver enzyme levels in the blood
Patienter med EGFR- eller ALK-mutationer i tumor, autoimmun sygdom, der havde krævet systemisk behandling inden for de seneste 2 år, lidelser, som krævede behandling med immunsuppressiva, og patienter, som havde fået mere end 30 Gy torakal strålebehandling inden for de forudgående 26 uger, blev ekskluderet fra studiet. 
The study excluded patients with EGFR or ALK genomic tumour aberrations; autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks.
Et hætteglas indeholder 50 mg pembrolizumab. 
One vial contains 50 mg of pembrolizumab.
Figur 2: Kaplan-Meier-kurve for progressionsfri overlevelse i hver behandlingsarm i KEYNOTE-006 (intent to treat-population) 
Figure 2: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-006 (intent to treat population)
Det kan overvejes at fortsætte behandlingen med pembrolizumab efter langsom udtrapning af eventuel nødvendig kortikosteroidbehandling hos patienter med endokrinopati grad 3 eller grad 4, som bedres til grad 2 eller lavere med hormonsubstitutionsbehandling, hvis det er indiceret. 
Withhold until adverse reactions recover to Grades 0-1* For patients with Grade 3 or Grade 4 endocrinopathy that improved to Grade 2 or lower and is controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed.
Figur 12: Kaplan-Meier-kurve for samlet overlevelse i hver behandlingsarm i KEYNOTE-045 (intent to treat-population) 
Figure 12: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-045 (intent to treat population)
nedsat udskillelse af hormoner produceret af binyrerne - nedsat indhold af kalium, natrium eller kalcium i blodet - søvnbesvær - svimmelhed; manglende energi; inflammation i nerverne, som medfører følelsesløshed, svaghed og en snurrende fornemmelse eller brændende smerter i arme og ben - tørre øjne - unormal hjerterytme - inflammation i lungerne - inflammation i tarmene; mundtørhed - rødt hævet hududslæt, nogle gange med blæredannelse; aknelignende hudproblemer; inflammation i huden; tør, kløende hud; hårtab 
leukocytes); decrease in the number of platelets (bruising or bleeding more easily) - reaction related to the infusion of the medicine - inflammation of the pituitary gland situated at the base of the brain; inflammation of the thyroid; decreased secretion of hormones produced by the adrenal glands - decreased potassium, sodium or calcium in the blood - trouble sleeping - dizziness; lack of energy; inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs - dry eye - abnormal heart rhythm - inflammation of the lungs - inflammation of the intestines; dry mouth - red raised rash, sometimes with blisters; acne-like skin problem; inflammation of the skin; dry,
Pembrolizumab 10 mg/kg hver 2. eller 3. uge (puljet) 
Pembrolizumab 10mg/kg every 2 or 3 weeks (pooled)
Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) - nedsat antal røde blodlegemer - nedsat antal hvide blodlegemer; nedsat antal blodplader (øget tendens til at få blå mærker eller øget blødningstendens) - nedsat indhold af kalium i blodet; nedsat appetit - svimmelhed; hovedpine; inflammation i nerverne, som medfører følelsesløshed, svaghed, en snurrende fornemmelse eller brændende smerter i arme og ben; ændret smagssans - kortåndethed; hoste - diarré; kvalme; opkastning; forstoppelse; mavesmerter - hududslæt; kløe; hårtab - smerter i muskler og knogler; ledsmerter - usædvanlig træthed eller svaghed; hævelser; feber - unormale prøveresultater for nyrefunktion. 
Very common (may affect more than 1 in 10 people) - decrease in the number of red blood cells - decreased number of white blood cells; decrease in the number of platelets (bruising or bleeding more easily) - decreased potassium in the blood; feeling less hungry - dizziness; headache; inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs; change in your sense of taste - shortness of breath; cough - diarrhoea; nausea; vomiting; constipation; stomach pain - skin rash; itching; hair loss - pain in the muscles and bones; joint pain - unusual tiredness or weakness; swelling; fever - abnormal kidney function test
Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) - nedsat antal røde blodlegemer - nedsat funktion af skjoldbruskkirtlen nedsat appetit - hovedpine kortåndethed; hoste - diarré; mavesmerter; kvalme; opkastning; forstoppelse - kløe; hududslæt - smerter i muskler og knogler; ledsmerter - træthedsfølelse; usædvanlig træthed eller svaghed; hævelser; feber. 
Very common (may affect more than 1 in 10 people) - decrease in the number of red blood cells - reduced thyroid gland activity - feeling less hungry - headache - shortness of breath; cough - diarrhoea; stomach pain; nausea; vomiting; constipation - itching; skin rash - pain in muscle and bones; joint pain - feeling tired; unusual tiredness or weakness; swelling; fever
hypofysitis d, tyroiditis hypofysitis d, tyroiditis e, binyrebarkinsufficiens 
Uncommon adrenal insufficiency hypophysitis d, thyroiditis hypophysitis d,
Pembrolizumab 10 mg/kg hver 3. uge: 
Pembrolizumab 10 mg/kg every 3 weeks:
Figur 6: Kaplan-Meier-kurve for samlet overlevelse i hver behandlingsarm i KEYNOTE-024 (intent to treat-population) 
Figure 6: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-024 (intent to treat population)
* Hazard ratio (pembrolizumab sammenlignet med ipilimumab) baseret på den stratificerede Cox proportional hazard-model 
* Hazard ratio (pembrolizumab compared to ipilimumab) based on the stratified Cox proportional hazard model
Pembrolizumabs sikkerhed og virkning blev undersøgt i KEYNOTE-002, et kontrolleret multicenterstudie af behandling af fremskredent melanom hos patienter, der tidligere har været behandlet med ipilimumab og med en BRAF- eller MEK-hæmmer, hvis der forekom en BRAF V600-mutation. 
KEYNOTE-002: Controlled trial in melanoma patients previously treated with ipilimumab The safety and efficacy of pembrolizumab were investigated in KEYNOTE-002, a multicentre, controlled study for the treatment of advanced melanoma in patients previously treated with ipilimumab and if BRAF V600 mutation-positive, with a BRAF or MEK inhibitor.
Ipilimumab Pembrolizumab 10 mg/kg hver 2. eller 3. uge (puljet) 
Ipilimumab Pembrolizumab 10 mg/kg every 2 or 3 weeks (pooled)
Administration af pembrolizumab var tilladt efter sygdomsprogression i henhold til RECIST baseret på BICR-vurdering eller efter seponering af pemetrexed, hvis patienten var klinisk stabil, og investigator vurderede, at patienten havde en klinisk fordel. 
Administration of pembrolizumab was permitted beyond RECIST-defined disease progression by BICR or beyond discontinuation of pemetrexed if the patient was clinically stable and deriving clinical benefit as determined by the investigator.
† (inklusive atrieflimren) 
cardiac arrhythmia (including atrial fibrillation)
Det primære resultatmål var ORR, baseret på en vurdering ved IRO i henhold til RECIST 1.1. 
The primary efficacy outcome measure was ORR as assessed by independent review using RECIST 1.1.
Figur 4: Kaplan-Meier-kurve for recidivfri overlevelse i hver behandlingsarm i KEYNOTE-054 (intent to treat-population) 
Figure 4: Kaplan-Meier curve for recurrence-free survival by treatment arm in KEYNOTE-054 (intent to treat population)
PRODUKTRESUMÉ 
Absorption
Pembrolizumab 2 mg/kg hver 3. uge: 
Pembrolizumab 2 mg/kg every 3 weeks:
Behandlingsarm OS-rate i måned 6 OS-rate i måned 9 HR (95% CI) 
Treatment arm OS rate at 6 months OS rate at 12 months HR (95% CI)
Hepatitis er rapporteret hos patienter, der fik pembrolizumab (se pkt. 
Hepatitis has been reported in patients receiving pembrolizumab (see section 4.8).
Se produktresuméet for axitinib for oplysninger vedrørende dosering af axitinib for RCC-patienter, der behandles med KEYTRUDA i kombination med axitinib. 
KEYTRUDA in combination with axitinib in RCC For RCC patients treated with KEYTRUDA in combination with axitinib, see the Summary of Product Characteristics (SmPC) regarding dosing of axitinib.
Pneumonitis er rapporteret hos patienter, der fik pembrolizumab (se pkt. 
Pneumonitis has been reported in patients receiving pembrolizumab (see section 4.8).
Intravenøs anvendelse i.v. 
Intravenous use
Administration af pembrolizumab var tilladt efter sygdomsprogression defineret i henhold til RECIST, hvis patienten var klinisk stabil, og investigator vurderede, at patienten havde en klinisk fordel. 
Administration of pembrolizumab was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator.
Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) - nedsat antal hvide blodlegemer (lymfocytter og eosinofiler) - type 1-diabetes (sukkersyge) - en tilstand hvor musklerne bliver svage og hurtigere bliver trætte - inflammation i hjertemusklen, som kan inkludere kortåndethed, uregelmæssig hjerterytme, træthed eller brystsmerter - inflammation i øjnene; øjensmerter, øjenirritation, kløe eller røde øjne; ubehagelig lysfølsomhed; 
Uncommon (may affect up to 1 in 100 people) - decreased number of white blood cells (lymphocytes and eosinophils) - type 1 diabetes - a condition in which the muscles become weak and tire easily - inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat,
Baseret på patienter med en bedste samlet respons, der er bekræftet som komplet eller partielt respons fra den endelige analyse 
Not statistically significant after adjustment for multiplicity Based on patients with a best overall response as confirmed complete or partial response from the final analysis
Patienterne havde PD-L1-ekspression med TPS  1% baseret på PD-L1 IHC 22C3 pharmDx 
Patients had PD-L1 expression with a  1% TPS based on the
5,6 (1,6+; 25,6+) 4,6 (1,4+; 31,4+) NR (1,5+; 38,9+) 5,0 (1,4+; 38,7+) 
PFS rate at 6 months (95% CI) 49.4 (40.3, 57.9) PFS rate at 12 months (95% CI) 23.9 (16.7, 31.7) PFS rate at 24 months (95% CI) 14.6 (8.9, 21.5) ORR
AUC 5 mg/ml/min intravenøst hver 3. uge i 4 serier efterfulgt af placebo og pemetrexed 500 mg/m intravenøst hver 3. uge (n=206). 
75 mg/m or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by pembrolizumab 200 mg and pemetrexed 500 mg/m intravenously every 3 weeks