natgillin/translations-raw huggingface dataset:
§% (95% CI) Komplet respons Partielt respons p-værdi Responsvarighed Median i måneder (interval)
§% (95% CI) Complete response Partial response p-Value Response duration Median in months (range)
Patienter med autoimmun sygdom, der havde krævet systemisk behandling inden for de seneste 2 år; lidelser, som krævede behandling med immunsuppressiva; eller patienter, som havde fået mere end 30 Gy torakal strålebehandling inden for de forudgående 26 uger, blev ekskluderet fra studiet.
Patients with 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 were ineligible.
Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende den endelige studierapport for studie P204: Et randomiseret, åbent klinisk fase III-studie, der sammenligner pembrolizumab med brentuximab vedotin hos forsøgspersoner med recidiverende eller refraktært klassisk Hodgkins lymfom - Endelig studierapport
Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P204: A Phase III, Randomised, Open-label, Clinical Trial to Compare Pembrolizumab with Brentuximab Vedotin in Subjects with Relapsed or Refractory Classical Hodgkin Lymphoma - Final Study Report
Figur 14: Kaplan-Meier-kurve for samlet overlevelse for pembrolizumab som monoterapi i KEYNOTE-048 med PD-L1-ekspression (CPS ≥ 1)
Figure 14: Kaplan-Meier curve for overall survival for pembrolizumab as monotherapy in KEYNOTE-048 with PD-L1 expression (CPS ≥ 1)
Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende den endelige studierapport for studie P087: Et klinisk fase II-studie af MK-3475 (pembrolizumab) hos forsøgspersoner med recidiverende eller refraktært (R/R) klassisk Hodgkins lymfom (cHL) - Endelig studierapport
Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P087, A Phase II Clinical Trial of MK-3475 (Pembrolizumab) in Subjects with Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL) - Final Study Report
KEYTRUDA som monoterapi er indiceret til behandling af lokalt fremskredent eller metastatisk NSCLC hos voksne efter tidligere behandling med minimum én kemoterapi, og hvis tumorer udtrykker PD-L1 med TPS ≥ 1%.
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen.
Hypofysitis forekom hos 36 (0,6%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 13 (0,2%), 19 (0,3%) og 1 (< 0,1%) patienter.
Hypophysitis occurred in 36 (0.6%) patients, including Grade 2, 3 or 4 cases in 13 (0.2%), 19 (0.3%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab.
Kortikosteroider skal administreres (initialdosis 0,5-1 mg/kg/dag [ved bivirkninger af grad 2] eller 1-2 mg/kg/dag [ved bivirkninger ≥ grad 3] prednison eller ækvivalent hermed efterfulgt af langsom udtrapning), og på basis af sværhedsgraden af leverenzymstigningen skal behandlingen med pembrolizumab pauseres eller seponeres (se pkt.
Corticosteroids should be administered (initial dose of 0.5-1 mg/kg/day (for Grade 2 events) and 1-2 mg/kg/day (for Grade ≥ 3 events) prednisone or equivalent followed by a taper) and, based on severity of liver enzyme elevations, pembrolizumab should be withheld or discontinued (see section 4.2).
HR* for PFS (95% CI) HR* for OS (95% CI) ORR %
PFS Hazard ratio* (95% CI) OS Hazard ratio* (95% CI) ORR %
KEYTRUDA er ikke undersøgt hos patienter med moderat eller svært nedsat leverfunktion (se pkt.
KEYTRUDA has not been studied in patients with moderate or severe hepatic impairment (see sections 4.4 and 5.2).
• KEYTRUDA 200 mg hver 3. uge, carboplatin AUC 5 mg/ml/min hver 3. uge eller cisplatin
• KEYTRUDA 200 mg every 3 weeks, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m2 every 3 weeks, and 5-FU 1,000 mg/m2/d 4 days continuous every
‡ % (95% CI) Komplet respons % Partielt respons % p-værdi Responsvarighed Median i måneder (interval)
‡ % (95% CI) Complete response % Partial response % p-Value Response duration Median in months (range)
Nefritis medførte seponering af pembrolizumab hos 10 (0,2%) patienter.
Nephritis led to discontinuation of pembrolizumab in 10 (0.2%) patients.
5 mg/ml/min hver 3. uge eller cisplatin 100 mg/m 2 hver 3. uge, og 5-FU 1.000 mg/m 2/dag kontinuerligt i 4 dage hver 3. uge (maksimalt 6 serier med platinbaseret behandling og 5-FU)
• Cetuximab 400 mg/m 2 load then 250 mg/m 2 once weekly, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m 2 every 3 weeks, and 5-FU 1,000 mg/m 2/d 4 days continuous every 3 weeks (maximum of 6 cycles of platinum and 5-FU)
Almindelig hypertyroidisme hypotyroidisme, hypertyroidisme hypofysitis d, tyroiditis e, binyrebarkinsufficiens
Common hyperthyroidism hypothyroidism, hyperthyroidism hypophysitis d,
Binyrebarkinsufficiens medførte seponering af pembrolizumab hos 4 (0,1%) patienter.
Adrenal insufficiency led to discontinuation of pembrolizumab in 4 (0.1%) patients.
Medianvarigheden var 1,9 måneder (interval: 1 dag til 25,3+ måneder).
The median duration was 1.9 months (range 1 day to 25.3+ months).
OS-rate i måned 12, % (95% CI)
12-month OS rate, % (95% CI)
De hyppigste bivirkninger (rapporteret hos mindst 20% af de pædiatriske patienter) var pyreksi (31%), opkastning (26%), hovedpine (22%), abdominalsmerter (21%), anæmi (21%) og obstipation (20%).
vomiting (26%), headache (22%), abdominal pain (21%), anaemia (21%) and constipation (20%).
ORR % * Hazard ratio (pembrolizumab kombinationsbehandling sammenlignet med kemoterapi) baseret på den stratificerede Cox proportional hazard-model
ORR % * Hazard ratio (pembrolizumab combination therapy compared to chemotherapy) based on the stratified Cox proportional hazard model
Pembrolizumab 10 mg/kg hver 3. uge n=181
Pembrolizumab 10 mg/kg every 3 weeks n=181
Tabel 26: Effektresultater for pembrolizumab plus kemoterapi og pembrolizumab som monoterapi ud fra PD-L1-ekspression i KEYNOTE 048 (CPS ≥ 1 til < 20)
Table 26: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 Expression in KEYNOTE 048 (CPS ≥ 1 to < 20)
Responsvarighed Median i måneder (interval)
Number of responders Median in months (range)
Pembrolizumab 2 mg/kg hver 3. uge n=180
Pembrolizumab 2 mg/kg every 3 weeks n=180
og paclitaxel 200 mg/m2 på dag 1 i hver 21-dages serie i 4 serier eller nab-paclitaxel 100 mg/m2 på dag 1, 8 og 15 i hver 21-dages serie i 4 serier, efterfulgt af pembrolizumab 200 mg hver 3. uge.
• Pembrolizumab 200 mg and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for 4 cycles, and paclitaxel 200 mg/m2 on Day 1 of each 21-day cycle for 4 cycles or nab paclitaxel 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle for 4 cycles, followed by pembrolizumab 200 mg every 3 weeks.
Der blev udført en analyse i KEYNOTE-048 hos patienter, hvis tumorer udtrykte PD-L1 CPS ≥ 20 [pembrolizumab plus kemoterapi: n=126 (49%) versus standardbehandling: n=110 (43%) og pembrolizumab som monoterapi: n=133 (52%) versus standardbehandling: n=122 (48%)] (se tabel 25).
An analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS ≥ 20 [pembrolizumab plus chemotherapy: n=126 (49%) vs. standard treatment: n=110 (43%) and pembrolizumab monotherapy: n=133 (52%) vs. standard treatment: n=122 (48%)] (see Table 25).
Tabel 23: Effektresultater for pembrolizumab plus kemoterapi i KEYNOTE-048 med PD-L1ekspression (CPS ≥ 1)
Table 23: Efficacy results for pembrolizumab plus chemotherapy in KEYNOTE-048 with PDL1 expression (CPS ≥ 1)
Hos patienterne i KEYNOTE-013 var baseline-karakteristika: medianalder 32 år (7% ≥ 65 år), 58% mænd, 94% kaukasere; og 45% og 55% havde henholdsvis ECOG-performance-status 0 og 1.
Among KEYNOTE-013 patients, the baseline characteristics were median age 32 years (7% age 65 or older), 58% male, 94% White; and 45% and 55% had an ECOG performance status 0 and 1, respectively.
Figur 17: Kaplan-Meier-kurve for progressionsfri overlevelse i hver behandlingsarm i KEYNOTE-426 (intent to treat-population)*
Figure 17: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-426 (intent to treat population)*
Pembrolizumab + platinbaseret kemoterapi + 5-FU n=242
Pembrolizumab + Platinum Chemotherapy + 5-FU n=242
Median i måneder (95% CI) 6-måneders OS-rate 12-måneders OS-rate
Median in months (95% CI) 6-month OS rate 12-month OS rate
KEYNOTE-048: Kontrolleret studie af monoterapi og kombinationsbehandling hos behandlingsnaive HNSCC-patienter i behandling for recidiverende eller metastatisk sygdom Pembrolizumabs virkning blev undersøgt i KEYNOTE-048, et randomiseret, åbent, aktivt kontrolleret multicenterstudie hos patienter med histologisk bekræftet metastatisk eller recidiverende HNSCC i mundhulen, svælget (farynx) eller struben (larynx), som ikke tidligere havde fået systemisk behandling for recidiverende eller metastatisk sygdom, og som blev anset for at være uhelbredeligt med lokal behandling.
The efficacy of pembrolizumab was investigated in KEYNOTE-048, a multicentre, randomized, open-label, active-controlled study in patients with histologically confirmed metastatic or recurrent HNSCC of the oral cavity, pharynx or larynx, who had not previously received systemic therapy for recurrent or metastatic disease and who were considered incurable by local therapies.
Det rekonstituerede KEYTRUDA-koncentrat er en klar til let opaliserende og farveløs til lysegul opløsning.
Reconstituted KEYTRUDA is a clear to slightly opalescent, colourless to slightly yellow solution.
Figur 7: Kaplan-Meier-kurve for samlet overlevelse i hver behandlingsarm i KEYNOTE-189 (intent to treat-population)
Figure 7: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-189 (intent to treat population)
Median i måneder (95% CI) 6-måneders PFS-rate 12-måneders PFS-rate
Median in months (95% CI) 6-month PFS rate 12-month PFS rate
Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende den endelige studierapport for studie P407: Et randomiseret, dobbeltblindet fase III-studie af carboplatin - paclitaxel/nabpaclitaxel-kemoterapi med eller uden pembrolizumab (MK-3475) som førstelinjebehandling hos forsøgspersoner med metastatisk planocellulær ikkesmåcellet lungecancer - Endelig studierapport
Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P407: A Randomised, Double-Blind, Phase III Study of Carboplatin - Paclitaxel/Nab-Paclitaxel Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects - Final Study Report
Behandlingen kunne fortsætte efter progression, hvis patienten var klinisk stabil, og investigator mente, at patienten havde en klinisk fordel.
Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator.
Pembrolizumab Placebo
Pembrolizumab
Figur 8: Kaplan-Meier-kurve for progressionsfri overlevelse i hver behandlingsarm i KEYNOTE-189 (intent to treat-population)
Figure 8: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-189 (intent to treat population)
Keytruda 50 mg pulver til koncentrat til infusionsvæske, opløsning pembrolizumab
KEYTRUDA 50 mg powder for concentrate for solution for infusion pembrolizumab
I en subgruppeanalyse viste pembrolizumab en reduceret fordel med hensyn til overlevelse sammenlignet med kemoterapi hos de få patienter, som aldrig havde røget.
In a subgroup analysis, a reduced survival benefit of pembrolizumab compared to chemotherapy was observed in the small number of patients who were never-smokers; however, due to the small number of patients, no definitive conclusions can be drawn from these data.
Sekundære resultatmål var OS og ORR (baseret på BICR-vurdering i henhold til RECIST 1.1).
Secondary efficacy outcome measures were OS and ORR (as assessed by BICR using RECIST 1.1).
Pembrolizumab + platinbaseret kemoterapi + 5-FU n=126
Pembrolizumab + Platinum Chemotherapy + 5-FU n=126
Kemoterapi
Chemotherapy
Figur 16: Kaplan-Meier-kurve for samlet overlevelse i hver behandlingsarm i KEYNOTE-426 (intent to treat-population)*
Figure 16: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-426 (intent to treat population)*
Pembrolizumab 10 mg/kg hver 2. uge n=31
Pembrolizumab 10 mg/kg every 2 weeks n=31
Pembrolizumab + platinbaseret kemoterapi + 5-FU n=116
Pembrolizumab + Platinum Chemotherapy + 5-FU n=116
KEYTRUDA 25 mg/ml koncentrat til infusionsvæske, opløsning.
KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Baseret på Miettinen- og Nurminen-metoden stratificeret ud fra PD-L1-status, platinbaseret kemoterapi og rygestatus
Based on patients with a best overall response as confirmed complete or partial response Based on Miettinen and Nurminen method stratified by PD-L1 status, platinum chemotherapy and smoking status
Behandlingen kunne fortsætte efter sygdomsprogression, hvis patienten var klinisk stabil, og investigator mente, at patienten havde en klinisk fordel.
Treatment could continue beyond disease progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator.
Hepatitis forekom hos 50 (0,8%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 8 (0,1%), 31 (0,5%) og 8 (0,1%) patienter.
Hepatitis occurred in 50 (0.8%) patients, including Grade 2, 3 or 4 cases in 8 (0.1%), 31 (0.5%) and 8 (0.1%) patients, respectively, receiving pembrolizumab.
Antal (% #) patienter med varighed ≥ 6 måneder Antal (% #) patienter med varighed ≥ 12 måneder
#) of patients with duration ≥ 6 months Number (%
Der er begrænsede data vedrørende sikkerhed fra patienter ≥ 75 år, som har fået adjuverende behandling for melanom.
Safety data of pembrolizumab in the adjuvant melanoma setting in patients ≥ 75 years are limited.
Tabel 25: Effektresultater for pembrolizumab plus kemoterapi og pembrolizumab som monoterapi ud fra PD-L1-ekspression i KEYNOTE 048 (CPS ≥ 20)
Table 25: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 Expression in KEYNOTE 048 (CPS ≥ 20)
Hjælpestoffer: L-histidin, L-histidin-hydrochloridmonohydrat, saccharose, polysorbat 80.
Excipients: L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80.
2. kvartal 2021
2Q 2021
Objektiv responsrate ORR % (95% CI) Komplet remission Partiel remission Responssvarighed Median i måneder (interval)
Objective response rate ORR % (95% CI) Complete Remission Partial Remission Response duration Median in months (range)
Administration af pembrolizumab og axitinib var tilladt efter sygdomsprogression i henhold til RECIST, hvis patienten var klinisk stabil, og investigator mente, at patienten havde en klinisk fordel.
Administration of pembrolizumab and axitinib was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator.
pneumonitis (interstitiel lungesygdom) m. abdominalsmerter (abdominalgener, øvre abdominalsmerter og nedre abdominalsmerter) n. colitis (mikroskopisk colitis, enterocolitis, hæmoragisk enterocolitis og autoimmun colitis) o. pankreatitis (autoimmun pankreatitis og akut pankreatitis) p. hepatitis (autoimmun hepatitis, immunmedieret hepatitis og lægemiddelinduceret leverskade) q. udslæt (erytematøst udslæt, follikulært udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, pruritisk udslæt, vesikuløst udslæt og genitalt udslæt)
pneumonitis (interstitial lung disease) m. abdominal pain (abdominal discomfort, abdominal pain upper and abdominal pain lower) n. colitis (colitis microscopic, enterocolitis, enterocolitis haemorrhagic, and autoimmune colitis) o. pancreatitis (autoimmune pancreatitis and pancreatitis acute) p. hepatitis (autoimmune hepatitis, immune-mediated hepatitis and drug induced liver injury) q. rash (rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash vesicular and genital rash)
Median i måneder (95% CI) Bedste samlede respons ORR % (95% CI) Komplet respons % Partielt respons % Responsvarighed Median i måneder (interval)
Median in months (95% CI) Overall response rate ORR % (95% CI) Complete response % Partial response % Response duration Median in months (range)
Sjælden (kan forekomme hos op til 1 ud af 1.000 personer) - nedsat antal hvide blodlegemer (eosinofiler) - inflammation i hjertemusklen, som kan vise sig som kortåndethed, uregelmæssig hjerterytme,
- a decreased number of white blood cells (eosinophils) - 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 komplet eller partielt respons Baseret på Miettinen og Nurminen-metoden stratificeret ud fra IMDC-risikogruppe og geografisk område Baseret på estimering i henhold til Kaplan-Meier
Based on the stratified Cox proportional hazard model Based on stratified log-rank test Assessed by BICR using RECIST 1.1 Based on patients with a best overall response as confirmed complete or partial response Based on Miettinen and Nurminen method stratified by IMDC risk group and geographic region Based on Kaplan-Meier estimation NA = not available
Binyrebarkinsufficiens forekom hos 46 (0,8%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 19 (0,3%), 20 (0,3%) og 3 (0,1%) patienter.
Adrenal insufficiency occurred in 46 (0.8%) patients, including Grade 2, 3 or 4 cases in 19 (0.3%), 20 (0.3%) and 3 (0.1%) patients, respectively, receiving pembrolizumab.
Alvorlige immunrelaterede hudreaktioner er rapporteret hos patienter, der fik pembrolizumab (se pkt.
Immune-related severe skin reactions have been reported in patients receiving pembrolizumab (see section 4.8).
Farmakoterapeutisk klassifikation: antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC18
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
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