natgillin/translations-raw huggingface dataset:
Tumour PD-L1 expression was determined using the PD-L1 IHC 288 pharmDx assay.
Expresia PD-L1 v nádore sa stanovila pomocou medódy PD-L1
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of pneumonitis including interstitial lung disease, was 7.8% (35/448).
U pacientov liečených nivolumabom v dávke 1 mg/kg v kombinácii s ipilimumabom v dávke 3 mg/kg pri melanóme bola incidencia pneumonitídy vrátane intersticiálneho ochorenia pľúc 7,8
Comparable to the overall population, median duration of response was increased with nivolumab vs. docetaxel for patients with no PD-L1 expression (18.3 months vs. 5.6 months) and for patients with PD-L1 expression (16.0 months vs. 5.6 months).
V porovnaní s celkovou populáciou bol medián trvania odpovede predĺžený s nivolumabom oproti docetaxelu u pacientov bez expresie PD-L1
Median time to onset was 1.2 months (range: 0.0-22.6).
Medián času do nástupu bol 1,2 mesiaca (rozsah: 0,0-22,6).
HRb (95% CI)
Výskyt (95 % CI)
Patients with a baseline performance score ≥ 2, active brain metastases or leptomeningeal metastases, autoimmune disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the pivotal clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1).
2, aktívnymi metastázami v mozgu alebo leptomeningeálnymi metastázami, autoimunitným ochorením a pacienti, ktorí dostali systémové imunosupresíva pred zaradením do štúdie boli z pivotných klinických skúšaní s nivolumabom alebo s nivolumabom v kombinácii s ipilimumabom vylúčení (pozri časti 4.5 a 5.1).
Efficacy by tumour PD-L1 expression: Objective responses to nivolumab were observed regardless of tumour PD-L1 expression.
Objektívne odpovede na nivolumab sa pozorovali bez ohľadu na expresiu PD-L1 v nádore.
Patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1).
Pacienti so súbežnými metastázami v mozgu, aktívnym autoimunitným ochorením alebo zdravotnými stavmi vyžadujúcimi si systémovú imunosupresiu alebo s ich akoukoľvek anamnézou boli z klinických skúšaní s nivolumabom alebo s nivolumabom v kombinácii s ipilimumabom vylúčení (pozri časti 4.5 a 5.1).
Results from post-hoc, exploratory analyses indicate that in patients with low (e.g. <1%) to no tumour PD-L1 expression, other patient characteristics (e.g. liver metastases, visceral metastases, baseline haemoglobin <10g/dL and ECOG performance status = 1) might contribute to the clinical outcome.
%) až žiadnou expresiou PD-L1 v nádore, inými charakteristikami pacienta (napr. metastázy v pečeni, viscerálne metastázy, východisková hladina hemoglobínu <
OS benefit was observed regardless of HPV status (HPV-positive: HR = 0.63; 95% CI: 0.38, 1.04, HPV-negative: HR = 0.64; 95% CI: 0.40, 1.03, and HPV-unknown: HR = 0.78; 95% CI: 0.55, 1.10).
0,64; 95 % CI: 0,40; 1,03 a HPV-neznámy: HR =
Patients with Karnofsky performance status < 70% and patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the study.
70 % a pacienti so súbežnými metastázami v mozgu, s aktívnym autoimunitným ochorením alebo zdravotnými stavmi vyžadujúcimi si systémovú imunosupresiu alebo s ich akoukoľvek anamnézou boli zo štúdie vyradení.
The median age was 60 years (range: 28-83) with 31% ≥ 65 years of age and 5% ≥ 75 years of age, 83% were male, and 83% were white.
% s vekom ≥ 65 rokov a 5 % s vekom ≥ 75 rokov, 83 % bolo mužov a 83 % bolo belochov.
Resolution occurred in 37 patients (77.1%) with a median time to resolution of 13.2 weeks (range: 0.1+-106.0+).
%) s mediánom času do vyriešenia 13,2 týždňa (rozsah: 0,1+-106,0+).
ECOG performance status score was 0 (73%) or 1 (27%).
Skóre výkonnostného stavu ECOG bolo 0 (73
Progression-free survival Median (95% CI) months Rate (95% CI) at 6 months
Prežívanie bez progresie Medián (95 % CI) mesiace Výskyt (95 % CI) po 6 mesiacoch Celkové prežívanie Medián (95 % CI) mesiace
Nine of 49 patients (18.4%) died from complications of allogeneic HSCT after nivolumab.
%) zomrelo na komplikácie alogénnej HSCT po podaní nivolumabu.
Median duration of response Months (range)
Trvanie odpovede Medián (rozsah) mesiace
Resolution occurred in 21 patients (91.3%) with a median time to resolution of 2.1 weeks (range: 0.1- 125.1+).
%) s mediánom času do vyriešenia 2,1 týždňa (rozsah: 0,1 - 125,1+).
For tumour PD-L1 expression < 1%, the median OS was 34.7 months for the nivolumab in combination with ipilimumab, and was 32.2 months in the sunitinib arm (HR = 0.70; 95% CI: 0.54, 0.92).
% bol medián OS 34,7 mesiaca a v skupine so sunitinibom bol 32,2 mesiaca (HR =
Resolution occurred in 63 patients (72.4%) with a median time to resolution of 6.1 weeks (range: 0.1+-96.7+); + denotes a censored observation.
%) s mediánom času do vyriešenia 6,1 týždňa (rozsah: 0,1+ - 96,7+);
Table 8: Efficacy Results (CA209066)
OS (CA209066)
CA209205 Cohort Cb
CA209205 Cohort
Intestinal perforation, inflammation of the stomach (gastritis), inflammation of the duodenum Skin disease with thickened patches of red skin, often with silvery scales (psoriasis), severe condition of the skin that causes red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body (erythema multiforme) Severe and possibly fatal peeling of the skin (Stevens-Johnson syndrome) Chronic disease of joints (spondyloarthropathy), disease in which the immune system attacks the glands that make moisture for the body, such as tears and saliva (Sjogren's syndrome), aching muscles, muscle tenderness of weakness, not caused by exercise (myopathy), inflammation of the muscles (myositis), stiffness in muscles and joints, muscle spasm (rhabdomyolysis), inflammation of the muscles causing pain or stiffness (polymyalgia rheumatica) Inflammation of the kidney
Chronické ochorenie kĺbov (spondylartropatia), ochorenie, pri ktorom imunitný systém napáda žľazy, ktoré zvlhčujú telo, ako sú slzné a slinné (Sjogrenov syndróm), bolesť svalov, citlivosť alebo zoslabnutie svalov, ktoré nie je spôsobené cvičením (myopatia), zápal svalov (myozitída), stuhnutosť svalov a kĺbov, svalové kŕče (rabdomyolýza), zápal svalov spôsobujúci bolesť alebo stuhnutosť (reumatická polymyalgia)
Baseline ECOG performance status was 0 (54%) or 1 (46%).
Východiskový výkonnostný stav podľa ECOG bol 0 (54
Among the patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in CA209067, 154/313 (49%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
U pacientov liečených nivolumabom v dávke 1 mg/kg v kombinácii s ipilimumabom v dávke 3 mg/kg v štúdii CA209067 malo 154/313 (49
Tumour PD-L1 expression was determined using the PD-L1 IHC 28-8 pharmDx assay.
IHC 28-8 pharmDx.
In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of nephritis or renal dysfunction was 8.8% (48/547).
U pacientov liečených nivolumabom v dávke 3 mg/kg v kombinácii s ipilimumabom v dávke 1 mg/kg pri RCC bola incidencia nefritídy alebo dysfunkcie obličiek 8,8
Docetaxel ──Δ─── Nivolumab 3 mg/kg (events: 190/292), median and 95% CI: 12.19 (9.66, 14.98) - - -- - - Docetaxel (events: 223/290), median and 95% CI: 9.36 (8.05, 10.68) The trial demonstrated a statistically significant improvement in OS for patients randomised to nivolumab as compared with docetaxel at the prespecified interim analysis when 413 events were observed (93% of the planned number of events for final analysis).
Nivolumab 3 mg/kg (udalosti: 190/292), medián a 95 % CI: 12,19 (9,66; 14,98) - - -- - - Docetaxel (udalosti: 223/290), medián a 95 % CI: 9,36 (8,05; 10,68)
Hazard ratio 98.52% CI p-value
Pomer rizika 98,52
Graft-versus-host disease.
Farmakoterapeutická skupina:
Not known tumour lysis syndromei Hepatobiliary disorders Common hepatitisc hepatitisc
Neznáme syndróm spôsobený rozpadom nádorui Poruchy pečene a žlčových ciest Časté hepatitídac hepatitídac
Survival benefit was observed regardless of whether patients had tumours that were designated PD-L1 negative or PDL1 positive (tumour membrane expression cut off of 1%, 5% or 10%).
Pozorovaný prínos OS bol zhodne preukázaný v podskupinách pacientov vrátane východiskového výkonnostného stavu ECOG, štádia M, metastáz v mozgu v anamnéze a východiskovej hladiny LDH. Prínos prežívania sa pozoroval bez ohľadu na to, či mali pacienti nádory, ktoré boli označené ako PD - L1 negatívne alebo PD - L1 pozitívne (expresia na membráne nádorovej bunky znížená o 5 % alebo 10 %).
Not known solid organ transplant rejectionh, sarcoidosish Endocrine disorders
Neznáme rejekcia transplantovaného solídneho orgánuh, sarkoidózah Poruchy endokrinného systému Časté hypotyreoidizmus, hypertyreoidizmus
PD-L1 Expression nivolumab investigator's choice OS by tumour PD-L1 expression Number of events (number of patients)
nivolumab voľba skúšajúceho OS pomocou expresie PD-L1 v nádore
Randomisation was stratified by tumour PD-L1 expression (≥ 5% vs. < 5%/indeterminate), and stage of disease per the AJCC staging system.
5 %/nestanovená) a stavu ochorenia podľa AJCC systému klasifikovania.
Nivolumab+ipilimumab vs ipilimumab (primary analysis) - HR (95% CI): 0.55 (0.45, 0.69); p-value: < 0.0001 Nivolumab vs ipilimumab (primary analysis) - HR (95% CI): 0.65 (0.53, 0.80); p-value: < 0.0001
Nivolumab+ipilimumab oproti ipilimumabu (primárna analýza) - HR (95 % CI): 0,55 (0,45; 0,69); phodnota: <
ipilimumab Median OS (95% CI)
ipilimumab Medián OS (95
Resolution occurred in 124 patients (93.9%) with a median time to resolution of 5.1 weeks (range: 0.1-106.9).
%) s mediánom času do vyriešenia 5,1 týždňa (rozsah: 0,1-106,9).
Unstratified Hazard Ratio (95% CI)
Nestratifikovaný pomer rizík (95
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of liver function test abnormalities was 29.5% (132/448).
U pacientov liečených nivolumabom v dávke 1 mg/kg v kombinácii s ipilimumabom v dávke 3 mg/kg pri melanóme bola incidencia abnormalít testov funkcie pečene 29,5
Resolution occurred in 132 patients (76.7%) with a median time to resolution of 5.9 weeks (range: 0.1-82.6+).
%) s mediánom času do vyriešenia 5,9 týždňa (rozsah: 0,1 - 82,6+).
Probability of Recurrence-Free Survival
Pravdepodobnosť prežívania bez rekurencie ochorenia
The majority of cases were Grade 1 in severity reported in 20.1% (518/2578) of patients.
Väčšina hlásených prípadov bola 1. stupňa závažnosti u 20,1
Nivolumab 3 mg/kg (events: 184/240), median and 95% CI: 7.72 (5.68,8.77) Investigator's choice (events: 105/121), median and 95% CI: 5.06 (4.04, 6.24)
Nivolumab 3 mg/kg (príhody: 184/240), medián a 95 % CI: 7,72 (5,68; 8,77)
Uncommon dehydration, metabolic acidosis Not known tumour lysis syndromei Hepatobiliary disorders Uncommon hepatitisc Rare cholestasis
Neznáme syndróm spôsobený rozpadom nádorui Poruchy pečene a žlčových ciest Menej časté hepatitídac Zriedkavé cholestáza
The majority of the patients had AJCC Stage IV disease (93%); 58% had M1c disease at study entry.
%); 58 % malo ochorenie v štádiu M1c.
Symptomatic Grade 2 or 3 hypothyroidism, hyperthyroidism, hypophysitis,
Symptomatický hypotyreoidizmus, hypertyreoidizmus, hypofyzitída 2. alebo 3. stupňa nedostatočnosť nadobličiek 2. stupňa, cukrovka 3. stupňa
Resolution occurred in 186 patients (89.4%) with a median time to resolution of 3.0 weeks (range: 0.1-159.4+).
%) s mediánom času do vyriešenia 3,0 týždne (rozsah: 0,1-159,4+).
Nivolumab monotherapy:
Monoterapia nivolumabom:
Progression Free Survival Events (%)
%) nežiaduce reakcie únava (48
In patients treated with nivolumab monotherapy, the incidence of nephritis or renal dysfunction was 2.8% (71/2578).
U pacientov liečených nivolumabom v monoterapii bola incidencia nefritídy alebo dysfunkcie obličiek 2,8
Hazard ratio 95% CI p-value
95 % CI p-hodnota p <
Randomisation was stratified by PD-L1 expression (≥ 5% vs. < 5% tumour cell membrane expression), BRAF status, and M stage per the American Joint Committee on Cancer (AJCC) staging system.
Štúdia zahŕňala dospelých pacientov, ktorí mali skóre výkonnostného stavu podľa ECOG 0 alebo 1, so štádiom IIIB/C alebo so štádiom IV podľa Amerického spoločného výboru pre rakovinu (AJCC, American Joint
NAME OF THE MEDICINAL PRODUCT OPDIVO 10 mg/mL concentrate for solution for infusion.
OPDIVO 10 mg/ml infúzny koncentrát.
Withhold dose(s) until symptoms resolve and management with corticosteroids is completec
Prerušte podávanie dávky (dávok), pokým príznaky neodznejú a nie je ukončená liečba kortikosteroidmic
Inflammation of the kidney, kidney failure (including abrupt loss of kidney function) Pain, chest pain
Zápal obličiek, zlyhanie obličiek (vrátane náhlej straty funkcie obličiek)
Resolution occurred in 140 patients (91.5%) with a median time to resolution of 2.4 weeks (range: 0.1-103.1+).
%) s mediánom času do vyriešenia 2,4 týždňa (rozsah: 0,1-103,1+).
Hazard ratioa 99.1% CI p-valueb,h Median (95% CI)
% CI p-hodnotab,h Medián (95
Subsequent systemic therapy was received by 31.8%, 44.3%, and 62.2% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively.
% s nivolumabom v monoterapii a 62,2 % v skupinách s ipilimumabom.
In patients treated with nivolumab monotherapy, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 5.2% for anaemia (all Grade 3), 1.0% for thrombocytopaenia, 1.0% for leucopoenia, 10.0% for lymphopaenia, 1.1% for neutropaenia, 2.1% for increased alkaline phosphatase, 2.7% for increased AST, 2.2% for increased ALT, 1.2% for increased total bilirubin, 0.9% for increased creatinine, 3.8% for hyperglycaemia, 1.0% for hypoglycaemia, 3.5% for increased amylase, 7.9% for increased lipase, 6.4% for hyponatraemia, 1.8% for hyperkalaemia, 1.5% for hypokalaemia, 1.2% for hypercalcaemia, 0.7% for hypermagnesaemia, 0.5% for hypomagnesaemia, 0.7% for hypocalcaemia, and 0.1% for hypernatraemia.
U pacientov liečených nivolumabom v monoterapii bol podiel pacientov, u ktorých došlo k posunu laboratórnych abnormalít do 3. alebo 4. stupňa od východiskového stavu, nasledovný: 5,2 % z dôvodu anémie (všetky 3. stupňa), 1,0 % z dôvodu trombocytopénie, 1,0 % z dôvodu leukopénie, 10,0 % z dôvodu lymfopénie, 1,1
n ipilimumab Median OS (95% CI)
+ ipilimumab Medián OS (95
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 2.8% for anaemia (all Grade 3), 1.2% for thrombocytopaenia, 0.5% for leucopoenia, 6.7% for lymphopaenia, 0.7% for neutropaenia, 4.3% for increased alkaline phosphatase, 12.4% for increased AST, 15.3% for increased ALT, 1.2% for increased total bilirubin, 2.4% for increased creatinine, 5.3% for hyperglycaemia, 8.7% for increased amylase, 19.5% for increased lipase, 1.2% for hypocalcaemia, 0.2% each for hypernatraemia and hypercalcaemia, 0.5% for hyperkalemia, 0.3% for hypermagnesaemia, 4.8% for hypokalaemia, and 9.5% for hyponatraemia.
U pacientov liečených nivolumabom v dávke 3 mg/kg v kombinácii s ipilimumabom v dávke 1 mg/kg pri RCC bol podiel pacientov, u ktorých došlo k zhoršeniu laboratórnych abnormalít do 3. alebo 4. stupňa od východiskového stavu nasledovný: 3,0 % z dôvodu anémie (všetky 3. stupňa), 0,7 % z dôvodu trombocytopénie, 0,6 % z dôvodu leukopénie, 5,1
Progression-free survival Rate (95% CI) at 60 months
Prežívanie bez progresie Miera (95 % CI) po 12 mesiacoch
Overall survivalc Events Hazard ratioa (95% CI) Rate (95% CI) at 24 months Confirmed objective response (95% CI) Median duration of response Months (range) Progression-free survival Rate (95% CI) at 24 months
Výskyt (95 % CI) po 6 mesiacoch Výskyt (95 % CI) po 12 mesiacoch Potvrdená objektívna odpoveďc (95 %
Nivolumab+Ipilimumab (events: 77/155), median and 95% CI: 12.35 (8.74, N.A.) ──Δ─── Nivolumab (events: 86/171), median and 95% CI: 14.00 (7.03, N.A.) Ipilimumab (events: 129/164), median and 95% CI: 3.91 (2.83, 4.17)
Nivolumab+Ipilimumab (udalosti: 77/155), medián a 95 % CI: 12,35 (8,74; N.A.)
Grade 2, Grade 3, and Grade 4 cases were reported in 4.4% (24/547), 0.7% (4/547), and 0.5% (3/547) of patients, respectively.
% (4/547) a 4. stupňa u 0,5
Figure 11: Kaplan-Meier curves of OS in intermediate/poor risk patients (CA209214)
OS u pacientov so stredným/s vysokým rizikom (CA209214)
1 vial
1. typu)
The Kaplan-Meier curves for OS are shown in Figure 10.
OS sú uvedené na obrázku 10.
The Kaplan-Meier curves for OS are shown in Figure 12.
OS sú uvedené na obrázku 12.
Nivolumab treatment resulted in rapid resolution of B-symptoms in 88.7% (47/53) of the patients, with a median time to resolution of 1.9 months.
Liečba nivolumabom mala za následok rýchle vyriešenie B-symptómov u 88,7
Grade 2, Grade 3, and Grade 4 cases were reported in 0.5% (3/547), 2.4% (13/547), and 0.4% (2/547) of patients, respectively.
Prípady 2. stupňa sa hlásili u 0,5 % (3/547),
Bristol-Myers Squibb A.E. Τηλ: + 357 800 92666
Τηλ: + 357 800 92666
The Kaplan-Meier curves for OS are shown in Figure 9.
OS sú uvedené na obrázku 9.
Resolution occurred in 428 patients (63.8%) with a median time to resolution of 17.1 weeks
K vyriešeniu došlo u 428 pacientov (63,8
Tumour PD-L1 expression levels were balanced between the two treatment groups (nivolumab vs. investigator's choice) at each of the predefined tumour PD-L1 expression levels of ≥ 1% (55% vs. 62%), ≥ 5% (34% vs. 43%), or ≥ 10% (27% vs.
Hladiny expresie PD-L1 v nádore boli medzi dvoma liečenými skupinami (nivolumab oproti voľbe skúšajúceho) vyrovnané pri všetkých preddefinovaných hladinách expresie PD-L1 v nádore ≥ 1
Grade 4 rash
4. stupňa hypertyreoidizmus
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of nephritis or renal dysfunction was 5.1% (23/448).
U pacientov liečených nivolumabom v dávke 1 mg/kg v kombinácii s ipilimumabom v dávke 3 mg/kg pri melanóme bola incidencia nefritídy alebo dysfunkcie obličiek 5,1
The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed ORR and PFS.
Meranými kľúčovými sekundárnymi koncovými ukazovateľmi účinnosti boli ORR a PFS hodnotené skúšajúcim.
Very common (may affect more than 1 in 10 people) Underactive thyroid gland (which can cause tiredness or weight gain),overactive thyroid gland (which can cause rapid heart rate, sweating and weight loss) Decreased appetite
Nedostatočná funkcia štítnej žľazy (ktorá môže spôsobiť únavu alebo prírastok telesnej hmotnosti), nadmerná funkcia štítnej žľazy (ktorá môže spôsobiť rýchly tep srdca, potenie a úbytok telesnej hmotnosti)
The majority of cases were Grade 1 or 2 in severity reported in 3.5% (91/2578) and 1.2% (32/2578) of patients respectively.
% (91/2 578) alebo 2. stupňa u 1,2 % (32/2 578) pacientov.
The observed OS benefit was consistently demonstrated across subgroups of patients including baseline ECOG performance status, M stage, history of brain metastases, and baseline LDH level.
Prínos RFS bol zhodne preukázaný v podskupinách vrátane expresie PD-L1 v nádore, stavu BRAF a štádia ochorenia.
The primary efficacy population included those intermediate/poor risk patients with at least 1 or more of 6 prognostic risk factors as per the International Metastatic RCC Database Consortium (IMDC) criteria (less than one year from time of initial renal cell carcinoma diagnosis to randomisation, Karnofsky performance status <80%, haemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dL, platelet count greater than the upper limit of normal, and absolute neutrophil count greater than the upper limit of normal).
Populácia s primárnou účinnosťou zahŕňala pacientov so stredným/s vysokým rizikom s minimálne 1 alebo viacerými zo 6 prognostických rizikových faktorov podľa kritérií medzinárodného združenia IMDC (IMDC, International Metastatic RCC
All were considered not related to nivolumab by investigators except arrhythmia (atrial fibrillation, tachycardia and ventricular arrhythmia).
Okrem arytmií (atriálna fibrilácia, tachykardia a ventrikulárna arytmia) boli všetky nežiaduce udalosti posúdené skúšajúcimi ako nesúvisiace s nivolumabom.
Among the patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in CA209214, 169/547 (31%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
U pacientov liečených nivolumabom v dávke 3 mg/kg v kombinácii s ipilimumabom v dávke 1 mg/kg v štúdii CA209214 malo 169/547 (31
The study included patients (18 years or older) who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen and an ECOG performance status score of 0 or 1.
Do štúdie boli zaradení pacienti (18 roční alebo starší), ktorí mali progresiu ochorenia počas alebo po jednom predchádzajúcom chemoterapeutickom režime založenom na platinovom
Resolution occurred in 296 patients (88.1%) with a median time to resolution of 2.1 weeks (range: 0.1-124.4+).
%) s mediánom času do vyriešenia 2,1 týždňa (rozsah: 0,1 - 124,4+).
Withhold dose(s)
Stabilizácia ochorenia (SD)
It includes 243 patients who had ASCT; Cohort A included 63 (26%) patients who were brentuximab vedotin naïve; Cohort B included 80 (33%) patients who had received brentuximab vedotin after ASCT failure; and Cohort C included 100 (41%) patients who had received brentuximab vedotin before and/or after ASCT out of which 33 (14%) patients received brentuximab vedotin only prior to ASCT.
%) pacientov, ktorí sa predtým neliečili brentuximab vedotinom; Kohorta B zahŕňala 80 (33
Nivolumab+Ipilimumab (events: 59/123), median and 95% CI: N.A. (26.45, N.A.) ──Δ─── Nivolumab (events: 71/117), median and 95% CI: 23.46 months (13.01, 36.53) Ipilimumab (events: 77/113), median and 95% CI: 18.56 months (13.67, 23.20)
Ipilimumab (udalosti: 77/113), medián a 95 % CI: 18,56 mesiacov (13,67; 23,20)
The PFS HRs for nivolumab vs. chemotherapy were 1.58 (95% CI: 0.87, 2.87) for BRAF mutationpositive patients and 0.82 (95% CI: 0.60, 1.12) for BRAF wild-type patients.
u pacientov s pozitívnou mutáciou BRAF a 0,82 (95 % CI: 0,60; 1,12) u pacientov s divokým typom BRAF.
A total of 272 patients were randomised to receive either nivolumab 3 mg/kg (n = 135) administered intravenously over 60 minutes every 2 weeks or docetaxel (n = 137) 75 mg/m2 every 3 weeks.
Celkovo bolo randomizovaných 272 pacientov, buď na intravenózne podávanie nivolumabu v dávke 3 mg/kg počas 60 minút každé 2 týždne (n =
Not known pericardial disordersj Vascular disorders Common hypertension hypertension
Poruchy ciev Časté hypertenzia hypertenzia
Headache
Vyrážka
Grade 2, Grade 3, and Grade 4 cases were reported in 4.7% (21/448), 1.1% (5/448), and 0.2% (1/448) of patients, respectively.
Prípady 2. stupňa sa hlásili u 4,7 % (21/448),
Grade 2, Grade 3, and Grade 4 cases were reported in 1.6% (7/448), 0.9% (4/448), and 0.7% (3/448) of patients, respectively.
2. stupňa, 3. stupňa a 4. stupňa sa vyskytla u 1,6 % (7/448), 1,3
The improvement in OS was similar between nivolumab in combination with ipilimumab and nivolumab monotherapy in patients with high tumour PD-L1 expression (PD-L1 ≥ 1%).
Pri nivolumabe v kombinácii s ipilimumabom pri expresii PD-L1 v nádore ≥ 1
OPDIVO infusion
Zatvorená injekčná liekovka
Among all randomised patients, the ORR was 27.2% (95% CI: 22.0, 32.9) in the nivolumab group and 9.8% (95% CI: 5.3, 16.1) in the chemotherapy group.
% (95 % CI: 22,0; 32,9) a v skupine s chemoterapiou 9,8
Common hypothyroidism, hyperthyroidism
Menej časté dehydratácia, metabolická acidóza
In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of diarrhoea or colitis was 28.2% (154/547).
U pacientov liečených nivolumabom v dávke 3 mg/kg v kombinácii s ipilimumabom v dávke 1 mg/kg pri RCC bola incidencia hnačky alebo kolitídy 28,2
Range
Randomizovaná