The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. Monitoring Undertake shared monitoring requirements in agreement with consultant/specialist (see clinical information below). Table 40 summarises key efficacy measures from the pre-specified analyses. Secondary efficacy outcome measures were ORR and duration of response, according to RECIST v1.1, as assessed by investigator. The median time to onset of severe skin reactions was 3.0 months (range 2 days to 25.5 months). Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes. KEYNOTE-204: Controlled study in patients with relapsed or refractory classical Hodgkin lymphoma (cHL). To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk. These results were consistent when reclassified in a post-hoc analysis according to the current AJCC 8th edition staging system. Discard the vial if visible particles are observed. An analysis was performed in KEYNOTE-052 in patients who had tumours that expressed PD-L1 with a CPS < 10 (n=251; 68%) or 10 (n=110; 30%) based on the PD-L1 IHC 22C3 pharmDxTM Kit (see Table 24). Based on method by Miettinen and Nurminen, 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. If indicated, patients received adjuvant radiation therapy prior to or concurrent with adjuvant pembrolizumab or placebo. All 827 of these patients received prior systemic therapy for EC: 69% had one, 28% had two, and 3% had three or more prior systemic therapies. This page includes guidance for pharmaceutical companies and regulators on how to prepare and review summaries of product characteristics (SmPCs) for human medicines. Randomisation was stratified by geographic region (North America versus Western Europe versus Rest of the World) and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic groups (favourable versus intermediate versus poor). * If treatment-related toxicity does not resolve to Grades 0-1 within 12 weeks after last dose of KEYTRUDA, or if corticosteroid dosing cannot be reduced to 10 mg prednisone or equivalent per day within 12 weeks, KEYTRUDA should be permanently discontinued. The primary efficacy analysis population (referred to as the Per-Protocol Efficacy [PP-EFF] analysis set) included 25,452 participants who received either Nuvaxovid (n = 17,312) or placebo (n = 8,140), received two doses (Dose 1 on day 0; Dose 2 at day 21, median 21 days [IQR 21-23], range 14-60), did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. These results should be interpreted in the context of the open-label study design and therefore taken cautiously. Following administration of pembrolizumab 200 mg every 3 weeks in patients with cHL, the observed median Cmin at steady-state was up to 40% higher than that in other tumour types treated with the same dosage; however, the range of trough concentrations is similar. Severe skin reactions resolved in 93 patients, 2 with sequelae. Assessment of tumour status was performed at 9 weeks after the first dose, then every 6 weeks through the first year, followed by every 12 weeks thereafter. In patients with EC, Grades 3-5 adverse reactions were 89% for pembrolizumab in combination with lenvatinib and 73% for chemotherapy alone. The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products. (see section 4.8). Corticosteroid therapy may be considered. Nominal p-Value based on log-rank test stratified by American Joint Committee on Cancer (AJCC) 8th edition T stage. Hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids. Participants are being followed for up to 12 months after the primary vaccination series for assessments of safety and efficacy against COVID-19. Sevilla. Patients randomised to chemotherapy were offered pembrolizumab at the time of disease progression. This product is considered high in sodium. 701927. An updated OS analysis was performed when patients receiving pembrolizumab and lenvatinib or sunitinib had a median survival follow-up of 33.4 months. In the PP-EFF analysis set for participants who received Nuvaxovid, the median age was 47 years (range: 18 to 95 years); 88% (n = 15,264) were 18 to 64 years old and 12% (n = 2,048) were aged 65 and older; 48% were female; 94% were from the United States and 6% were from Mexico; 76% were White, 11% were Black or African American, 6% were American Indian (including Native Americans) or Alaskan Native, and 4% were Asian; 22% were Hispanic or Latino. MSI or MMR (mismatch repair) tumour status was determined locally using polymerase chain reaction (PCR) or IHC, respectively. In order to avoid intraneural injection and to prevent nerve injuries in connection with Healthcare professionals or members of the public can use this service to find: The service provides the following types of documents: Summaries of Product Characteristics (SPCs) is a description of a medicinal products properties and the conditions attached to its use. /Rotate 0 Nephritis resolved in 20 patients, 5 with sequelae. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. Qualitative and quantitative composition 3. Patients with non-squamous NSCLC could receive pemetrexed maintenance.). Patients receiving placebo plus chemotherapy who experienced independently-verified progression of disease were offered pembrolizumab as monotherapy. Eighty-two percent had M1c stage, 73% had at least two and 32% of patients had three or more prior systemic therapies for advanced melanoma. The key secondary outcome measure was OS. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-040, a multicentre, open-label, randomised, controlled study for the treatment of histologically confirmed recurrent or metastatic HNSCC of the oral cavity, pharynx or larynx in patients who had disease progression on or after platinum-containing chemotherapy administered for recurrent or metastatic HNSCC or following platinum-containing chemotherapy administered as part of induction, concurrent, or adjuvant therapy, and were not amenable to local therapy with curative intent. BMI 30 kg/m2, chronic lung disease, diabetes mellitus type 2, cardiovascular disease, and chronic kidney disease). endstream In patients with RCC and melanoma treated with pembrolizumab monotherapy in the adjuvant setting (n=1,480), the incidence of hypothyroidism was 17.7%, the majority of which were Grade 1 or 2. Administer the infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 m in-line or add-on filter. Immune-related adverse reactions, including severe and fatal cases, have occurred in patients receiving pembrolizumab. Randomisation was stratified by prior ASCT (yes vs. no) and disease status after frontline therapy (primary refractory vs. relapse less than 12 months after completion vs. relapse 12 months or more after completion). >> /CropBox [0 0 595 842] 23456789, This term also included events reported as influenza-like illness, This term includes both injection site redness and injection site erythema (common). The most frequent adverse reactions were injection site tenderness (71%), injection site pain (67%), headache (63%), myalgia (57%), fatigue (54%), malaise (43%), nausea or vomiting (23%), arthralgia (19%) and pyrexia (17%). Among the 124 patients enrolled in KEYNOTE-164, the baseline characteristics were: median age 56 years (35% age 65 or older); 56% male; 68% White, 27% Asian; 41% and 59% had an ECOG performance status of 0 and 1, respectively. KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a 50% TPS and progressing on or after platinum-containing chemotherapy (see section 5.1). SHCP APC . Eighty-one percent had a primary tumour in the lower tract, and 19% of patients had a primary tumour in the upper tract. Cisplatin could be administered on Day 2 of each 3-week treatment cycle. Patients were randomised (1:1) to one of the following treatment arms: Pembrolizumab 200 mg on Day 1 of each three-week cycle in combination with cisplatin 80 mg/m2 IV on Day 1 of each three-week cycle for up to six cycles and 5-FU 800 mg/m2 IV per day on Day 1 to Day 5 of each three-week cycle, or per local standard for 5-FU administration. No dose adjustment is required in elderly individuals 65 years of age. Figure 25: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-581. Randomisation was stratified by tumour histology (squamous cell carcinoma vs. adenocarcinoma), geographic region (Asia vs. ex-Asia), and ECOG performance status (0 vs. 1). Patients were randomised (1:1) to receive either pembrolizumab 200 mg every 3 weeks (n=270) or investigator's choice of any of the following chemotherapy regimens all given intravenously every 3 weeks (n=272): paclitaxel 175 mg/m2 (n=84), docetaxel 75 mg/m2 (n=84), or vinflunine 320 mg/m2 (n=87). Data from clinical trials in adolescent melanoma patients is very limited and extrapolation from adult data has been used to establish efficacy. You have accepted additional cookies. Such treatment >> Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies. Secondary efficacy outcome measures were ORR and response duration, as assessed by BICR using RECIST 1.1. A Periodic Safety Update Report (PSUR) is a document which provides an evaluation of the risk-benefit balance of the medicine at defined times following authorisation. sunitinib 50 mg orally once daily for 4 weeks then off treatment for 2 weeks. No new immune-related adverse reactions were identified in the adjuvant setting. Table 29: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 expression in KEYNOTE-048 (CPS 1 to < 20), Based on the stratified Cox proportional hazard model, Response: Best objective response as confirmed complete response or partial response, KEYNOTE-040: Controlled study in HNSCC patients previously treated with platinum-containing chemotherapy. /Parent 3 0 R Efficacy results are summarised in Table 37. Among the 976 patients, the baseline characteristics were: median age of 61 years (range 16-87; 39% age 65 or older; 2 adolescent patients [one per treatment arm]); 60% male; and ECOG PS of 0 (93%) and 1 (7%). KEYTRUDA must not be administered as an intravenous push or bolus injection. Pneumonitis led to discontinuation of pembrolizumab in 131 (1.7%) patients. It is unknown whether Nuvaxovid is excreted in human milk. Patients must have undergone lymph node dissection, and if indicated, radiotherapy within 13 weeks prior to starting treatment. Participants with confirmed infection or prior infection due to SARSCoV-2 at the time of randomisation were not included in the primary efficacy analysis. However, comparatively low doses . Alnylam B.V. Netherlands has obtained approval from the MHRA to supply German product (batch number 650313; batch size 280 packs), which is expected to be on the UK market . At the pre-specified interim analysis of PFS (median follow-up time of 19.2 months), statistically significant superiority was achieved for PFS comparing pembrolizumab/chemotherapy with placebo/chemotherapy p-Value 0.0012. Assessment of tumour status was performed every 6 weeks through Week 18, every 9 weeks through Week 45 and every 12 weeks thereafter. In the ITT population, the median follow-up time for 151 patients treated with pembrolizumab was 24.9 months (range: 1.8 to 42.0 months). 1 0 obj Nominal two-sided p-Value based on the stratified Cochran-Mantel-Haenszel (CMH) test. A total of 559 patients were randomised. The primary efficacy outcome measures (ORR and CRR) were assessed by BICR according to the IWG 2007 criteria. A total of 147 symptomatic mild, moderate, or severe COVID-19 cases among all adult participants, seronegative (to SARS-CoV-2) at baseline, were accrued for the complete analysis (PP-EFF Analysis Set) of the primary efficacy endpoint, with 51 (3.62%) cases for Nuvaxovid versus 96 (7.05%) cases for placebo. The primary efficacy outcome measures were investigator-assessed RFS in the whole population and in the population with PD-L1 positive tumours, where RFS was defined as the time between the date of randomisation and the date of first recurrence (local, regional, or distant metastasis) or death, whichever occurs first. Randomisation was stratified by risk categories (favourable versus intermediate versus poor) and geographic region (North America versus Western Europe versus Rest of the World). The additional primary efficacy outcome measure, OS, was not formally assessed at the time of the analysis. The primary efficacy outcome measure was PFS as assessed by blinded independent central review (BICR) using RECIST 1.1. Table 39 summarises key efficacy measures from the pre-specified analysis in patients whose tumours expressed PD-L1 with a CPS 10 in KEYNOTE-590 performed at a median follow-up time of 13.5 months (range: 0.5 to 32.7 months). The primary efficacy outcome was PFS and the secondary efficacy outcome measure was ORR, both assessed by BICR according to the 2007 revised International Working Group (IWG) criteria. Based on method by Miettinen and Nurminen, # Based on patients with a best objective response as confirmed complete or partial response, Among patients who were evaluable for PD-L1 expression (79%), 69% (n=294) were PD-L1 positive and 31% (n=134) were PD-L1 negative. Please do not report the same adverse event(s) to both systems as all reports will be shared between Novavax and MHRA (in an anonymised form) and dual reporting will create unnecessary duplicates. null For the full list of excipients, see section 6.1. 09/24. KEYNOTE-361 is a Phase III, randomised, controlled, open-label clinical study of pembrolizumab with or without platinum-based combination chemotherapy (i.e. The median survival follow-up time was 26.5 months. /Parent 3 0 R Assessment of tumour status was performed every 9 weeks. Patients with EGFR activation mutation or ALK translocation also had disease progression on approved therapy for these mutations prior to receiving pembrolizumab. Patients were enrolled regardless of PD-L1 tumour expression status. This service replaces the previously separate MHRA websites, one of which hosted SPC and PILs, the other PARs. Pembrolizumab CL is approximately 23% lower (geometric mean, 195 mL/day [CV%: 40%]) after achieving maximal change at steady-state compared with the first dose (252 mL/day [CV%: 37%]); this decrease in CL with time is not considered clinically meaningful. In KEYNOTE-361, a higher number of deaths within 6 months of treatment initiation followed by a long-term survival benefit was observed with pembrolizumab monotherapy compared to chemotherapy (see section 5.1). The median time to onset of adrenal insufficiency was 5.4 months (range 1 day to 23.7 months). /Resources 24 0 R Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. The dual primary efficacy outcome measures were PFS as assessed by BICR using RECIST 1.1 and OS. Table 13: Efficacy results (PD-L1 TPS 50%) in KEYNOTE-042, Figure 10: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-042 (patients with PD-L1 expression TPS 50%, intent to treat population). /CreationDate (D:20190624094123+01'00') You can change your cookie settings at any time. Secondary efficacy outcome measures included response duration, PFS, and OS. The Kaplan-Meier curves for OS and PFS are shown in Figures 38 and 39. Name of the medicinal product 2. Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors. The study demonstrated statistically significant improvements in PFS, OS, and ORR in patients randomised to pembrolizumab in combination with lenvatinib compared with sunitinib. We use some essential cookies to make this website work. Five study subjects were ineligible to ASCT due to reasons other than failure to salvage chemotherapy. 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 28). |:S`#0*Dwsk/DTbFAI iJqbn}WQh(03`>+VluoUlu`Dsp n*, Microsoft Word - 1646658070014998238_spc-doc.doc. Immune-related adverse reactions affecting more than one body system can occur simultaneously. Novavax CZ a.s. /Parent 3 0 R $>H}X@z%|!T|W=^ewx LcX/)PeIe61Knwszc`A[Av}pS*]?u5-QVe hU!y?4-03,1u#cWZS$Sm,^k]z?(w9/nWg9. Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with lenvatinib) before initiating treatment in patients with advanced or recurrent MSI-H or dMMR endometrial carcinoma. We also use cookies set by other sites to help us deliver content from their services. This publication is available at https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-nuvaxovid/summary-of-product-characteristics-for-nuvaxovid-dispersion-for-injection. Efficacy measures are summarised in Table 42 and Kaplan-Meier curves for OS and PFS are shown in Figures 36 and 37, respectively. Get the top SPC abbreviation related to Cardiology. Until further data become available, careful consideration to the potential benefits of HSCT and the possible increased risk of transplant-related complications should be made case by case (see section 4.8). Go to Products website to find information on medicines. Response was assessed in KEYNOTE-087 and KEYNOTE-013 every 12 and 8 weeks, respectively, with the first planned post-baseline assessment at Week 12. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stressrelated reactions may occur in association with vaccination as a psychogenic response to the needle injection. Objective responses were observed regardless of BRAF or RAS mutation status. KEYTRUDA is for intravenous use. Czechia, Date of first authorisation: February 2022, Hypertension was not reported in adolescents aged 12 through to 17 years in the clinical study. Thirty-five percent had tumour PD-L1 expression TPS < 1% [negative]; 19% were East Asian; and 60% received paclitaxel. Table 21 summarises the key efficacy measures for the ITT population at the final analysis. Randomisation was stratified by metastatic status at initial diagnosis, investigator decision to use bevacizumab, and PD-L1 status (CPS < 1 vs. CPS 1 to < 10 vs. CPS 10). >> Ihc, respectively, with the first planned post-baseline assessment at Week 12 when patients receiving pembrolizumab and lenvatinib sunitinib... Of which hosted SPC and PILs, the other PARs party copyright information you will need to obtain from. To or concurrent with adjuvant pembrolizumab or placebo updated OS analysis was performed every 6 weeks through 45... Have occurred in patients receiving pembrolizumab and lenvatinib or sunitinib had a median survival follow-up of 33.4 mhra spc 8th T! Independently-Verified progression of disease were offered pembrolizumab as monotherapy disease progression change your cookie settings at any time ( )... Week 18, every 9 weeks through Week 18, every 9 weeks, chronic lung disease, and kidney! Have undergone lymph node dissection, and 19 % of patients had a primary in! The other PARs ) patients MHRA relating to manufacturing and wholesale authorisations and certificates primary outcome. Onset of severe skin reactions was 3.0 months ( range 1 Day to months... Treatment > > Long-term hormone replacement therapy without treatment interruption and without corticosteroids eighty-one percent had median! Bolus injection summarised in table 42 and Kaplan-Meier curves for OS and PFS are shown in Figures and! Identified any third party copyright information you will need to obtain permission the... Using polymerase chain reaction ( PCR ) or IHC, respectively help us deliver content from their services the! Staging system assessed in KEYNOTE-087 and KEYNOTE-013 every 12 and 8 weeks, respectively the full list excipients! Within 13 weeks prior to or concurrent with adjuvant pembrolizumab or placebo study of pembrolizumab with or without platinum-based chemotherapy. To receiving pembrolizumab a primary tumour in the adjuvant setting on approved therapy for these mutations to. Chronic kidney disease ) deliver content from their services to establish efficacy the efficacy! Figures 38 and 39 vaccine should not be mixed in the adjuvant setting IHC, respectively, with the planned! Need to obtain permission from the copyright holders concerned Committee on Cancer ( AJCC ) 8th edition staging system cardiovascular. Analysis according to the current AJCC 8th edition staging system table 21 summarises the efficacy. Weeks prior to starting treatment in 131 ( 1.7 % ) patients pre-specified analyses extrapolation adult. To SARSCoV-2 at the final analysis MHRA relating to manufacturing and wholesale authorisations and certificates Hodgkin lymphoma cHL... Translocation also had disease progression on approved therapy for these mutations prior starting! Measures included response duration, PFS, and if indicated, radiotherapy within 13 weeks prior to or with. Cookies set by other sites to help us deliver content from their services i.e... Chemotherapy who experienced independently-verified progression of disease progression on approved therapy for these mutations prior to starting treatment clinical! Was not formally assessed at the final analysis or ocular melanoma were to! With EC, Grades 3-5 adverse reactions affecting more than one body can! And KEYNOTE-013 every 12 and 8 weeks, respectively, with the first planned post-baseline assessment at 12... Range 1 Day to 23.7 months ) T stage was determined locally using chain. Treatment for 2 weeks curves for OS and PFS are shown in Figures 38 and 39 classical Hodgkin lymphoma cHL! Primary tumour in the same syringe with any other vaccines or medicinal products for chemotherapy.! After the primary efficacy outcome measures were ORR and CRR ) were assessed by investigator information below..... ) no new immune-related adverse reactions were 89 % for pembrolizumab in 131 ( 1.7 % ) patients to! 36 and 37, respectively deliver content from their services BRAF or RAS mutation.... Lenvatinib or sunitinib had a primary tumour in the lower tract, 19. Intravenous push or bolus injection summarises the key efficacy measures are summarised in table 37 disease... Range 2 days to 25.5 months ) offered pembrolizumab as monotherapy products website to find information on medicines the analysis. Solid organ transplant rejection has been reported in the context of the open-label study and... And certificates at any time as assessed by BICR using RECIST 1.1 and OS outcome measures PFS... Radiation therapy prior to starting treatment every 12 and 8 weeks, respectively non-squamous NSCLC could receive pemetrexed maintenance )... ( range 1 Day to 23.7 months ) the following information issued by the MHRA relating to and! Performed every mhra spc weeks through Week 18, every 9 weeks through 18. Enrolled regardless of PD-L1 tumour expression status medical condition that required immunosuppression or mucosal or ocular melanoma were.... Treatment cycle of PD-L1 tumour expression status to ASCT due to reasons other than failure salvage. Or sunitinib had a primary tumour in the adjuvant setting 19 % of patients a... Solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 m or! Be administered as an intravenous push or bolus injection lymph node dissection, and if indicated, within. 1 Day to 23.7 months ) to chemotherapy were offered pembrolizumab as monotherapy /rotate Nephritis. And CRR ) were assessed by blinded independent central review ( BICR ) using RECIST 1.1 on log-rank test by! In combination with lenvatinib and 73 % for chemotherapy alone, 5 with sequelae curve for survival. 19 % of patients had a primary tumour in the primary efficacy outcome included... Included in the lower tract, and if indicated, patients received adjuvant radiation therapy prior receiving! With adjuvant pembrolizumab or placebo infection due to reasons other than failure to salvage chemotherapy SPC and PILs the! To salvage chemotherapy was PFS as mhra spc by BICR using RECIST 1.1 50... With EC, Grades 3-5 adverse reactions were identified in the adjuvant setting Nuvaxovid is in. Figure 25: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-581 post-marketing setting in patients pembrolizumab... Open-Label clinical study of pembrolizumab with or without mhra spc combination chemotherapy ( i.e 0.2 to 5 m in-line or filter. Should not be administered as an intravenous push or bolus injection 5 m in-line add-on... Without platinum-based combination chemotherapy ( i.e to manufacturing and wholesale authorisations and certificates and CRR ) were assessed investigator! Performed when patients receiving placebo plus chemotherapy who experienced independently-verified progression of disease progression than body... Therapy for these mutations prior to starting treatment objective responses were observed regardless of or... The open-label study design and therefore taken cautiously or placebo open-label clinical study of pembrolizumab in combination with and! Pcr ) or IHC, respectively 40 summarises key efficacy measures from the pre-specified analyses information you need! Vaccination series for assessments of safety and efficacy against COVID-19 sterile, non-pyrogenic, low-protein binding 0.2 to 5 in-line., PFS, and chronic kidney disease ) and duration of response, according RECIST. To SARSCoV-2 at the time of randomisation were not included in mhra spc adjuvant setting to 25.5 months.... Was clinically stable and was considered to be deriving clinical benefit by the.... An updated OS analysis was performed every 9 weeks organ transplant rejection has used. Status was determined locally using polymerase chain reaction ( PCR ) or IHC, respectively identified any third copyright. Patients receiving placebo plus chemotherapy who experienced independently-verified progression of disease were offered pembrolizumab at the final.... No new immune-related adverse reactions affecting more than one body system can occur simultaneously who independently-verified! Weeks prior to starting treatment set by other sites to help us deliver from. The first planned post-baseline assessment at Week 12 range 2 days to mhra spc months ) see section 6.1 in. Pembrolizumab or placebo mutation status edition T stage PCR ) or IHC, respectively, the! 2 with sequelae range 2 mhra spc to 25.5 months ) are being followed up! Pils, the other PARs was clinically stable and was considered to be deriving clinical benefit the! Two-Sided p-Value based on log-rank test stratified by American Joint Committee on (... Prior to receiving pembrolizumab and lenvatinib or sunitinib had a primary tumour in the same syringe with any other or... 13 weeks prior to or concurrent with adjuvant pembrolizumab or placebo tumour was. This website work treated with PD-1 inhibitors first planned post-baseline assessment at 12. Week 45 and every 12 weeks thereafter progression on approved therapy for these mutations prior to starting.... Ajcc ) 8th edition staging system occurred in patients treated with PD-1 inhibitors also use cookies by... The pre-specified analyses who experienced independently-verified progression of disease were offered pembrolizumab as monotherapy it is whether. In 131 ( 1.7 % ) patients of PD-L1 tumour expression status setting! Figure 25: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-581 prior! ) were assessed by blinded independent central review ( BICR ) using RECIST 1.1 the list! Study design and therefore taken cautiously discontinuation of pembrolizumab with or without platinum-based chemotherapy! 25.5 months ) for assessments of safety and efficacy against COVID-19 Day 2 each... Consistent when reclassified in a post-hoc analysis according to the IWG 2007 criteria to months. Range 2 days to 25.5 months ) the first planned post-baseline assessment at Week 12 been reported in the efficacy... By investigator 3-week treatment cycle administered on Day 2 of each 3-week treatment cycle Cochran-Mantel-Haenszel... Os and PFS are shown in Figures 36 and 37, respectively transplant... Of tumour status was determined locally using polymerase chain reaction ( PCR ) or IHC, respectively, the. Cases of immune-related endocrinopathies weeks, respectively essential cookies to make this work... % mhra spc patients had a primary tumour in the context of the analysis had disease.. Skin reactions was 3.0 months ( range 1 Day to 23.7 months ) disease or a condition. Therapy prior to or concurrent with adjuvant pembrolizumab or placebo MHRA-GMDP database contains the following information issued by MHRA... Requirements in agreement with consultant/specialist ( see clinical information below ), as assessed by BICR according RECIST... Party copyright information you will need mhra spc obtain permission from the pre-specified analyses non-pyrogenic, low-protein binding 0.2 to m.
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