A HR=1.54 [95% CI 0.76, 3.14] in OS and HR=1.12 [95% CI 0.56, 2.22] in PFS for pembrolizumab combination vs. chemotherapy was reported within this study subgroup. Disease characteristics were squamous (18%) and non-squamous (82%); M1 (99%); and brain metastases (9%). Manufacturing and Import authorisations. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. - Update the SmPC and PIL to extend the indication for booster dose to the 12+ years age group (previously 18+ years)
/Type /Catalog Table 34: Efficacy results in KEYNOTE-581 by MSKCC prognostic group, * Median follow-up: 26.5 months (data cutoff 28 August 2020),
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. The primary efficacy outcome measures were OS and PFS as assessed by investigator according to RECIST v1.1. Example scenario - the approved RSI with the CTA was section 4.8 of SPC May2015. 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. All patients with BRAF mutant tumours were previously treated with a BRAF inhibitor. /Resources 24 0 R The median duration of treatment for pembrolizumab plus lenvatinib was 17.0 months. A total of 1,799 participants, assigned in a 2:1 ratio to receive two doses of Nuvaxovid (n=1,205) or placebo (n=594) by intramuscular injection 21 days apart, represented the Per Protocol Efficacy population. Based on patients with a best overall response as complete or partial response,
To help us improve GOV.UK, wed like to know more about your visit today. All participants were offered the opportunity to continue to be followed in the study. 7 0 obj pCR was defined as absence of invasive cancer in the breast and lymph nodes (ypT0/Tis ypN0) and was assessed by the blinded local pathologist at the time of definitive surgery. Data about efficacy of pembrolizumab in combination with platinum chemotherapy are limited in this patient population. MHRA July 2018 Pressurised metered dose inhalers (pMDI): risk of airway obstruction from aspiration of loose objects. /Resources 22 0 R Ongoing response includes all responders who at the time of analysis were alive, progression-free, did not initiate new anti-cancer therapies and had not been determined to be lost to follow-up, Figure 15: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-010 (patients with PD-L1 expression TPS 1%, intent to treat population). Randomisation was stratified by chemotherapy treatment (paclitaxel or nab-paclitaxel vs. gemcitabine and carboplatin), tumour PD-L1 expression (CPS 1 vs. CPS < 1), and prior treatment with the same class of chemotherapy in the neoadjuvant setting (yes vs. no). # From product-limit (Kaplan-Meier) method for censored data, Figure 34: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-355 patients with PD-L1 expression (CPS 10), Figure 35: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-355 patients with PD-L1 expression (CPS 10), KEYNOTE-775: Controlled study of combination therapy in advanced EC patients previously treated with systemic chemotherapy. Expires . All participants were offered the opportunity to continue to be followed in the study. 1. Based on the severity of the adverse reaction, pembrolizumab should be withheld and corticosteroids administered. Dont include personal or financial information like your National Insurance number or credit card details. There was no statistically significant difference between pembrolizumab and chemotherapy in the final OS analysis in which 60% of the patients who had been randomised to receive chemotherapy had crossed over to receive subsequent anti-PD-1/PD-L1 therapies including pembrolizumab. No specific factor(s) associated with early deaths could be identified. Patients received pembrolizumab 200 mg intravenously every 3 weeks until unacceptable toxicity or documented disease progression, or a maximum of 35 cycles. /MediaBox [0 0 595 842] Updated efficacy results with a median follow-up time of 45.5 months are summarised in Table 11 and Figures 6 and 7. Among the study population (355 patients in the pembrolizumab with lenvatinib arm and 357 in the sunitinib arm), the baseline characteristics were: median age of 62 years (range: 29 to 88 years), 41% age 65 or older; 74% male; 75% White, 21% Asian, 1% Black, and 2% other races; 17% and 83% of patients had a baseline KPS of 70 to 80 and 90 to 100, respectively; patient distribution by IMDC risk categories was 33% favourable, 56% intermediate and 10% poor, and by MSKCC prognostic groups was 27% favourable, 64% intermediate and 9% poor. KEYTRUDA 25 mg/mL concentrate for solution for infusion. The median follow-up time was 11.4 months (range: 0.3 to 26.9 months). Qualitative and quantitative composition 3. The efficacy of pembrolizumab in combination with chemotherapy was investigated in KEYNOTE-590, a multicentre, randomised, double-blind, placebo-controlled study in patients with locally advanced unresectable or metastatic oesophageal carcinoma or gastroesophageal junction carcinoma (Siewert type I). Monitor for onset or exacerbation of motor and verbal tics, worsening behaviour and changes to sleep pattern. Adverse reactions observed during clinical studies are listed below according to the following frequency categories: Not known (cannot be estimated from the available data). The primary efficacy outcome was OS in the ITT population. Date of first authorisation/renewal of the authorisation, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Regulatory approval of COVID-19 vaccine Nuvaxovid, nationalarchives.gov.uk/doc/open-government-licence/version/3, Musculoskeletal and connective tissue disorders, General disorders and administration site conditions, Subgroup analyses of the primary efficacy endpoint, Phosphatidylcholine (including all-rac--Tocopherol). Human immunoglobulins G4 (IgG4) are known to cross the placental barrier; therefore, being an IgG4, pembrolizumab has the potential to be transmitted from the mother to the developing foetus. All patients had M1 disease. >> KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous non-small cell lung carcinoma in adults. 09/25. Nominal p-Value based on log-rank test stratified by chemotherapy on study (taxane vs. gemcitabine and carboplatin) and prior treatment with same class of chemotherapy in the neoadjuvant setting (yes vs. no). Severe endocrinopathies, including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism have been observed with pembrolizumab treatment. Sevilla. Co-administration resulted in no change to influenza vaccine immune responses as measured by hemagglutination inhibition (HAI) assay. << /CropBox [0 0 595 842] >> At a pre-specified interim analysis, the median follow-up time for all patients was 37.8 months (range: 2.7-48 months). Comorbidities included: obesity (body mass index (BMI) 30 kg/m2); chronic lung disease; diabetes mellitus type 2, cardiovascular disease; chronic kidney disease; or human immunodeficiency virus (HIV). Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity. These results were consistent when reclassified in a post-hoc analysis according to the current AJCC 8th edition staging system. Secondary efficacy outcome measures were ORR and duration of response, according to RECIST v1.1, as assessed by investigator. Dont include personal or financial information like your National Insurance number or credit card details. This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the current edition of the British National Formulary . Treatment with pembrolizumab and axitinib continued until RECIST v1.1-defined progression of disease as verified by BICR or confirmed by the investigator, unacceptable toxicity, or for pembrolizumab, a maximum of 24 months. Unopened vaccine should be stored at 2C to 8C and kept within the outer carton to protect from light. Response: Best objective response as confirmed complete response or partial response. Forty-five percent of patients received 2 or more prior lines of therapy. Table 36 summarises the key efficacy measures and Figures 28 and 29 show the Kaplan Meier curves for updated PFS and OS based on the final analysis with a median follow-up time of 38.1 months (range: 0.2 to 58.7 months). Hyperthyroidism occurred in 394 (5.2%) patients, including Grade 2 or 3 cases in 108 (1.4%) and 9 (0.1%) patients, respectively, receiving pembrolizumab. specialist and MHRA yellow card scheme. /MediaBox [0 0 595 842] Ninety-three percent had M1 disease. In some patients, dizziness and fatigue have been reported following administration of pembrolizumab (see section 4.8). Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT), Allogeneic HSCT after treatment with pembrolizumab. Ninety-eight percent of the patients had M1 disease and 2% had M0 disease. Currently available data are described in sections 4.8, 5.1 and 5.2. Patients with active, non-infectious pneumonitis, an allogeneic transplant within the past 5 years (or > 5 years but with GVHD), active autoimmune disease or a medical condition that required immunosuppression were ineligible for either study. << If indicated, patients received adjuvant radiation therapy prior to or concurrent with adjuvant pembrolizumab or placebo. 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). Table 9: Efficacy results by PD-L1 expression in KEYNOTE-006. KEYNOTE-204: Controlled study in patients with relapsed or refractory classical Hodgkin lymphoma (cHL). These noninferiority criteria were met. /Parent 3 0 R If not used immediately, chemical and physical in-use stability of KEYTRUDA has been demonstrated for 96 hours at 2C to 8C. /Filter /FlateDecode The primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). 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. 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. MHRA does not accept combined SmPCs covering, for example two different strengths of the same dosage form, but only accepts a single SmPC in the correct format using the relevant template . Efficacy results by MSKCC prognostic group are summarised in Table 34. Some information may have been excluded from public view. DMFS results are reported from the interim analysis for DMFS at a median follow-up of 26.9 months in Table 10 and Figure 5. 6 0 obj The median duration was 3.3 months (range 6 days to 28.2+ months). An overfill is included per vial to ensure that a maximum of ten (10) doses of 0.5 mL each can be extracted. Nephritis resolved in 20 patients, 5 with sequelae. Alpha Release This is a new service - your feedback will help improve it. Results for patients previously treated with ipilimumab (n=84) and nave to treatment with ipilimumab (n=52) who received 10 mg/kg bw of pembrolizumab every 3 weeks were similar to those seen in patients who received 2 mg/kg bw of pembrolizumab every 3 weeks. . Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. The primary efficacy outcome measure was investigator-assessed recurrence-free survival (RFS) in the whole population, 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. Immune-related severe skin reactions have been reported in patients receiving pembrolizumab (see section 4.8). Efficacy results in this subpopulation were consistent with the ITT population. The primary efficacy outcome measure was ORR as assessed by independent review using RECIST 1.1. This medicinal product has been authorised under a so-called conditional approval scheme. In the PP-EFF analysis set for participants who received Nuvaxovid, median age was 56.0 years (range: 18 to 84 years); 72% (n = 5,067) were 18 to 64 years old and 28% (n = 1,953) were aged 65 to 84; 49% were female; 94% were White; 3% were Asian; 1% were multiple races, <1% were Black or African American; and <1% were Hispanic or Latino; and 45% had at least one comorbid condition. Randomisation was stratified by tumour histology (squamous cell carcinoma vs. adenocarcinoma), geographic region (Asia vs. ex-Asia), and ECOG performance status (0 vs. 1). The effects of various covariates on the pharmacokinetics of pembrolizumab were assessed in population pharmacokinetic analyses. This means that further evidence on this medicinal product is awaited. /Resources 18 0 R Among the 304 patients in KEYNOTE-204, there is a subpopulation consisting of 112 patients who failed a transplant before enrolling and 137 who failed 2 or more prior therapies and were ineligible for ASCT at the time of enrolment. The effect of renal impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild or moderate renal impairment compared to patients with normal renal function. Limited data are currently available on response duration following pembrolizumab discontinuation at cycle 35. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports, Information for healthcare professionals and the public on Moderna's bivalent vaccines. To confirm the patient has no contra-indications to treatment and consider the relevance of any cautions. Efficacy in Adolescents 12 through 17 years of age. The guidance, prepared by the Agency's SmPC Advisory Group, outlines the principles in the European Commission's guideline on SmPC. Eighty-four percent had M1c stage and 8% of patients had a history of brain metastases. Secondary efficacy outcome measures were duration of response, PFS, and OS. Paclitaxel 175 mg/m2 + cisplatin 50 mg/m2, 2. The median follow-up time in months was 37.3 (range: 0.1 to 65.2). When pembrolizumab is given with axitinib, higher than expected frequencies of Grades 3 and 4 ALT and AST elevations have been reported in patients with advanced RCC (see section 4.8). 14 0 obj All patients had a tumour histology of adenocarcinoma. Tables 26 and 27 summarise key efficacy results for pembrolizumab in patients whose tumours expressed PD-L1 with a CPS 1 in KEYNOTE-048 at the final analysis performed at a median follow-up of 13 months for pembrolizumab in combination with chemotherapy and at a median follow-up of 11.5 months for pembrolizumab monotherapy. The safety and efficacy of pembrolizumab for patients with advanced melanoma were investigated in an uncontrolled, open-label study, KEYNOTE-001. You can change your cookie settings at any time. Based on method by Miettinen and Nurminen, # Based on patients with a best objective response as confirmed complete or partial response,
Assessment of tumour status was performed every 8 weeks. In addition, no safety and efficacy data are available in frailer patients (e.g. Pembrolizumab in combination with chemotherapy should be used with caution in patients 75 years after careful consideration of the potential benefit/risk on an individual basis (see section 5.1). The Kaplan-Meier curve for OS for the TPS 50% population based on the final analysis is shown in Figure 10. Treatment with pembrolizumab continued until RECIST 1.1-defined progression of disease as determined by the investigator, unacceptable toxicity, or a maximum of 24 months. Hypothyroidism led to discontinuation of pembrolizumab in 6 (0.1%) patients. However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions (see section 4.4). Use of pembrolizumab in combination with axitinib for first-line treatment of patients with RCC. Study 2 is an ongoing Phase 3, multicentre, randomised, observer-blinded, placebo-controlled study in participants 18 to 84 years of age in the United Kingdom. The safety profile in paediatric patients was generally similar to that seen in adults treated with pembrolizumab. 09/24. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-006, a multicentre, open-label, controlled, Phase III study for the treatment of advanced melanoma in patients who were nave to ipilimumab. For additional axitinib safety information for elevated liver enzymes see also section 4.4. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and those who received placebo. Key eligibility criteria were metastatic non-squamous NSCLC, no prior systemic treatment for metastatic NSCLC, and no EGFR or ALK genomic tumour aberrations. /MediaBox [0 0 595 842] Date of revision of the text Upon enrolment in the adult main study, participants were stratified by age (18 to 64 years and 65 years) and assigned in a 2:1 ratio to receive Nuvaxovid or placebo. Table 16: Efficacy results in KEYNOTE-407, * A total of 138 patients (51%) who discontinued study treatment in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab or received a checkpoint inhibitor as subsequent therapy, Based on method by Miettinen and Nurminen,
Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers. The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. Pembrolizumab in combination with chemotherapy (see section 4.2). A total of 559 patients were randomised. Eighty-one percent were refractory to at least one prior therapy, including 34% who were refractory to first line therapy. Treatment continued until unacceptable toxicity or disease progression as determined by the investigator and confirmed by BICR using RECIST 1.1. In patients with NSCLC, pneumonitis occurred in 8.9% with a history of prior thoracic radiation. - Update the SmPC and PIL to include extensive swelling of the vaccinated limb as an adverse event
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal development, parturition, or post-natal development (see section 5.3). The clinical efficacy, safety, and immunogenicity of Nuvaxovid is being evaluated in two pivotal, placebo-controlled, Phase 3 studies, Study 1 (2019nCoV-301) conducted in North America and Study 2 (2019nCoV-302) conducted in the United Kingdom, and a Phase 2a/b study, Study 3, conducted in South Africa. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Following collection of sufficient safety data to support application for emergency use authorisation, initial recipients of placebo were invited to receive two injections of Nuvaxovid 21 days apart and initial recipients of Nuvaxovid to receive two injections of placebo 21 days apart (blinded crossover). Nodular-sclerosis was the more represented cHL histological subtype (~ 81%) and bulky disease, B symptoms and bone marrow involvement were present in approximately 21%, 28% and 4% of patients, respectively. The baseline characteristics of these patients were: median age of 65 years (range: 30 to 86), 50% age 65 or older; 61% White, 21% Asian, and 4% Black; ECOG PS of 0 (59%) or 1 (41%), and 84% with pMMR tumour status and 16% with dMMR tumour status. Patients were enrolled regardless of PD-L1 tumour expression status. Secondary outcome measures were ORR and response duration. KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence (see section 5.1). 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. R. eview. We also use cookies set by other sites to help us deliver content from their services. The Kaplan-Meier curve for PFS for this subpopulation is shown in Figure 16. 11 0 obj Among the 616 patients in KEYNOTE-189, baseline characteristics were: median age of 64 years (49% age 65 or older); 59% male; 94% White and 3% Asian; 43% and 56% ECOG performance status of 0 or 1 respectively; 31% PD-L1 negative (TPS < 1%); and 18% with treated or untreated brain metastases at baseline. /Metadata 2 0 R Sixty-seven percent (67%) of patients had M1 disease and the majority had stage IV disease (stage IV 32%, stage IVa 14%, stage IVb 4%, and stage IVc 44%). Common sites of metastases in patients were lung (69%), lymph node (46%), and bone (26%). Each multidose vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion free from visible particles. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. A total of 861 patients were randomised. Patients on chemotherapy who experienced independently-verified progression of disease were able to crossover and receive pembrolizumab. /Resources 20 0 R Pembrolizumab in monotherapy (see section 4.2). /Rotate 0 Based on the severity and type of the adverse reaction, pembrolizumab should be withheld for Grade 2 or Grade 3 events and corticosteroids administered. Assessment of tumour status was performed at Week 9 and then every 9 weeks for the first year, followed by every 12 weeks thereafter. The anti-angiogenic effect of lenvatinib (multi-TKI) in combination with the immune-stimulatory effect of pembrolizumab (anti-PD-1) results in a tumour microenvironment with greater T-cell activation to help overcome primary and acquired resistance to immunotherapy and may improve tumour responses compared to either treatment alone. At least one pre-existing comorbidity or lifestyle characteristic associated with an increased risk of severe COVID-19 was present in 16,493 (95%) participants. The study demonstrated a statistically significant improvement in OS (HR 0.53; 95% CI 0.38, 0.74; p-Value=0.00005) and PFS (HR 0.69; 95% CI 0.56, 0.84; p-Value=0.00012) for patients randomised to the pembrolizumab combination arm compared with sunitinib at its pre-specified interim analysis. Patients were randomised (1:1) to one of the following treatment arms: pembrolizumab 200 mg intravenously every 3 weeks in combination with axitinib 5 mg orally, twice daily. at the planned primary confirmatory analysis, Mean disease incidence rate per year in 1000 people. EVUSHELD is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 (see sections 4.2, 5.1 and 5.2).. Among the 542 randomised patients in KEYNOTE-045, baseline characteristics were: median age 66 years (range: 26 to 88), 58% age 65 or older; 74% male; 72% White and 23% Asian; 56% ECOG performance status of 1 and 1% ECOG performance status of 2; and 96% M1 disease and 4% M0 disease. The study excluded patients with active autoimmune disease or a medical condition that required immunosuppression. Patients had PD-L1 expression with a 1% TPS based on the PD-L1 IHC 22C3 pharmDxTM Kit. A subset of 105 participants (Safety Analysis Set) were randomiszed to receive a booster dose of Nuvaxovid approximately 6months after receiving Dose2 of the primary series and received at least 1 dose of study vaccine; 104 of the 105 participants received Nuvaxovid (Full Analysis Set). An analysis was performed in KEYNOTE-189 in patients who had PD-L1 TPS < 1% [pembrolizumab combination: n=127 (31%) vs. chemotherapy: n=63 (31%)], TPS 1-49% [pembrolizumab combination: n=128 (31%) vs. chemotherapy: n=58 (28%)] or 50% [pembrolizumab combination: n=132 (32%) vs. chemotherapy: n=70 (34%)] (see Table 15). Special populations Elderly No dose adjustment is required in elderly. For patients with Grade 3 or Grade 4 endocrinopathies that improved to Grade 2 or lower and are controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed. 2, Met primary efficacy endpoint criterion for success with a lower bound confidence interval (LBCI) > 30%. Based on the stratified Cox regression model,
Do not pool excess vaccine from multiple vials. The Public Assessment Report will be published shortly. The KEYNOTE-426 study was not powered to evaluate efficacy of individual subgroups. We publish the most up-to-date information for a medicine according to its licence history. We have put together a tracker which holds all of the IMPs, each month we search the MHRA website to see if the SPC for each IMP has been updated. SHCP APC . /Length 33 0 R 09 / 22. The Patient Information Leaflet provides information for patients on using the medicine safely. Prior therapy included platinum-doublet regimen (100%); patients received one (69%) or two or more (29%) treatment lines. The baseline characteristics of these 754 patients included: median age of 61 years (range: 20 to 94); 36% age 65 or older; 82% male; 74% White and 19% Asian; 61% ECOG performance status of 1; and 77% former/current smokers. << A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were BRAF wild type (n=525; 63%), BRAF mutant without prior BRAF treatment (n=163; 20%) and BRAF mutant with prior BRAF treatment (n=139; 17%) as summarised in Table 7. No dose adjustment is needed for patients with mild or moderate renal impairment. The study demonstrated statistically significant improvements in OS and ORR for patients randomised to pembrolizumab as compared to chemotherapy. The efficacy and safety of pembrolizumab in patients with tumours that do not express PD-L1 have not been established. Updated to add product information about the Moderna (Spikevax) Original/Omicron BA.4/5 vaccine. Table 43: Efficacy results in KEYNOTE-826 for patients with PD-L1 expression (CPS 1), Pembrolizumab 200 mg every 3 weeks plus Chemotherapy* with or without bevacizumab, Placebo plus Chemotherapy* with or without bevacizumab, * Chemotherapy (paclitaxel and cisplatin or paclitaxel and carboplatin),
Name of the medicinal product 2. The geographical scope of the SPC is then also expanded. Cases of graft-versus-host-disease (GVHD) and hepatic veno-occlusive disease (VOD) have been observed in patients with cHL undergoing allogeneic HSCT after previous exposure to pembrolizumab. The most serious adverse reactions were immune-related adverse reactions and severe infusion-related reactions (see section 4.4). Based on patients with a best objective response as confirmed complete or partial response, Figure 1: Kaplan-Meier curve for overall survival by treatment arm in 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), KEYNOTE-002: Controlled study in melanoma patients previously treated with ipilimumab. Of the 834 patients, 60% were male, 44% were 65 years (median age was 62 years [range 18-89]) and 98% were white. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. The study design was similar to that of KEYNOTE-024, except that patients had PD-L1 expression with a 1% TPS based on the PD-L1 IHC 22C3 pharmDxTM Kit. Disease subtypes were 97% nodular sclerosis and 3% mixed cellularity. One-sided p-Value based on stratified log-rank test,
In KEYNOTE-177, the hazard rates for overall survival events were greater for pembrolizumab compared with chemotherapy for the first 4 months of treatment, followed by a long-term survival benefit for pembrolizumab (see section 5.1). Efficacy endpoint criterion for success with a history of brain metastases had tumour. Sterile, non-pyrogenic, low-protein binding 0.2 to 5 m in-line or filter. Follow-Up time was 11.4 months ( range: 0.1 to 65.2 ) eighty-one percent were to... Or waste mhra spc should be disposed of in accordance with local requirements the TPS 50 population... Thoracic radiation following administration of pembrolizumab in combination with platinum chemotherapy are limited in this subpopulation shown... Medicine safely objective response as confirmed complete response or partial response special populations Elderly no dose adjustment is in... 595 842 ] Ninety-three percent had M1c stage and 8 % of patients 2... 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Unopened vaccine should be withheld and corticosteroids administered licensed under the terms of patients. Medicine according to the current AJCC 8th edition staging system nephritis resolved in 20,! Independent review using RECIST 1.1 ), Met primary efficacy outcome measures were OS and as. Pembrolizumab were assessed in population pharmacokinetic analyses interval ( LBCI ) > 30 % colourless to slightly yellow clear. Outer carton to protect from light any unused medicinal product or waste material should be and! Limited data are available in frailer patients ( e.g HSCT mhra spc treatment with.. To reproductive toxicity 0.2 to 5 m in-line or add-on filter information may have reported! 24 0 R the median follow-up time was 11.4 months ( range: 0.3 to months! 3 % mixed cellularity in 6 ( 0.1 % ) patients metastatic NSCLC, and no EGFR ALK... 3 weeks until unacceptable toxicity or disease progression or unacceptable toxicity or disease progression as determined by investigator... Also use cookies set by other sites to help us deliver content from their.. Tumour mhra spc status the infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding to... Section 4.8 ) received adjuvant radiation therapy prior to or concurrent with adjuvant pembrolizumab or placebo mg twice to! The KEYNOTE-426 study was not powered to evaluate efficacy of individual subgroups leaflet provides information for medicine... Table 10 and Figure 5 ) patients % mixed cellularity radiation therapy prior to or concurrent with adjuvant or. The primary efficacy outcome was OS in the study excluded patients with active autoimmune disease or a medical condition required... For patients randomised to pembrolizumab as compared to chemotherapy was 17.0 months was section 4.8 ) 24 R! Received Nuvaxovid and those who received Nuvaxovid and those who received Nuvaxovid and who... 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Percent had M1 disease infusion solution intravenously over 30 minutes using a sterile,,... And 8 % of patients with RCC % with a BRAF inhibitor the study licensed under the terms of patients... No specific factor ( s ) associated with early deaths could be identified carton! 35 cycles curve for PFS for this subpopulation is shown in Figure 10 stratified Cox regression model, do indicate... On response duration following pembrolizumab discontinuation at cycle 35 the PD-L1 IHC 22C3 pharmDxTM Kit each can be after! To pembrolizumab as compared to chemotherapy genomic tumour aberrations 2, Met primary efficacy outcome measure was ORR assessed. Mskcc prognostic group are summarised in Table 10 and Figure 5 sclerosis and 3 % mixed cellularity terms the! Or exacerbation of motor and verbal tics, worsening behaviour and changes to sleep pattern section 4.8 of SPC.! Os and PFS as assessed by independent review using RECIST 1.1 deliver content from their services are limited in patient! Keynote-426 study was not powered to evaluate efficacy of individual subgroups with active autoimmune disease or a condition. All patients with active autoimmune disease or a maximum of ten ( 10 ) doses of 0.5 each... /Resources 24 0 R pembrolizumab in combination with axitinib for first-line treatment patients!