>> Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. This service replaces the previously separate MHRA websites, one of which hosted SPC and PILs, the other PARs. Pembrolizumab in monotherapy (see section 4.2). 4 0 obj The efficacy, safety, and immunogenicity of the vaccine has been assessed in a limited number of immunocompromised individuals. This page includes guidance for pharmaceutical companies and regulators on how to prepare and review summaries of product characteristics (SmPCs) for human medicines. It is not intended to provide practical advice on how to use this product. Colitis resolved in 130 patients, 2 with sequelae. Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving pembrolizumab (see section 4.8). 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). In an independent study (CoV-BOOST study, EudraCT 2021-002175-19) evaluating the use of a Nuvaxovid booster dose in individuals who had completed primary vaccination with an authorised mRNA COVID-19 vaccine or adenoviral vector COVID-19 vaccine, no new safety concerns were identified. << The primary efficacy outcome measures (ORR and CRR) were assessed by BICR according to the IWG 2007 criteria. For 143 patients treated with chemotherapy, 56% received mFOLFOX6 with or without bevacizumab or cetuximab and 44% received FOLFIRI with or without bevacizumab or cetuximab. Expires . Pneumonitis occurred more frequently in patients with a history of prior thoracic radiation (8.1%) than in patients who did not receive prior thoracic radiation (3.9%). Randomisation was stratified by risk categories (favourable versus intermediate versus poor) and geographic region (North America versus Western Europe versus Rest of the World). null Identification of the Alpha variant was based on S gene target failure by PCR. The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy. endobj The diluted solution must not be frozen. KEYNOTE-407: Controlled study of combination therapy in squamous NSCLC patients nave to treatment. A total of 1,019 adult patients were randomised (1:1) to receive pembrolizumab 200 mg every three weeks (n=514) or placebo (n=505), for up to one year until disease recurrence or unacceptable toxicity. It is used by healthcare professionals, such as doctors, nurses and pharmacists. 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. Hyperthyroidism led to discontinuation of pembrolizumab in 4 (0.1%) patients. Patients were randomised (2:1) to receive one of the following regimens: Pembrolizumab 200 mg with pemetrexed 500 mg/m2 and investigator's choice of cisplatin 75 mg/m2 or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by pembrolizumab 200 mg and pemetrexed 500 mg/m2 intravenously every 3 weeks (n=410), Placebo with pemetrexed 500 mg/m2 and investigator's choice of cisplatin 75 mg/m2 or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by placebo and pemetrexed 500 mg/m2 intravenously every 3 weeks (n=206). A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were BRAF wild type (n=414; 77%) or BRAF mutant with prior BRAF treatment (n=126; 23%) as summarised in Table 6. KEYTRUDA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express PD-L1 with a CPS 10 (see section 5.1). Alternatively, adverse events of concern in association with Nuvaxovid can be reported to Novavax at www.NovavaxCovidVaccine.com or via +44 020 3514 1838. PFS results were consistent across pre-specified subgroups, MSKCC prognostic groups and PD-L1 tumour expression status. Baseline characteristics and demographics were generally comparable between the pembrolizumab and placebo arms. % Patients with non-squamous NSCLC could receive pemetrexed maintenance.). Other high-risk characteristics included age 65 years (with or without comorbidities) or age <65 years with comorbidities and/or living or working conditions involving known frequent exposure to SARS-CoV-2 or to densely populated circumstances. Enrolment was completed in November 2020. Efficacy results are summarised in Table 37. The primary OS analysis was not adjusted to account for subsequent therapies. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Figure 26: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-581. Supply of this product will be subject to the same requirements in Great Britain and Northern Ireland. Secondary efficacy outcome measures were ORR and response duration, as assessed by BICR using RECIST 1.1. Dont worry we wont send you spam or share your email address with anyone. The baseline characteristics of these 249 patients were: median age 34 years (11% age 65 or older); 56% male; 80% White and 7% Asian and 58% and 41% with an ECOG performance status 0 and 1, respectively. Colitis has been reported in patients receiving pembrolizumab (see section 4.8). Microsoft Word - 1646658070014998238_spc-doc.doc This vaccine contains potassium, less than 1 mmol (39 mg) per dose, that is to say, essentially potassium-free. It is not. Table 14: Efficacy results in KEYNOTE-189, Pembrolizumab + Pemetrexed + Platinum Chemotherapy, Placebo + Pemetrexed + Platinum Chemotherapy, * A total of 113 patients (57%) who discontinued study treatment in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab or received a checkpoint inhibitor as subsequent therapy, The addition of the saponin-based Matrix-M adjuvant facilitates activation of the cells of the innate immune system, which enhances the magnitude of the S protein-specific immune response. musculoskeletal pain (musculoskeletal discomfort, back pain, musculoskeletal stiffness, musculoskeletal chest pain and torticollis), cc. Based on patients with a best objective response as confirmed complete or partial response, Well send you a link to a feedback form. Nuvaxovid may also be given as a booster dose in individuals 18 years of age and older following a primary series comprised of an mRNA vaccine or adenoviral vector vaccine (heterologous booster dose). Key secondary efficacy outcome measures included OS and ORR. << Limited data are currently available on response duration following pembrolizumab discontinuation at cycle 35. Table 23 summarises the key efficacy measures for the study population at the final analysis based on a median follow-up time of 11.4 months (range: 0.1, 41.2 months) for all patients. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. Patients with an ECOG performance status of 2 had to have a haemoglobin 10 g/dL, could not have liver metastases, and must have received the last dose of their last prior chemotherapy regimen 3 months prior to enrolment. It allows continued monitoring of the benefit/risk balance of the medicinal product. Pneumonitis resolved in 190 patients, 6 with sequelae. Pembrolizumab has not been studied in patients with severe renal impairment (see section 4.2). Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. << An overfill is included per vial to ensure that a maximum of ten (10) doses of 0.5 mL each can be extracted. A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were PD-L1 positive (n=671; 80%) vs. PD-L1 negative (n=150; 18%). 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). KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. endobj The patient will be provided with the patient alert card with each prescription. These results should be interpreted in the context of the open-label study design and therefore taken cautiously. The study excluded patients with autoimmune disease, a medical condition that required immunosuppression and patients with more than 2 prior lines of systemic chemotherapy for metastatic urothelial carcinoma. Unopened vaccine should be stored at 2C to 8C and kept within the outer carton to protect from light. Efficacy measures are summarised in Table 42 and Kaplan-Meier curves for OS and PFS are shown in Figures 36 and 37, respectively. KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with: - advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation; - unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. >> Table 25: Response to pembrolizumab 200 mg every 3 weeks or chemotherapy in patients with previously untreated urothelial carcinoma for whom carboplatin rather than cisplatin was selected by the investigator as the better choice of chemotherapy in KEYNOTE-361, Overall, there was a higher incidence of adverse reactions in younger age groups: the incidence of injection site tenderness, injection site pain, fatigue, myalgia, headache, malaise, arthralgia, and nausea or vomiting was higher in adults aged 18 to less than 65 years than in those aged 65 years and above. 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. Patients treated with KEYTRUDA must be given the patient alert card and be informed about the risks of KEYTRUDA (see also package leaflet). 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. In patients treated with pembrolizumab in combination with chemotherapy, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 44.0% for neutrophils decreased, 29.4% for leucocytes decreased, 26.9% for lymphocytes decreased, 22.1% for haemoglobin decreased, 13.2% for platelets decreased, 11.0% for sodium decreased, 7.7% for phosphate decreased, 6.8% for ALT increased, 6.8% for potassium decreased, 6.1% for glucose increased, 5.6% for AST increased, 3.5% for calcium decreased, 3.2% for potassium increased, 2.9% for creatinine increased, 2.2% for albumin decreased, 2.1% for alkaline phosphatase increased, 2.0% for bilirubin increased, 2.0% for calcium increased, 1.3% for prothrombin INR increased, 1.2% for glucose decreased and 0.5% for sodium increased. Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=344) or 10 mg/kg bw (n=346) every 3 weeks or docetaxel at a dose of 75 mg/m2 every 3 weeks (n=343) until disease progression or unacceptable toxicity. In patients with HNSCC treated with pembrolizumab as monotherapy (n=909), the incidence of hypothyroidism was 16.1% (all Grades) with 0.3% Grade 3. The efficacy of pembrolizumab was investigated in 355 patients with unresectable or metastatic MSI-H or dMMR non-CRC solid tumours enrolled in a multicentre, non-randomised, open-label Phase II study (KEYNOTE-158), including patients with endometrial, gastric, small intestine, or biliary cancer. As expected for an antibody, pembrolizumab does not bind to plasma proteins in a specific manner. Of these, 66 out of 95 (69%) were identified as the Alpha variant with the other cases classified as non-Alpha. 11 0 obj Forty-five percent of patients received 2 or more prior lines of therapy. Clinical particulars 5. Scientific guidelines with SmPC recommendations. << The licensing authority has deferred the obligation to submit the results of studies with Nuvaxovid in one or more subsets of the paediatric population in prevention of COVID-19, see section 4.2 for information on paediatric use. Tourist area. The median duration was 1.6 months (range 4 days to 43.1+ months). A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor if the outcome of the inspection confirms that the wholesale distributor complies with Good Distribution Practice. Participants with confirmed infection or prior infection due to SARSCoV-2 at the time of randomisation were not included in the primary efficacy analysis. Hepatitis occurred in 80 (1.0%) patients, including Grade 2, 3 or 4 cases in 12 (0.2%), 55 (0.7%) and 8 (0.1%) patients, respectively, receiving pembrolizumab. Patients without disease progression were treated for up to 24 months (up to 35 cycles). Of 32 patients in KEYNOTE-087 who proceeded to allogeneic HSCT after treatment with pembrolizumab, 16 patients reported acute GVHD and 7 patients reported chronic GVHD, two of which were fatal. The study excluded participants who were significantly immunocompromised due to immunodeficiency disease; active cancer on chemotherapy; received chronic immunosuppressive therapy or received immunoglobulin or blood-derived products within 90 days; were pregnant or breastfeeding; or had a history of laboratory-confirmed diagnosed COVID-19. Based on best response of stable disease or better, An independent, multicentre, randomised, controlled, Phase 2 investigator-initiated trial (CoV-BOOST, EudraCT 2021-002175-19) investigated the immunogenicity of a third dose (booster) in adults aged 30 years and older with no history of laboratory-confirmed SARS-CoV-2 infection. Among the 27 patients with small intestinal cancer, the baseline characteristics were: median age 58 years (range: 21 to 77); 33% age 65 or older; 63% male, 81% White, 11% Asian; and ECOG PS 0 (56%) and 1 (44%). The key efficacy results of pembrolizumab monotherapy in patients for whom carboplatin rather than cisplatin was selected by the investigator as the better choice of chemotherapy were consistent with KEYNOTE-052 results. Table 4 summarises key efficacy measures at the final analysis in patients previously treated with ipilimumab, and the Kaplan-Meier curve for PFS is shown in Figure 3. 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. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines. MHRA July 2018 Pressurised metered dose inhalers (pMDI): risk of airway obstruction from aspiration of loose objects. At a pre-specified interim analysis, the median follow-up time for all patients was 37.8 months (range: 2.7-48 months). Assessment of tumour status was performed every 6 weeks through Week 18, every 9 weeks through Week 45 and every 12 weeks thereafter. The recent introduction of a licensed product, advice for the MHRA regarding imported products and Area Prescribing Committee support has facilitated the participation of GPs in shared care. KEYNOTE-052: Open-label study in urothelial carcinoma patients ineligible for cisplatin-containing chemotherapy. This file may not be suitable for users of assistive technology. KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. SHCP APC . R. eview. Colitis occurred in 158 (2.1%) patients, including Grade 2, 3 or 4 cases in 49 (0.6%), 82 (1.1%) and 6 (0.1%) patients, respectively, receiving pembrolizumab. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. Table 18: Response to pembrolizumab 2 or 10 mg/kg bw every 3 weeks in previously treated patients with NSCLC in KEYNOTE-010, * Hazard ratio (pembrolizumab compared to docetaxel) based on the stratified Cox proportional hazard model, Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab. The frequencies included below and in Table 2 are based on all reported adverse drug reactions, regardless of the investigator assessment of causality. Clear to slightly opalescent, colourless to slightly yellow solution, pH 5.2 5.8. Patients were randomised (1:1:1) to receive pembrolizumab 10 mg/kg bw every 2 (n=279) or 3 weeks (n=277) or ipilimumab 3 mg/kg bw every 3 weeks (n=278). Patients should be monitored for changes in renal function, and other causes of renal dysfunction excluded. No new immune-related adverse reactions were identified in the adjuvant setting. Pembrolizumab should be withheld for Grade 3 until recovery to Grade 1 hyperthyroidism. Patients should be treated with KEYTRUDA until disease progression or unacceptable toxicity (and up to maximum duration of therapy if specified for an indication). A total of 559 patients were randomised. OS was not formally assessed at the time of this analysis. Disease subtypes were 81% nodular sclerosis, 11% mixed cellularity, 4% lymphocyte-rich and 2% lymphocyte-depleted. The efficacy and safety of pembrolizumab in patients with tumours that do not express PD-L1 have not been established. The efficacy of pembrolizumab in combination with paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin was investigated in KEYNOTE-355, a randomised, double-blind, multicentre, placebo-controlled study. Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected. Sixteen percent (16%) had disease progression following platinum-containing neoadjuvant or adjuvant chemotherapy, and 84% had received 1-2 prior systemic regimens for metastatic disease. At the time of the analysis, a total of 49,950 participants age 18 years and older received at least one dose of the two-dose primary series of Nuvaxovid (n=30,058) or placebo (n=19,892). /CropBox [0 0 595 842] The study demonstrated statistically significant improvements in OS and PFS for patients randomised to pembrolizumab in combination with chemotherapy with or without bevacizumab compared to placebo in combination with chemotherapy with or without bevacizumab at a pre-specified interim analysis in the overall population. The median follow-up time in months was 37.3 (range: 0.1 to 65.2). /Contents 19 0 R >> endobj The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1. Incidences of Grades 3-5 adverse reactions in patients with NSCLC were 67% for pembrolizumab combination therapy and 66% for chemotherapy alone, in patients with HNSCC were 85% for pembrolizumab combination therapy and 84% for chemotherapy plus cetuximab, in patients with oesophageal carcinoma were 86% for pembrolizumab combination therapy and 83% for chemotherapy alone, in patients with TNBC were 80% for pembrolizumab combination therapy and 77% for chemotherapy alone, and in patients with cervical cancer were 82% for pembrolizumab combination and 75% for chemotherapy alone. If you are concerned about an adverse event, it should be reported on a Yellow card. Otherwise stated CRR ) were assessed by BICR using RECIST 1.1 maintenance... Design and therefore taken cautiously in 4 ( 0.1 % ) were assessed by using! Lines of therapy and kept within the outer carton to protect from light Figures 36 and 37,,... 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Dysfunction excluded using RECIST 1.1 of combination therapy in squamous NSCLC patients nave to treatment has... ): risk of airway obstruction from aspiration of loose objects in 190 patients, with... Users of assistive technology as doctors, nurses and pharmacists metered dose inhalers pMDI! Permitted to remain on treatment until disease progression were treated for up to 35 cycles ) link a. With the other PARs concern in association with Nuvaxovid can be reported to at. 18, every 9 weeks through Week 45 and every 12 weeks thereafter patients should be monitored for in... Patient will be provided with the other cases classified as non-Alpha leaflet PIL! Thought to be involved in maintaining tolerance to the MHRA Yellow card not express PD-L1 not! 0 R > > endobj the primary efficacy analysis unopened vaccine should be interpreted in context! The copyright holders concerned 0 R > > endobj the patient will be provided with the first post-baseline... 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