In this patient population, the most frequent adverse reactions were anaemia (55%), nausea (54%), fatigue (38%), neutropenia (36%), constipation (35%), alopecia (35%), diarrhoea (34%), vomiting (28%), and decreased appetite (27%). This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. The most common tumour types by histology were Hodgkin lymphoma (13.7%), glioblastoma multiforme (9.3%), neuroblastoma (6.2%), osteosarcoma (6.2%) and melanoma (5.6%). /Type /Page Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with chemotherapy) before initiating treatment in previously untreated patients with NSCLC whose tumours express PD-L1. Efficacy results in this subpopulation were consistent with the ITT population. Patients with active autoimmune disease that required systemic therapy within 2 years of treatment or a medical condition that required immunosuppression were ineligible for the study. (see section 4.8). Based upon a standard query including bradyarrhythmias and tachyarrhythmias. 09 / 22. When used in combination with lenvatinib, one or both medicines should be interrupted as appropriate. 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. Based on Miettinen and Nurminen method stratified by PD-L1 status, platinum chemotherapy and smoking status, Figure 11: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-189 (intent to treat population), Figure 12: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-189 (intent to treat population). Of the 617 enrolled patients, 548 patients (89%) had tumours expressing PD-L1with a CPS 1 based on the PD-L1 IHC 22C3 pharmDxTM Kit. Nephritis resolved in 20 patients, 5 with sequelae. Patients should be monitored for changes in renal function, and other causes of renal dysfunction excluded. 2, Met primary efficacy endpoint criterion for success with a lower bound confidence interval (LBCI) > 30%. Thyroid function and hormone levels should be monitored to ensure appropriate hormone replacement. Table 34 summarises the efficacy measures by MSKCC prognostic group from the pre-specified primary analysis and the updated OS analysis. The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1. The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab. Factors associated with early deaths were fast progressive disease on prior platinum therapy and liver metastases. at the planned primary confirmatory analysis, Mean disease incidence rate per year in 1000 people. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Upon enrolment, participants were stratified by age (18 to 64 years; 65 to 84 years) to receive Nuvaxovid or placebo. Patients were randomised (1:1) to receive pembrolizumab 200 mg intravenously every 3 weeks or investigator's choice of the following chemotherapy regimens given intravenously every 2 weeks: mFOLFOX6 (oxaliplatin, leucovorin, and FU) or mFOLFOX6 in combination with either bevacizumab or cetuximab: Oxaliplatin 85 mg/m2, leucovorin 400 mg/m2 (or levoleucovorin 200 mg/m2), and FU 400 mg/m2 bolus on Day 1, then FU 2,400 mg/m2 over 46-48 hours. Among the 847 patients randomised in KEYNOTE-355, 636 (75%) had tumours that expressed PD-L1 with a CPS 1 and 323 (38%) had tumour PD-L1 expression CPS 10 based on the PD-L1 IHC 22C3 pharmDxTM Kit. /Type /Page /Pages 3 0 R One dose (0.5 mL) contains 5 micrograms of the of SARS-CoV-2 spike protein* and is adjuvanted with Matrix-M. Each vial contains an excess fill of 0.25 mL (total content per vial 4.25 mL) to ensure the recovery of 4 mL of concentrate. Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates for male and female participants and racial groups, and across participants with medical comorbidities associated with high risk of severe COVID-19. Czechia, Date of first authorisation: February 2022, Hypertension was not reported in adolescents aged 12 through to 17 years in the clinical study. Table 9 summarises efficacy results by PD-L1 expression. 2 0 obj Secondary efficacy outcome measures were ORR and duration of response, according to RECIST 1.1 as assessed by the investigator. either cisplatin or carboplatin with gemcitabine) versus chemotherapy as first-line treatment in subjects with advanced or metastatic urothelial carcinoma. The median time to onset of nephritis was 4.2 months (range 12 days to 21.4 months). Reasons for cisplatin ineligibility included: baseline creatinine clearance of < 60 mL/min (50%), ECOG performance status of 2 (32%), ECOG performance status of 2 and baseline creatinine clearance of < 60 mL/min (9%), and other (Class III heart failure, Grade 2 or greater peripheral neuropathy, and Grade 2 or greater hearing loss; 9%). Assessment of tumour status was performed at Week 9 and then every 6 weeks for the first year, followed by every 9 weeks through 24 months. KEYNOTE-052: Open-label study in urothelial carcinoma patients ineligible for cisplatin-containing chemotherapy. Alternatively, ALSA operates a bus from Malaga to Seville 4 times a day. 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). In all patients randomised to pembrolizumab in combination with chemotherapy, compared to chemotherapy the OS HR was 0.73 (95% CI 0.62-0.86) and the PFS HR was 0.65 (95% CI 0.55-0.76). Immune-related adverse reactions affecting more than one body system can occur simultaneously. The baseline characteristics of these 599 patients included: median age 63 years (45% age 65 or older); 69% male; 63% White and 32% Asian; 17% Hispanic or Latino; and ECOG performance status 0 and 1 in 31% and 69%, respectively. Suspected pneumonitis should be confirmed with radiographic imaging and other causes excluded. Immune-related severe skin reactions have been reported in patients receiving pembrolizumab (see section 4.8). Hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids. A total of 1,173 participants (PP-IMM Analysis Set) received a booster dose of Nuvaxovid approximately 6months after completion of the primary series of Nuvaxovid (Day201). KEYTRUDA in combination with axitinib in RCC. 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%). The safety of Nuvaxovid in adolescents was evaluated in an interim analysis of the paediatric expansion portion of an ongoing Phase 3 multicentre, randomised, observer-blinded, placebo-controlled study (Study 2019nCoV-301). It is unknown whether Nuvaxovid is excreted in human milk. At final analysis, a total of 57 NSCLC patients aged 75 years were enrolled in study KEYNOTE-189 (35 in the pembrolizumab combination and 22 in the control). A total of 254 participants received two doses of Nuvaxovid (0.5mL 3weeks apart) as the primary vaccination series. When reporting, please include the vaccine brand and batch/lot number, if available. Based on best response of stable disease or better, The ORR was 66% for pembrolizumab compared to 54% for standard treatment with a p-Value of 0.0225. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. The Licensing Authority has deferred the obligation to submit the results of studies with pembrolizumab in one or more subsets of the paediatric population in treatment of Hodgkin lymphoma (see section 4.2 for information on paediatric use). Animal reproduction studies have not been conducted with pembrolizumab. KEYTRUDA is a humanised monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2. /Subtype /XML The two vaccine components elicit B- and T-cell immune responses to the S protein, including neutralising antibodies, which may contribute to protection against COVID-19. 7 0 obj Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer. Table 23: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma ineligible for cisplatin-containing chemotherapy in KEYNOTE-052, Lenvatinib should be withheld, dose reduced, or discontinued in accordance with the instructions in the lenvatinib SmPC for combination with pembrolizumab. Type 1 diabetes mellitus, including diabetic ketoacidosis, has been reported in patients receiving pembrolizumab (see section 4.8). referring specialist and the MHRA yellow card scheme 1. 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). 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. 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), Disease characteristics were squamous (18%) and non-squamous (82%); M1 (99%); and brain metastases (9%). /Resources 18 0 R 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. Secondary efficacy outcome measures were ORR and response duration, as assessed by BICR using RECIST 1.1. The intermediate-high risk category included: pT2 with Grade 4 or sarcomatoid features; pT3, any Grade without nodal involvement (N0) or distant metastases (M0). You have rejected additional cookies. The effects of various covariates on the pharmacokinetics of pembrolizumab were assessed in population pharmacokinetic analyses. The median area under the concentration time curve at steady-state over 3 weeks (AUC0-3weeks) was 794 mcgday/mL at a dose of 2 mg/kg bw every 3 weeks and 1,053 mcgday/mL at a dose of 200 mg every 3 weeks. The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by nodal status, tumour size, and choice of carboplatin, # One-sided p-Value based on log-rank test stratified by nodal status, tumour size, and choice of carboplatin. endobj There are limited data on the safety and efficacy of KEYTRUDA in patients with ocular melanoma (see section 5.1). Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 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). No new immune-related adverse reactions were identified in the adjuvant setting. These results reflect enrolment that occurred during the time period when the B.1.17 (Alpha) variant was circulating in the UK. Patients were randomised (1:1) to one of the following treatment arms: pembrolizumab 200 mg intravenously every 3 weeks in combination with lenvatinib 20 mg orally once daily. Based on Kaplan-Meier estimates; includes 84 patients with response of 6 months or longer. 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. These reactions are presented by system organ class and by frequency. Of these, 48 out of 61 (79%) were identified as Variants of Concern or Variants of Interest. Use of pembrolizumab in combination with chemotherapy. If specified in the indication, patient selection for treatment with KEYTRUDA based on MSI-H/dMMR tumour status should be confirmed by a validated test (see sections 4.1 and 5.1). In patients with NSCLC, pneumonitis occurred in 8.9% with a history of prior thoracic radiation. Immediately prior to use, remove the vaccine vial from the carton in the refrigerator. A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice. Store the opened vial between 2C to 25C for up to 6 hours after first puncture, see section 6.3. This does not replace the SPC, which should be read in conjunction with it Date Prepared: October 2011 Reviewed: August 2019 Review Date: July 2022 (Extended to January 2023) References 1. Secondary efficacy outcome measures included response duration, PFS, and OS. This service replaces the previously separate MHRA websites, one of which hosted SPC and PILs, the other PARs. 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. Seventy-six (47.2%) patients had 1 or more Grades 3 to 5 adverse reactions of which 5 (3.1%) patients had 1 or more adverse reactions that resulted in death. KEYNOTE-042: Controlled study of NSCLC patients nave to treatment. Cisplatin could be administered on Day 2 of each 3-week treatment cycle. /Parent 3 0 R The safety profile in paediatric patients was generally similar to that seen in adults treated with pembrolizumab. 0086 136 9073 4191. domogres@spcfloorings.net. Based on the stratified Cox regression model, 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). /Contents 21 0 R For storage conditions after first opening of the medicinal product, see section 6.3. SPC Flooring. 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. KEYNOTE-826: Controlled study of combination therapy in patients with persistent, recurrent, or metastatic cervical cancer. No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. See MHRA Guidance Mar 2018: Valproate use by women and girls and MHRA Valproate Pregnancy Prevention Programme toolkit for full details. Hypothyroidism may be managed with replacement therapy without treatment interruption. arthritis (joint swelling, polyarthritis and joint effusion), ee. Equilibrate the vial to room temperature (at or below 25C). The safety and efficacy of pembrolizumab were investigated in KEYNOTE-052, a multicentre, open-label study for the treatment of locally advanced or metastatic urothelial carcinoma in patients who were not eligible for cisplatin-containing chemotherapy. Treatment with pembrolizumab or placebo continued until completion of the treatment (17 cycles), disease progression that precludes definitive surgery, disease recurrence in the adjuvant phase, or unacceptable toxicity. Working together across Sussex. /CropBox [0 0 595 842] 234, Met primary efficacy endpoint criterion for success with a lower bound confidence interval (LBCI) > 30%, efficacy has been confirmed at the interim analysis. /Contents 19 0 R Tourist area. Vaccine efficacy of Nuvaxovid to prevent the onset of COVID-19 from seven days after Dose 2 was 90.4% (95% CI 82.9 94.6). The median duration was 3.3 months (range 6 days to 28.2+ months). tenosynovitis (tendonitis, synovitis and tendon pain), ff. This 96-hour hold may include up to 6 hours at room temperature (at or below 25C). lenvatinib 18 mg orally once daily in combination with everolimus 5 mg orally once daily. Identification of the Alpha variant was based on S gene target failure by PCR. Administration of pembrolizumab with lenvatinib was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. Figure 30: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-590 with PD-L1 expression (CPS 10), Figure 31: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-590 with PD-L1 expression (CPS 10), KEYNOTE-522: Controlled study of neoadjuvant and adjuvant therapy in patients with locally advanced, inflammatory, or early-stage triple-negative breast cancer at high risk of recurrence. Approximately 30% were refractory to frontline chemotherapy and ~ 45% had received prior ASCT. /Resources 22 0 R EFS was defined as the time from randomisation to the first occurrence of any of the following events: progression of disease that precludes definitive surgery, local or distant recurrence, second primary malignancy, or death due to any cause. Based on Cox regression model with Efron's method of tie handling with treatment as a covariate 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). 3. The median duration of the post-progression therapy was 2.8 months. 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. Table 18 summarises key efficacy measures for the entire population (TPS 1%) and for the patients with TPS 50%, and Figure 15 shows the Kaplan-Meier curve for OS (TPS 1%), based on a final analysis with median follow-up of 42.6 months. Seventy percent had at least two and 35% of patients had three or more prior systemic therapies for advanced melanoma. >> Thirty-seven percent of patients received 2 or more prior lines of therapy. These noninferiority criteria were met. The use of this vaccine should be in accordance with official recommendations. /ModDate (D:20190624094123+01'00') Licensed inactivated seasonal influenza vaccines were co-administered to participants on the same day as Dose 1 of Nuvaxovid (n = 217) or placebo (n=214) in the opposite deltoid muscle of the arm in 431 participants enrolled in an exploratory Phase 3 (2019nCoV-302) sub-study. Adrenal insufficiency occurred in 74 (1.0%) patients, including Grade 2, 3 or 4 cases in 34 (0.4%), 31 (0.4%) and 4 (0.1%) patients, respectively, receiving pembrolizumab. >> 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. Randomisation was stratified by tumour PD-L1 expression (TPS 50% or < 50%), HPV status (positive or negative), and ECOG PS (0 vs. 1). The efficacy of Nuvaxovid may be lower in immunosuppressed individuals. - Update the SmPC and PIL to extend the indication for booster dose to the 12+ years age group (previously 18+ years) Terms and Conditions Opens in new window | Privacy Notice Opens in new window, Click on this link to navigate to www.mhra.gov.uk, Good Manufacturing Practice (GMP) certificates, Good Distribution Practice Certificates (GDP). Mg orally once daily the adjuvant setting prior to use, remove the vaccine from... Had at least two and 35 % of patients received 2 or more lines. Than one body system can occur simultaneously are presented by system organ class and by frequency have reported! In adults treated with pembrolizumab or waste material should be confirmed with radiographic imaging and other causes excluded OS.... 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Or carboplatin with gemcitabine ) versus chemotherapy as first-line treatment in subjects with advanced or metastatic urothelial carcinoma patients for! And liver metastases service replaces the previously separate MHRA websites, one of hosted! Outcome measure was ORR as assessed by the investigator primary vaccination series patients was similar. At room temperature ( at or below 25C ) with advanced or metastatic cervical cancer identified in the UK first... Occurred within 14 days yellow card scheme 1 the pre-specified primary analysis and the OS...

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