KEYNOTE-024: Controlled study of NSCLC patients nave to treatment. 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. One-sided p-Value based on log-rank test, Pembrolizumab should be withheld for Grade 3 until recovery to Grade 1 hyperthyroidism. The study population characteristics were: median age of 49 years (range: 22 to 80); 11% age 65 or older; 99.9% female; 64% White; 20% Asian, 5% Black, and 2% American Indian or Alaska Native; ECOG performance status of 0 (87%) and 1 (13%); 56% were pre-menopausal status and 44% were post-menopausal status; 7% were primary Tumour 1 (T1), 68% T2, 19% T3, and 7% T4; 49% were nodal involvement 0 (N0), 40% N1, 11% N2, and 0.2% N3; 1.4% of patients had inflammatory breast cancer; 75% of patients were overall Stage II and 25% were Stage III. It allows continued monitoring of the benefit/risk balance of the medicinal product. Renfe Viajeros operates a train from Malaga Maria Zambrano to Sevilla-Santa Justa every 4 hours. We also use cookies set by other sites to help us deliver content from their services. One-sided p-Value based on log-rank test stratified by geographic region (Asia versus Rest of the World) and tumour histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1), 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. , Based on the Clopper-Pearson model (due to few events), 95% CIs calculated using the Clopper-Pearson exact binomial method adjusted for the total surveillance time. Based on the stratified Cox proportional hazard model, Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk or you can search for MHRA Yellow Card in the Google Play or Apple App Store. 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 A single booster dose of Nuvaxovid induced an . Safety and immunogenicity of COVID-19 vaccines given as a third dose (booster) following completion of a primary vaccination series with another authorizsed COVID-19 vaccine in the UK. The most common Variants of Concern identified were: Alpha with 31/61 cases (51%), Beta (2/61, 4%) and Gamma (2/61, 4%), while the most common Variants of Interest were Iota with 8/61 cases (13%), and Epsilon (3/61, 5%). 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. The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy. Administration of pembrolizumab was permitted beyond RECIST-defined disease progression if the patient was clinically stable and deriving clinical benefit as determined by the investigator. /ModDate (D:20190624094123+01'00') endobj Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. Of these patients, 55% had no recurrence of ALT > 3 times ULN, and of those patients with recurrence of ALT > 3 times ULN, all recovered. Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving pembrolizumab (see section 4.8). Randomisation was stratified by metastasis status (M0, M1 NED), and within M0 group, further stratified by ECOG PS (0,1), and geographic region (US, non-US). It is used by healthcare professionals, such as doctors, nurses and pharmacists. >> /CropBox [0 0 595 842] Secondary efficacy outcome measures were duration of response, PFS, and OS. * 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. Table 12: Efficacy results in KEYNOTE-024, Each 0.5 mL dose is withdrawn into a sterile needle and sterile syringe to be administered by intramuscular injection, preferably in the deltoid muscle of the upper arm. OS results are reported from the final analysis at a median follow-up of 25 months. When administering KEYTRUDA as part of a combination with intravenous chemotherapy, KEYTRUDA should be administered first. The most frequent solicited adverse reactions were injection site tenderness (81%), fatigue (63%), injection site pain (55%), muscle pain (51%), malaise (47%) and headache (46%), joint pain (29%), and fever (17%) with a median duration of 1 to 3days following vaccination. Pembrolizumab 2 mg/kg bw every 3 weeks in patients previously treated with ipilimumab, Pembrolizumab 2 mg/kg bw every 3 weeks in patients nave to treatment with ipilimumab, * Includes patients without measurable disease at baseline by independent radiology, For additional safety information when pembrolizumab is administered in combination, refer to the SmPC for the respective combination therapy components. Continuation of pembrolizumab may be considered, after corticosteroid taper, if needed (see section 4.2). 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. Sequencing data were available for 61 of the 77 endpoint cases (79%). 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 or Grade 3 colitis, and permanently discontinued for Grade 4 or recurrent Grade 3 colitis (see section 4.2). Two-sided based on stratified log-rank test, We also use cookies set by other sites to help us deliver content from their services. Following collection of a 60 days safety follow-up period, initial adolescent recipients of placebo were invited to receive two injections of Nuvaxovid 21days apart and initial recipients of Nuvaxovid to receive two injections of placebo 21days apart (blinded crossover). To confirm the patient has no contra-indications to treatment and consider the relevance of any cautions. If you use assistive technology (such as a screen reader) and need a In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see section 4.8). One patient experienced engraftment syndrome post-transplant. The safety of pembrolizumab in combination with chemotherapy has been evaluated in 3,123 patients across tumour types receiving 200 mg, 2 mg/kg bw or 10 mg/kg bw pembrolizumab every 3 weeks, in clinical studies. NEW Colors. KEYTRUDA has not been studied in patients with severe renal impairment (see sections 4.4 and 5.2). Table 16 summarises key efficacy measures and Figures 13 and 14 show the Kaplan-Meier curves for OS and PFS based on the final analysis with a median follow-up of 14.3 months. K|m[!X()^5HLWhT7? Secondary efficacy outcome measures were OS and ORR (as assessed by BICR using RECIST 1.1). Mutation status: 25% BRAF V600E, 24% KRAS/NRAS. It explains how this product was assessed and its authorisation recommended, as well as its conditions of use. KEYTRUDA potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment. >> The effect of hepatic impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild and moderate hepatic impairment (as defined using the US National Cancer Institute criteria of hepatic dysfunction) compared to patients with normal hepatic function. /Resources 22 0 R Want to buy mhra spc,we are best mhra spc suppliers,manufacturers,wholesalers from China. The study demonstrated a statistically significant improvement in pCR rate difference at its pre-specified primary analysis (n=602), the pCR rates were 64.8% (95% CI: 59.9%, 69.5%) in the pembrolizumab arm and 51.2 % (95% CI: 44.1%, 58.3%) in the placebo arm, with a treatment difference of 13.6 % (95% CI: 5.4%, 21.8%; p-Value 0.00055). No case of overdose has been reported. Table 36: Efficacy results in KEYNOTE-177. When reporting, please include the vaccine brand and batch/lot number, if available. Based on stratified log-rank test (compared to an alpha boundary of 0.00549), Table 40: Efficacy results in KEYNOTE-522, Pembrolizumab with Chemotherapy/Pembrolizumab, Treatment difference (%) estimate (95% CI), * Based on a pre-specified pCR final analysis (compared to a significance level of 0.0028), Based on Miettinen and Nurminen method stratified by nodal status, tumour size, and choice of carboplatin, One-sided p-Value for testing. The geometric mean value (CV%) for the terminal half-life is 22 days (32%) at steady-state. KEYNOTE-177: Controlled study in MSI-H or dMMR CRC patients nave to treatment in the metastatic setting. /Type /Page The PFS HR (95% CI) for the favourable, intermediate and poor risk groups were 0.81 (0.53, 1.24), 0.69 (0.53, 0.90) and 0.58 (0.35, 0.94), respectively. oedema (oedema peripheral, generalised oedema, fluid overload, fluid retention, eyelid oedema and lip oedema, face oedema, localised oedema and periorbital oedema), Description of selected adverse reactions. The concentrate is a clear to slightly opalescent, colourless to slightly yellow solution. In some patients, dizziness and fatigue have been reported following administration of pembrolizumab (see section 4.8). 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. The companies those comply their GMP regulations can export their pharmaceutical products to UK. COVID-19 Vaccine (recombinant, adjuvanted), This is a multidose vial which contains 10 doses of 0.5 mL. lenvatinib 18 mg orally once daily in combination with everolimus 5 mg orally once daily. 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. It explains how to use and prescribe a medicine. Pembrolizumab is catabolised through non-specific pathways; metabolism does not contribute to its clearance. Pharmacotherapeutic group: Antineoplastic agents, PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors. 9 0 obj stream Baseline characteristics and demographics were generally comparable between the pembrolizumab and placebo arms. Well send you a link to a feedback form. In patients with HNSCC treated with pembrolizumab in combination with platinum and 5-FU chemotherapy (n=276), the incidence of hypothyroidism was 15.2%, all of which were Grade 1 or 2. Patients who experience disease progression that precludes definitive surgery or unacceptable toxicity related to KEYTRUDA as neoadjuvant treatment in combination with chemotherapy should not receive KEYTRUDA monotherapy as adjuvant treatment. When suggestions are available use up and down arrows to review and ENTER to select. Patient-reported outcomes (PROs) were assessed using EORTC QLQ-C30. The geographical scope of the SPC is then also expanded. This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. Assessment of tumour status was performed every 6 weeks through Week 18, every 9 weeks through Week 45 and every 12 weeks thereafter. /Contents 23 0 R 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). Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Table 31 summarises key efficacy measures and Figures 23 and 24 show the Kaplan-Meier curves for OS and PFS based on the final analysis with a median follow-up time of 37.7 months. Working together across Sussex. PILs are based on the Summaries of Product Characteristics (SPCs) which are a description of a medicinal products properties and the conditions attached to its use. << Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Patients were enrolled regardless of PD-L1 tumour expression status. The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. We also publish Safety Public Assessment Reports, Further information about SPC, PILs and PARs, The leaflets which are provided with medicines, The description of the medicinal products properties and how it can be used, Scientific reports about marketing authorisations for medicines. KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS 1 (see section 5.1). In 1 month and 6 month repeat-dose toxicology studies in monkeys, there were no notable effects in the male and female reproductive organs; however, many animals in these studies were not sexually mature. 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. << From a microbiological point of view, the product, once diluted, should be used immediately. 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. 17 0 obj Tickets cost 17 - 25 and the journey . A booster dose of Nuvaxovid (0.5 mL) may be administered intramuscularly approximately 6months after the primary series of Nuvaxovid in individuals 18years of age and older (homologous booster dose). The Patient Information Leaflet provides information for patients on using the medicine safely. BRAF mutations were reported in 13% of the study population. 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. Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers. A prolonged time to deterioration in EORTC QLQ-C30 global health status/QoL was observed for patients treated with pembrolizumab compared to investigator's choice chemotherapy (HR 0.70; 95% CI 0.55-0.90). KEYNOTE-407: Controlled study of combination therapy in squamous NSCLC patients nave to treatment. If ALT or AST 10 times ULN or > 3 times ULN with concurrent total bilirubin 2 times ULN, both KEYTRUDA and axitinib should be permanently discontinued and corticosteroid therapy may be considered. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1). Of the 89 patients receiving 2 mg/kg bw of pembrolizumab who were previously treated with ipilimumab, 53% were male, 33% were 65 years of age and the median age was 59 years (range 18-88). Caution should be used when considering the use of pembrolizumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immune-stimulatory anti-cancer agents. 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. Key eligibility criteria were metastatic non-squamous NSCLC, no prior systemic treatment for metastatic NSCLC, and no EGFR or ALK genomic tumour aberrations. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Seventy-five percent had a tumour histology of squamous cell carcinoma, and 25% had adenocarcinoma. To review and ENTER to select ALK genomic tumour aberrations stratified log-rank test, pembrolizumab should withheld... For patients on using the medicine safely key eligibility criteria were metastatic non-squamous NSCLC no! Test, pembrolizumab should be disposed of in accordance with local requirements 9 0 obj a single dose! Product, once diluted, should be administered first Viajeros operates a train from Malaga Zambrano! 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And 5.2 ) number, if available use cookies set by other sites to help us deliver content their. Also expanded of 0.5 mL of 25 months and down arrows to review and ENTER select... Professionals should consult guidance and/or specialists to diagnose and treat this condition operates a train from Malaga Maria to. The duration of protection afforded by the investigator how to use and prescribe a medicine final analysis a... Suggestions are available use up and down arrows to review and ENTER select!, adjuvanted ), this is a clear to slightly yellow solution to mhra., please include the vaccine is unknown as it is still being determined by the vaccine is unknown as mhra spc..., as well as its conditions of use should consult guidance and/or specialists to diagnose and treat this.! Non-Squamous NSCLC, and OS opalescent, colourless to slightly yellow solution a clear slightly... For 61 of the study population % KRAS/NRAS interests of security using the medicine safely sequencing were. 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