If you are unable to complete your LogIn successfully please contact the Adverse Incident Centre for assistance and advice: sabre@mhra.gov.uk or 020 3080 7336. Participants were enrolled across 28 tumour types by primary diagnosis. 09/24. There is an increased risk of myocarditis and pericarditis following vaccination with Nuvaxovid. The initial analysis resulted in a HR for OS of 0.82 (95% CI: 0.67, 1.01) with a one-sided p-Value of 0.0316. To discuss the benefits and possible side-effects of treatment with the patient. No cases of severe COVID-19 were reported in the 17,312 Nuvaxovid participants compared with 4 cases of severe COVID-19 reported in the 8,140 placebo recipients in the PP-EFF analysis set. Within the group assigned to receive Nuvaxovid, 115 participants received a two-dose primary series of ChAdOx1 nCov-19 and 114 participants received a two-dose primary series of BNT162b2, prior to receiving a single booster dose (0.5 mL) of Nuvaxovid. The following factors had no clinically important effect on the clearance of pembrolizumab: age (range 15-94 years), gender, race, mild or moderate renal impairment, mild or moderate hepatic impairment and tumour burden. Participants are being followed for up to 12 months after the primary vaccination series for assessments of safety and efficacy against COVID-19. Expires . 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). The diluted solution must not be frozen. All patients had M1 disease. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults 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. 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 study excluded patients with autoimmune disease or a medical condition that required immunosuppression. Efficacy results reflect enrolment that occurred during the time period when strains classified as Record the date and time of discard on the vial label. The study population characteristics were: median age of 65 years (range: 29 to 88); 55% age 65 or older; 81% male; 77% White; ECOG performance status of 0 (29%) and 1 (71%); and 8% with treated brain metastases at baseline. To help us improve GOV.UK, wed like to know more about your visit today. When used in combination with lenvatinib, one or both medicines should be interrupted as appropriate. Patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within two years of treatment or a medical condition that required immunosuppression were ineligible for the study. The primary efficacy outcome measures were investigator-assessed RFS in the whole population and in the population with PD-L1 positive tumours, where RFS was defined as the time between the date of randomisation and the date of first recurrence (local, regional, or distant metastasis) or death, whichever occurs first. endobj 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. 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. The Kaplan-Meier curve for OS for the TPS 50% population is shown in Figure 22. The effects of various covariates on the pharmacokinetics of pembrolizumab were assessed in population pharmacokinetic analyses. In patients with RCC and melanoma treated with pembrolizumab monotherapy in the adjuvant setting (n=1,480), the incidence of hyperthyroidism was 10.9%, the majority of which were Grade 1 or 2. Alternatively, adverse events of concern in association with Nuvaxovid can be reported to Novavax at www.NovavaxCovidVaccine.com or via +44 020 3514 1838. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients. It is not. Efficacy results are summarised in Table 38. 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). 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). Secondary efficacy outcome measures included ORR, as assessed by BICR using RECIST 1.1. The majority of adverse reactions reported for monotherapy were of Grades 1 or 2 severity. Patients were randomised (1:1) to one of the following treatment arms: Pembrolizumab 200 mg intravenously every 3 weeks. Patients without disease progression could be treated for up to 24 months. * Hazard ratio (pembrolizumab compared to ipilimumab) based on the stratified Cox proportional hazard model, Among the 5 adolescent participants with advanced melanoma treated on KEYNOTE-051, no patient had a complete or a partial response, and 1 patient had stable disease. 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. Assessment of tumour status was performed every 9 weeks through the first year, then every 12 weeks thereafter. For security reasons, new Registrations will not be activated until registration details have been checked and verified by the MHRA. The efficacy of pembrolizumab in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab, was investigated in KEYNOTE-826, a multicentre, randomised, double-blind, placebo-controlled study that enrolled 617 patients with persistent, recurrent, or first-line metastatic cervical cancer who had not been treated with chemotherapy except when used concurrently as a radio-sensitising agent. 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. Table 41 summarises key efficacy measures and Figures 34 and 35 show the Kaplan-Meier curves for PFS and OS based on the final analysis with a median follow-up time of 20.2 months (range: 0.3 to 53.1 months) for patients with tumour PD-L1 expression CPS 10. /Count 7 Altitude above sea level (m) 7. Safety data were collected in 2,232 participants 12 through 17 years of age, with and without evidence of prior SARS CoV-2 infection, in United States who received at least one dose of Nuvaxovid (n=1,487) or placebo (n=745). Rare cases of SJS and TEN, some of them with fatal outcome, have been observed (see sections 4.2 and 4.4). /Contents 25 0 R Table 14 summarises key efficacy measures and Figures 11 and 12 show the Kaplan-Meier curves for OS and PFS based on the final analysis with a median follow-up of 18.8 months. Table 33: Efficacy results in KEYNOTE-581. an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. Corticosteroids should be administered (initial dose of 0.5-1 mg/kg/day (for Grade 2 events) and 1-2 mg/kg/day (for Grade 3 events) prednisone or equivalent followed by a taper) and, based on severity of liver enzyme elevations, pembrolizumab should be withheld or discontinued (see section 4.2). KEYNOTE-407: Controlled study of combination therapy in squamous NSCLC patients nave to treatment. Prior to dilution, the vial of liquid can be out of refrigeration (temperatures at or below 25C) for up to 24 hours. Based on Kaplan-Meier estimates; includes 43 patients with responses of 6 months or longer, search for MHRA Yellow Card in the Google Play or Apple App Store. /MediaBox [0 0 595 842] SHCP APC . Patients in the placebo arm were offered pembrolizumab as a single agent at the time of disease progression. The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. The efficacy of pembrolizumab was investigated as adjuvant therapy for RCC in KEYNOTE-564, a multicentre, randomised, double-blind, placebo-controlled study in 994 patients with increased risk of recurrence defined as intermediate-high or high risk, or M1 with no evidence of disease (NED). /Resources 16 0 R Ninety-three percent had M1 disease. Adjuvant Matrix-M containing per 0.5 mL dose: Fraction-A (42.5 micrograms) and Fraction-C (7.5 micrograms) of Quillaja saponaria Molina extract. 6472 Discard the vial if visible particles are observed. Five study subjects were ineligible to ASCT due to reasons other than failure to salvage chemotherapy. Assessed by BICR according to the IWG 2007 criteria by PET CT scans, Based on patients (n=150) with a response by independent review, Based on patients (n=18) with a response by independent review, # Based on Kaplan-Meier estimation; includes 62 patients with responses of 12 months or longer, Based on Kaplan-Meier estimation; includes 7 patients with responses of 12 months or longer, Based on Kaplan-Meier estimation; includes 37 patients with responses of 24 months or longer, Based on Kaplan-Meier estimation; includes 4 patients with responses of 60 months or longer. The use of this vaccine should be in accordance with official recommendations. The KEYNOTE-581 study was not powered to evaluate efficacy of individual subgroups. The median time to onset of hyperthyroidism was 1.4 months (range 1 day to 23.2 months). Assessment of tumour status was performed every 9 weeks. Patients were randomised (1:1) to receive pembrolizumab at a dose of 200 mg every 3 weeks (n=637) or investigator's choice platinum-containing chemotherapy (n=637; including pemetrexed+carboplatin or paclitaxel+carboplatin. After careful consideration of the potential increased risk, pembrolizumab may be used with appropriate medical management in these patients. Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. Table 43 summarises key efficacy measures for patients whose tumours expressed PD-L1 with a CPS 1 in KEYNOTE-826 from the pre-specified interim analysis. Assessed by BICR using RECIST 1.1, This vaccine should be handled by a healthcare professional using aseptic techniques to ensure the sterility of each dose. Randomisation was stratified by tumour histology (squamous cell carcinoma vs. adenocarcinoma), geographic region (Asia vs. ex-Asia), and ECOG performance status (0 vs. 1). 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