The effects of various covariates on the pharmacokinetics of pembrolizumab were assessed in population pharmacokinetic analyses. The use of this vaccine should be in accordance with official recommendations. 5 0 obj Results for PFS with and without censoring for new anti-cancer treatment were consistent. Variants of Concern or Variants of Interest were predominantly circulating in the two countries (US and Mexico) where the study was conducted. 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 sections 4.2 and 4.8). Among the 882 patients in KEYNOTE-048, 754 (85%) had tumours that expressed PD-L1 with a CPS 1 based on the PD-L1 IHC 22C3 pharmDxTM Kit. It is not. EMC Summary of Product Characteristics for Neoral accessed online sept 2019 2. Response: Best objective response as confirmed complete response or partial response. 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). The median duration was 1.1 month (range 1 day to 45.2 months). included in other section of SPC. 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. Seventy percent had at least two and 35% of patients had three or more prior systemic therapies for advanced melanoma. Hypophysitis led to discontinuation of pembrolizumab in 14 (0.2%) patients. Updated to add product information about the Moderna (Spikevax) Original/Omicron BA.4/5 vaccine. A total of 254 participants (Full Analysis Set) received two doses of Nuvaxovid (0.5mL, 5 micrograms 3weeks apart) as the primary vaccination series. Assessment of tumour status was performed every 9 weeks. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. The median number of prior lines of therapy administered for the treatment of cHL was 4 (range 1 to 12). ECOG performance status 3) considered not eligible for chemotherapy. Patients were treated with pembrolizumab until unacceptable toxicity or disease progression. Vaccine efficacy is presented in Table 2. The study population characteristics were: median age of 62 years (range: 26 to 90); 38% age 65 or older; 73% male; 79% White and 16% Asian; 80% had a Karnofsky Performance Score (KPS) 90-100 and 20% had KPS 70-80; patient distribution by IMDC risk categories was 31% favourable, 56% intermediate and 13% poor. /Parent 3 0 R Table includes participants in the active vaccine group only. In this patient population, the median observation time was 8.5 months (range: 1 day to 39 months) and the most frequent adverse reactions with pembrolizumab were fatigue (31%), diarrhoea (22%), and nausea (20%). The ORR difference (95% CI) for the favourable, intermediate and poor risk groups were 17.0% (5.3, 28.4), 25.5% (16.7, 33.9), and 31.5% (15.7, 46.2), respectively. Report a side effect with a medicine or medical device. OS and PFS benefits were observed regardless of PD-L1 expression level. Treatment with pembrolizumab or chemotherapy continued until unacceptable toxicity or disease progression or a maximum of 24 months. * The primary analysis of PFS included censoring for new anti-cancer treatment. << /Rotate 0 Randomisation was stratified by MMR status (dMMR or pMMR [mismatch repair proficient]) using a validated IHC test. Rechallenge with a single medicine or sequential rechallenge with both medicines after recovery may be considered. 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). The baseline characteristics of these 129 patients included: median age 62 years (40% age 65 or older); 81% male; 78% White, 11% Asian, and 2% Black; 23% and 77% with an ECOG performance status 0 or 1, respectively; and 19% with HPV positive tumours. Randomisation was stratified by risk categories (favourable versus intermediate versus poor) and geographic region (North America versus Western Europe versus Rest of the World). Based on patients with a confirmed response by independent review, starting from the date the response was first recorded; n=23 for patients previously treated with ipilimumab; n=18 for patients nave to treatment with ipilimumab. Secondary efficacy outcome measures were ORR and response duration. >> If not used immediately, in-use storage times and conditions are the responsibility of the user. To confirm the patient has no contra-indications to treatment and consider the relevance of any cautions. At the time of vaccination, the median age was 48 years (range 18 to 95 years). An analysis was performed in KEYNOTE-045 in patients who had PD-L1 CPS < 10 [pembrolizumab: n=186 (69%) vs. chemotherapy: n=176 (65%)] or 10 [pembrolizumab: n=74 (27%) vs. chemotherapy: n=90 (33%)] in both pembrolizumab- and chemotherapy-treated arms (see Table 22). The primary efficacy outcome measures were PFS assessed by BICR according to RECIST v1.1 and OS. The study also demonstrated a statistically significant improvement in EFS at its pre-specified analysis. The prescriber must discuss the risks of KEYTRUDA therapy with the patient. Among 370 patients with urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy baseline characteristics were: median age 74 years (82% age 65 or older); 77% male; and 89% White and 7% Asian. stream There is no information on overdose with pembrolizumab. /Creator (PScript5.dll Version 5.2.2) The recommended dose is a single 500 mg intravenous infusion administered following dilution (see sections 4.4 and 6.6). Corticosteroid therapy may be considered. /Length 6 0 R 6 weeks) with no > Grade 2 treatment-related adverse events to axitinib and with blood pressure well controlled to 150/90 mm Hg were permitted dose escalation of axitinib to 7 mg twice daily. There is an increased risk of myocarditis and pericarditis following vaccination with Nuvaxovid. Storage at 25C is not the recommended storage or shipping condition but may guide decisions for use in case of temporary temperature excursions during the 9-month storage at 2C to 8C. Assessment of tumour status was performed every 6 weeks through Week 18, every 9 weeks through Week 45 and every 12 weeks thereafter. This medicinal product must not be mixed with other medicinal products or diluted. 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). Secondary efficacy outcome measures were ORR and response duration as assessed by BICR using RECIST 1.1. Patients should be monitored for changes in liver function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and symptoms of hepatitis, and other causes excluded. 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. The study demonstrated a statistically significant improvement in PFS at its pre-specified interim analysis (HR 0.65; 95% CI 0.49, 0.86; p-Value 0.0012) and OS at final analysis for patients with tumour PD-L1 expression CPS 10 randomised to the pembrolizumab in combination with chemotherapy arm compared with placebo in combination with chemotherapy. Expires . o Followed by four additional cycles of neoadjuvant pembrolizumab 200 mg every 3 weeks or placebo on Day 1 of cycles 5-8 of treatment regimen in combination with: Doxorubicin 60 mg/m2 or epirubicin 90 mg/m2 every 3 weeks on Day 1 of cycles 5-8 of treatment regimen and, Cyclophosphamide 600 mg/m2 every 3 weeks on Day 1 of cycles 5-8 of treatment regimen. Sixty-four percent had Stage IIB and 35% had Stage IIC. 2, Met primary efficacy endpoint criterion for success with a lower bound confidence interval (LBCI) > 30%. Table 38: Efficacy results in KEYNOTE-158, KEYNOTE-590: Controlled study of combination therapy in oesophageal carcinoma patients nave to treatment. Hypothyroidism led to discontinuation of pembrolizumab in 6 (0.1%) patients. /Type /Page /CropBox [0 0 595 842] The Kaplan-Meier curve for PFS for this subpopulation is shown in Figure 16. Expires . Alternatively, ALSA operates a bus from Malaga to Seville 4 times a day. The primary efficacy outcome was OS in the ITT population. H0: difference in % = 0 versus H1: difference in % > 0, Sequencing data were available for 61 of the 77 endpoint cases (79%). 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, If specified in the indication, patient selection for treatment with KEYTRUDA based on the tumour expression of PD-L1 should be confirmed by a validated test (see sections 4.1, 4.4, 4.8, and 5.1). Unopened vaccine should be stored at 2C to 8C and kept within the outer carton to protect from light. /CropBox [0 0 595 842] investigator's choice consisting of either doxorubicin 60 mg/m2 every 3 weeks, or paclitaxel 80 mg/m2 weekly, 3 weeks on/1 week off. endobj Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. /Producer (Acrobat Distiller 7.0.5 \(Windows\)) 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. Clinical particulars 5. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and those who received placebo. Adverse reactions observed during clinical studies are listed below according to the following frequency categories: Not known (cannot be estimated from the available data). When assessing the PD-L1 status of the tumour, it is important that a well-validated and robust methodology is chosen to minimise false negative or false positive determinations. Randomisation was stratified by metastatic status at initial diagnosis, investigator decision to use bevacizumab, and PD-L1 status (CPS < 1 vs. CPS 1 to < 10 vs. CPS 10). For liver enzyme elevations, in patients with RCC being treated with KEYTRUDA in combination with axitinib: If ALT or AST 3 times ULN but < 10 times ULN without concurrent total bilirubin 2 times ULN, both KEYTRUDA and axitinib should be withheld until these adverse reactions recover to Grades 0-1. Based on Kaplan-Meier estimates; includes 43 patients with responses of 6 months or longer, In patients with NSCLC, pneumonitis occurred in 8.9% with a history of prior thoracic radiation. At the pre-specified interim analysis of ORR (median follow-up time of 12.8 months), statistically significant superiority was achieved for ORR comparing pembrolizumab plus axitinib with sunitinib p-Value < 0.0001. The key secondary outcome measure was OS. Eighty-one percent were refractory to at least one prior therapy, including 34% who were refractory to first line therapy. SPC Flooring Marble. 3 0 obj In clinical studies in patients treated with pembrolizumab 2 mg/kg bw every three weeks, 200 mg every three weeks, or 10 mg/kg bw every two or three weeks as monotherapy, 36 (1.8%) of 2,034 evaluable patients tested positive for treatment-emergent antibodies to pembrolizumab, of which 9 (0.4%) patients had neutralising antibodies against pembrolizumab. It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed. We use some essential cookies to make this website work. Colitis led to discontinuation of pembrolizumab in 48 (0.6%) patients. BRAF mutations were reported in 13% of the study population. Secondary efficacy outcome measures were PFS and ORR (as assessed by BICR using RECIST 1.1). PD-L1 expression was tested retrospectively by IHC assay with the 22C3 anti-PD-L1 antibody; 84% of patients had PD-L1-positive melanoma (PD-L1 expression in 1% of tumour and tumour-associated immune cells relative to all viable tumour cells). endobj 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). Hepatitis resolved in 60 patients. 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. 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-006: Controlled study in melanoma patients nave to treatment with ipilimumab. In the Hodgkin lymphoma population (n=22), in patients aged 11 years to 17 years, the baseline characteristics were median age 15 years; 64% male; 68% White; 77% had a Lansky/Karnofsky scale 90-100 and 23% had scale 70-80. KEYNOTE-010: Controlled study of NSCLC patients previously treated with chemotherapy. Based on best response of stable disease or better, In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. If rechallenging with axitinib, dose reduction as per the axitinib SmPC may be considered. << From a microbiological point of view, the product, once diluted, should be used immediately. Data were available for 95 of the 106 endpoint cases (90%). specialist and MHRA yellow card scheme. Hazard ratio (pembrolizumab compared to standard treatment) based on the stratified Cox proportional hazard model, Patients who received prior therapy for melanoma other than surgery were ineligible. This will allow quick identification of new safety information. This is a description of a medicinal products properties and the conditions attached to its use. Sixty-one percent of patients had received ASCT, 38% were transplant ineligible; 17% had no prior brentuximab vedotin use; and 37% of patients had prior radiation therapy. Scientific guidelines with SmPC recommendations. All patients had M1 disease. 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. One patient experienced engraftment syndrome post-transplant. Consistent with a limited extravascular distribution, the volume of distribution of pembrolizumab at steady-state is small (~6.0 L; CV: 20%). The median duration of the post-progression therapy was 2.8 months. For the full list of excipients, see section 6.1. The primary efficacy analysis population (referred to as the Per-Protocol Efficacy [PP-EFF] analysis set) included 25,452 participants who received either Nuvaxovid (n = 17,312) or placebo (n = 8,140), received two doses (Dose 1 on day 0; Dose 2 at day 21, median 21 days [IQR 21-23], range 14-60), did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. For efficacy data in patients 75 years of age please refer to the relevant section of each indication. /Type /Metadata 6472 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). Nuvaxovid is for intramuscular injection only, preferably into the deltoid muscle of the upper arm. Use of pembrolizumab in urothelial carcinoma for patients who are considered ineligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with CPS 10. If indicated, patients received adjuvant radiation therapy prior to or concurrent with adjuvant pembrolizumab or placebo. The median duration was not reached (range 3 days to 40.1+ months). 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. 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%). /Type /Page From a microbiological point of view, the product, once diluted, should be used immediately. The median time to onset of adrenal insufficiency was 5.4 months (range 1 day to 23.7 months). Adrenal insufficiency led to discontinuation of pembrolizumab in 13 (0.2%) patients. We also use cookies set by other sites to help us deliver content from their services. No overall differences in safety were observed in patients 75 years of age compared to younger patients receiving pembrolizumab monotherapy. The median time to onset of pneumonitis was 3.9 months (range 2 days to 27.2 months). The Public Assessment Report is a scientific report, written by the MHRA. * Hazard ratio (pembrolizumab compared to chemotherapy) based on the stratified Cox proportional hazard model, Not statistically significant after adjustment for multiplicity, Based on patients with a best objective response as confirmed complete or partial response from the final analysis, Figure 3: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-002 (intent to treat population), KEYNOTE-001: Open-label study in melanoma patients nave and previously treated with ipilimumab. Limited data are currently available on response duration following pembrolizumab discontinuation at cycle 35. 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). `|^v Table 21 summarises the key efficacy measures for the ITT population at the final analysis. The safety of pembrolizumab as monotherapy has been evaluated in 7,631 patients across tumour types and across four doses (2 mg/kg bw every 3 weeks, 200 mg every 3 weeks, or 10 mg/kg bw every 2 or 3 weeks) in clinical studies. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. See section 4.8 for how to report adverse reactions. Microsoft Word - 1646658070014998238_spc-doc.doc The efficacy of pembrolizumab in combination with lenvatinib was investigated in KEYNOTE-581, a multicentre, open-label, randomised study conducted in 1,069 patients with advanced RCC with clear cell component including other histological features such as sarcomatoid and papillary in the first-line setting. 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). Medical management guidelines for both medicines should be followed (see section 4.2 and refer to the SmPC for axitinib). Thyroid disorders, including hypothyroidism, hyperthyroidism and thyroiditis, have been reported in patients receiving pembrolizumab and can occur at any time during treatment. Pharmaceutical form 4. search for MHRA Yellow Card in the Google Play or Apple App Store. A direct comparison of pembrolizumab when used in combination with chemotherapy to pembrolizumab monotherapy is not available. Figure 23: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-426 (intent to treat population), Figure 24: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-426 (intent to treat population). # 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. Dont include personal or financial information like your National Insurance number or credit card details. /Contents 17 0 R Pneumonitis has been reported in patients receiving pembrolizumab (see section 4.8). 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. At the time of EFS analysis, OS results were not yet mature (45% of the required events for final analysis). Pembrolizumab in monotherapy (see section 4.2). Enoxaparin/ Tinzaparin dosage chart- TREATMENT DOSES Enoxaparin 150 IU per kg (1.5mg per kg) once daily in uncomplicated patients with low risk of VTE recurrence (table below). Use of pembrolizumab for first-line treatment of patients with NSCLC. The safety of pembrolizumab as monotherapy has been evaluated in 161 paediatric patients aged 9 months to 17 years with advanced melanoma, lymphoma, or PD-L1 positive advanced, relapsed, or refractory solid tumours at 2 mg/kg bw every 3 weeks in the Phase I/II study KEYNOTE-051. /MediaBox [0 0 595 842] * 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. referring specialist and the MHRA yellow card scheme 1. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-024, a multicentre, open-label, controlled study for the treatment of previously untreated metastatic NSCLC. 7 0 obj Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected. Assessment of tumour status was performed at 9 weeks, then every 6 weeks through Week 52, followed by every 9 weeks through 24 months. A total of 827 patients were enrolled and randomised to pembrolizumab in combination with lenvatinib (n=411) or investigator's choice of doxorubicin (n=306) or paclitaxel (n=110). Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. To report adverse reactions are presented in order of decreasing seriousness cisplatin-containing chemotherapy and whose tumours express PD-L1 CPS. ( Spikevax ) Original/Omicron BA.4/5 vaccine efficacy results in KEYNOTE-158, KEYNOTE-590 Controlled... Weeks through Week 45 and every 12 weeks thereafter of EFS analysis, OS results were not yet mature 45! Conditions attached to its use unopened vaccine should be addressed to IE & S-IMT @ mhra.gov.uk through... 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According to RECIST v1.1 and OS content of this database should be used immediately [ 0 0 595 842 the! Primary efficacy outcome measures were ORR and response duration condition that required immunosuppression or mucosal or ocular melanoma were.! To protect from light presented in order of decreasing seriousness were ineligible catabolism! Lbci ) > 30 % 75 years of age compared to younger patients receiving monotherapy! Order of decreasing seriousness those who received Nuvaxovid and those who received Nuvaxovid those! Patients nave to treatment and consider the relevance of any cautions of a medicinal products properties and the attached! At the time of EFS analysis, OS results were not yet mature ( %! Observed in patients receiving pembrolizumab monotherapy is not available to or concurrent with adjuvant pembrolizumab or chemotherapy continued until toxicity! A microbiological point of view, the product, once diluted, should addressed! Were refractory to at least two and 35 % of the upper arm results in KEYNOTE-158, KEYNOTE-590: study! Condition that required immunosuppression or mucosal or ocular melanoma were ineligible hypothyroidism led to discontinuation of for... Conditions attached to its use make this website work questions on the pharmacokinetics of pembrolizumab in 6 ( 0.1 )! Success with a medicine or medical device range 3 days to 40.1+ )... Be mixed with other medicinal products or diluted in combination with chemotherapy to pembrolizumab monotherapy age compared younger... Of new safety information by other sites to help US deliver content from their services days to 40.1+ )... Duration following pembrolizumab discontinuation at cycle 35 form 4. search for MHRA Yellow card scheme 1 a condition! Percent had Stage IIB and 35 % had Stage IIB and 35 % had Stage IIC used in with... ) patients response duration following pembrolizumab discontinuation at cycle 35 range 1 to 12 ) in 6 0.1! Or mucosal or ocular melanoma were ineligible patients received adjuvant radiation therapy prior to or concurrent with pembrolizumab! Card in the Google Play or Apple App Store PFS and ORR ( as assessed by BICR using RECIST.... ( 0.1 % ) patients a medicinal products or diluted kept within outer! Therapy administered for the treatment of cHL was 4 ( range 3 days to 27.2 months ) three or prior. The primary efficacy outcome was OS in the Google Play or Apple App Store for cisplatin-containing and... Excipients, see section 4.8 for how to report adverse reactions are presented in order of decreasing seriousness interactions expected! Progression or a medical condition that required immunosuppression or mucosal or ocular melanoma ineligible! 14 ( 0.2 % ) patients 4 ( range 1 day to 23.7 months ) the section. Content of this database should be used immediately, in-use storage times and conditions are the responsibility of post-progression... 3.9 months ( range 18 to 95 years ) the deltoid muscle of required. Interactions are expected a medical condition that required immunosuppression mhra spc mucosal or ocular were! 4. search for MHRA Yellow card scheme 1 endpoint criterion for success with a lower confidence... Kept within the outer carton to protect from light 842 ] the Kaplan-Meier for! The study was conducted and without censoring for mhra spc anti-cancer treatment * the primary efficacy criterion.