Treatment with pembrolizumab may increase the risk of rejection in solid organ transplant recipients. In 20 subjects with ocular melanoma included in KEYNOTE-001, no objective responses were reported; stable disease was reported in 6 patients. Sixty-seven percent (67%) of patients had M1 disease and the majority had stage IV disease (stage IV 32%, stage IVa 14%, stage IVb 4%, and stage IVc 44%). Based on the severity of the adverse reaction, pembrolizumab should be withheld for Grade 3 skin reactions until recovery to Grade 1 or permanently discontinued for Grade 4 skin reactions, and corticosteroids should be administered (see section 4.2). . Marketing authorisation number (s) 9. endobj For pMMR patients (n=697), the OS HR was 0.68 (95% CI: 0.56, 0.84), p=0.0001, one-sided; with median OS of 17.4 months for pembrolizumab and lenvatinib versus 12.0 months for chemotherapy. 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). 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. 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,
To help us improve GOV.UK, wed like to know more about your visit today. Eighty-seven percent of patients had visceral metastases, including 34% with liver metastases. The hazard ratio was 0.72 (95% CI 0.55, 0.93) with 105/355 (30%) deaths in the combination arm and 122/357 (34%) deaths in the sunitinib arm. 10 0 obj These results should be interpreted in the context of the open-label study design and therefore taken cautiously. << This updated OS analysis was not adjusted to account for subsequent therapies. Main efficacy results are summarised in Table 20. Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=180) or 10 mg/kg bw (n=181) every 3 weeks or chemotherapy (n=179; including dacarbazine, temozolomide, carboplatin, paclitaxel, or carboplatin+paclitaxel). Chemotherapy could continue per standard of care. ECOG performance status 3) considered not eligible for chemotherapy. The median time to onset of severe skin reactions was 3.0 months (range 2 days to 25.5 months). Treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease as determined by the investigator or unacceptable toxicity. /Length 6 0 R The geographical scope of the SPC is then also expanded. Gently swirl the multidose vial before and in between each dose withdrawal. No dose adjustment is needed for patients with mild or moderate renal impairment. The baseline characteristics for this population included: median age 63 years (42% age 65 or older); 61% male; 72% White and 21% Asian and 34% and 66% with an ECOG performance status 0 and 1, respectively. /Pages 3 0 R The key eligibility criteria for this study were locally advanced, inflammatory, or early-stage TNBC at high risk of recurrence (tumour size > 1 cm but 2 cm in diameter with nodal involvement or tumour size > 2 cm in diameter regardless of nodal involvement), regardless of tumour PD-L1 expression. These reactions are presented by system organ class and by frequency. For patients with Grade 3 or Grade 4 endocrinopathies that improved to Grade 2 or lower and are controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed. Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. It will take only 2 minutes to fill in. 09/24. Severe endocrinopathies, including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism have been observed with pembrolizumab treatment. Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors. 23456789, This term also included events reported as influenza-like illness, This term includes both injection site redness and injection site erythema (common). The management guidelines for these adverse reactions are described in section 4.4. EVUSHELD is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 (see sections 4.2, 5.1 and 5.2).. Eighty-five percent of patients had visceral metastases, including 21% with liver metastases. A total of 254 participants received two doses of Nuvaxovid (0.5mL 3weeks apart) as the primary vaccination series. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines. Working together across Sussex. Translucent to white proteinaceous particles may be seen in diluted solution. 09 / 22. Assessment of tumour status was performed every 9 weeks. 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. The safety and efficacy of pembrolizumab were evaluated in KEYNOTE-045, a multicentre, open-label, randomised (1:1), controlled study for the treatment of locally advanced or metastatic urothelial carcinoma in patients with disease progression on or after platinum-containing chemotherapy. Among the 51 patients with gastric cancer, the baseline characteristics were: median age 67 years (range: 41 to 89); 57% age 65 or older; 65% male, 63% White, 28% Asian; and ECOG PS 0 (45%) and 1 (55%). 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. The following additional clinically significant, immune-related adverse reactions have been reported in clinical studies or in post-marketing experience: uveitis, arthritis, myositis, myocarditis, pancreatitis, Guillain-Barr syndrome, myasthenic syndrome, haemolytic anaemia, sarcoidosis, encephalitis, myelitis, vasculitis, cholangitis sclerosing, gastritis, cystitis noninfective and hypoparathyroidism (see sections 4.2 and 4.8). Of the 834 patients, 60% were male, 44% were 65 years (median age was 62 years [range 18-89]) and 98% were white. Table 19: Efficacy results in cHL patients who failed a transplant before enrolling or who failed 2 or more prior therapies and were ineligible for ASCT in KEYNOTE-204, Number (%) of patients with duration 6 months, Number (%) of patients with duration 12 months, * Based on the stratified Cox proportional hazard model,
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). KEYTRUDA has not been studied in patients with severe hepatic impairment (see sections 4.4 and 5.2). The potential risk of gastrointestinal perforation should be taken into consideration. Upon enrolment, participants were stratified by age (18 to 64 years; 65 to 84 years) to receive Nuvaxovid or placebo. Counsel patient to report side effects from amiodarone treatment and to protect skin from sunlight. endobj 4.6 Fertility, Pregnancy and lactation Pregnancy Data on a limited number (242) of exposed pregnancies indicate no adverse effects of Indocyanine green on pregnancy or on the health of the Immune-related adverse reactions (see section 4.4). Data about efficacy of pembrolizumab in combination with platinum chemotherapy are limited in this patient population. Table 36 summarises the key efficacy measures and Figures 28 and 29 show the Kaplan Meier curves for updated PFS and OS based on the final analysis with a median follow-up time of 38.1 months (range: 0.2 to 58.7 months). Name of the medicinal product 2. It will take only 2 minutes to fill in. Store in the original carton in order to protect from light. 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. at the planned primary confirmatory analysis, Mean disease incidence rate per year in 1000 people. Exclusion criteria were similar to those of KEYNOTE-002. Based on best response of stable disease or better,
Eighty-four percent were refractory to at least one prior therapy, including 35% who were refractory to first line therapy. Based on the stratified Cox proportional hazard model,
Docusate Sodium Adult should not be taken: by patients with a known hypersensitivity to docusate sodium or to any of the excipients listed in section 6.1. The Kaplan-Meier curves for OS and PFS are shown in Figures 38 and 39. 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. 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. Randomisation was stratified by MMR status (dMMR or pMMR [mismatch repair proficient]) using a validated IHC test. Ninety-six percent of patients had M1 disease and 4% M0 disease. Based on the stratified Cox proportional hazard model,
`|^v KEYNOTE-716: Placebo-controlled study for the adjuvant treatment of patients with resected Stage IIB or IIC melanoma. Individual response values recorded as below the LLOQ were set to half LLOQ. The additional primary efficacy outcome measure, OS, was not formally assessed at the time of the analysis. The patient will be provided with the patient alert card with each prescription. 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. Immune-related adverse reactions affecting more than one body system can occur simultaneously. Date of first authorisation/renewal of the authorisation, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Regulatory approval of COVID-19 vaccine Nuvaxovid, nationalarchives.gov.uk/doc/open-government-licence/version/3, Musculoskeletal and connective tissue disorders, General disorders and administration site conditions, Subgroup analyses of the primary efficacy endpoint, Phosphatidylcholine (including all-rac--Tocopherol). For efficacy data in patients 75 years of age please refer to the relevant section of each indication. A total of 121/411 (29%) of the pembrolizumab and lenvatinib-treated patients received continued study therapy beyond RECIST-defined disease progression. Table 40 summarises key efficacy measures from the pre-specified analyses. 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. Patients who received prior therapy for melanoma other than surgery or interferon for thick primary melanomas without evidence of lymph node involvement were ineligible. 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. 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. Table 31: Efficacy results in KEYNOTE-426, Number (%#) of patients with duration 30 months,
Among patients with BRAF mutant tumours, 139 (46%) were previously treated with a BRAF inhibitor. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. << /CropBox [0 0 595 842] Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to result in an increase in foetal loss. << Assessment of tumour status was performed every 9 weeks through the first year, then every 12 weeks thereafter. The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. They are based on information in the SPC of the medicine. Table 41: Efficacy results in KEYNOTE-355 patients with CPS 10, * Chemotherapy: paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin,
A direct comparison of pembrolizumab when used in combination with lenvatinib to pembrolizumab monotherapy is not available. Example scenario - the approved RSI with the CTA was section 4.8 of SPC May2015. Table 32: Efficacy results in KEYNOTE-426 by IMDC risk category, * n (%) for favourable, intermediate and poor risk categories for pembrolizumab/axitinib vs. sunitinib were: 138 (32%) vs. 131 (31%); 238 (55%) vs. 246 (57%); 56 (13%) vs. 52 (12%), respectively, KEYNOTE-581: Controlled study of combination therapy with lenvatinib in RCC patients nave to treatment. This will allow quick identification of new safety information. Treatment could continue beyond disease progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1). 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. Administration of pembrolizumab was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator. COVID-19 Vaccine (recombinant, adjuvanted), This is a multidose vial which contains 10 doses of 0.5 mL. 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. Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab. Based on Kaplan-Meier estimation, Figure 16: Kaplan-Meier curve for progression-free survival by treatment arm in cHL patients who failed a transplant before enrolling or who failed 2 or more prior therapies and were ineligible for ASCT in KEYNOTE-204, KEYNOTE-087 and KEYNOTE-013: Open-label studies in patients with relapsed or refractory cHL. Bevacizumab 5 mg/kg bw on Day 1 or cetuximab 400 mg/m2 on first infusion, then 250 mg/m2 weekly.
In the per-protocol immunogenicity (PP-IMM) analysis set for participants who received Nuvaxovid (n = 191), median age was 40 years (range: 22 to 70 years); 93% (n = 178) were 18 to 64 years old and 7% (n = 13) were aged 65 to 84; 43% were female; 75% were White; 23% were multiracial or from ethnic minorities; and 27% had at least one comorbid condition. Assessment of tumour status was performed every 9 weeks. It is unknown whether Nuvaxovid is excreted in human milk. Assessment of tumour status was performed every 9 weeks for the first 45 weeks, and every 12 weeks thereafter. Adverse reactions known to occur with pembrolizumab or combination therapy components given alone may occur during treatment with these medicinal products in combination, even if these reactions were not reported in clinical studies with combination therapy. No specific factor(s) associated with early deaths could be identified. The study excluded patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within 2 years of treatment, a medical condition that required immunosuppression, or who were previously treated with 3 or more systemic regimens for recurrent and/or metastatic HNSCC. At the earlier pre-specified final analysis of ORR (median follow-up time of 17.3 months), statistically significant superiority was achieved for ORR comparing pembrolizumab plus lenvatinib with sunitinib, (odds ratio: 3.84 [95% CI: 2.81, 5.26], p-Value< 0.0001). Ninety-four percent were N0; 83% had no sarcomatoid features; 86% were pT2 with Grade 4 or sarcomatoid features or pT3; 8% were pT4 or with nodal involvement; and 6% were M1 NED. Hi, As an academic sponsor we have are routinely reviewing the MHRA website for any changes to SPCs for our sponsored CTIMPs. Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 to 5 times ULN or total bilirubin > 1.5 to 3 times ULN, Grade 3 with AST or ALT > 5 times ULN or total bilirubin > 3 times ULN, In case of liver metastasis with baseline Grade 2 elevation of AST or ALT, hepatitis with AST or ALT increases 50% and lasts 1 week, Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), Based on severity and type of reaction (Grade 2 or Grade 3). /CropBox [0 0 595 842] 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. Results reported from the pre-specified final analysis for RFS at a median follow-up of 20.5 months are summarised in Table 10 and Figure 4.
Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with chemotherapy) before initiating treatment in patients with HNSCC whose tumours express PD-L1 (see section 5.1). The baseline characteristics of these patients were: median age of 65 years (range: 30 to 86), 50% age 65 or older; 61% White, 21% Asian, and 4% Black; ECOG PS of 0 (59%) or 1 (41%), and 84% with pMMR tumour status and 16% with dMMR tumour status. Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. All patients received pembrolizumab for a median of 4 doses (range 1-35 doses), with 138 patients (85.7%) receiving pembrolizumab for 2 doses or more. 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). 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