Latest & greatest articles for nivolumab

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Top results for nivolumab

1. Nivolumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V

Nivolumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Nivolumab (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 May 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-11 Nivolumab (...) (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-11 Version 1.0 Nivolumab (renal cell carcinoma) 13 May 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 4 February

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

2. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. (PubMed)

Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. In an early-phase study involving patients with advanced non-small-cell lung cancer (NSCLC), the response rate was better with nivolumab plus ipilimumab than with nivolumab monotherapy, particularly among patients with tumors that expressed programmed death ligand 1 (PD-L1). Data are needed to assess the long-term benefit of nivolumab plus ipilimumab in patients with NSCLC.In this open-label, phase 3 trial, we randomly assigned (...) patients with stage IV or recurrent NSCLC and a PD-L1 expression level of 1% or more in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. The patients who had a PD-L1 expression level of less than 1% were randomly assigned in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy alone. All the patients had received no previous chemotherapy. The primary end point reported here was overall survival with nivolumab plus

2019 NEJM

3. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. (PubMed)

Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. Nivolumab plus ipilimumab or nivolumab alone resulted in longer progression-free and overall survival than ipilimumab alone in a trial involving patients with advanced melanoma. We now report 5-year outcomes in the trial.We randomly assigned patients with previously untreated advanced melanoma to receive one of the following regimens: nivolumab (at a dose of 1 mg per kilogram of body weight) plus ipilimumab (3 mg (...) per kilogram) every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram every 2 weeks); nivolumab (3 mg per kilogram every 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilogram every 3 weeks for four doses) plus nivolumab-matched placebo. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group, as compared with the ipilimumab group.At a minimum follow-up of 60 months

2019 NEJM

4. Nivolumab (Opdivo) - for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC)

Nivolumab (Opdivo) - for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC) 1 Published 10 June 2019 1 SMC2153 nivolumab 10mg/ml concentrate for solution for dilution (Opdivo®) Bristol-Myers Squibb Pharmaceuticals Ltd 10 May 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised (...) as follows: ADVICE: following a full submission assessed under the end of life process nivolumab (Opdivo ® ) is accepted for use within NHSScotland. Indication under review: in combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC). Overall survival was significantly longer in the nivolumab plus ipilimumab group compared with a multiple receptor tyrosine kinase inhibitor in a phase III study in treatment naïve patients

2019 Scottish Medicines Consortium

5. Nivolumab with ipilimumab for untreated advanced renal cell carcinoma

Nivolumab with ipilimumab for untreated advanced renal cell carcinoma Niv Nivolumab with ipilimumab for untreated olumab with ipilimumab for untreated advanced renal cell carcinoma advanced renal cell carcinoma T echnology appraisal guidance Published: 15 May 2019 www.nice.org.uk/guidance/ta581 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations (...) and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Nivolumab with ipilimumab for untreated advanced renal cell carcinoma (TA581) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 24Contents Contents 1

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

6. Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial

Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial In the ongoing phase 3, CheckMate 214 trial, nivolumab plus ipilimumab improved overall survival compared with sunitinib in patients with intermediate or poor risk, previously untreated, advanced renal cell carcinoma. We aimed to assess whether health-related quality of life (HRQoL) could be used to further describe (...) the benefit-risk profile of nivolumab plus ipilimumab versus sunitinib.In the phase 3, randomised, controlled, CheckMate 214 trial, patients aged 18 years and older with previously untreated, advanced or metastatic renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries. Patients were categorised by risk status into favourable, intermediate, and poor risk subgroups and randomly assigned (1:1) to open-label nivolumab 3 mg/kg plus ipilimumab 1 mg

2019 EvidenceUpdates

7. Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease

Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease Niv Nivolumab for adjuvant treatment of olumab for adjuvant treatment of completely resected melanoma with completely resected melanoma with lymph node in lymph node inv volv olvement or metastatic ement or metastatic disease disease T echnology appraisal guidance Published: 23 January 2019 nice.org.uk/guidance/ta558 © NICE 2019. All rights reserved. Subject to Notice of rights (...) . They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

8. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial

Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial Previously reported results from the phase 3 CheckMate 067 trial showed a significant improvement in objective responses, progression-free survival, and overall survival with nivolumab plus ipilimumab or nivolumab alone compared with ipilimumab alone in patients with advanced melanoma. The aim of this report is to provide 4-year (...) updated efficacy and safety data from this study.In this phase 3 trial, eligible patients were aged 18 years or older with previously untreated, unresectable, stage III or stage IV melanoma, known BRAFV600 mutation status, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned 1:1:1 to receive intravenous nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four doses, followed by nivolumab 3 mg/kg every 2 weeks, or nivolumab 3 mg/kg every 2

2018 EvidenceUpdates

9. Nivolumab (Opdivo) - melanoma

Nivolumab (Opdivo) - melanoma 1 Published 10 December 2018 1 SMC2112 nivolumab 10mg/mL concentrate for solution for infusion (Opdivo®) Bristol-Myers Squibb Pharmaceuticals Limited 9 November 2018 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission nivolumab (Opdivo ® ) is accepted for use (...) within NHSScotland. Indication under review: As monotherapy for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Adjuvant treatment with nivolumab improved recurrence free survival compared with another immunotherapy in adults with melanoma with involvement of lymph nodes or metastatic disease who had undergone complete resection. SMC advice takes account of the benefit of Patient Access Schemes (PAS

2018 Scottish Medicines Consortium

10. Diffuse alveolar hemorrhage with pseudoprogression during nivolumab therapy in a patient with malignant melanoma (PubMed)

Diffuse alveolar hemorrhage with pseudoprogression during nivolumab therapy in a patient with malignant melanoma Nivolumab, an anti-PD-1 antibody, has been shown to be effective in many cancers, such as malignant melanoma and lung cancer; however, nivolumab therapy can result in pseudoprogression. Diffuse alveolar hemorrhage (DAH) is persistent or recurrent pulmonary hemorrhage as a result of drugs, autoimmune diseases, or infections. DAH with pseudoprogression during nivolumab administration (...) has rarely been reported. Herein, we describe our experience with one such case. A 41-year-old woman exhibited bloody sputum and ground glass opacities in the lungs along with tumor growth during nivolumab therapy for multiple lung metastases of malignant melanoma. We diagnosed DAH with pseudoprogression as a result of nivolumab and administered steroid therapy. The DAH subsequently improved and the tumor shrank. This case illustrates that nivolumab can cause DAH with pseudoprogression, which can

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2018 Thoracic cancer

11. Nivolumab (Opdivo) - to treat stomach cancer, including cancers that occur at the junction of the stomach and oesophagus

Nivolumab (Opdivo) - to treat stomach cancer, including cancers that occur at the junction of the stomach and oesophagus 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 27 July 2018 EMA/504630/2018 EMEA/H/C/003985/II/0039 (...) Withdrawal of application for a change to the marketing authorisation for Opdivo (nivolumab) On 27 June 2018, Bristol-Myers Squibb Pharma EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new use of Opdivo for the treatment of stomach cancer. What is Opdivo? Opdivo is a cancer medicine currently authorised to treat the following cancers: melanoma (skin cancer), non-small cell lung cancer, renal cell carcinoma (kidney cancer

2018 European Medicines Agency - EPARs

12. Durable response to nivolumab in a lung adenocarcinoma patient with idiopathic pulmonary fibrosis (PubMed)

Durable response to nivolumab in a lung adenocarcinoma patient with idiopathic pulmonary fibrosis The efficacy and safety of immune-checkpoint inhibitors in non-small cell lung cancer patients with idiopathic pulmonary fibrosis (IPF) remain unknown. Herein, we describe the case of a 62-year-old man with multiple pleural tumors and carcinomatous pleurisy. High-resolution computed tomography indicated usual interstitial pneumonia, and a respiratory function test revealed a restrictive disorder (...) and decreased diffusion capacity. He was diagnosed with lung adenocarcinoma and IPF. After failure of initial chemotherapy, he was treated with nivolumab and achieved a complete response without any sign of exacerbation of IPF. The response to nivolumab has persisted for > 1 year. This is the first report of a non-small cell lung cancer patient with IPF who has been treated with immune-checkpoint inhibitors for such a long period and achieved a sustained response.© 2018 The Authors. Thoracic Cancer

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2018 Thoracic cancer

13. Combined Nivolumab and Ipilimumab in Melanoma Metastatic to the Brain. (PubMed)

Combined Nivolumab and Ipilimumab in Melanoma Metastatic to the Brain. Brain metastases are a common cause of disabling neurologic complications and death in patients with metastatic melanoma. Previous studies of nivolumab combined with ipilimumab in metastatic melanoma have excluded patients with untreated brain metastases. We evaluated the efficacy and safety of nivolumab plus ipilimumab in patients with melanoma who had untreated brain metastases.In this open-label, multicenter, phase 2 (...) study, patients with metastatic melanoma and at least one measurable, nonirradiated brain metastasis (tumor diameter, 0.5 to 3 cm) and no neurologic symptoms received nivolumab (1 mg per kilogram of body weight) plus ipilimumab (3 mg per kilogram) every 3 weeks for up to four doses, followed by nivolumab (3 mg per kilogram) every 2 weeks until progression or unacceptable toxic effects. The primary end point was the rate of intracranial clinical benefit, defined as the percentage of patients who had

2018 NEJM

14. Neutrophil‐to‐lymphocyte ratio after four weeks of nivolumab administration as a predictive marker in patients with pretreated non‐small‐cell lung cancer (PubMed)

Neutrophil‐to‐lymphocyte ratio after four weeks of nivolumab administration as a predictive marker in patients with pretreated non‐small‐cell lung cancer Although phase III trials have shown improved overall and progression-free survival (PFS) using nivolumab compared to docetaxel in patients with non-small-cell lung cancer, the progressive disease ratio of nivolumab is higher than docetaxel. Furthermore, nonconventional response patterns of nivolumab make it difficult to determine (...) the time point for nivolumab discontinuation. Therefore, a method to detect non-responders to nivolumab at an early time point is crucial. This retrospective study was conducted to identify immunological and nutritional markers, including neutrophil-to-lymphocyte ratios (NLR), which would predict the efficacy of nivolumab treatment. Because the expression of these markers fluctuates dramatically during treatment, repeat evaluation was performed.We retrospectively investigated 30 patients with non-small

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2018 Thoracic cancer

15. Presence of few PD‐1‐expressing tumor‐infiltrating immune cells is a potential predictor of improved response to salvage chemotherapy following nivolumab for non‐small cell lung cancer: An exploratory case series (PubMed)

Presence of few PD‐1‐expressing tumor‐infiltrating immune cells is a potential predictor of improved response to salvage chemotherapy following nivolumab for non‐small cell lung cancer: An exploratory case series The combination of PD-1 inhibitors and cytotoxic drugs is reported to enhance anti-tumor activity in non-small cell lung cancer; however, the underlying synergistic mechanisms remain uncertain. This retrospective case series was designed to investigate objective response (...) and survival rates of salvage chemotherapy following nivolumab and explore the immunohistochemical profiles of tumor-infiltrating immune cells.The medical records of 37 patients administered nivolumab were retrospectively reviewed. Overall response rate and progression-free survival were compared among three groups: salvage chemotherapy following nivolumab, nivolumab therapy alone, and chemotherapy preceding nivolumab.Eight cases met the study criteria. Salvage chemotherapy following nivolumab improved

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2018 Thoracic cancer

16. Nivolumab-induced cold agglutinin syndrome successfully treated with rituximab (PubMed)

Nivolumab-induced cold agglutinin syndrome successfully treated with rituximab 30072374 2019 03 18 2473-9537 2 15 2018 08 14 Blood advances Blood Adv Nivolumab-induced cold agglutinin syndrome successfully treated with rituximab. 1865-1868 10.1182/bloodadvances.2018019000 Hasanov Merve M 0000-0002-6102-4917 Department of Internal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX; and. Konoplev Sergej N SN Department of Hematopathology

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2018 Blood advances

17. Nivolumab

Nivolumab Top results for nivolumab - Trip Database or use your Google+ account Find evidence fast ALL of these words: Title only Anywhere in the document ANY of these words: Title only Anywhere in the document This EXACT phrase: Title only Anywhere in the document EXCLUDING words: Title only Anywhere in the document Timeframe: to: Combine searches by placing the search numbers in the top search box and pressing the search button. An example search might look like (#1 or #2) and (#3 or #4 (...) ) Loading history... Population: Intervention: Comparison: Outcome: Population: Intervention: Latest & greatest articles for nivolumab The Trip Database is a leading resource to help health professionals find trustworthy answers to their clinical questions. Users can access the latest research evidence and guidance to answer their clinical questions. We have a large collection of systematic reviews, clinical guidelines, regulatory guidance, clinical trials and many other forms of evidence. If you wanted

2018 Trip Latest and Greatest

18. Low-dose nivolumab can be effective in non-small cell lung cancer: alternative option for financial toxicity (PubMed)

Low-dose nivolumab can be effective in non-small cell lung cancer: alternative option for financial toxicity Nivolumab is used at 3 mg/kg or fixed doses of 240 mg every 2 weeks. There was no dose-response/toxicity relationship of nivolumab. This study evaluated the efficacy of low-dose nivolumab as an alternative to the financial toxicity of standard-dose nivolumab in treatment of non-small cell lung cancer (NSCLC).Outcomes of patients with NSCLC treated with nivolumab as a routine practice (...) at two tertiary hospitals in Korea were retrospectively analysed. Patients who could not afford standard nivolumab treatment received low-dose nivolumab (20 or 100 mg fixed dose every 3 weeks). Others received standard dose of 3 mg/kg every 2 weeks. Progression-free survival (PFS) and overall survival (OS) were measured and compared between low-dose and standard-dose groups in overall and stratified analyses according to programmed death-ligand 1 (PD-L1) status.Among the 47 patients with NSCLC, 18

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2018 ESMO open

19. Nivolumab for adults with Hodgkin's lymphoma (a rapid review using the software RobotReviewer). (PubMed)

Nivolumab for adults with Hodgkin's lymphoma (a rapid review using the software RobotReviewer). Hodgkin's lymphoma (HL) is a cancer of the lymphatic system, and involves the lymph nodes, spleen and other organs such as the liver, lung, bone or bone marrow, depending on the tumour stage. With cure rates of up to 90%, HL is one of the most curable cancers worldwide. Approximately 10% of people with HL will be refractory to initial treatment or will relapse; this is more common in people (...) range of malignancies. Nivolumab is an anti-(PD)-1 monoclonal antibody and currently approved by the US Food and Drug Administration (FDA) for the treatment of melanoma, non-small cell lung cancer, renal cell carcinoma and, since 2016, for classical Hodgkin's lymphoma (cHL) after treatment with ASCT and brentuximab vedotin.To assess the benefits and harms of nivolumab in adults with HL (irrespective of stage of disease).We searched CENTRAL, MEDLINE, Embase, International Pharmaceutical Abstracts

2018 Cochrane

20. Nivolumab (squamous cell carcinoma of the head and neck) - Addendum to Commission A17-24

Nivolumab (squamous cell carcinoma of the head and neck) - Addendum to Commission A17-24 1 Translation of addendum A17-54 Nivolumab (Plattenepithelkarzinom des Kopf-Hals-Bereichs) – Addendum zum Auftrag A17-24 (Version 1.0; Status: 25 October 2017). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 25 October 2017 1.0 Commission: A17-54 Version: Status (...) : IQWiG Reports – Commission No. A17-54 Nivolumab (squamous cell carcinoma of the head and neck) – Addendum to Commission A17-24 1 Addendum A17-54 Version 1.0 Nivolumab – Addendum to Commission A17-24 25 October 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (squamous cell carcinoma of the head and neck) – Addendum to Commission A17-24 Commissioning agency: Federal Joint Committee

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)