nivolumab (Opdivo)
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Indications
- treatment of renal cell carcinoma
- urothelial carcinoma
- locally advanced or metastatic urothelial carcinoma during or following platinum-containing chemotherapy
- adjuvant nivolumab after radical surgery
- FDA-approved as adjuvant therapy regardless of prior neoadjuvant chemotherapy, nodal involvement, or PD-L1 status
- metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy[2]
- FDA-approved regardless of PD-L1 expression[6]
- in combination with chemotherapy for neoadjuvant treatment of NSCLC[14]
- treatment of cutaneous melanoma in combination with ipilimumab[3]
- alone better than ipilimumab for resected cutaneous melanoma & less toxic (both drugs made by Bristol-Myers Squibb)[8]
- refractory Hodgkin's lymphoma
- hepatocellular carcinoma previously treated with sorafenib
- refractory metastatic colorectal cancer with microsatellite instability or mismatch repair deficiency
- neoadjuvant chemotherapy for Merkel cell carcinoma[12]
- adjuvant therapy for resected esophageal cancer[13][15]
- adjuvant therapy for resected gastroesophageal junction cancer[13][15]
- in combination with ipilimumab (Yervoy) for neoadjuvant treatment of colorectal adenocarcinoma with mismatch repair deficiency[19]
Benefit/risk
- extends median overall survival by 3 months in patients with non-small cell lung cancer compared with docetaxel (12.2 vs 9.4 months)[2]*
- a subset of patients with high PD-L1 expression showed even greater benefit, median overall survival 17-19 months[2]*
* study (CheckMate study) funded by Bristol-Myers Squibb
Dosage
- 3 mg/lg every 2 weeks beun 4 weeks prior to surgery[10]
Adverse effects
- most common
- immunosuppression-related effects[2]
- may increase risk of autoimmune disease[7]
- colitis, diarrhea most commonly in association with ipilimumab
- inflammatory arthritis & sicca syndrome induced by nivolumab & ipilimumab[7]
- treatment-related deaths due to pneumonitis[16]
- may increase risk of autoimmune disease[7]
Toxicity:
- discontinue nivolumab
- high-dose intravenous glucocorticoids[5]
- drug adverse effects of checkpoint inhibitor(s)
- drug adverse effects of pharmaceutical monoclonal antibodies
Mechanism of action
- blocks ligand activation of programmed cell death-1 receptor (PD-1 receptor) on activated T cells
More general terms
References
- ↑ Wikipedia: Nivolumab http://en.wikipedia.org/wiki/Nivolumab
- ↑ 2.0 2.1 2.2 2.3 2.4 FDA News Release. March 4, 2015. FDA expands approved use of Opdivo to treat lung cancer. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436534.htm
Chustecka Z Nivolumab in Lung Cancer Shows 'Unprecedented' Survival. Medscape Oncology. May 29, 2015. from the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting. http://www.medscape.com/viewarticle/845647?nlid=82185_2202
American Society of Clinical Oncology (ASCO) 2015 Annual Meeting: Abstract LBA109, presented May 30, 2015; abstract 8009, presented May 31, 2015 - ↑ 3.0 3.1 Robert C, Schachter J, Long GV et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med 2015 Apr 19; [e-pub] <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25891173 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1503093
Postow MA et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med 2015 Apr 20 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25891304 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1414428 - ↑ Brahmer J et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 2015 May 31 PMID: https://www.ncbi.nlm.nih.gov/pubmed/26028407
- ↑ 5.0 5.1 Larkin J et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 2015 May 31; PMID: https://www.ncbi.nlm.nih.gov/pubmed/26027431
- ↑ 6.0 6.1 West HJ Should Atezolizumab Be the First-Choice Immunotherapy in Second-Line Non-Small Cell Lung Cancer? Medcape Oncology. Oct 31, 2016 http://www.medscape.com/viewarticle/871119
- ↑ 7.0 7.1 7.2 Cappelli LC et al. Inflammatory arthritis and sicca syndrome induced by nivolumab and ipilimumab. Ann Rheum Dis 2017 Jan; 76:43 PMID: https://www.ncbi.nlm.nih.gov/pubmed/28000525 Free Article
- ↑ 8.0 8.1 Davenport L Clear Benefit With Adjuvant Nivolumab in Resected Melanoma Medscape - Sep 12, 2017. http://www.medscape.com/viewarticle/885539
- ↑ Forde PM, Chaft JE, Smith KN et al Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 Apr 16. [Epub ahead of print] PMID: https://www.ncbi.nlm.nih.gov/pubmed/29658848 Free Article
- ↑ 10.0 10.1 Pal S, Phillips JD A New Path for Nivolumab? Established as second-line treatment in NSCLC, the checkpoint inhibitor navigates new therapeutic terrain (March of the Mabs, Part 2) MedPage Today. ASCO Reading Room Aug 17, 2018
- ↑ Hellmann MD, Ciuleanu TE, Pluzanski A et al Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden. N Engl J Med 2018; 378:2093-2104. May 31, 2018 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29658845 Free full text https://www.nejm.org/doi/full/10.1056/NEJMoa1801946
- ↑ 12.0 12.1 Kuznar W with expert critique by Klil-Drori AJ Neoadjuvant Nivolumab Tames Resectable Merkel Cell Carcinoma. May reduce the extent of surgery required. MedPage Today. ASCO Reading Room 11.24.2018 https://www.medpagetoday.com/reading-room/asco/skin-cancer/76465
- ↑ 13.0 13.1 13.2 Kelly RJ, Ajani JA, Kuzdzal J et al Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med 2021; 384:1191-1203. April 1. PMID: https://www.ncbi.nlm.nih.gov/pubmed/33789008 https://www.nejm.org/doi/full/10.1056/NEJMoa2032125
- ↑ 14.0 14.1 Bankhead C A Win for Nivolumab as Preoperative Therapy for Lung Cancer. Pathologic CR rate 12 times higher with the addition of anti-PD-1 agent to chemo. MedPage Today April 11, 2021 https://www.medpagetoday.com/meetingcoverage/aacr/92038
Forde PM, et al Nivolumab + platinum-doublet chemotherapy vs chemotherapy as neoadjuvant treatment for resectable (Ib-IIIa) non-small cell lung cancer in the phase III CheckMate 816 trial. American Association for Cancer Research (AACR) 2021; Abstract CT003.
Bassett M First Neoadjuvant Immunotherapy OK'd in Lung Cancer
FDA approves nivolumab plus chemotherapy in resectable, non-small cell lung cancer. MedPage Today March 7, 2022 https://www.medpagetoday.com/hematologyoncology/lungcancer/97534 - ↑ 15.0 15.1 15.2 Mulcahy N FDA Oks Nivolumab After Surgery for Esophageal of GEJ Cancer. Practice-Changing Use of Immunotherapy Medscape - May 20, 2021. https://www.medscape.com/viewarticle/951352
- ↑ 16.0 16.1 Bajorin DF, Witjes JA, Gschwend JE Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N Engl J Med 2021; 384:2102-2114. June 3 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34077643 https://www.nejm.org/doi/full/10.1056/NEJMoa2034442
- ↑ Bassett M PD-1 Inhibitor OK'd as Adjuvant Therapy for Bladder Cancer. Nivolumab gets FDA approval for those at high risk of recurrence after surgery. MedPage Today August 20, 2021 https://www.medpagetoday.com/hematologyoncology/othercancers/94154
- ↑ HIGHLIGHTS OF PRESCRIBING INFORMATION OPDIVO (nivolumab) injection, for intravenous use https://packageinserts.bms.com/pi/pi_opdivo.pdf
- ↑ 19.0 19.1 Davenport L 'Unprecedented' Responses to Neoadjuvant Treatment in dMMR Colon Cancer. Medscape. Sept 11, 2022 https://www.medscape.com/viewarticle/980548