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How long does Opdivo (nivolumab) take to work and how do you know if it is working?

Medically reviewed by N. France, BPharm. Last updated on Nov 23, 2020.

Official Answer

by Drugs.com

Opdivo (nivolumab) is a monoclonal antibody or type of immunotherapy used to treat a number of different types of cancer. Opdivo is a programmed death-1 (PD-1) inhibitor that helps the T cells of your immune system identify and attack cancer cells. It does this by helping to block the cancer cell’s ability to disguise itself and evade detection by the immune system.

Opdivo is administered via a 30-60 minute intravenous infusion every 2-4 or 6 weeks.

How long does Opdivo take to work?

Immunotherapy works differently to traditional chemotherapeutics and can take longer to work because once Opdivo starts helping the immune system to uncover the cancer cells, it takes time for the immune system to identify and attack them.

During clinical trials of Opdivo researchers measure the ‘time to response’, which provides a time frame in which you’d expect to see a patient’s cancer show signs that it is responding to treatment and Opdivo is starting to work.

‘Time to response’ is the time taken from the day a patient is assigned to receive a particular therapy until the first day that the patient has a partial or complete response to the treatment. The ‘time to response’ observed in a number of clinical trials used to gain approval of Opdivo are reported in the table below.

Time to response following treatment with Opdivo

Cancer Type
(Trial name)
Median Time to Response
Melanoma
(CheckMate-066)
Opdivo: 2.1 months (range 1.2-7.6)
vs
Dacarbazine 2.1 months (range 1.8-3.6)
Small cell lung cancer
(CheckMate-032)
Opdivo: 1.5 months
Opdivo + Yervoy (ipilimumab): 1.4 months
Renal-cell carcinoma
(CheckMate-214)
Opdivo + Yervoy: 2.8 months (range 0.9-11.3)
vs
Sutent (sunitinib): 3.0 months (range 0.6-15.0)
Classic Hodgkin Lymphoma
(CheckMate-205)
Opdivo: 2.1 months (range 1.9-2.7)
Squamous cell carcinoma of the head and neck
(CheckMate-141)
Opdivo: 2.1 months (range 1.8-7.4)
vs
Investigator’s choice (methotrexate, docetaxel or cetuximab) : 2.0 (range 1.9-4.6)
Hepatocellular carcinoma
(CheckMate-040)
Opdivo + Yervoy every 3 weeks (4 doses) then Opdivo every 2 weeks (Arm A): 32% (95% CI 20-47): 2.0 months (range 1.3 to 2.7 months)

How do you know if Opdivo is working?

To tell if you’re responding to treatment with Opdivo your doctor will order periodic tests, such as CT (computed tomography) and PET (positron emission tomography) scans and MRI (magnetic resonance imaging). These tests help work out whether the size of your tumors is changing.

It’s important to note that sometimes with immunotherapy treatments like Opdivo, it can initially look like your cancer is progressing even though it is getting better. This is called 'pseudoprogression' and results in a short-term increase in the size of a tumor, or the appearance of a new tumor, followed by delayed tumor shrinkage.

References
  • Opdivo. How Does Opdivo Work With My Immune System? Available from: https://www.opdivo.com/about-opdivo/how-opdivo-works-monotherapy. [Accessed November 24, 2020].
  • OncoLink. All About Immunotherapy. Available from: https://www.oncolink.org/cancer-treatment/immunotherapy/all-about-immunotherapy. [Accessed November 24, 2020].
  • Food and Drug Administration (FDA). Opdivo. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s071lbl.pdf. [Accessed November 24, 2020].
  • Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372(4):320-330. doi:10.1056/NEJMoa1412082.
  • Ready NE, Ott PA, Hellmann MD, et al. Nivolumab Monotherapy and Nivolumab Plus Ipilimumab in Recurrent Small Cell Lung Cancer: Results From the CheckMate 032 Randomized Cohort. J Thorac Oncol. 2020;15(3):426-435. doi:10.1016/j.jtho.2019.10.004.
  • Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018;378(14):1277-1290. doi:10.1056/NEJMoa1712126.
  • Armand P, Engert A, Younes A, et al. Nivolumab for Relapsed/Refractory Classic Hodgkin Lymphoma After Failure of Autologous Hematopoietic Cell Transplantation: Extended Follow-Up of the Multicohort Single-Arm Phase II CheckMate 205 Trial [published correction appears in J Clin Oncol. 2018 Sep 10;36(26):2748]. J Clin Oncol. 2018;36(14):1428-1439. doi:10.1200/JCO.2017.76.0793.
  • Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression. Oral Oncol. 2018;81:45-51. doi:10.1016/j.oraloncology.2018.04.008.
  • Yau T, Kang YK, Kim TY, et al. Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib: The CheckMate 040 Randomized Clinical Trial [published online ahead of print, 2020 Oct 1]. JAMA Oncol. 2020;6(11):e204564. doi:10.1001/jamaoncol.2020.4564.
  • Ma Y, Wang Q, Dong Q, Zhan L, Zhang J. How to differentiate pseudoprogression from true progression in cancer patients treated with immunotherapy. Am J Cancer Res. 2019;9(8):1546-1553. Published 2019 Aug 1.
  • Opdivo. Questions Patients May Have. Available from: https://www.opdivo.com/patient-caregiver-support/faqs. [Accessed November 24, 2020].

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