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How long does Opdivo prolong life and what’s its success rate?

What's the overall survival rate and duration of survival in patients treated with Opdivo? How many people respond to treatment with Opdivo - what's the objective response rate (ORR)?

Medically reviewed by N. France, BPharm. Last updated on Nov 22, 2020.

Official Answer

by Drugs.com

Opdivo (nivolumab) is an immunotherapy used to treat a wide variety of cancer types. How long treatment with this monoclonal antibody prolongs or extends life depends on the type and stage of cancer it is used to treat.

In some situations Opdivo will prolong life for longer when used in combination with other medications, while in others it is better used alone. In other types of cancer it provides no survival benefit over existing therapies, but patients may be more likely to respond to treatment with Opdivo than to treatment it was compared against.

How long Opdivo prolongs life and how successful it is at treating patients with cancer is typically measured in clinical trials by looking at overall rates of patient survival, and duration of patient survival/response or progression-free survival. How successful Opdivo is as a treatment is also measured in clinical trials by looking at the number of patients who respond to the therapy with either complete or partial responses, which is known as the objective response rate (ORR)

The table below outlines by cancer type how long Opdivo prolongs survival and how many patients respond to treatment according to the results of key clinical trials used to gain approval of this drug.

Cancer Type
(Trial name)
Survival rates and duration of survival Percentage of people that had a complete or partial response to treatment
(Objective response rate, ORR)
Melanoma - unresectable or metastatic
(CheckMate-037)
Ongoing response
  • Opdivo: 87% had ongoing responses ranging from 2.6+ to 10+ months
  • Opdivo: 13/38 had ongoing responses of ≥ 6 months


Median duration of overall survival

  • Opdivo: 15.7 months (95% CI: 12.9, 19.9)
    vs
    Dacarbazine or paclitaxel + carboplatin: 14.4 months (95% CI: 11.7, 18.2) (HR 0.95; 95.54% CI: 0.73, 1.24)
Objective response rate
  • Opdivo: 31·7% (95% CI 23·5-40·8)
    vs
    Dacarbazine or paclitaxel + carboplatin: 10·6%, 95% CI 3·5-23·1)
Melanoma - previously untreated
(CheckMate-066)
Overall survival rate
  • Opdivo: 72.9% (95% CI 65.5-78.9)
    vs
    Dacarbazine: 42.1% (95% CI 33.0-50.9)
Objective response rate
  • Opdivo: 40% (95% CI, 33.3 to 47.0)
    vs
    Dacarbazine: 13.9% (95% CI, 9.5 to 19.4)
Melanoma - previously untreated, unresectable or metastatic
(CheckMate-067)
Median duration of overall survival
  • Opdivo + Yervoy: 60+ months
    vs
    Opdivo: 36.9 months
    vs
    Yervoy: 19.9 months

Overall survival rate

  • Opdivo + Yervoy: 52%
    vs
    Opdivo: 44%
    vs
    Yervoy: 26%
Objective response rate
  • Opdivo + Yervoy: 58%
    vs
    Opdivo: 45%
    vs
    Yervoy: 19%
Melanoma - adjuvant treatment for completely resected Stage IIIB/C or Stage IV disease
(CheckMate-238)
Recurrence free survival (minimum 4 years’ follow up)
  • Opdivo: 51·7% (95% CI 46·8-56·3)
    vs
    Yervoy: 41.2% (95% CI36.4-45.9)
Non-small cell lung cancer - metastatic with PD-L1 expression level of ≥ 1%
(CheckMate-227)
Median duration of overall survival
  • Opdivo + Yervoy: 17.1 months (95% CI 15.0-20.1)
    vs
    Chemotherapy: 14.9 months (95% CI 12.7-16.7)

Overall survival rate

  • Opdivo: 40% at 2 years
    vs
    Chemotherapy: 32.8%
Non-small cell lung cancer - first-line treatment of metastatic or recurrent disease
(CheckMate-9LA)
Median duration of overall survival
(minimum 12.7 months’ follow up)
  • Opdivo + Yervoy + chemotherapy: 15.6 months
    vs
    Chemotherapy: 10.9 months (HR 0.66, 95% CI: 0.55–0.80)

Overall survival rate

  • Opdivo + Yervoy + chemotherapy: 63% at 1 year
    vs
    Chemotherapy: 47%
Overall response rate
  • Opdivo + Yervoy: 38% (95% CI 33-43)
    vs
    Chemotherapy: 25% (95% CI 21-30)
Non-small cell lung cancer - second-line treatment of metastatic disease
(CheckMate-017, CheckMate-057)
Overall survival rate
(minimum 3 years’ follow up)
  • Opdivo: 17% (95% CI 14-21)
    vs
    Docetaxel: 8% (95% CI 6-11)


Patients with liver metastasis also had improved overall survival rates when treated with Opdivo compared with docetaxel

Small cell lung cancer
CheckMate-032
Median duration of overall survival
(minimum 28.4 and 29 months’ follow up, respectively)
  • Opdivo + Yervoy: 4.7 months (95% CI 3.1-8.3)
    vs
    Opdivo: 5.7 months (95% CI 3.8-7.6)

Overall survival rate

  • Opdivo + Yervoy: 16.9% at 24 months
    vs
    Opdivo: 17.9%
Objective response rate
  • Opdivo + Yervoy: 21.9%
    vs
    Opdivo: 11.6% (95% CI 1.06-4.26; p=0.03)
Malignant pleural mesothelioma
(CheckMate-743)
Median duration of overall survival
  • Opdivo + Yervoy: 18.1 months (95% CI 16.8, 21.5)
    vs
    Chemotherapy: 14.1 months (95% CI 12.5, 16.2)

Median progression-free survival

  • Opdivo + Yervoy: 6.8 months (95% CI 5.6, 7.4)
    vs
    Chemotherapy: 7.2 months (95% CI 6.9, 8.1)
Renal cell carcinoma - advanced
(CheckMate-025)
Median duration of overall survival
  • Opdivo: 25.8 months (95% CI 22.2-29.8)
    vs
    Everolimus: 19.7 months (95% CI 17.6-22.1)

Progression-free survival was also improved in the Opdivo group

Objective response rate
  • Opdivo: 23%
    vs
    Everolimus: 4%
Renal cell carcinoma - previously untreated
(CheckMate-214)
Overall survival rate
  • Opdivo + Yervoy: 75% (95% CI 70-80) at 18 months
    vs
    Sutent (sunitinib) 60% (95% CI 55-65)

Median duration of overall survival

  • Opdivo + Yervoy: not reached
    vs
    Sutent: 26 months (P ﹤0.001)
Progression-free survival
  • Opdivo + Yervoy: 11.6 months
    vs
    Sutent: 8.4 (P = 0.03)
Objective response rate
  • Opdivo + Yervoy: 42%
    vs
    Sutent (sunitinib) 27% (P ﹤0.001)
Classical Hodgkin lymphoma
(CheckMate-205)
Median duration of response
  • Opdivo: 16.6 months (95% CI 13.2-20.3)

Median progression-free survival

  • Opdivo: 14.7 months (95% CI 11.3-18.5)
Of the evaluable patients in the trial treated past conventional disease progression, 61% had stable or further reduced target tumor burdens
Objective response rate
  • Opdivo: 69% across all three treatment groups (95% CI 63-75)
Squamous cell carcinoma of the head and neck - recurrent or metastatic disease
(CheckMate-141)
Overall survival rate
  • Opdivo: 16.9% at 24 months
    vs
    Docetaxel, methotrexate or Erbitux (cetuximab): 6%

Overall survival benefit was not impacted by PD-L1 expression of human papilloma virus (HPV) status.

Median duration of overall survival
Opdivo: 7.5 months (95% CI 5.5, 9.1) at the interim analysis
vs
Docetaxel, methotrexate or Erbitux (cetuximab): 5.1 month (95% CI 4.0, 6.0)
Objective response rates were similar between the two treatment groups.
Urothelial Carcinoma - locally advanced or metastatic disease
(CheckMate-275)
Median overall survival
(minimum 37 months’ follow up)
  • Opdivo: 8.6 months (95% CI 6.1-11.3)

Median progression-free survival

  • Opdivo: 1.9 months (95% CI 1.9-2.3)
Objective response rate
  • Opdivo: 20.7% (16.1-26.1)
Colorectal cancer - microsatellite instability-high or mismatched repair deficient metastatic disease
(CheckMate-142)
Proportion of responders with ≥ 12 months response duration
  • Opdivo: 82%
    vs
    Opdivo + Yervoy: 77%
Overall response rate
(minimum of 27.5 and 33.7 months’ follow up, respectively)
  • Opdivo: 60% (95% CI 50, 69)
    vs
    Opdivo + Yervoy: 38% (95% CI 27, 50)
Hepatocellular carcinoma
(CheckMate-040)
Overall survival rate
  • Opdivo + Yervoy every 3 weeks (4 doses) then Opdivo every 2 weeks (Arm A): 61% (95% CI 46-72) at 12 months and 48% (95% CI 32-61) at 24 months

Medial duration of overall survival

  • Opdivo + Yervoy every 3 weeks (4 doses) then Opdivo every 2 weeks (Arm A): Not reached in patients with complete or partial responses, 14.5 months (95% CI 8.4-29.6) in patients with stable disease and 8.3 months (95% CI 6.6-10.8)
Objective response rate
  • Opdivo + Yervoy every 3 weeks (4 doses) then Opdivo every 2 weeks (Arm A): 32% (95% CI 20-47)
Esophageal squamous cell cancer
(ATTRACTION-3)
Median duration of overall survival
  • Opdivo: 10.9 months (95% CI 9.2-13.3)
    vs
    Docetaxel or paclitaxel: 8.4 months (95% CI 7.2-9.9)

Median progression-free survival
Opdivo: 1.7 months (95% CI 1.5, 2.7)
vs
Docetaxel or paclitaxel: 3.4 months (95% CI 3.0, 4.2)

Overall response rate
  • Opdivo: 19.3% (95% CI 13.7, 26.0)
    vs
    Docetaxel or paclitaxel: 21.5% (95% CI 15.4, 28.8)
References
  • Food and Drug Administration (FDA). Opdivo. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s071lbl.pdf. [Accessed November 23, 2020].
  • Weber JS, D'Angelo SP, Minor D, et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015;16(4):375-384. doi:10.1016/S1470-2045(15)70076-8.
  • 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.
  • Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019;381(16):1535-1546. doi:10.1056/NEJMoa1910836.
  • Ascierto PA, Del Vecchio M, Mandalá M, et al. Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2020;21(11):1465-1477. doi:10.1016/S1470-2045(20)30494-0.
  • Hellmann MD, Paz-Ares L, Bernabe Caro R, et al. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019;381(21):2020-2031. doi:10.1056/NEJMoa1910231.
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  • Vokes EE, Ready N, Felip E, et al. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Ann Oncol. 2018;29(4):959-965. doi:10.1093/annonc/mdy041.
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  • Food and Drug Administration (FDA). FDA approves nivolumab and ipilimumab for unresectable malignant pleural mesothelioma. October 2, 2020. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-and-ipilimumab-unresectable-malignant-pleural-mesothelioma. [Accessed November 23, 2020].
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