How long does it prolong life and what’s the success rate?

Drugs.com

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 - completely resected stage IIB or IIC melanoma (Checkmate-76K)

Outcomes

  • Opdivo reduced the risk of recurrence, new primary melanoma, or death by 58% compared to placebo (HR: 0.42; 95% CI: 0.30-0.59; P<0.0001)
  • At one year, the recurrence-free survival (RFS) rate was 89% (95% CI: 86-92) for Opdivo versus 79% (95% CI: 74-84) for placebo
  • One-year RFS rates by stage for patients who received Opdivo were 93% (95% CI: 89–95) in stage IIB versus 84% (95% CI: 77–89) with placebo, and 84% (95% CI: 78–88) in stage IIC versus 72% (95% CI: 62–80) with placebo
    		•
    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
    Non-small cell lung cancer - neoadjuvant treatment of resectable disease (CheckMate-816)

    Median event-free survival (minimum 21 months’ follow up)

  • Opdivo + platinum doublet chemotherapy: 31.6 months (95% CI 30.2-not reached) vs Platinum-doublet chemotherapy: 20.8 months (95% CI 14.0-26.7) (HR 0.63, 95% CI 0.45, 0.87)

    • Overall survival rate

  • Overall survival was not statistically significant between Opdivo + platinum doublet chemotherapy recipients and patients who received platinum doublet chemotherapy alone
    		•
    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)
    		•
    Renal cell carcinoma - advanced, previously untreated (CheckMate-9ER) Overall survival rate
  • Overall survival was not reached in either the Opdivo + Cabometyx (cabozantinib) group or the Sutent group during the 18.1 months median follow up period
    • Median duration of response
  • Opdivo + Cabometyx: 20.2 months (95% CI 17.3, not reached) vs Sutent: 11.5 months (95% CI 8.3, 18.4)
    • Median progression-free survival
  • Opdivo + Cabometyx: 16.6 months vs Sutent: 8.3 months (P <0.0001)
    		•  Objective response rate
  • Opdivo + Cabometyx: 55.7% vs Sutent 27.1% (P ﹤0.0001)
    		•
    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)
    		•
    Urothelial Carcinoma - adjuvant therapy in high-risk patients following surgery (CheckMate-274) Median disease-free survival (intention to treat population)
  • Opdivo: 20.8 months (95% CI 16.5-27.6) vs Placebo: 10.8 months (95% CI 8.3-13.9)

    • (PD-L1≥1% population)

  • Opdivo: not reached (95% CI 21.2-not estimable) vs Placebo: 8.4 months (95% CI 5.6-21.2)
    		•
    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)
    		•
    Esophageal squamous cell cancer - first-line treatment of unresectable advanced or metastatic disease (CheckMate-648)

    Median duration of overall survival All randomized patients

  • Opdivo + cisplatin + fluorouracil: 13.2 months (95% CI 11.1-15.7) vs Opdivo + Yervoy: 12.8 months (95% CI 11.3-15.5) vs Cisplatin + fluorouracil: 10.7 months (95% CI 9.4-11.9)

    • Median progression-free survival

  • There was no statistically significant difference in median progression-free survival among the groups when the results from all randomized patients were included
    		•  Overall response rate All randomized patients
  • Opdivo + cisplatin + fluorouracil: 47.4% (95% CI 41.8-53.0) vs Opdivo + Yervoy: 27.7% (95% CI 22.9-32.9) vs Cisplatin + fluorouracil: 26.9% (95% CI 22.1-32.0)
    		•
    Gastric cancer - previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma (CheckMate-649)

    Median duration of overall survival Patients whose tumours expressed PD-L1 CPS ≥ 5

  • Opdivo + mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) or CapeOX (capecitabine and oxaliplatin): 14.4 months (95% CI 13.1, 16.2) vs mFOLFOX6 or CapeOX: 11.1 months (95% CI 10.0, 12.1), (p<0.0001)

    • All randomized patients

  • Opdivo + mFOLFOX6 or CapeOX: 13.8 months (95% CI 12.6, 14.6) vs mFOLFOX6 or CapeOX: 11.6 months (95% CI 10.9, 12.5), (p=0.0002)

    • Median progression-free survival Patients whose tumours expressed PD-L1 CPS ≥ 5

  • Opdivo + mFOLFOX6 or CapeOX: 7.7 months (95% CI 7.0, 9.2) vs mFOLFOX6 or CapeOX: 6.0 months (95% CI 5.6, 6.9), (p<0.0001)
    		•  Overall response rate Patients whose tumours expressed PD-L1 CPS ≥ 5
  • Opdivo + mFOLFOX6 or CapeOX: 237 (50%) (95% CI 46, 55) vs mFOLFOX6 or CapeOX: 138 (38%) (95% CI 34, 43)

    • All randomized patients

  • Opdivo + mFOLFOX6 or CapeOX: 370 (47%) (95% CI 43, 50) vs mFOLFOX6 or CapeOX: 293 (37%) (95% CI 34, 40)
    		•
    Gastric cancer - completely resected esophageal or gastroesophageal junction cancer (CheckMate-577) Median disease free survival
  • Opdivo: 22.4 months (95% CI 16.6, 34.0) vs Placebo: 11.0 months (95% CI 8.3, 14.3) (p=0.0003)
    		•

    Related medical questions

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Popular Keywords