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How effective is Opdivo?

Medically reviewed by Carmen Pope, BPharm. Last updated on Jan 15, 2025.

Official answer

by Drugs.com

The effectiveness of Opdivo at prolonging or extending life depends on the type and stage of cancer it is used to treat and if it is used alone or in combination with other treatments (such as Yervoy). There are several ways clinical trials measure success:

  • Overall survival rates
    • How long patients live after starting treatment
    • Varies by cancer type and stage.
  • How long the patient responds for
  • Progression-free survival
    • Time without cancer growing
    • Important indicator of treatment effectiveness
  • Objective response rate (ORR) – this is the combined total of the percentage of patients whose cancer shrinks (partial response) or disappears completely (complete response) after treatment.

Treatment Approaches

Monotherapy

  • Opdivo is used alone for certain cancers
  • Effectiveness varies by cancer type

Combination Therapy

  • Opdivo is often combined with Yervoy or chemotherapy treatments
  • May increase survival in specific cases

Important Considerations

  • Results vary significantly by cancer type
  • Individual responses differ
  • Stage of cancer affects outcomes
  • Treatment combinations may improve results

The table below outlines by cancer type key the clinical trials behind the FDA approval of Opdivo that reported either survival rates, duration of survival, and/or overall response rate.

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)

Unresectable or Metastatic Urothelial Carcinoma - in combination with cisplatin and gemcitabine (CheckMate-901)

Median overall survival

  • Opdivo + cisplatin and gemcitabine followed by Opdivo monotherapy: 21.7 months versus 18.9 months with cisplatin/gemcitabine alone (95% CI 0.63-0.96; p=0.0171)

Objective response rate

  • Opdivo + cisplatin + gemcitabine: 57.6% (95% CI: 51.8-63.2)
    • vs
  • Cisplatin + gemcitabine: 43.1% (95% CI:37.5-48.9)
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 questions

References
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