Randomised controlled trialindependent cross-checkabstract only checked I-CHM-08 standard review
Immunotherapy lets half of patients with advanced melanoma live at least five years
Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.
Overview
Larkin J et al.. N Engl J Med 2019 · PMID 31562797 · DOI 10.1056/NEJMoa1910836
5-year survival 52% with combined immunotherapy vs 26% with the older drug.
Does the study support the specific claim? No · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Report 5-year survival.
- How was the study done?
RCT.
- How many people, animals or samples were studied?
Advanced melanoma.
- What was actually found?
52% 5-year OS.
- How large was the observed effect?
HR 0.52.
- What do the results mean in everyday life?
The immune system can fight cancer when helped.
- What are the study's limitations?
Industry funding.
- What does it say about Elawady's specific claim?
Contradicts immune claim.
- Do the results apply to Germany and Europe?
High.
- What can explicitly not be concluded from this study?
Effect in other cancers.
Scientific in-depth review
1. Full reference
- Authors
- Larkin J et al.
- Journal
- N Engl J Med
- Year
- 2019
- Identifier
- PMID 31562797 DOI 10.1056/NEJMoa1910836
- Verification
- verified – PubMed esummary + efetch 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Funded by Bristol-Myers Squibb and others
2. Research question
Long-term survival with immune checkpoint inhibitors.
3. Study design and population
- Study design
- Randomised controlled trial – Randomised controlled trial (CheckMate 067), 5-year update
- Population
Previously untreated advanced melanoma
- Country
International
- Period
Minimum 60 months follow-up
- Sample size
not stated in abstract
- Inclusion and exclusion criteria
Untreated advanced melanoma
4. Methods and endpoints
- Exposure / intervention
Nivolumab + ipilimumab; nivolumab
- Comparator
Ipilimumab
- Endpoints
PFS, OS
- Statistical methods
HR
5. Actual results
- Results
5-year OS 52% (nivo+ipi), 44% (nivo), 26% (ipi); HR for death 0.52 and 0.63 vs ipilimumab. No sustained QoL deterioration.
- Absolute risks
5-year OS 52% vs 26%
- Authors' conclusion
Sustained long-term survival with nivolumab-containing regimens.
6. Strengths
- Randomised
- Long follow-up
7. Weaknesses
- Industry funded
- Active comparator
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Industry funding; otherwise robust design.
9. Assessment of the statistical interpretation
Shows that releasing immune checkpoints lets the immune system control metastatic cancer in many patients.
10. Relevance to the specific claim
Contradicts 'the immune system does not attack cancer'; shows modern therapy achieves long survival in metastatic disease.
11. Independent contrary findings
12. Transferability to Germany and Europe
High.
13. Overall methodological judgement
Strong evidence.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | some concerns |
| Precision of results | high |
| Directness | indirect |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
15. Linked fact checks
- The immune system does not fight cancer (no antibodies form against it), which shows the body accepts the tumour; therefore attacking it with chemotherapy is wrong. – Studies contradicting or limiting the claim
- Oncology only buys time: 'survival rates' are meaningless, patients die during treatment, and early diagnosis only makes you 'die early'. – Studies contradicting or limiting the claim
- Cancer is the body's own plan ('a self plan'): body cells are ordered to transform because this was necessary for the person's life; it is not caused by external agents. – Studies contradicting or limiting the claim