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results
 
 

: CHECKMATE 214

 

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
 
 
 reported September 2017
 

HOW MANY

people participated in the trial?

A total of 1070 patients at 184 sites in 27 countries worldwide took part in the trial.

STUDY

DESIGN

What did the study look like?

All participating patients were randomly divided into two groups. Patients in one group were assigned nivolumab (OpdivoTM) in combination with ipilimumab (YervoyTM). Patients in the other group were treated with sunitinib (SutentTM), which is an approved treatment for RCC.

  • nivolumab (Opdivo™) is a fully human monoclonal antibody targeting PD-1
  • ipilimumab (Yervoy™) is a fully human monoclonal antibody targeting CTLA-4
  • sunitinib (Sutent™) is an oral, small-molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor
Studien Design Checkmate214 web

1) The combination of nivolumab and ipilimumab was given intravenously every 3 weeks for 4 doses.

2) After that patients received nivolumab intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the end of the study.

3) Sunitinib was taken by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the end of the study.

RESULTS

of the study

Undeniably, from the kidney cancer point of view, the most talked-about presentation at ESMO 2017 was the results of the Checkmate-214 study (ipi–nivo vs sunitinib in 1st line mRCC). The most striking results presented were a complete response (i.e. no evidence of disease) rate of 16% in patients with intermediate and poor risk features whose tumour tested positive for PD-L1.

The key take-home message is that this combination resulted in an overall survival advantage for the entire population in the study, but this survival advantage shown in these data was mainly driven by the patients who were defined as intermediate or poor risk at the outset of the study. From the patient perspective, it’s important to note that, in these data, the patients with low risk disease seemed to have better outcomes with sunitinib than with this new combination.

For further information: ESMO 2017: Nivolumab Plus Ipilimumab versus Sunitinib in First-Line Treatment for Advanced or Metastatic RCC

CONCLUSION

 

For the patient community, this represents a renewed emphasis on the importance of risk stratification in determining which therapy is best for them. For the majority of patients who are low risk, treatments such as sunitinib or pazopanib may remain the standard for this patient group.

One point that patient advocates should pay attention to is the significant number of patients on the ipi–nivo combination arm who required steroids (60%) to manage side-effects. There are significant toxicities associated with steroid use. Although this study presents really exciting results for the kidney cancer community, the IKCC raises the need for improved side effect management strategies for these patients, and encourages patients to continue enrolling in clinical trials that are testing other combinations including immune checkpoint antibodies together with targeted therapies.

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your experience 

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Disclaimer: This is a patient-friendly summary of the results of this clinical trial which has been medically reviewed, but is provided for informational purposes only.
 
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