3 year follow-up of the CheckMate 9ER trial: NIVO + cabozantinib vs sunitinib for first-line treatment of aRCC

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Published: 19 Feb 2023
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Dr Mauricio Burotto - Bradford Hill, Recoleta, Chile

Dr Mauricio Burotto speaks to ecancer about the results of the 3-year follow-up from the phase 3 CheckMate 9ER trial at the 2023 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium.

He begins by outlining the results of the CheckMate 9ER trial. First-line nivolumab plus cabozantinib demonstrated superiority over sunitinib with 25.4 mo minimum follow-up in patients with aRCC.

After a 3-year minimum follow-up, survival and response benefits were maintained with nivolumab plus cabozantinib and remained consistent with previous follow-ups.

The median overall survival with N+C improved by 11.8 mo since the previous data cut. No new safety signals emerged with additional follow-up in either arm.

Dr Burotto concludes by stating that these results continue to support N+C as a first-line treatment for patients with aRCC.

The study is about advanced kidney cancer patients with metastatic renal cell carcinoma. This study is about treatment with a combination of pills – a TKI and immunotherapy in combination – compared with a pill that is sunitinib in this patient population. These results are the long-term results of the study with 44 months of follow-up. The main results of the study that were published three years ago in The New England Journal of Medicine show that the combination was better than the sunitinib, the monotherapy, regarding the progression-free survival, overall survival and response, that means shrink the tumour. 

These long-term results show this improvement is maintained over time and it’s independent of if the patient is an intermediate- or a high-risk patient. Regarding the response, the combination is better than sunitinib, than the monotherapy, in patients with favourable, intermediate and poor risk.

This is a randomised phase III trial that randomised 1:1 the combination of drugs with the monotherapy that is sunitinib. The main outcome of the trial was PFS, that is progression-free survival. It was a multicentre study in many parts of the world and in Chile we were the top enrollers in the world for this trial. For that reason I am presenting the data.

Many people thought at the beginning, with the results at the first publication, we don’t know how will be the results and the outcome in the long term. With these results after more than three years of follow-up the people and the medical oncologists can be very confident that the treatment is safe and is efficacious over time and is a very good option for metastatic RCC patients.

How do you think this will impact future treatment of advanced renal cell carcinoma?

I think it will be very important to put more patients in clinical trials. At the end we advance in medical oncology treatments having these big trials made all over the world. We have to put more patients in the studies to get more data to have more options for our cancer patients in the future