Subcutaneous delivery of nivolumab is effective in treating metastatic ccRCC

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Published: 30 Jan 2024
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Dr Saby George - Roswell Park Comprehensive Cancer Center, New York, USA

Dr Saby George speaks to ecancer about the pharmacokinetics, efficacy, and safety results from CheckMate 67T trial.

This study evaluated the pharmacokinetics and objective response rate non-inferiority of subcutaneous nivolumab compared to intravenous nivolumab in patients with locally advanced or metastatic clear cell renal cell carcinoma.

In this study the co-primary pharmacokinetics and key powered secondary objective response rate endpoints were met.

The results support the use of nivolumab subcutaneously as a new option to improve healthcare efficiency.

The safety profile for administering nivolumab either way was the same.

Subcutaneous administration of nivolumab is effective in treating metastatic ccRCC

Dr Saby George - Roswell Park Comprehensive Cancer Center, New York, USA

The study CheckMate 67T which was a late breaking abstract today, presented at GU ASCO 2024, was a large randomised phase III trial comparing the subcutaneously administered nivolumab to intravenously administered nivolumab in treatment refractory kidney cancer patients.

We presented the results of PK, efficacy and safety today. This was tested in treatment refractory kidney cancer patients who had 1-2 prior therapies and who did not have prior immunotherapies before enrolment. The study randomised patients in a 1:1 fashion to receive subcutaneously administered nivolumab given every four weeks versus intravenously administered nivolumab given every two weeks. The coprimary endpoints were the pharmacokinetic endpoints of PK, C average day 28 and C minimum at steady state. The key powered secondary endpoint was objective response rate by blinded independent central review.

These results are after a minimum follow-up of 8 months on the study and the study enrolled patients at 73 different centres across 17 countries. The results showed that the study met its coprimary endpoints for PK as well as met its secondary endpoint for objective response rate. So both were tested for non-inferiority against the intravenously administered nivolumab.

The safety was consistent across both the arms and the study was fairly well balanced. Most importantly, the subcutaneous administration took only five minutes or less as opposed to the median administration time for intravenously given nivolumab was 30 minutes.

Do you think this will clinically impact the treatment?

Of course this is thought to be practice changing because this may reduce the treatment burden, this may reduce the time required for treatment, reduce the need for an infusion chair, intravenous access, port placement etc. Patients prefer subcutaneously administered treatment over IV because of the convenience itself – it’s easy, it can be given in clinic, reduce time spent in the cancer centre.

So considering every of these advantages, I bet this will be taken up significantly by the oncologists and patients.

Is there anything else you’d like to add?

One more thing I would like to add. This has the potential to improve access so patients in remote areas can be given it in clinic as opposed to large infusion centres which are typically seen in big towns or major cities. So it may improve access to care. By decompressing infusion centres off of intravenously given nivolumab, one of the advantages is that we can save a lot of infusion chair times, thus allowing patients to receive treatment faster in general. Compared to you know, if this is adding to wait time, this may be reduced, especially at large centres like ours.