“It would also be useful to learn whether the combination of cabozantinib and nivolumab is effective in non-clear cell carcinoma,” added Berthold. The question is whether the responses to treatment are durable or patients progress at some point.” He said longer-term data are needed for CheckMate 9ER: “The 18 months of follow-up is still quite short. However, the medical community is divided about whether two immunotherapies or immunotherapy plus an anti-angiogenic drug is the better choice, since the different combinations appear to have similar effectiveness.” (4)Ĭommenting on the findings, Dr Dominik Berthold, Head, Specialised Consultation for Urological Cancers Medical Oncology Service, Department of Oncology, Lausanne University Hospital, Switzerland said: “CheckMate 9ER met its efficacy endpoints and the combination can be considered a new first-line treatment option. Similar to the CheckMate 9ER trial, the KEYNOTE-426 and JAVELIN Renal 101 trials (2,3) combined an immune checkpoint inhibitor with an anti-angiogenic drug, whereas CheckMate 214 combined two immune checkpoint inhibitors. The findings add to mounting evidence showing the advantages of combination therapy over single drugs. As for immune-related side-effects, 19% of patients in the experimental arm needed corticosteroids just 4% needed corticosteroids for 30 days or longer. The overall rate of serious adverse events was similar between arms, but liver toxicity was more common in the combination arm. But only 3% had to stop both drugs because of toxicity compared to 9% of patients in the sunitinib arm. More than 50% of patients in the combination arm needed a dose reduction of cabozantinib due to adverse events. There was a consistent benefit of the combination over sunitinib in numerous subgroups including age, sex, PD-L1 expression, bone metastases, International Metastatic RCC Database Consortium (IMDC) risk group, and region of the world. The combination was superior to sunitinib for progression-free survival, overall survival, and response rate. The trial took two drugs used as monotherapies in the second line, nivolumab and cabozantinib, and combined them for use as a first-line treatment against standard of care, sunitinib. The late breaking results are presented at ESMO 2020. LUGANO, Switzerland – The results of the phase 3 CheckMate 9ER trial have provided a new first-line treatment option for patients with metastatic kidney cancer.
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