The results of the phase 3 CheckMate 9ER trial have provided a new first-line treatment option for patients with metastatic kidney cancer.
The late breaking results are presented at ESMO 2020.
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 combination was superior to sunitinib for progression-free survival, overall survival, and response rate.
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.
More than 50% of patients in the combination arm needed a dose reduction of cabozantinib due to adverse events.
But only 3% had to stop both drugs because of toxicity compared to 9% of patients in the sunitinib arm.
The overall rate of serious adverse events was similar between arms, but liver toxicity was more common in the combination arm.
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 findings add to mounting evidence showing the advantages of combination therapy over single drugs.
Similar to the CheckMate 9ER trial, the KEYNOTE-426 and JAVELIN Renal 101 trials combined an immune checkpoint inhibitor with an anti-angiogenic drug, whereas CheckMate 214 combined two immune checkpoint inhibitors.