Results of Phase 3 Study Find New First-Line Treatment Option for Metastatic Kidney Cancer

The CheckMate 9ER trial took 2 drugs used as monotherapies in the second line of therapy, nivolumab and cabozantinib, and combined them for use as a first-line treatment against standard of care, sunitinib.

The results of a phase 3 study presented at the 2020 European Society for Medical Oncology Meeting found a new first-line treatment option for patients with metastatic kidney cancer, according to the study authors.

The CheckMate 9ER trial took 2 drugs used as monotherapies in the second line of therapy, 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, according to the study. Further, there was a consistent benefit of the combination over sunitinib in numerous subgroups, including age, sex, programmed death-ligand 1 expression, bone metastases, International Metastatic RCC Database Consortium risk group, and region of the world.

The findings showed more than 50% of patients in the combination arm needed a dose reduction of cabozantinib due to adverse events (AEs), but only 3% had to stop both drugs because of toxicity compared with 9% of patients in the sunitinib arm. The overall rate of serious AEs was similar between arms, but liver toxicity was more common in the combination arm, according to the study authors. For immune-related AEs, 19% of patients in the experimental arm needed corticosteroids, whereas just 4% needed corticosteroids for 30 days or longer.

“The results with combination therapy were statistically significant and clinically meaningful. The risk of progression or death was cut by almost 50%, death was cut by 40%, and the response rate doubled. This will become an important treatment option to choose from,” study author Toni K. Choueiri, MD in a press release.

Even with these results, longer-term data are needed for CheckMate 9ER, according to the study authors.

“The 18 months of follow-up is still quite short. The question is whether the responses to treatment are durable or patients progress at some point,” said Dominik Berthold, MD, specialized consultation for Urological Cancers Medical Oncology Service in a press release.

Berthold also added that it would be useful to learn whether the combination of cabozantinib and nivolumab is effective in non-clear cell carcinoma.

“This is a minority of patients with advanced kidney cancer which are not well studied and were excluded from this trial,” Berthold said.

REFERENCE

New first-line treatment option for metastatic kidney cancer, according to results of phase 3 study. ESMO 2020. https://www.esmo.org/meetings/esmo-virtual-congress-2020/meeting-resources/news/esmo2020-metastatic-kidney-cancer-nivolumab-cabozantinib-checkmate9er. Published September 19, 2020. Accessed September 22, 2020.