- In patients with advanced clear cell renal cell carcinoma (aRCC), the first-line therapy with nivolumab-cabozantinib doubles the progression-free survival (PFS) and significantly improves overall survival (OS) versus sunitinib.
- The combination is well tolerated and leads to a better quality of life (QoL) versus sunitinib.
- Nivolumab-cabozantinib is a potential new first-line treatment in this population.
Why this matters?
- With expanding treatment options for patients with aRCC, the overall, efficacy, safety and QoL benefits as well as patient characteristics should be taken in to account when choosing the therapy.
- Phase 3 study CheckMate 9ER.
- 651 patients randomized to the combination (nivolumab 240 mg IV Q2W + cabozantinib 40 mg PO QD; n=323) or sunitinib (50 mg PO, cycles of 4 weeks on/2 off; n=328) until disease progression or unacceptable toxicity.
- Primary endpoint: PFS.
- Secondary endpoints: OS, objective response rate (ORR), safety.
- Exploratory endpoints: HRQoL, efficacy in prespecified subgroups.
- Funding: Bristol-Myers Squibb, Ono Pharmaceutical Company Ltd., Exelixis Inc.
- Median follow-up: 18.1 months.
- Median PFS doubled with the combination (HR 0.51, P<.0001 median v months in combination vs. respectively sunitinib.>
- OS significantly improved in the nivolumab-cabozantinib (HR 0.60; P=.0010; medians not reached) vs. sunitinib.
- ORR: 55.7% v 27.1% in nivolumab-cabozantinib and sunitinib group, respectively.
- Benefits were consistent over sunitinib across many baseline characteristics.
- The overall rate of adverse events was similar between arms with a low rate of treatment-related discontinuation in the combination group.
“CheckMate 9ER met its efficacy endpoints and the combination can be considered a new first-line treatment option. It would also be useful to learn whether the combination of cabozantinib and nivolumab is effective in non-clear cell carcinoma”. Dominik Berthold, Head, Specialised Consultation for Urological Cancers Medical Oncology Service, Department of Oncology, Lausanne University Hospital, Switzerland.
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