ESMO 2020 — Towards a new combination therapy as first-line treatment in advanced renal cell carcinoma

  • Cristina Ferrario — Agenzia Zoe
  • Oncology Conference reports
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  • 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.  

Study design

  • 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.

Key results

  • 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.

Expert commentary

“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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