(Renal Cell Carcinoma) Is Opdivo Plus Cabozantinib Effective?
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CheckMate-9ER: 3-Year Follow-Up of Nivolumab Plus Cabozantinib
- March 20, 2023
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From February 16–18, 2023, Mauricio Burotto and colleagues from Bradford Hill Clinical Research Center presented at ASCO GU 2023 in San Francisco, California, the 3-year follow-up efficacy and safety data of the CheckMate-9ER Phase 3 trial evaluating nivolumab (Opdivo) plus cabozantinib in treatment-naive patients with advanced or metastatic renal cell carcinoma.
Trial Design
CheckMate-9ER was an international, randomized, open-label Phase 3 trial enrolling 323 treatment-naive patients with advanced or metastatic renal cell carcinoma, randomized to:
- Opdivo (240 mg, 2-week cycles) + cabozantinib (40 mg once daily) group
- Sunitinib group (50 mg once daily for 4 weeks on, 2 weeks off, 6-week cycles)
Primary endpoint: PFS. Secondary endpoints: OS, ORR, and adverse event rate.
Efficacy Results (at median follow-up of 36.5 months)
| Endpoint | Opdivo + Cabozantinib | Sunitinib |
|---|---|---|
| Median PFS | 16.6 months | 8.4 months |
| Median OS | 49.5 months | 35.5 months |
| ORR | 56% | 28% |
| Complete response rate | 12% | 5% |
Safety Profile
- Any adverse events: Opdivo + Cabozantinib 97% / Sunitinib 93%
- Grade 3 or higher adverse events: Opdivo + Cabozantinib 67% / Sunitinib 55%
Conclusions
Based on the 3-year follow-up of CheckMate-9ER, Mauricio Burotto and colleagues concluded that nivolumab plus cabozantinib maintained sustained survival and response rates in treatment-naive advanced or metastatic renal cell carcinoma, with an improvement in OS compared to prior follow-up, supporting the regimen as a first-line treatment option.
Source: https://meetings.asco.org/abstracts-presentations/216519
- Immunotherapy
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