(Melanoma) Efficacy of Opdivo as Adjuvant Therapy After Resection?
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At the European Society for Medical Oncology (ESMO) Annual Meeting held in Barcelona, Spain from September 27 to October 1, 2019, Jeffrey S. Weber presented the results from the CheckMate 238 Phase III clinical trial: a 3-year follow-up analysis evaluating the efficacy and safety of anti-PD-1 antibody Opdivo (nivolumab) or anti-CTLA-4 Yervoy (ipilimumab) as adjuvant therapy in patients with resected malignant melanoma.
The CheckMate 238 Phase III clinical trial evaluated Opdivo or Yervoy as adjuvant therapy in patients with resected malignant melanoma, with recurrence-free survival (RFS) as the primary endpoint. Treatment groups were as follows:
- Opdivo group: Initial treatment with Opdivo 3 mg/kg every 2 weeks for 4 cycles, followed by Opdivo 3 mg/kg every 12 weeks for 1 year (N=453)
- Yervoy group: Initial treatment with Yervoy 10 mg/kg every 4 weeks for 4 cycles, followed by Yervoy 10 mg/kg every 12 weeks for 1 year (N=453)
At a median follow-up of 36 months, the results showed a significant improvement in the primary endpoint of recurrence-free survival with Opdivo compared to Yervoy. The 3-year recurrence-free survival rates were: Opdivo group 58% vs. Yervoy group 45%.
In the subgroup analysis by PD-L1 expression and BRAF mutation status:
- PD-L1 ≥5%: Opdivo vs. Yervoy showed a 43% improvement in RFS
- PD-L1 <5%: Opdivo vs. Yervoy showed a 27% improvement in RFS
- BRAF mutation positive: Opdivo vs. Yervoy showed a 21% improvement in RFS
- BRAF mutation negative: Opdivo vs. Yervoy showed a 40% improvement in RFS
All subgroups demonstrated improvement with Opdivo.
Based on the CheckMate 238 trial results, Jeffrey S. Weber concluded: In patients with resected malignant melanoma receiving adjuvant therapy with anti-PD-1 antibody Opdivo or anti-CTLA-4 Yervoy, Opdivo demonstrated significantly improved recurrence-free survival compared to Yervoy regardless of PD-L1 expression or BRAF mutation status.
Source: ESMO 2019 Oncology News
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