(Renal Cell Carcinoma) Is Opdivo Monotherapy or Opdivo Plus Yervoy Effective?
Medical Supporter — Avis d’information
Cet article est une synthèse d’informations médicales internationales et ne constitue pas un avis médical ; il ne remplace pas le diagnostic ni le plan de traitement de votre médecin traitant. Les informations présentées sont compilées à partir de publications publiques et de déclarations officielles d’établissements médicaux japonais ; l’adéquation et les résultats de toute thérapie varient selon chaque patient et doivent être évalués individuellement par un médecin qualifié.
- May 16, 2022
- 1 min read
On April 20, 2022, Dr. Michael B. Atkins and colleagues from Georgetown Lombardi Comprehensive Cancer Center published results in the Journal of Clinical Oncology from the Phase 2 clinical trial (NCT03117309) evaluating the efficacy and safety of Opdivo (nivolumab) monotherapy and Opdivo plus Yervoy (ipilimumab) in treatment-naive patients with advanced clear cell renal cell carcinoma (ccRCC).
This Phase 2 trial enrolled 123 treatment-naive patients with advanced ccRCC. Patients first received Opdivo monotherapy (Part A, up to 96 weeks); those with disease progression or stable disease at 48 weeks switched to Opdivo plus Yervoy (Part B). The primary endpoint was 1-year progression-free survival (PFS) rate in patients with PD-L1 expression of 0% and ≥20%.
Results:
Overall ORR: 34.1%. ORR by IMDC risk category: favorable-risk 57.1%, intermediate-/poor-risk 25.0%, sarcomatoid features 36.4%.
ORR by PD-L1 expression: 0% PD-L1: 26.9%; 1–20% PD-L1: 50.0%; ≥20% PD-L1: 75.0%. Median duration of response: 27.6 months. Primary endpoint 1-year PFS: 0% PD-L1: 34.6%; ≥20% PD-L1: 75.0%.
In Part A, 96 patients experienced disease progression or stable disease, of whom 35 entered Part B. Part B ORR: 11.4%. Grade 3 or higher adverse events: Opdivo monotherapy 35%; Opdivo plus Yervoy 43%.
Conclusion: Based on the Phase 2 trial results, Dr. Atkins and colleagues concluded that Opdivo monotherapy demonstrated meaningful anti-tumor activity in treatment-naive advanced ccRCC patients, with activity correlated with PD-L1 expression. The combination of Opdivo plus Yervoy showed limited anti-tumor activity in this setting.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.21.02938
-
Clinical Trial Medications
-
Immunotherapy
- (Lung Cancer) Phase II results for Topotecan and Topotecan + Berzosertib combination.
- (Lung Cancer) Efficacy of Enhertu in HER2-mutant non-small cell lung cancer (NSCLC).
- (Lung Cancer) Clinical outcomes of anti-B7-H3 antibody-drug conjugate DS-7300.
Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).
Vous envisagez des soins au Japon ? Besoin d’informations et d’aide ?
Nous vous aidons à rassembler les informations nécessaires pour un déplacement médical au Japon, à contacter les établissements japonais et à organiser une consultation de second avis.La première consultation est gratuite ; un conseiller vous aide à clarifier les prochaines étapes.
Figure 1
Figure 2
Figure 3
Figure 4