(Renal Cell Carcinoma) Is Opdivo Monotherapy or Opdivo Plus Yervoy Effective?
Medical Supporter — Informationshinweis
Dieser Artikel ist eine Zusammenfassung internationaler medizinischer Informationen und stellt keine medizinische Beratung dar; er ersetzt nicht die Diagnose oder den Behandlungsplan Ihres behandelnden Arztes. Die dargestellten Informationen stammen aus öffentlichen Veröffentlichungen und offiziellen Angaben führender japanischer medizinischer Einrichtungen; Eignung und Wirkung einer Therapie sind individuell und müssen von einem qualifizierten Arzt beurteilt werden.
- 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).
Behandlung in Japan im Blick? Brauchen Sie Informationen und Unterstützung?
Wir helfen Ihnen, die für eine medizinische Reise nach Japan nötigen Informationen zu ordnen, kontaktieren japanische Einrichtungen und organisieren eine Zweitmeinungsberatung.Die Erstberatung ist kostenlos; ein Berater hilft Ihnen, die nächsten Schritte zu klären.
Figure 1
Figure 2
Figure 3
Figure 4