(Gastric Cancer) Is Keytruda ± Chemotherapy 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.
- October 2, 2020
- Reading time: 2 minutes
On September 3, 2020, Kohei Shitara published results in JAMA Oncology from the KEYNOTE-062 Phase 3 clinical trial comparing pembrolizumab (Keytruda) monotherapy and pembrolizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment in advanced gastric or gastroesophageal junction (G/GEJ) cancer patients.
The KEYNOTE-062 Phase 3 trial randomized advanced G/GEJ cancer patients (N=763) in a 1:1:1 ratio to three first-line treatment arms. Primary endpoints were PFS and OS in PD-L1-positive (CPS ≥1 and CPS ≥10) populations.
- Pembrolizumab monotherapy arm: Keytruda 200 mg every 3 weeks (N=256)
- Pembrolizumab + chemotherapy arm: Keytruda 200 mg every 3 weeks + chemotherapy (N=257)
- Placebo arm: placebo + chemotherapy (N=250)
Results at median follow-up of 29.4 months:
Overall Survival (Primary Endpoint) in PD-L1-positive (CPS ≥1): Median OS was 10.6 months (pembrolizumab monotherapy) / 12.5 months (pembrolizumab + chemotherapy) / 11.1 months (placebo). Although the pembrolizumab monotherapy arm performed better than the placebo arm, superiority was not demonstrated.
Overall Survival in PD-L1-positive (CPS ≥10): Median OS was 17.4 months (pembrolizumab monotherapy) / 12.3 months (pembrolizumab + chemotherapy) / 10.8 months (placebo). Superiority of pembrolizumab was not demonstrated.
Safety: Grade 3–5 adverse events occurred in 17% (pembrolizumab monotherapy) / 73% (pembrolizumab + chemotherapy) / 69% (placebo).
Based on the KEYNOTE-062 trial results, Kohei Shitara concluded that pembrolizumab monotherapy and pembrolizumab plus chemotherapy as first-line treatment for advanced G/GEJ cancer showed better OS than the placebo arm, with a lower incidence of adverse events in the monotherapy arm.
Source: Efficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer — The KEYNOTE-062 Phase 3 Randomized Clinical Trial (JAMA Oncol. 2020 Sep 3. doi:10.1001/jamaoncol.2020.3370)
- Immunotherapy
- Clinical trial drugs
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