Gastric Cancer: Pembrolizumab as Potential New First-Line Standard Therapy
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هذه المقالة ملخص لمعلومات طبية دولية وليست نصيحة طبية، ولا يمكن أن تحل محل تشخيص طبيبك المعالج أو خطة العلاج. المعلومات المعروضة مجمّعة من منشورات عامة وبيانات رسمية لكبرى المؤسسات الطبية اليابانية؛ وتختلف ملاءمة ونتائج أي علاج من مريض لآخر ويجب أن يقيّمها طبيب مؤهل لكل حالة على حدة.
KEYNOTE-062 Trial Results
- July 8, 2019
- Reading time: 2 minutes
Between May 31 and June 4, 2019, the ASCO 2019 Annual Meeting in Chicago presented results from the KEYNOTE-062 Phase III clinical trial evaluating the safety and efficacy of pembrolizumab monotherapy as first-line treatment for gastric and gastroesophageal junction cancer.
Trial Design and Treatment Arms
KEYNOTE-062 was a Phase III randomized controlled trial with three parallel treatment arms:
Arm 1 - Pembrolizumab Monotherapy:
- Pembrolizumab 200 mg IV on Day 1
- Every 3 weeks
Arm 2 - Pembrolizumab Plus Chemotherapy:
- Pembrolizumab 200 mg IV on Day 1
- Plus Cisplatin 80 mg/m² on Day 1
- Plus 5-Fluorouracil 800 mg/m²/day on Days 1-5, or Capecitabine 1,000 mg/m² twice daily on Days 1-14
- Every 3 weeks
Arm 3 - Placebo Plus Chemotherapy (Control):
- Placebo on Day 1
- Plus Cisplatin 80 mg/m² on Day 1
- Plus 5-Fluorouracil 800 mg/m²/day on Days 1-5, or Capecitabine 1,000 mg/m² twice daily on Days 1-14
- Every 3 weeks
Primary endpoints: progression-free survival and overall survival
Patient Demographics
- Median Age: 62 years
- Tumor Location: Gastric cancer 69%, gastroesophageal junction cancer 30%
- PD-L1 Expression: Combined Positive Score (CPS) ≥1 in 100% of patients; CPS ≥10 in 37% (N=281 patients)
Clinical Trial Results
CPS ≥1 Subgroup (All Enrolled Patients)
Overall Survival (Primary Endpoint):
- Pembrolizumab monotherapy: 10.6 months
- Chemotherapy: 11.1 months
- Hazard Ratio: 0.91
Pembrolizumab monotherapy demonstrated non-inferior overall survival compared to chemotherapy control, meeting trial criteria for equivalence.
CPS ≥10 Subgroup (PD-L1 High-Expressing Tumors)
Overall Survival:
- Pembrolizumab monotherapy: 17.4 months
- Chemotherapy: 10.8 months
- Hazard Ratio: 0.69
2-Year Overall Survival Rate:
- Pembrolizumab: 39%
- Chemotherapy: 22%
Safety Profile
Grade 3+ Adverse Event Incidence:
- Pembrolizumab monotherapy: 17%
- Pembrolizumab plus chemotherapy: 73%
- Chemotherapy alone: 69%
Pembrolizumab monotherapy demonstrated the lowest adverse event rate. Most common treatment-related events included nausea and fatigue. No novel, unexpected adverse events were identified; safety profile was consistent with prior immunotherapy trials.
Clinical Conclusions
Principal investigator Josep Tabernero concluded that in PD-L1 positive, HER2-negative gastric and gastroesophageal junction cancer patients, first-line pembrolizumab monotherapy demonstrates overall survival outcomes comparable to or superior to chemotherapy, potentially establishing a new first-line standard treatment approach.
Related Gastric Cancer Treatment
- Immunotherapy
- Clinical Trial Therapeutics
- (Lung Cancer) Topotecan and Topotecan Plus Berzosertib Phase II Trial Results
- (Lung Cancer) HER2-Mutant Non-Small Cell Lung Cancer Treatment with Enhertu
- (Lung Cancer) Anti-B7-H3 Antibody DS-7300 Clinical Efficacy
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نساعدك في تنظيم المعلومات اللازمة للسفر الطبي إلى اليابان، والتواصل مع المؤسسات الطبية اليابانية، وترتيب استشارة رأي ثانٍ.الاستشارة الأولى مجانية؛ سيساعدك المستشار على توضيح الخطوات التالية.
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