(Esophageal/Gastric Cancer) ASCO-GI 2018: Second-Line Pembrolizumab Plus Margetuximab Shows Efficacy in HER2-Positive Advanced Gastric and GEJ Adenocarcinoma
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Энэ нийтлэл нь олон улсын эмнэлгийн мэдээллийн эмхэтгэл бөгөөд эмнэлгийн зөвлөгөө биш; таны эмчийн оношлогоо, эмчилгээний төлөвлөгөөг орлохгүй. Энд буй мэдээлэл нь Японы томоохон эмнэлгийн байгууллагуудын нээлттэй эх сурвалжаас эмхэтгэсэн бөгөөд аливаа эмчилгээний тохиромж, үр дүн өвчтөн бүрээр өөр тул мэргэшсэн эмч тус бүрчлэн үнэлэх ёстой.
- April 6, 2018
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At the Gastrointestinal Cancers Symposium (ASCO-GI 2018) held in San Francisco, California, January 18–20, 2018, Dr. Daniel V.T. Catenacci of the University of Chicago Pritzker School of Medicine presented Phase 1b/2 clinical trial results (NCT02689284) evaluating pembrolizumab (Keytruda) plus the anti-HER2 antibody margetuximab as second-line therapy in patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with trastuzumab.
Trial Design
This trial evaluated second-line treatment in patients with HER2-positive gastric or GEJ adenocarcinoma who had received prior trastuzumab. The regimen consisted of a 21-day cycle with pembrolizumab 200 mg plus margetuximab at either 10 mg/kg or 15 mg/kg. The primary endpoint was response rate.
Two dosing cohorts were evaluated: 9 patients received 10 mg/kg, and the higher-dose 15 mg/kg cohort included 48 patients.
Efficacy Results
Of the 48 patients in the 15 mg/kg cohort, 38 were evaluable:
- Partial response (PR): 18.4% (N=7)
- Stable disease (SD): 28.9% (N=11)
Subgroup analysis of PR patients:
- North American patients (N=30): Response rate 8.3%
- Asian patients (N=18): Response rate 35.7%
By tumor location:
- Gastric cancer patients: 80%
- GEJ adenocarcinoma: 53%
Safety
Among all patients, one serious adverse event (AE) occurred. All other patients tolerated the combination of pembrolizumab plus margetuximab without that level of reaction, indicating a relatively high tolerability profile.
Conclusions
Based on these results, Dr. Daniel V.T. Catenacci concluded that second-line pembrolizumab plus margetuximab demonstrated meaningful antitumor activity and confirmed tolerability in HER2-positive advanced gastric and GEJ adenocarcinoma patients.
Source: Phase 1b/2 study of margetuximab (M) plus pembrolizumab (P) in advanced HER2+ gastroesophageal junction (GEJ) or gastric (G) adenocarcinoma (GEA). (ASCO-GI 2018, Abstract No. 140)
Tags: #GastricCancer #EsophagealCancer
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