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Association details:
| Biomarker: | CLDN18.2 expression + HER-2 negative |
|---|---|
| Cancer: | Gastroesophageal Junction Adenocarcinoma |
| Drug: | Vyloy (zolbetuximab-clzb) (CLDN18.2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 GLOW Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-negative Locally Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
Published date:
12/16/2022
Excerpt:
Astellas Pharma Inc...announced positive topline results from the Phase 3 GLOW clinical trial evaluating the efficacy and safety of zolbetuximab in combination with CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin)...The GLOW study met its primary endpoint showing statistical significance in progression-free survival (PFS) for patients treated with zolbetuximab plus CAPOX compared to placebo plus CAPOX. In addition, the study met a key secondary endpoint, overall survival (OS), showing statistical significance for patients treated with zolbetuximab plus CAPOX compared to placebo plus CAPOX.
Secondary therapy:
CAPOX
Trial ID:
Source:
Title:
Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 SPOTLIGHT Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-Negative Locally Advanced or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
Published date:
11/17/2022
Excerpt:
Astellas Pharma Inc...announced positive topline results from the Phase 3 SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in combination with mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil)...The SPOTLIGHT trial enrolled 566 patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. The study met its primary endpoint showing statistical significance in progression-free survival (PFS) for patients treated with zolbetuximab plus mFOLFOX6 compared to placebo plus mFOLFOX6.
Secondary therapy:
Modified FOLFOX6
Trial ID:
