Portfolio Demonstration Only. ZELVARA (celdatuzumab-mkrz) is not a real drug product. All brand names, clinical data, and regulatory information on this site are entirely fictional, created to demonstrate pharmaceutical HCP website design and development capabilities. This site is part of Daniel Tran's portfolio.
First and only CLDN18.2-targeted therapy
ZELVARA® (celdatuzumab-mkrz)
For the first-line treatment of adults with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, in combination with chemotherapy.
Targeting CLDN18.2. Advancing Survival.
BEACON-1 Trial Results — ZELVARA + mFOLFOX6 vs Placebo + mFOLFOX6
Overall Survival
0.74
Hazard Ratio
95% CI: 0.60–0.92 · p=0.0041
18.6 vs 15.2 months median OS
Progression-Free Survival
0.73
Hazard Ratio
95% CI: 0.59–0.91 · p=0.0049
10.8 vs 8.4 months median PFS
Overall Response Rate
48.6%
ORR (ZELVARA + chemo)
vs 39.2% (placebo + chemo)
CR: 4.2% · PR: 44.4%
BEACON-1: Phase 3, randomized, double-blind, placebo-controlled trial. N=565 patients with CLDN18.2+/HER2− advanced gastric or GEJ adenocarcinoma.
Why CLDN18.2?
Claudin 18.2 (CLDN18.2) is a tight junction protein normally expressed in gastric epithelial cells. In gastric and GEJ adenocarcinomas, CLDN18.2 is frequently overexpressed on the tumor cell surface, making it an attractive therapeutic target.
Approximately 38–52% of gastric/GEJ cancers express CLDN18.2 at levels suitable for targeted therapy. ZELVARA binds specifically to CLDN18.2, engaging the immune system to destroy tumor cells through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Learn more about the mechanism of action →Pivotal Clinical Trials
BEACON-1
| Design | Randomized, double-blind, placebo-controlled |
| Arms | ZELVARA + mFOLFOX6 vs Placebo + mFOLFOX6 |
| N | 565 patients |
| Primary EP | PFS per BICR |
BEACON-2
| Design | Randomized, double-blind, placebo-controlled |
| Arms | ZELVARA + CAPOX vs Placebo + CAPOX |
| N | 510 patients |
| Primary EP | PFS per BICR |
Important Safety Information
Warnings and Precautions: ZELVARA can cause severe nausea and vomiting. Administer antiemetic prophylaxis prior to and during treatment. Infusion-related reactions have been reported. Based on its mechanism of action, ZELVARA can cause fetal harm.
Most Common Adverse Reactions (≥20%): nausea (70.2%), vomiting (64.8%), decreased appetite (42.1%), fatigue (38.4%), diarrhea (28.7%), and peripheral neuropathy (22.5%).