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.

NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines^®)

ZELVARA + chemotherapy is included as an NCCN Category 1, preferred regimen for first-line treatment of CLDN18.2+/HER2− advanced gastric/GEJ adenocarcinoma.^†

See Efficacy Data Explore MOA

Not a real patient.

Proven Efficacy

BEACON-1 Trial Results

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.

The Science

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 About the Mechanism of Action

Clinical Evidence

Pivotal Clinical Trials

Phase 3

BEACON-1

Design	Randomized, double-blind, placebo-controlled
Arms	ZELVARA + mFOLFOX6 vs Placebo + mFOLFOX6
N	565 patients
Primary EP	PFS per BICR

Phase 3

BEACON-2

Design	Randomized, double-blind, placebo-controlled
Arms	ZELVARA + CAPOX vs Placebo + CAPOX
N	510 patients
Primary EP	PFS per BICR

Differentiated Therapy

Why ZELVARA for Your CLDN18.2+ Patients

Dual Mechanism

ADCC + CDC: Two independent immune-mediated pathways of tumor cell destruction targeting CLDN18.2

Consistent Benefit

Statistically significant OS and PFS improvement across two Phase 3 trials with different chemo backbones

Manageable Safety

Predictable AE profile with proactive antiemetic prophylaxis. No new safety signals vs. known mAb class effects

Note: Cross-trial comparisons should be interpreted with caution due to differences in study design, patient populations, and endpoints. Please refer to the full Prescribing Information for comprehensive clinical data.

Explore

Clinical Resources

Efficacy

KM curves, forest plots, and response data

Safety

Adverse events and tolerability profile

Dosing

Calculator, infusion schedule, premedication

Resources

Downloads, patient support, reimbursement

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%).

Please see full Prescribing Information.

^†Referenced with permission from the NCCN Guidelines^® for Gastric Cancer V.1.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed January 15, 2025. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. To view the most recent version, visit NCCN.org. NCCN Guidelines^® and NCCN Category 1 are registered trademarks of National Comprehensive Cancer Network, Inc. This is a mock citation created for portfolio demonstration purposes only. This content has not been reviewed or endorsed by the National Comprehensive Cancer Network^® (NCCN^®).

Important Safety Information

INDICATIONS AND USAGE

ZELVARA (celdatuzumab-mkrz) is indicated, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative, claudin 18.2 (CLDN18.2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. CLDN18.2 positivity should be determined by an FDA-approved test.

Warnings and Precautions

Nausea and Vomiting: ZELVARA can cause severe nausea and vomiting. In the BEACON-1 trial, nausea occurred in 70.2% of patients treated with ZELVARA plus chemotherapy, including Grade 3 events in 14.8%. Vomiting occurred in 64.8%, including Grade 3 events in 12.1%. Administer antiemetic prophylaxis prior to and during treatment. Withhold, dose reduce, or permanently discontinue based on severity. Infusion-Related Reactions: Infusion-related reactions have been reported. Monitor patients during and after infusion. Interrupt or slow the rate of infusion for mild to moderate reactions. Permanently discontinue for severe or life-threatening reactions. Embryofetal Toxicity: Based on its mechanism of action and findings from animal studies, ZELVARA can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.

Adverse Reactions

The most common adverse reactions (≥20%) in patients receiving ZELVARA plus chemotherapy were nausea (70.2%), vomiting (64.8%), decreased appetite (42.1%), fatigue (38.4%), diarrhea (28.7%), and peripheral neuropathy (22.5%). Serious adverse reactions occurred in 42% of patients treated with ZELVARA plus chemotherapy, including vomiting (8.2%), nausea (4.1%), dehydration (3.8%), and decreased appetite (2.4%). Fatal adverse reactions occurred in 2.1% of patients.

Drug Interactions

No formal drug interaction studies have been conducted with ZELVARA. No clinically significant pharmacokinetic interactions are expected based on the known elimination pathways of celdatuzumab.

Use in Specific Populations

Pregnancy: ZELVARA can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Lactation: Advise women not to breastfeed during treatment and for 3 months after the last dose. Females and Males of Reproductive Potential: Verify pregnancy status prior to initiation. Advise females to use effective contraception during treatment and for 3 months after the last dose. Pediatric Use: The safety and efficacy of ZELVARA have not been established in pediatric patients. Hepatic Impairment: No dose adjustment is recommended for patients with mild hepatic impairment. ZELVARA has not been studied in patients with moderate or severe hepatic impairment.

ZELVARA® (celdatuzumab-mkrz)

Proven Efficacy

The Science

Clinical Evidence

BEACON-1

BEACON-2

Differentiated Therapy

Dual Mechanism

Consistent Benefit

Manageable Safety

Explore

Efficacy

Safety

Dosing

Resources

Important Safety Information

WARNING: NAUSEA AND VOMITING

Important Safety Information

INDICATIONS AND USAGE

Warnings and Precautions

Adverse Reactions

Drug Interactions

Use in Specific Populations

ZELVARA^® (celdatuzumab-mkrz)