Journal: Future oncology (London, England)
This article reviews early real‑world experience incorporating zolbetuximab into routine care for advanced gastric and gastroesophageal junction adenocarcinoma that express CLDN18.2 at high levels (2+/3+ in ≥75% of tumor cells).
Key points:
- Rationale and indication
- CLDN18.2 is emerging as an important biomarker and therapeutic target in advanced gastric/GEJ adenocarcinoma.
- Zolbetuximab, an anti‑CLDN18.2 monoclonal antibody, gained approval based on phase III data showing improved outcomes when added to first‑line fluoropyrimidine–platinum chemotherapy in CLDN18.2‑positive disease.
- Efficacy (from trials, briefly contextualized)
- Adding zolbetuximab to standard fluoropyrimidine–platinum improved key endpoints versus chemotherapy alone in biomarker‑selected patients.
- Toxicity profile
- The most frequent adverse events are gastrointestinal, especially nausea and vomiting.
- These effects are most pronounced during initial treatment cycles and are more problematic in patients with an intact stomach (no prior gastrectomy).
- Practical challenges in real‑world use
- Implementation is not straightforward despite clear trial benefits.
- Challenges include:
- Prolonged infusion and chair time.
- Short post‑reconstitution drug stability, requiring tight coordination by pharmacy and infusion staff.
- Need for extended post‑infusion observation.
- Difficult tolerability for some patients, driven mainly by GI toxicity early on.
- Contribution of the report
- Provides a detailed description of one center’s clinical experience integrating zolbetuximab into practice.
- Offers a practical drug evaluation focusing on workflow, toxicity management, and logistical considerations to help clinicians optimize use of this new targeted therapy.