CHMP Recommends Approval of Lindis Biotech's Korjuny (catumaxomab) for Malignant Ascites
Key Insights
The CHMP has recommended KORJUNY® (catumaxomab) for malignant ascites (search) in adults with EpCAM (search)-positive carcinomas (search) who cannot receive further systemic anticancer therapy.
Clinical data from a Phase II/III trial demonstrated a statistically significant improvement in puncture-free survival for patients treated with KORJUNY®.
If approved by the European Commission, KORJUNY® will be the only drug available for cancer-directed treatment of malignant ascites (search) in the EU.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the approval of KORJUNY® (catumaxomab) for the intraperitoneal treatment of malignant ascites (search) (MA) in adults with epithelial cell adhesion molecule (EpCAM (search))-positive carcinomas (search). This decision marks a potential resurgence for catumaxomab, a trifunctional anti-CD3 (search) x anti-EpCAM antibody, which was previously available but withdrawn for commercial reasons. The positive opinion is a critical step toward making KORJUNY® the only approved drug for this specific cancer-directed treatment in the European Union. The European Commission is expected to make a final decision by the end of 2024.
Malignant ascites (search), characterized by the accumulation of fluid in the peritoneal cavity, is a common complication of advanced-stage cancers, including those of ovarian, gastric, colorectal, pancreatic, prostate, lung, and endometrial origin. Current management strategies primarily involve paracentesis, a procedure to drain the fluid, but this provides only temporary relief and can lead to complications. There are currently no evidence-based treatment guidelines or specific management recommendations for MA.
Clinical Evidence Supporting Approval
The CHMP recommendation is based on data from a Phase II/III study (IP-REM-AC-01), a randomized, international, multi-center clinical trial. The study demonstrated a statistically significant improvement in the primary endpoint of puncture-free survival. Patients treated with KORJUNY® experienced a four-fold increase in puncture-free survival compared to those treated with puncture alone (Heiss et al., 2010).
Prof. Carsten Bokemeyer, Director of the Department of Medical Oncology and Hematology at the University of Hamburg, UKE, emphasized the clinical significance of this development: "The availability of catumaxomab as a specific tumor-directed therapy is a clear benefit for patients in this difficult situation. Catumaxomab reduces the need for punctures, improves quality of life, and even seems to improve life expectancy in a number of cases."
Catumaxomab: A Bispecific Trifunctional Antibody
Catumaxomab is a bispecific trifunctional antibody that targets both the tumor cells and the immune system. One binding site of the antibody binds to the EpCAM (search) marker, which is highly expressed on various carcinomas (search), including cancer stem cells. The other binding sites activate T-cells and Fc-gamma receptor-positive cells (macrophages), leading to tumor cell destruction and a patient-specific vaccination effect.
Future Development
Lindis Biotech (search) is also investigating catumaxomab in other indications, including high and intermediate-risk non-muscle invasive bladder cancer (search) (HR-NMIBC). A Phase I dose escalation and expansion study (CATUNIBLA) has completed recruitment, with encouraging interim data presented at the ESMO 2024 conference in Barcelona. This suggests a broader potential for catumaxomab in treating EpCAM (search)-positive carcinomas (search).
Dr. Horst Lindhofer, Chief Executive Officer of Lindis Biotech (search), expressed enthusiasm about the CHMP recommendation and the opportunity to bring this pioneering therapy back onto the market. "We very much look forward to the formal approval of this treatment and to further develop the potential of this unique immunotherapy in other indications with high unmet medical need, such as bladder cancer (search)."