EMA Authorizes Korjuny for Malignant Ascites

In its October 2024 meeting, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave the green light for Korjuny (catumaxomab, Lindis Biotech GmbH) to be used for the intraperitoneal treatment of malignant ascites in patients not eligible for further systemic anticancer therapy.
The active substance of Korjuny is catumaxomab, a monoclonal bispecific trifunctional antibody that targets epithelial cell adhesion molecules (EpCAMs) on tumor cells and CD3 antigen on T cells. It induces an immunoreaction against EpCAM-expressing tumor cells. 
EpCAMs are transmembrane glycoproteins that mediate cell adhesion in epithelia and are involved in cell migration, proliferation, and differentiation.
Catumaxomab was registered in 2009 for the treatment of malignant ascites of various EpCAM-positive malignancies, including ovarian, gastric, breast, and colorectal cancer.
Fewer Paracenteses Needed
Catumaxomab reduces the need for paracenteses in patients with malignant ascites. 
In a phase 2/3 trial, it showed a clear clinical benefit in patients with malignant ascites secondary to epithelial cancers, especially gastric cancer, with an acceptable safety profile. 
For the trial, 258 cancer patients with recurrent symptomatic malignant ascites resistant to conventional chemotherapy were randomly assigned to paracentesis plus catumaxomab or paracentesis alone and stratified by cancer type: 129 ovarian and 129 nonovarian. 
Puncture-free survival was significantly longer in the catumaxomab group (median, 46 days vs 11 days) as was median time to next paracentesis (77 vs 13 days). In addition, catumaxomab patients had fewer signs and symptoms of ascites than control patients, with overall survival showing a positive trend for the catumaxomab group.
The CASIMAS two-arm, randomized, multicenter, open-label, phase 3b study investigated the safety and efficacy of four 3-hour catumaxomab infusions with/without prednisolone premedication to reduce catumaxomab-related adverse events in patients with malignant ascites due to epithelial cancer. The study confirmed the safety and efficacy of catumaxomab administered in this manner.
In the SECIMAS trial, the feasibility of a re-challenge with four catumaxomab intraperitoneal infusions in patients who had already received a first cycle of four infusions in the phase 3 CASIMAS study was investigated. It found that most patients benefitted from a second cycle of catumaxomab and concluded that a re-challenge seemed to be feasible and safe for selected patients with recurrent malignant ascites due to carcinoma after a first cycle of catumaxomab.
Korjuny must be administered under the supervision of a physician experienced in the use of anticancer medicinal products. The most common side effects of the treatment are pyrexia, abdominal pain, nausea, and vomiting.
 
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