European Medicines Agency Approval for Cancer-Related Abdominal Fluid Accumulation (Ascites): Catumaxomab

In October 2024, the European Medicines Agency (EMA) approved Lindis Biotech's Korjuny, containing catumaxomab, for the treatment of malignant ascites. This approval is an important step, particularly because of its potential to improve quality of life in patients with advanced cancer.

Korjuny stands out as an effective option for patients with abdominal ascites who are unsuitable for standard systemic anticancer treatment.

Malignant ascites is defined, particularly in advanced epithelial cancers such as ovarian, gastric, and colorectal cancer, as fluid accumulation in the abdominal cavity, a condition that causes patients considerable discomfort. Abdominal ascites means a buildup of fluid in the abdominal cavity. It is not a chemical acid; it is simply the name used in medical terminology.

Catumaxomab: The Power of a Trifunctional Antibody

The active ingredient in Korjuny, catumaxomab, is a monoclonal bispecific trifunctional antibody. It targets epithelial cell adhesion molecules (EpCAM) on tumor cells and the CD3 antigen on immune cells. By triggering an interaction between these two antigens, catumaxomab enables the immune system to attack cancer cells, offering an effective, targeted approach to fighting cancer.

EpCAM molecules are found on tumor cell surfaces and play a role in cell migration, proliferation, and differentiation. EpCAM-targeted treatments may therefore be effective particularly in EpCAM-positive cancers such as ovarian, gastric, breast, and colorectal cancer.

An Old Approval, a New Commercial Product

Catumaxomab, formerly marketed as Removab, was approved by the European Medicines Agency (EMA) in 2009 for malignant ascites caused by EpCAM-positive cancers. However, the drug was voluntarily withdrawn from the United States market in 2013 and the European market in 2017 for commercial reasons. The main reason concerned commercial expectations: the product served a limited patient population, and marketing costs and low sales made it economically unsustainable. Manufacturer Neovii Biotech decided to stop marketing it and ask the European Commission to withdraw it from the market.

It is stated that there was no problem with the drug's efficacy or safety; it simply failed to perform sufficiently in terms of commercial profitability. Interestingly, in 2024 it was approved for reintroduction to the European market under a different name (Korjuny) and a new manufacturer (Lindis Biotech).

Efficacy Supported by Clinical Data

In treating malignant ascites, Korjuny offers significant advantages compared with fluid drainage (paracentesis) alone.

Paracentesis is a procedure performed by a doctor, usually under ultrasound (USG) guidance. It involves inserting a needle into the abdomen to remove excess fluid.

Results

A phase 2/3 study demonstrated clinically meaningful benefits of catumaxomab in patients with malignant ascites. The 258 participants were randomly assigned to two groups: paracentesis alone or paracentesis plus catumaxomab. The results showed that the catumaxomab group's puncture-free interval had a median of 46 days, compared with 11 days in the paracentesis-only group. Median time to the next paracentesis was also significantly longer with catumaxomab (77 days versus 13 days).

Treatment improved quality of life while substantially reducing cancer-related abdominal fluid accumulation and its associated signs and symptoms. CASIMAS, a phase 3b study, confirmed the safety and efficacy of catumaxomab infusions and concluded that prednisolone premedication could reduce treatment-related adverse effects.

Retreatment: The Treatment Cycle

A second phase 3 study, SECIMAS, investigated whether catumaxomab rechallenge was safe. Patients benefiting from the first treatment cycle could receive further infusions, which were considered a safe treatment strategy.

Adverse Effects and Safety Profile

Although catumaxomab was generally well tolerated, some patients experienced common adverse effects including fever, abdominal pain, nausea, and vomiting. Premedication with drugs such as prednisolone is therefore recommended. However, the studies indicate that treatment is safe and does not cause serious adverse effects.

Conclusion: A New Alternative in the Fight Against Cancer

EMA approval of Korjuny is an important milestone in improving quality of life for patients with advanced cancer. Catumaxomab's efficacy and safety have been demonstrated in clinical studies. Its ability to reduce the need for paracentesis in malignant ascites makes it particularly attractive. With the possibility of rechallenge and an acceptable safety profile, Korjuny stands out as a promising cancer treatment option.

This drug offers new hope, particularly to patients unsuitable for systemic treatments such as chemotherapy.