Approval Status of Cancer Cell Therapy at Risk After Halting Phase III Trial 

MolMed Zalmoxis cell therapy

Following an unfavorable interim analysis, Milan-based MolMed has suspended a phase III trial of its cell therapy Zalmoxis that could threaten the conditional marketing authorization the treatment received in 2016. 

The halted clinical trial was evaluating the effects of Zalmoxis on patients with high-risk leukemia that have received a bone marrow transplant. The cell therapy consists of donor immune cells that are engineered to fight relapse and the transplant rejecting the body.

In an interim analysis, performed when about 50% of the expected 170 patients were enrolled, the therapy failed to meet the primary endpoint of the study. MolMed determined that those patients treated with Zalmoxis were not disease-free for a significantly longer time than those treated with the current standard of care. In response, the company has suspended the trial. 

The phase III study TK008 is currently suspended, not terminated,” a company representative told me. “The results of the interim analysis are not complete nor conclusive, as we have to investigate the interim analysis results in more detail.”

According to the representative, the interim analysis was not foreseen in the initial study plan. Instead, it was carried out as part of a review of the company’s product development plan. 

The results of the interim trial could threaten the approval status of Zalmoxis. Back in 2016, the EMA granted the cell therapy a conditional marketing approval. The approval was subject to the completion of this clinical trial, with the goal of confirming the efficacy and safety of Zalmoxis in patients with high-risk blood cancer. 

“This is clearly disappointing for Molmed,” Alan O’Connell, Partner ar the investor firm Seroba Life Sciences, told me. “The phase III trial was important to support the conditional approval for the product. As with other companies, the EMA provided approval on the condition that they increased the existing data pool by completing ongoing studies, or from new trials. Without this supporting data, the approval of Zalmoxis remains conditional as I understand.” 

The company is now waiting for a discussion with regulators to figure out the next steps. We have to wait for both EMA feedback on the conditional marketing approval renewal for the next year and for EMA indications following the interim analysis results,” said the representative.  

They emphasized that the company’s financial performance is not at risk. In 2018, MolMed made €28M in sales, of which just €223,000 came from sales of Zalmoxis. 

Image via Shutterstock

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