PharmaMar’s cancer drug Zepsyre has failed to prove more effective than chemo to treat ovarian cancer in Phase III, leading to a big hit to its stock.

Based in Madrid, PharmaMar develops cancer drugs derived from marine organisms. Unfortunately, one of these compounds, lurbinectedin (Zepsyre), has failed to show better efficacy in treating ovarian cancer than chemotherapy in a Phase III trial.

The announcement of the results on Friday afternoon made PharmaMar stock on Madrid’s exchange market plunge by 39%. The stock has slightly recovered since, but it’s still down by 29%.

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The results come from a Phase III clinical trial called CORAIL, in which PharmaMar was testing the efficacy of lurbinectedin in patients with ovarian cancer whose tumor is resistant to a first line of treatment with platinum therapy. When comparing lurbinectedin to two chemotherapy agents, topotecan and liposomal doxorubicin (PLD), PharmaMar’s drug showed about the same efficacy in keeping patients free of cancer progression.

Although the drug failed to meet the primary endpoint of improved efficacy, PharmaMar has remarked that it did show a better safety profile than the chemo drugs. This means that the drug could still have potential as a treatment for ovarian cancer with fewer side effects than chemotherapy.

Commenting on the plans for lurbinectedin, PharmaMar COO Pascal Besman told me: “We intend to discuss the data with regulators. In looking at the efficacy in the context of the safety profile, based on what we know at this early stage, these data are intriguing.”

Besman also mentioned that the company will keep the development of lurbinectedin in other cancer indications as planned. “We are well past half-way in our ATLANTIS relapsed small cell lung cancer trial,” he said, “and we expect to start our second line endometrial trial in the first half of this year.”

The failure of the CORAIL trial has been a big blow to PharmaMar, especially after another of its late-stage candidates, plitidepsin (Aplidin), was rejected as a treatment for multiple myeloma by the EMA earlier this month. The hit seems even bigger when considering that, as one of Spain’s leaders in oncology innovation, PharmaMar sets a role model for many aspiring biotechs within the country’s growing ecosystem.


Images via Shidlovski /Shutterstock; Google Finance

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