Novartis drug against prostate cancer shortly before approval

Frankfurt In Europe, a novel drug against prostate cancer is about to be approved. The drug Pluvicto from the Basel-based pharmaceutical company Novartis promises improved therapy and longer survival times, especially for patients with advanced prostate tumors that have already metastasized.

Novartis is expecting official marketing approval from the EU Commission in the next few days. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency EMA had already recommended approval in mid-October. The drug has been approved in the USA since March. The success is preceded by around a decade of fundamental work at the German Cancer Research Center (DKFZ).

The approval is based on a study in patients whose cancer continued to spread despite previous hormone and chemotherapy. According to Novartis, the risk of death among patients was reduced by 38 percent. The average survival time (“overall survival”) improved compared to the standard treatment from 11.3 to 15.3 months. This is considered a major advance in this patient group.

In addition, the Basel-based group also announced the positive results of another study on Monday, in which patients without previous chemotherapy were treated with Pluvicto. Novartis now intends to apply for a corresponding extension of the approvals in 2023.

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The medical need in prostate cancer therapy is still significant. According to data from the Robert Koch Institute, there are around 68,000 new cases and around 15,000 deaths every year in Germany alone. Across Europe, the number of new cases is estimated at around 470,000 and the number of deaths at more than 108,000. Pluvicto is initially only an option for a small proportion of patients. Analysts already see peak sales for the new development at more than $1.5 billion.

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The Novartis drug is thus an example of step-by-step progress in the treatment of prostate cancer and of the potential of a special class of active substances: the so-called radioligand therapies. These are medicines that transport a radioactive component to the tumor cells in a targeted manner and thus, in principle, combine radiotherapy and drug therapy.

In the case of the Novartis drug, a radioactive variant of the heavy metal lutetium, the isotope lutetium-177, is used. Coupled to a connecting molecule, it is transported in a targeted manner to a receptor that is particularly common on prostate cancer cells, the prostate-specific membrane antigen (PSMA). There it is taken up by the cancer cells. The radiation from the lutetium isotope causes DNA damage in the cell, which then dies. The radioactivity of the lutetium isotope is short-lived with a half-life of a few days.

Also a German research success of the DKFZ

The therapy was originally researched by scientists from the German Cancer Research Center (DKFZ) and the Heidelberg University Hospital. From the point of view of DKFZ board member Michael Baumann, the active substance is therefore also an “outstanding example of the transfer of excellent research results into clinical application”.

In 2014, the DKFZ had exclusively awarded the rights to further develop and market the therapy to ABX GmbH in Radeberg. This licensed the rights to the US company Endocyte in 2017, which in turn was taken over by Novartis a year later.

The Swiss group strengthened its commitment in the field of radioligand therapy with another takeover, the almost four billion dollar purchase of the French company Advanced Accelerator Applications (AAA). In the meantime, all activities in this area have been bundled.

Up until now, prostate cancer has primarily been treated with the surgical removal of the tumor and the use of drugs that block the growth-promoting effect of sex hormones, especially testosterone.

Other pharmaceutical companies such as Bayer are also researching in the field

There has also been progress in this field in recent years. Bayer, for example, was able to show at the beginning of the year that its drug Nubeqa also has advantages in metastatic prostate carcinoma. The drug, which blocks hormone receptors on cancer cells, has been approved since 2019.

With Pluvicto, Novartis is primarily targeting those types of cancer that no longer respond to hormone blockade. “The landscape of prostate cancer treatment has changed significantly in recent years,” says Ute Simon, Head of Medicine at the Novartis subsidiary AAA, describing the positioning of the new development.

Simon says: “With radioligand therapy, we can offer additional hope for patients for whom other therapies have failed.” In the medium term, however, the ambitions go further. The aim is to use this treatment approach in earlier phases of the disease.

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The field is likely to remain in flux over the next few years. In addition to Novartis, a number of pharmaceutical and biotech companies are working on radioligand therapies against prostate cancer. The Australian biotech company Terex and the US company Point Bio Pharma are also testing active ingredients with lutetium-177 in advanced clinical studies.

In Germany, the Munich biotech company ITM Isotope Technologies, among others, is involved in the field with a project that is still in the preclinical development stage.

The Bayer Group also relies heavily on the technology and recently strengthened its position here through the takeover of the US companies Noria Therapeutics and PSMA Therapeutics. He has been in the field for a long time with his cancer drug Xofigo, which also contains a radioactive component and is specifically aimed at bone metastases from prostate tumors.

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