Arfolitixorin – potential cornerstone of standard treatment

 

Arfolitixorin – potential cornerstone of standard treatment

There is a great demand for improved treatment of metastasised colorectal cancer (mCRC). Although there have been medical advances in the treatment of mCRC in recent years, they have been focused on niche patient populations in later lines of treatment. Arfolitixorin has the potential to become part of the standard first-line treatment for mCRC and the market value is estimated to have the potential to reach blockbuster levels, i.e. over USD 1 billion.

Colorectal cancer is an increasing form of cancer

The number of people affected is increasing annually. In 2020, there were 1.9 million new cases of colon cancer per year. By 2040, new cases are expected to reach 3.1 million, an increase of 60%.

No new drugs for all-comers since 2004

The number of drug candidates in colorectal cancer in clinical development is extensive, but there are few drugs being developed for the treatment of first-line patients. The complexity of the disease has historically meant that few projects have managed to reach all the way to phase III. No new drugs for the treatment of “all-comers comers”, i.e. all mCRC patients, regardless of genetic profile in first-line treatment, have been approved since 2004, and there are presently few projects for these patients in late development phase. The new medicines that may reach the market are intended for the treatment of patients in later lines of therapy.

One of the reasons for the great demand for new treatments is because, compared to breast and lung cancer, there are few target molecules in mCRC patients which can be attacked with new drugs, e.g. depending on the cancer form’s high rate of mutation. New drugs such as immunotherapies are targeted at patient subgroups. PD-1 inhibitors, such as Keytruda, can be used in only about 4% of mCRC patients, or B-Raf inhibitors, such as Encorafenib+binimetinib, which is intended for 8-10% of mCRC patients in the second line.

Low threshold to becoming part of the standard treatment

The long-established standard regimens of 5-FU-based chemotherapy, which are the standard of care for more than 70% of patients with mCRC, are expected to remain the standard of care for the foreseeable future. This is because there are no drug candidates in development to replace the current standard therapy.
A strong argument for future marketing of arfolitixorin is that the product can be added without any major change in treatment strategy, as arfolitixorin is intended to directly replace folates such as leucovorin in current standard therapies.

Moreover, today’s existing treatment options are largely generic, which means that they do not have active sales forces, nor are they exposed to competition from proprietary products. As a result, any competitive pressure on the market for arfolitixorin is expected to be low.

As arfolitixorin can be included as a cornerstone in standard treatments with 5-FU for other cancers, and considering the long patent protection, the commercial potential is considered to be very large.