Roche takes Loxo and Bayer in the cancer class defined by the gene

MUNICH (Reuters) – Roche's entrectinib-based cancer pill has been shown to reduce tumors in 57% of patients in a group that can only be identified by genetic profile, with the Swiss drug manufacturer challenging alliance of Bayer and Loxo Oncology in a new targeted treatment area.

The results of tests on patients with a gene abnormality known as the NTRK fusion, which occurs at less than 1% of several types of tumors, were presented at the annual conference of the European Society of Medical Oncology ( ESMO) in Munich this Sunday.

In Germany, Loxo, a partner of Bayer and in the United States, published data on its competing compound, larotrectinib, which slightly improved the results previously obtained with high efficiency in a larger trial.

Traditionally, oncologists have made treatment decisions based on the origin of the tumor in the body, increasingly aided by growing knowledge of the complex genetic factors of cancer.

Under the agnostic approach of tumors, also known as pan-tumors, drug manufacturers ignore the perspective of the original organ and group patients based solely on genetic mutations of signature, but the success in real life will depend on the rapid diffusion of comprehensive gene sequencing tools. for tissue samples.

Individually, mutations are so rare that it is unlikely that the cancer units will perform dedicated tests for each one.

Roche's Foundation Medicine provides complete kits, in competition with Thermo Fisher Scientific and Caris Life Sciences.

"This is one of the reasons we've acquired Foundation Medicine, to make this complete genomic profiling a routine early in the disease," said Daniel O'Day, Roche's Pharmaceuticals Division Manager.

The Loxo pill against larotrectinib, developed in conjunction with Bayer, showed that last year, it shrank tumors in 75% of patients with NTRK fusion gene abnormalities, occurring in the lung, pancreas or more a dozen other organs.

On Sunday, the response rate to larotrectinib in an expanded group of 122 study participants – compared with 55 initially and now on 24 types of tumors – was established at 81%.

Roche said the results of the two NTRK fusion tests were not comparable because they consisted of different types of patients. The Loxo study, for example, included some cancers in children, whereas Roche plans to study them separately.

The Roche compound is designed to fight against several oncogenic mutations. Last month, he unveiled data on the inhibition of intrectinib on 77% of lung cancer patients carrying a mutation called ROS1.

The Keytruda from Merck & Co, in May of last year, became the first drug to gain approval for pan-tumor use, although this market remains relatively small for the mega-reseller drug. Bayer and Loxo test a second pan-tumor drug, LOXO-195.

O'Day of Roche Pharmaceutical would host a larger area.

"The two things must happen: genome profiling and enough targeted drugs are needed to encourage physicians to do this very comprehensive diagnosis in the first place. This is the world we are entering, "he said.

Although response rates may encourage a race for more drugs of this type, the need for gene mutations or appropriate mergers will be a daunting challenge, said Ulrik Lassen, oncologist of Rigshospitalet of Copenhagen, co-author of the study on larotrectinib.

"You have to look at a lot of patients to find the needle in the haystack. The method is complicated, expensive and time consuming. When we use these technologies better, we will be able to find more oncogenic mergers and companies will be smart enough to find the agents that target them. "

Roche acquired Entrectinib under its US $ 1.7 billion acquisition agreement with Ignyta Inc., a US $ 1.7 billion drug company, last December.

Immuno-oncology remains another major area of ​​activity for Roche, which has also released positive results regarding the use of its drug Tecentriq in a group of patients with cancer. breast and whose prognosis is particularly dark.