Nerviano, 5 November 2021
Entrectinib, the kinase inhibitor drug that was invented and initially developed by Nerviano Medical Sciences (a member of NMS Group) and that is now marketed by Roche and partners, has won the Prix Galien Italia 2021 award as an antitumor therapy with agnostic indication in the category of Chemically Synthesized Drugs.
The Prix Galien was created in France in 1970, aiming to promote significant advances in pharmaceutical research. Drugs introduced into the public market and projects from the research teams considered most innovative are identified by an independent panel and awarded with one of the industry’s most prominent awards for pharmaceutical research and development. The national edition in Italy – the Prix Galien Italia, coordinated by the Galien Foundation of New York and the Italian publisher Springer Healthcare, is in its 29th edition this year. It is considered one of the most important biomedical and pharmacological awards in Italy.
Entrectinib, awarded this year for its excellence in innovation, was originally invented and developed into a drug product at Nerviano. It is highly active against tumors with rearranged forms of either one of the three kinases called ALK, ROS, and TRK, and its initial Phase I study, which started in 2012, was initiated by NMS at two major hospitals in Milan – the IRCCS Istituto Nazionale dei Tumori (INT) and the Niguarda Cancer Center. This first-in-human (FIH) study generated some of the key data later used to obtain worldwide marketing approval of the drug in the two different oncological indications, with patient selection based on molecular defects in the NTRK and ROS genes.
Entrectinib, designed to efficiently cross the blood brain barrier in order to treat ROS1-rearranged lung cancer patients with CNS metastases, demonstrated a high level of efficacy in such patients – a key factor for its approval in this type of cancer. Also, with entrectinib NMS provided the first clinical evidence that NTRK gene fusion products, present at a low but significant frequency in several different tumor types, represent a druggable target for solid tumors – a finding which later led to the marketing approval of one of the first precision medicine drugs to receive an agnostic indication (approval for use against any type of tumor with a given genetic context and independently from the tissue origin), i.e. that for use against NTRK rearranged solid tumors.
The success of the Phase I clinical study of entrectinib initiated by NMS led to a collaboration with the biotech Ignyta, who continued clinical development of the drug in a global Phase II registration trial, prior to being acquired by Roche. Receiving several regulatory authority approvals between 2019 and 2020 in various major geographic regions, entrectinib is now marketed worldwide by Roche and partners. In September 2021 the Italian drug regulatory agency AIFA also approved entrectinib for marketing and reimbursement in its homeland.
Link to the full coverage of the Prix Galien 2021 Award from Pharmastar in Italian: Premio Galeno Italia 2021: tra i vincitori entrectinib, mogamulizumab, vaccino Ebola, risdiplam, terapia genica per la SMA. Premiata anche terapia digitale