ArQule ($ARQL), stiamo forse lucidando le maniglie sul Titanic?
Titolo complicato, citazione rubata a “Fight Club” che l’amico Matteo apprezzerà, se la legge. Il senso è questo: sto tessendo le lodi di una compagnia destinata a fallire nell’impresa di portare a compimento con successo la sperimentazione del proprio farmaco di punta?
ArQule come esce dall’ultima notizia che ha causato un sanguinoso meno diciotto sul mercato americano? Perché ieri ho incrementato nel portafoglio virtuale?
Tante domande alle quali spero di poter rispondere in modo chiaro. Se non riesco nell’impresa, commentate o mandate mail.
Si comincia dalla notizia, presa direttamente dall’8K della società:
ArQule, Inc. (ArQule) has been informed by Kyowa Hakko Kirin Co., Ltd. (Kyowa), which has exclusive development rights to tivantinib in Japan and certain parts of Asia, of Kyowa’s decision to temporarily suspend patient enrollment in its ongoing Phase 3 ATTENTION (Asian Trial of Tivantinib plus Erlotinib for NSCLC without EGFR Mutation) trial. The ATTENTION trial investigates the use of tivantinib and erlotinib versus erlotinib and placebo in second line non-squamous non-small cell lung cancer (NSCLC). This trial is being conducted by Kyowa in Japan, South Korea and Taiwan.Kyowa has taken this action following the recommendation of an independent Safety Review Committee (SRC) in Japan after the reporting of suspected cases of interstitial lung disease (ILD) in the study. The SRC has requested additional information and analyses regarding these cases of ILD which showed an imbalance between the arms of the trial.During review of the additional information, treatment of patients already enrolled in the study is continuing pursuant to the protocol for the study. Updates on the status of this review and a determination regarding whether to restart patient enrollment will be provided as warranted.Daiichi Sankyo, Inc. (Daiichi Sankyo) and ArQule are developing tivantinib in the Americas, Europe and certain other regions of the world. The partners are conducting in those regions the Phase 3 MARQUEE trial (Met Inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus Placebo in NSCLC) that completed recruitment of approximately 1,000 patients in May 2012. Kyowa’s decision regarding the ATTENTION trial is unrelated to the MARQUEE trial.Erlotinib (Tarceva™) was approved by the U.S. Food and Drug Administration (FDA) in November, 2004 for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. Tivantinib is an investigational selective c-MET inhibitor in Phase 3 clinical development in combination with erlotinib for non-squamous NSCLC in the U.S. under a Special Protocol Assessment agreed upon with the FDA. Clinical trials of tivantinib and erlotinib reported to date have demonstrated that this combination was well tolerated by patients, without apparent drug-drug interaction.In April, 2007, ArQule entered into an exclusive license agreement with Kyowa to develop and commercialize tivantinib in Japan and parts of Asia, including South Korea, Taiwan and China (including Hong Kong). In December 2008, ArQule and Daiichi Sankyo signed a license, co-development and co-commercialization agreement to co-develop tivantinib in the U.S., Europe, South America and the rest of the world excluding territories covered by ArQule’s agreement with Kyowa.
La questione si riassume così: nella fase 3 denominata ATTENTION si è riscontrato un numero maggiore di malattie interstiziali del polmone nel braccio di pazienti trattati con Tivantinib rispetto al controllo. In base a questo fatto si è deciso di sospendere l’arruolamento di pazienti fino a nuovo ordine, ossia fino a che la situazione non verrà chiarita.
In attesa che una nuova fase 3 inizi, sono due gli studi registrativi che ArQule sta conducendo in questo momento:
|1||Active, not recruiting||ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer
|2||Recruiting||A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib