Servier will be partnering with Clovis Oncology, an American biopharmaceutical company, for the development of lucitanib

25/11/2013

Suresnes, November 25, 2013 – Servier will be partnering with Clovis Oncology, an American biopharmaceutical company, for the development of lucitanib.

Clovis Oncology, an American biopharmaceutical company announced on November 19th that it has signed a definitive agreement to acquire EOS (Ethical Oncology Science S.p.A., a privately-held Italian biopharmaceutical company from which since 2012 Servier has obtained a sublicense for lucitanib rights except for Japan and USA.

In a communiqué released in Boulder, Colorado, Patrick J. Mahaffy, Clovis Oncology’s president and CEO declared: “We are pleased to expand our clinical development program to include lucitanib – it has demonstrated proof of concept in a Phase I/IIa study with objective responses in patients with FGF-aberrant breast cancer as well as other angiogenesis-sensitive tumors.”

While maintaining exclusive rights for lucitanib in the U.S. and Japan, Clovis intends to collaborate with Servier on the global clinical development of lucitanib.

Lucitanib is an oral, dual-selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 and 2 (FGFR 1/2) and vascular endothelial growth factor (VEGF) receptors 1-3 (VEGFR1-3). 

In an ongoing Phase I/IIa clinical study, lucitanib has demonstrated multiple objective responses in FGF aberrant breast cancer patients, and objective responses have also been observed in patients with tumors often sensitive to VEGFR inhibitors, such as renal cell and thyroid cancer.

Dr Emmanuel Canet, Head of Research and Development at Servier, declared that Clovis’ decision to acquire EOS and pursue the development of lucitanib was a great opportunity, leading the way for a strong global clinical evaluation for lucitanib.

If the on-going Phase II monotherapy studies for lucitanib are successfully completed, Clovis and Servier intend to pursue future development of lucitanib as monotherapy and/or in combination with estrogen antagonists in treatment-refractory breast cancer.  Other potential indications that may be considered for development include squamous NSCLC, bladder, head and neck cancer, and other solid tumors with FGF-aberrancies.

About Lucitanib and Growth Factors

Fibroblast growth factors (FGFs) and VEGFs each play a role in tumor growth and angiogenesis and both are validated targets in oncology.  Lucitanib is unique in its pattern of clinical inhibition of both FGFR and VEGFR tyrosine kinases.  Lucitanib has the potential of providing benefit to cancer patients by targeting two relevant tumor growth factors in targeted patient populations identified by molecular markers. 

Lucitanib Clinical Development
The first clinical trial of lucitanib was initiated in Europe in September 2010 and is currently ongoing.  This trial is an open-label, dose-escalation, Phase I/IIa study to determine the maximum tolerated dose (MTD), recommended Phase 2 dose, efficacy, pharmacokinetics and pharmacodynamics of lucitanib in adult patients with advanced solid tumors.
Doses evaluated in the study ranged from 5mg to 30mg given once per day.  Twenty milligrams once per day was identified as the MTD. Overall, the toxicity profile observed to date is consistent with what was expected from preclinical studies, with hypertension, proteinuria, asthenia and subclinical hypothyroidism requiring supplementation being commonly observed. Other common treatment-related adverse events include gastrointestinal symptoms such as diarrhea, abdominal pain, nausea and vomiting. 
Subsequent to MTD identification, a dose expansion phase was initiated in defined populations expected to derive benefit from lucitanib, and initial data show encouraging activity in patients who were either FGF-aberrant or angiogenesis inhibitor-sensitive.  Six of 12 evaluable FGF-aberrant breast cancer patients achieved RECIST partial responses and the median progression-free survival was 9.4 months in these 12 patients.  These patients were heavily pre-treated, with at least three or as many as 14 prior treatment regimens. In addition, responses were observed across other tumor types as well. 
A Phase II program has been initiated to further explore lucitanib in multiple indications including a U.S. study in patients with treatment-refractory FGF-aberrant breast cancer and a global study in patients with metastatic squamous NSCLC. In parallel with these planned Clovis-sponsored studies, a Servier-sponsored Phase II study of lucitanib monotherapy in patients with advanced breast cancer is currently enrolling.

About Servier
   
Servier is a privately-run French research-based pharmaceutical company. Current therapeutic domains for Servier medicines are cardiovascular, metabolic, neurological, psychiatric and bone and joint diseases, as well as oncology. Servier is established in 140 countries worldwide with over 20,000 employees and a 2012 turnover of €3.9 billion. Servier invests 25% of its turnover in R&D.

More information is available at: www.servier.com

Les Laboratoires Servier
Servier Communication Department
Tel:  +33 (0)1 55 72 60 37
E-mail: presse@servier.fr

About Clovis Oncology   

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK.

More information is available at:   www.clovisoncology.com