• Study eval­u­ated the benefit of isatuximab in com­bi­na­tion with standard of care in prolonging pro­gres­sion free sur­vival as com­pared to standard of care in patients with re­lapsed / re­frac­tory multiple myeloma
• First ran­dom­ized Phase 3 trial to eval­u­ate the benefit of adding a mono­clonal anti­body to poma­lido­mide and dexa­meth­a­sone for treat­ment of re­lapsed / re­frac­tory multiple myeloma
• Multiple ongoing Phase 3 studies with isatuximab, an inves­ti­ga­tional agent, in com­bi­na­tion with standard of care ther­a­pies in newly diag­nosed and re­lapsed / re­frac­tory multiple myeloma

Paris, France (Press Release) – The pivotal Phase 3 trial of isatuximab in patients with re­lapsed / re­frac­tory multiple myeloma met the pri­mary end­point of prolonging pro­gres­sion free sur­vival in patients treated with isatuximab in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone versus poma­lido­mide and low-dose dexa­meth­a­sone alone (standard of care).

Results will be sub­mitted to an upcoming medical meeting and are antic­i­pated to form the basis of regu­la­tory sub­missions planned for later this year.

"We are ex­cited by these results, which rep­re­sent sig­nif­i­cant progress in our ambition to extend the lives of multiple myeloma patients," said John Reed, Head of Research and Development at Sanofi. "We look for­ward to engaging with regu­la­tory author­i­ties with the goal of bringing this poten­tial new treat­ment to patients as quickly as possible."

Multiple myeloma is the second most common hema­to­logic malig­nan­cy¹, with more than 138,000² new cases world­wide each year. Multiple myeloma remains incurable in the vast majority of patients, resulting in sig­nif­i­cant dis­ease burden.

The ran­dom­ized, multi-center, open label Phase 3 study, known as ICARIA-MM, enrolled 307 patients with re­lapsed / re­frac­tory multiple myeloma across 96 centers spanning 24 countries. All study par­tic­i­pants re­ceived two or more prior anti-myeloma ther­a­pies, in­­clud­ing at least two consecutive cycles of lena­lido­mide and a pro­te­a­some in­hib­i­tor given alone or in com­bi­na­tion. During the trial, isatuximab was admin­istered through an in­tra­venous in­fusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in com­bi­na­tion with standard doses of poma­lido­mide and dexa­meth­a­sone for the duration of treat­ment. The safety profile was eval­u­ated as a sec­ond­ary end­point.

About isatuximab clin­i­cal devel­op­ment pro­gram

Isatuximab targets a specific epitope of CD38 capable of triggering multiple, distinct mech­a­nisms of action that are believed to promote pro­grammed tumor cell death (apoptosis) and immuno­modu­la­tory activity. CD38 is highly and uniformly ex­pressed on multiple myeloma cells and is a cell surface re­cep­tor target for anti­body-based thera­peutics in multiple myeloma and other malig­nan­cies. The clin­i­cal sig­nif­i­cance of these findings is under in­ves­ti­ga­tion.

ICARIA-MM is one of four ongoing Phase 3 clin­i­cal trials eval­u­ating isatuximab in com­bi­na­tion with cur­rently avail­able standard treat­ments for people with re­lapsed / re­frac­tory or newly-diagnosed multiple myeloma.

Isatuximab re­ceived orphan desig­na­tion for re­lapsed / re­frac­tory multiple myeloma by the U.S. Food and Drug Admin­istra­tion and the European Medicines Agency. Isatuximab is an inves­ti­ga­tional agent and the safety and efficacy has not been eval­u­ated by the U.S. Food and Drug Admin­istra­tion, the European Medicines Agency, or any other regu­la­tory authority. Isatuximab is also under in­ves­ti­ga­tion for the treat­ment of other hema­to­logic malig­nan­cies and solid tumors.

About Sanofi

Sanofi is dedicated to sup­porting people through their health chal­lenges. We are a global bio­pharma­ceu­tical com­pany focused on human health. We prevent illness with vaccines, provide inno­va­tive treat­ments to fight pain and ease suffer­ing. We stand by the few who suffer from rare dis­eases and the millions with long-term chronic con­di­tions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific inno­va­tion into health­care solu­tions around the globe.

Sanofi, Empowering Life

Sanofi Forward-Looking Statements

This press release con­tains for­ward-looking state­ments as defined in the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995, as amended. Forward-looking state­ments are state­ments that are not historical facts. These state­ments in­clude pro­jec­tions and esti­mates and their under­lying assump­tions, state­ments re­gard­ing plans, objectives, intentions and ex­pec­ta­tions with respect to future fi­nan­cial results, events, operations, services, prod­uct devel­op­ment and poten­tial, and state­ments re­gard­ing future per­for­mance. Forward-looking state­ments are generally identified by the words "expects", "antic­i­pates", "believes", "intends", "esti­mates", "plans" and similar ex­pres­sions. Although Sanofi's man­agement believes that the ex­pec­ta­tions reflected in such for­ward-looking state­ments are reason­able, in­­vestors are cautioned that for­ward-looking in­for­ma­tion and state­ments are subject to various risks and un­cer­tain­ties, many of which are dif­fi­cult to predict and generally beyond the con­trol of Sanofi, that could cause actual results and devel­op­ments to differ ma­teri­ally from those ex­pressed in, or im­plied or pro­jected by, the for­ward-looking in­for­ma­tion and state­ments. These risks and un­cer­tain­ties in­clude among other things, the un­cer­tain­ties in­her­ent in re­search and devel­op­ment, future clin­i­cal data and analysis, in­­clud­ing post mar­ket­ing, de­ci­sions by regu­la­tory author­i­ties, such as the FDA or the EMA, re­gard­ing whether and when to approve any drug, device or biological appli­ca­tion that may be filed for any such prod­uct can­di­dates as well as their de­ci­sions re­gard­ing labelling and other matters that could affect the avail­a­bil­ity or commercial poten­tial of such prod­uct can­di­dates, the absence of guar­an­tee that the prod­uct can­di­dates if approved will be commercially suc­cess­ful, the future ap­­prov­al and commercial success of thera­peutic alter­na­tives, Sanofi's ability to benefit from ex­ternal growth oppor­tu­ni­ties and/or obtain regu­la­tory clear­ances, risks asso­ci­ated with intellectual property and any related pend­ing or future lit­i­ga­tion and the ultimate out­come of such lit­i­ga­tion, trends in ex­change rates and prevailing interest rates, volatile economic con­di­tions, the impact of cost con­tainment ini­tia­tives and sub­se­quent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, in­­clud­ing those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended De­cem­ber 31, 2017. Other than as required by appli­­cable law, Sanofi does not under­take any obli­ga­tion to update or revise any for­ward-looking in­for­ma­tion or state­ments.

References:

1. Kazandjian. Multiple myeloma epidemiology and survival: A unique malig­nan­cy. Semin Oncol. 2016;43(6):676-681. doi:10.1053/j/seminoncol.2016.11.004
2. Cowan AJ, Allen C, Barac A, et al. Global Burden of Multiple Myeloma: A Systematic Analysis for the Global Burden of Disease Study 2016. JAMA Oncol. 2018;4(9):1221-1227. doi:10.1001/jamaoncol.2018.2128

Source: Sanofi.