• IKEMA trial results released early based on recom­men­da­tion of an Independent Data Monitoring Com­mit­tee
• Addition of Sarclisa sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death com­pared to car­filz­o­mib and dexa­meth­a­sone alone
• Results will be sub­mitted to an upcoming medical meeting and form the basis for regu­la­tory sub­missions later this year

Paris, France (Press Release) – The Phase 3 IKEMA clin­i­cal trial eval­u­ating Sarclisa® (isatuximab) added to car­filz­o­mib and dexa­meth­a­sone met the pri­mary end­point at its first planned interim analysis, demonstrating sig­nif­i­cantly prolonged pro­gres­sion-free sur­vival com­pared to standard of care car­filz­o­mib and dexa­meth­a­sone alone in patients with re­lapsed multiple myeloma. There were no new safety signals identified in this study.

“When Sarclisa was added to standard-of-care treat­ment car­filz­o­mib and dexa­meth­a­sone in this phase 3 trial, results clearly dem­onstrated a sig­nif­i­cant re­duc­tion in risk of dis­ease pro­gres­sion or death,” said John Reed, M.D., Ph.D., Global Head of Research and De­vel­op­ment at Sanofi. “This is the sec­ond pos­i­tive phase 3 trial for Sarclisa, further sup­port­ing the poten­tial our med­i­cine has to im­prove out­comes for patients struggling with re­lapsed multiple myeloma.”

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

About the Trial

The ran­dom­ized, multi-center, open label Phase 3 IKEMA clin­i­cal trial en­rolled 302 patients with re­lapsed multiple myeloma across 69 centers spanning 16 countries. All study par­tic­i­pants re­ceived one to three prior anti-myeloma ther­a­pies. During the trial, Sarclisa 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 car­filz­o­mib twice weekly at the 20/56mg/m2 dose and dexa­meth­a­sone at the standard dose for the duration of treat­ment. The pri­mary end­point of IKEMA is pro­gres­sion-free sur­vival. Secondary end­points in­clude over­all re­sponse rate, the rate of very good partial re­sponse or greater, minimal residual dis­ease, com­plete re­sponse rate, over­all sur­vival and safety.

The use of Sarclisa in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone in re­lapsed multiple myeloma is inves­ti­ga­tional and has not been fully eval­u­ated by any regu­la­tory authority.

About Sarclisa

Sarclisa is a mono­clonal anti­body that binds to a spe­cif­ic epitope on the CD38 re­cep­tor on multiple myeloma cells. It is designed to work through many mech­a­nisms of action in­clud­ing pro­grammed tumor cell death (apoptosis) and immuno­modu­la­tory ac­­tiv­ity. CD38 is highly and uniformly ex­pressed on the surface of multiple myeloma cells, making it a poten­tial target for anti­body-based thera­peutics such as Sarclisa.

Sarclisa is approved in the U.S. in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of adults with re­lapsed re­frac­tory multiple myeloma who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Admin­istra­tion.

Sarclisa has also re­ceived pos­i­tive CHMP opinion in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of adults with re­lapsed and re­frac­tory multiple myeloma who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. A final de­ci­sion on the Marketing Authorisation Appli­ca­tion for Sarclisa in the E.U. is ex­pec­ted in the coming months. The safety and efficacy of Sarclisa has not been fully eval­u­ated by any regu­la­tory authority outside of the U.S., Switzerland, Canada and Australia.

Sarclisa con­tinues to be eval­u­ated in multiple ongoing Phase 3 clin­i­cal trials in com­bi­na­tion with current standard treat­ments for people with multiple myeloma. It is also under in­ves­ti­ga­tion for the treat­ment of other blood cancer types (hematologic malig­nan­cies) and solid tumors.

For more in­for­ma­tion on Sarclisa clin­i­cal trials please visit www.clinicaltrials.gov.

About Multiple Myeloma

Multiple myeloma is the sec­ond most common hema­to­logic malig­nan­cy, with more than 138,000 new diagnoses of multiple myeloma world­wide yearly. Despite avail­able treat­ments, multiple myeloma remains an incurable malig­nan­cy, and is asso­ci­ated with sig­nif­i­cant patient burden. Since multiple myeloma does not have a cure, most patients will relapse. Re­lapsed multiple myeloma is the term for when the cancer returns after treat­ment or a period of remission. Re­frac­tory multiple myeloma refers to when the cancer does not respond or no longer responds to ther­apy.

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 re­gard­ing the mar­ket­ing and other poten­tial of the prod­uct, or re­gard­ing poten­tial future revenues from the prod­uct. 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, unexpected regu­la­tory actions or delays, or gov­ern­ment reg­u­la­tion generally, that could affect the avail­a­bil­ity or commercial poten­tial of the prod­uct, the fact that prod­uct may not be commercially suc­cess­ful, the un­cer­tainties in­her­ent in re­search and de­vel­op­ment, in­clud­ing future clin­i­cal data and analysis of existing clin­i­cal data relating to the prod­uct, in­clud­ing post mar­ket­ing, unexpected safety, quality or manu­fac­tur­ing issues, com­pe­ti­tion in general, risks asso­ci­ated with in­tel­lec­tual property and any related future lit­i­ga­tion and the ultimate out­come of such lit­i­ga­tion, and volatile economic and mar­ket con­di­tions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business part­ners, and the fi­nan­cial con­di­tion of any one of them, as well as on our employees and on the global economy as a whole. Any ma­teri­al effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and addi­tional impacts may arise of which we are not cur­rent aware and may exacerbate other pre­vi­ously identified risks. The risks and un­cer­tainties also in­clude the un­cer­tainties 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, 2019. Other than as required by appli­cable law, Sanofi does not under­take any obli­ga­tion to update or revise any for­ward-looking in­for­ma­tion or state­ments.

Source: Sanofi.