• Positive CHMP opinion based on data from ICARIA-MM, the first ran­dom­ized Phase 3 trial to eval­u­ate an anti-CD38 in com­bi­na­tion with pom-dex
• Sarclisa in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death in adults by 40% com­pared to pom-dex alone in the trial
• Sarclisa was approved by the FDA on March 2 in com­bi­na­tion with pom-dex for the treat­ment of cer­tain adults with RRMM
• Multiple myeloma remains an incurable cancer asso­ci­ated with sig­nif­i­cant patient burden and need for addi­tional treat­ments

Paris, France (Press Release) – The European Medicines Agency’s Com­mit­tee for Medicinal Products for Human Use (CHMP) has adopted a pos­i­tive opinion for Sarclisa® (isatuximab). The CHMP rec­om­mends Sarclisa in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) for the treat­ment of adult patients with re­lapsed and re­frac­tory multiple myeloma (MM) who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy.

The European Com­mis­sion (EC) will review the CHMP recom­men­da­tion and a final de­ci­sion on the Marketing Authorisation Application for Sarclisa in the E.U. is ex­pec­ted in the coming months. Sarclisa has not been approved for commercial use in the E.U. Sarclisa was approved in the US on March 2 in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) for the treat­ment of adults with RRMM who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor.

“Relapsed and re­frac­tory multiple myeloma is a complicated dis­ease that con­tin­uously de­vel­ops resistance to treat­ment, creating a sig­nif­i­cant need for con­tinued inno­va­tion,” said John Reed, M.D., Ph.D., Sanofi’s Global Head of Research & Development. “This pos­i­tive CHMP opinion for Sarclisa brings us closer to our ambition to de­liver a new treat­ment option for patients in Europe with re­lapsed and re­frac­tory multiple myeloma.”

Sarclisa Phase 3 Study Results in Patients with RRMM

The CHMP pos­i­tive opinion is based on data from ICARIA-MM, the first ran­dom­ized Phase 3 trial to eval­u­ate an anti-CD38 mono­clonal anti­body (mAB) in com­bi­na­tion with pom-dex. In the ICARIA-MM study, Sarclisa added to pom-dex (Sarclisa com­bi­na­tion ther­apy; n=154) dem­onstrated a statistically sig­nif­i­cant im­prove­ment of pro­gres­sion free sur­vival (PFS) with a median PFS of 11.53 months com­pared to 6.47 months with pom-dex alone (n=153; HR 0.596, 95% CI: 0.44-0.81, p=0.0010). Sarclisa com­bi­na­tion ther­apy also dem­onstrated a sig­nif­i­cantly greater over­all re­sponse rate com­pared to pom-dex alone (60.4% vs. 35.3%, p<0.0001). In addi­tional analyses, Sarclisa com­bi­na­tion ther­apy com­pared to pom-dex alone showed a treat­ment benefit con­sis­tent across select subgroups reflective of real-world practice, in­clud­ing patients with high risk cytogenetics, those aged 75 years and older, patients with renal insufficiency, and patients who were re­frac­tory to lena­lido­mide.

The most common adverse reac­tions (all grades occurring in 20% or more of patients) in patients who re­ceived Sarclisa com­bi­na­tion ther­apy were neu­tro­penia (96%), in­fusion-related reac­tions (39%), pneu­monia (31%), upper res­pira­tory tract in­fec­tion (57%) and diarrhea (26%). Serious adverse reac­tions that occurred in more than 5% of patients who re­ceived Sarclisa com­bi­na­tion ther­apy in­cluded pneu­monia (25.3%) and febrile neu­tro­penia (12.3%). Permanent dis­con­tinu­a­tion of Sarclisa com­bi­na­tion ther­apy due to an adverse reac­tion (Grades 3-4) occurred in 7% of patients, and 3% of patients dis­con­tinued due to an in­fusion-related reac­tion.

Multiple Myeloma: A Significant Burden to Patients

Multiple myeloma is the second most common hema­to­logic malig­nan­cy¹, with more than 138,000 new diagnoses of multiple myeloma world­wide yearly.² In Europe, approx­i­mately 39,000 patients are diag­nosed with multiple myeloma each year.³ 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 Sarclisa

CD38 is highly and uniformly ex­pressed on multiple myeloma cells and cell surface re­cep­tors, making it a poten­tial target for anti­body-based thera­peutics such as 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. The clin­i­cal sig­nif­i­cance of these findings is under in­ves­ti­ga­tion.

Sarclisa is approved in the U.S. in com­bi­na­tion with pom-dex 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.

Outside of the U.S., Sarclisa is an inves­ti­ga­tional agent and its safety and efficacy have not been estab­lish­ed by any regu­la­tory authority world­wide.

Sarclisa con­tinues to be eval­u­ated in multiple ongoing Phase 3 clin­i­cal trials in com­bi­na­tion with current standard treat­ments across the multiple myeloma treat­ment con­tin­uum. It is also under in­ves­ti­ga­tion for the treat­ment of other hema­to­logic malig­nan­cies and solid tumors. The safety and efficacy of these addi­tional uses have not been reviewed by any regu­la­tory authority world­wide.

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 fact that prod­uct can­di­dates if approved may not be commercially suc­cess­ful, the future ap­­prov­al and commercial success of thera­peutic alter­na­tives, Sanofi’s ability to benefit from ex­ternal growth oppor­tu­ni­ties, to com­plete related trans­actions 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 and mar­ket con­di­tions, the impact of global disruptions, in­clud­ing pandemics, 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, 2019. 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. Inter­na­tional Myeloma Foundation. Myeloma Action Month. http://mam.myeloma.org/educate/. Accessed Jan­u­ary­ 2019. 2/6.
3. João C, Costa C, Coelho I, Vergueiro MJ, Ferreira M, Silva MG. Long‐term sur­vival in multiple myeloma. Clinical Case Reports. 2014;2(5):173-179. doi:10.1002/ccr3.76. 3. Schey SA, Morris J, Maguire Á, Dhanasiri

Source: Sanofi.