• EC ap­prov­al based on data from first ran­dom­ized Phase 3 trial (ICARIA-MM) to report results eval­u­ating an anti-CD38 mono­clonal anti­body com­bined with poma­lido­mide and dexa­meth­a­sone (pom-dex)
• Sarclisa in com­bi­na­tion with pom-dex sig­nif­i­cantly reduced the risk of pro­gres­sion or death by 40% versus pom-dex alone
• Multiple myeloma is the sec­ond most common blood cancer, with approx­i­mately 40,000 new cases per year in Europe

{{image}}Paris, France (Press Release) – The Euro­pean Com­mis­sion (EC) has approved Sarclisa® (isatuximab) 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.

Sarclisa is a mono­clonal anti­body (mAb) that binds to a spe­cif­ic epitope on the CD38 re­cep­tor of MM cells.

“The EC ap­prov­al of Sarclisa rep­re­sents an im­por­tant addi­tional thera­peutic op­tion and may set a new standard of care for myeloma patients in Europe who are in need of new ef­fec­tive treat­ments because their dis­ease has returned or they have be­come re­frac­tory to their pre­vi­ous treat­ment,” said John Reed, M.D., Ph.D., Global Head of Research and De­vel­op­ment at Sanofi. “Sarclisa in com­bi­na­tion with pom-dex dem­onstrated median pro­gres­sion-free sur­vival of nearly one year, a five-month im­prove­ment over pom-dex alone, in patients who had already failed at least two prior ther­a­pies.”

Sarclisa Efficacy and Safety Profile in Difficult-to-Treat Patients

In the Phase 3 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=0.001). 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.

“As patients ex­peri­ence relapse of their mul­ti­ple myeloma or be­come re­frac­tory to their cur­rent ther­apy, they be­come more dif­fi­cult to treat with in­creas­ingly poor prognoses. In the ICARIA-MM trial, Sarclisa com­bi­na­tion ther­apy showed a treat­ment benefit con­sis­tent across re­lapsed and re­frac­tory mul­ti­ple myeloma subgroups,” said Philippe Moreau, M.D., Department of He­ma­tol­ogy, University Hospital of Nantes, France. “Sarclisa offers an im­por­tant new treat­ment op­tion and a poten­tially new standard of care for these patients with re­lapsed, re­frac­tory dis­ease.”

As outlined in the Summary of Product Characteristics (SmPC), the most fre­quent adverse reac­tions observed with Sarclisa (occurring in 20% or more of patients) are neu­tro­penia (46.7%), in­fusion reac­tions (38.2%), pneu­monia (30.9%), upper res­pira­tory tract in­fec­tion (28.3%), diarrhea (25.7%) and bronchitis (23.7%). The most fre­quent serious adverse reac­tions are pneu­monia (9.9%) and febrile neu­tro­penia (6.6%).

For more in­for­ma­tion on the safety of Sarclisa, please refer to the SmPC.

An Important New Option for Treating Multiple Myeloma

Sarclisa is admin­istered by in­tra­venous (IV) admin­istra­tion and is dosed at 10 mg/kg, in com­bi­na­tion with pom-dex, every week for four weeks and then every two weeks, until dis­ease pro­gres­sion or unacceptable toxicity. Assuming no rate ad­just­ments based on in­fusion-related reac­tions, the first in­fusion takes three to four hours, the sec­ond in­fusion takes less than two hours, and the remaining in­fusions can de­crease to 75 min­utes from the third in­fusion onwards. A treat­ment cycle is 28 days. The EC mar­ket­ing authori­za­tion for Sarclisa is appli­cable to the 27 member states of the Euro­pean Union (EU), plus the UK, Iceland, Liechtenstein and Norway.

Multiple Myeloma: A Significant Burden to Patients

MM is the sec­ond most common hema­to­logic malig­nan­cy,¹ with more than 138,000 new cases world­wide each year.² In Europe, approx­i­mately 40,000 patients are diag­nosed with MM yearly.³ MM remains incurable in the vast majority of patients, re­sult­ing in sig­nif­i­cant dis­ease burden.

About Sarclisa

Sarclisa is a mAb that binds to a spe­cif­ic epitope on the CD38 re­cep­tor. CD38 is highly and uni­formly ex­pressed on MM cells, making it a poten­tial target for anti­body-based thera­peutics such as Sarclisa. It is de­signed to induce pro­grammed tumor cell death (apoptosis) and immuno­modu­la­tory ac­­tiv­ity.

In addi­tion to the EU, Sarclisa has also been approved in the U.S., Switzerland, Canada and Australia in com­bi­na­tion with pom-dex for the treat­ment of cer­tain adults with re­lapsed re­frac­tory MM. 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 con­tinues to be eval­u­ated in mul­ti­ple on­go­ing Phase 3 clin­i­cal trials in com­bi­na­tion with cur­rent standard treat­ments across the MM 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, cost con­tainment ini­tia­tives and sub­se­quent changes thereto, 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.

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.