Sanofi's Sarclisa Gains FDA Approval for New First-Line Indication in Transplant-Ineligible Multiple Myeloma, Challenging J&J's Darzalex Dominance

Sep 23, 2024 11:58 CST Updated 11:58

Sanofi

Pharmaceutical R&D Developer

On September 21, Sanofi announced,FDA has approved Sanofi's CD38 antibody Sarclisa （isatuximab）Combination of bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment regimen for adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (ASCT).

According to its press release,Sarclisa is the first drug to be used in combination with the standard therapy VRd.Anti-CD38TherapyCompared with VRd alone, it can significantly reduce disease progression or death in NDMM patients who are ineligible for transplant (Reduce by 40%）。In addition,This is alsoSarclisa in the United StatesApprovedThe Third Indication。The CDE also accepted the sBLA this May.

Results of the IMROZ Phase 3 Study Support Sarclisa for NDMM Patients Ineligible for ASCT

Recently, at the 2024 ASCO Annual Meeting, Sanofi presented the IMROZ Phase 3 study data,In the IMROZ study, Sarclisa-VRd followed by Sarclisa-Rd reached the primary endpoint of PFS, compared with VRd followed by Rd, in NDMM patients unsuitable for ASCT.The risk of recurrence or death was significantly reduced by 40% (HR 0.60; 95% CI: 0.44 to 0.81, p=0.0009).。

At a median follow-up of 59.7 months,The median PFS for Sarclisa-VRd combination therapy was not reached, while it was 54.3 months for the VRd combination therapy group. The estimated PFS rate at 60 months for patients treated with Sarclisa-VRd was 63.2%, compared to 45.2% for VRd.

Source: NEJM

Sarclisa-VRd also achieved several secondary endpoints, demonstrating deep responses in this patient population:

About three-quarters (74.7%) Patients receiving Sarclisa-VRd achieved complete response (CR) or better, compared to 64.1% of patients receiving VRd (OR 1.7; 95% CI: 1.097-2.5; p=0.0160).
More than half (55.5%) Patients receiving Sarclisa-VRd achieved MRD-negative CR, compared to 40.9% of patients receiving VRd (OR 1.8; 95% CI: 1.229-2.646; p=0.0026).

The safety and tolerability of Sarclisa observed in this study are consistent with the established profile of Sarclisa and VRd.Consistent safety profile, no new safety signals observed.

Source of the image:2024 ASCO

SanofiExpressed continued advancement of Sarclisa clinical progress,Sarclisa is expected to launch in the U.S. as early as 2024, with rollouts in other countries starting in 2025 and continuing through 2026.

The Sarclisa development program includes multiple Phase 2 and Phase 3 studies, covering the continuum of MM treatment.Six potential indications. In addition, the company is evaluating a subcutaneous administration method for Sarclisa in clinical studies.

Source: Sanofi official website

Sarclisa (isatuximab) is a monoclonal antibody that binds to a specific epitope on the CD38 receptor of MM cells, inducing unique anti-tumor activity.It is designed to work through multiple mechanisms of action, including programmed tumor cell death (apoptosis) and immunomodulatory activity.CD38 is highly expressed on multiple myeloma cellsPlain expression, is the cell surface receptor target for antibody therapy in multiple myeloma and other malignancies.

CD38In terms of the competitive landscape, Sanofi's Sarclisa and Johnson & Johnson's Darzalex (daratumumab) are both CD38 inhibitors.Darzalex isThe world's first targeted CD38 drugPosition, far ahead in both the number of indications and sales.

As early as 2019Darzalex It has been approved in the United States for use in combination with lenalidomide and dexamethasone to treat newly diagnosed multiple myeloma patients with the same indication.Darzalex's treatment label includes seven different multiple myeloma indications.Darzalex Global Sales in 2023 Reached $9.74 Billion, accounting for 11.4% of Johnson & Johnson's total annual revenue., joining the ranks of "billion-dollar molecules."H1 2024 Sales Reach $5.57 Billion, Up 18.6% Year-over-Year!According toEvaluate's Top 10 Best-Selling Drugs Worldwide in 2024，The drug is expected to generate nearly $12 billion in revenue this year.

Sarclisa in ChinaMarch 2020First approved by the FDA for marketing, used in combination with pomalidomide and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including lenalidomide and a proteasome inhibitor.March 2021,SarclisaApproved by the FDA to expand new indications for combination useSanofiZomibIn combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.Currently available in more than 50 countriesFor relapsed and refractory multiple myeloma.

However, the sales volume of Sarclisa has been relatively slow since its launch. The global sales from 2020 to 2023 were €176 million, €294 million, and €381 million, respectively.In the first half of this year, the sales of Sarclisa reached 227 million euros (approximately 253 million US dollars), increasing by 32% year-on-year.. This new indication expansion may significantly enhance its market prospects.

End

Statement:All articles published on this official account (including original and reprinted articles) are intended to convey more information, with sources and authors clearly attributed. This official account welcomes sharing in friend circles or large groups.Reproduction in any form by media or institutions without authorization is prohibited.。

Reprint/Business/Contribution| Contact WeChatwfj_GM

Business Cooperation

Call for Papers

Click to learn more

Previous Review

1	May \| 20 Pharmaceutical Companies Lay Off Staff (List Attached)
2	$1.8 Billion: ADC Goes Global! Yilian Biotech Announces New Licensing Deal
3	2024 ASCO \| MSD/Kelun TROP2 ADC, Innovent, Limin CLDN18.2 ADC Data Released