Multiple myeloma - March 2021
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Multiple myeloma - March 2021
CHMP recommended approval of Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma
26 Feb 2021
Sarclisa (Isatuximab – Anti-CD38 monoclonal antibody) – Sanofi
- CHMP adopted a positive opinion for a second indication for Sarclisa (isatuximab), in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy
- Recommendation was based on data from Phase 3 IKEMA study
- Trial details: IKEMA; Phase 3 in MM; N= 302; sarclisa on day 1, 8, 15 and 22 of 1st cycle, then on day 1 and 15 of subsequent cycles + carfilzomib IV on day 1, 2, 8, 9, 15 and 16 + dexamethasone IV or PO on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle; Primary outcomes: PFS; PCD: Nov’20; Active, not recruiting; Location: Global
- Interim results:
Parameter | Sarclisa combination therapy | Carfilzomib + dexamethasone (Kd) |
PFS | Not yet reached | 19.15 mo |
ORR | 86.6% | 82.9% |
CR rate | 39.7% | 27.6% |
VGPR rate | 72.6% | 56.1% |
SAEs | 59.3% | 57.4% |
Fatal adverse events | 3.4% | 1.6% |
- Combination therapy reduced the risk of disease progression or death by 47% (p=0.0007) versus standard of care Kd alone in patients with MM
- Minimal residual disease -negative complete response was observed in 29.6% of patients in the Sarclisa combination therapy arm versus 13% of patients in the Kd arm, indicating that nearly 30% of patients treated with Sarclisa combination therapy achieved undetectable levels of MM at 10-5 sensitivity
- The final decision is expected from the European Commission in the coming months
Sarclisa received positive opinion from CHMP for approval based on positive Phase 3 IKEMA study
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CI Scientists Remarks:
- Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity
- In 2020, Sarclisa was approved in combination with PomDex for the treatment of 2L+ MM globally
- With this positive recommendation from EMA, this will be the second approved combination in MM for Sarclisa
- Sanofi is also expanding Sarclisa in other patient segments in MM
1L Newly diagnosed MM transplant ineligible | Sarclisa + Borte + Lena + Dex | Anticipated submission: 2022 |
1L Newly diagnosed MM transplant eligible | Sarclisa + Borte + Lena + Dex | Anticipated submission: 2024 |
Smoldering MM | Sarclisa + Lena + Dex | NA |
– Dr. Kowndinya, CI Scientists