Al-Ola A Abdallah: Another BCMA Bite Approval
Al-Ola A Abdallah, Associate Professor and Plasma Cell Disorder Program Director of the Division of HMCT at the University of Kansas Medical Center, shared a post on X:
“Breaking News another BCMA bite approval.
FDA Accelerated Approval: Lynozyfic (linvoseltamab-gcpt). A new BCMAxCD3 bispecific for relapsed/refractory multiple myeloma (MM) after ≥4 prior lines of therapy.
Lynozyfic Mechanism: A bispecific antibody that redirects CD3+ T cells to kill BCMA+ MM cells. Engineered with Regeneron’s VelocImmune platform.
Approval based on the LINKER-MM1 Trial (Ph 1/2):
- n = 80 (heavily pre-treated MM)
- ORR: 70%
- CR or better: 45%
- Median time to response: 0.95 mo
- DoR not reached – 72% estimated at 12 months.
Dosing Highlights:
- Weekly ×14 weeks
- Q2W starting week 14
- Q4W if VGPR or better after ≥24 weeks
- Hospitalization required after each of the 1st two step-up doses
Boxed Warnings and Key Adverse Events:
- CRS
- Neurotoxicity (incl. ICANS)
- Infections, neutropenia, hepatotoxicity
- Common AEs: MSK pain, cough, fatigue, URTI, diarrhea, nausea
Ongoing Clinical Development:
- Phase 2 dose expansion (IV)
- Phase 1b combo trial (LINKER-MM2)
- Phase 3 monotherapy trial (LINKER-MM3)
- Subcutaneous formulation under study.
Access Support for Community Oncologists: Regeneron launches Lynozyfic Surround™ for financial + educational resources. 1-844-RGN-HEME
Bottom Line for Clinicians:
- New BCMAxCD3 bispecific with high ORR in R/R MM
- Response-adapted dosing = less burden
- Early efficacy + ongoing trials → potential broader impact.”
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