CARVYKTI is a BCMA-targeted autologous CAR-T therapy with dual-binding domains for enhanced avidity. FDA-approved in 2022 (≥4 prior lines) and 2024 (earlier use), it offers deep, durable responses with one-time dosing and no maintenance.

CARTITUDE-1 is a Phase Ib/II multicenter study evaluating CARVYKTI in heavily pretreated RRMM patients—88% triple-class refractory, 99% refractory to last therapy—who typically face a median PFS <6 months and OS ~1 year. Patients received a single cilta-cel infusion, with long-term monitoring ongoing in the 15-year CARTinue study.

Key Findings

• 33% of patients (n=32/97) achieved PFS ≥5 years after a single CARVYKTI infusion without any maintenance therapy.

• These patients had a median of six prior therapies, with ~47% penta-drug refractory, reflecting a high disease burden.

• In a subset (n=12), 100% remained MRD-negative and imaging-negative over 5 years, showing deep, sustained responses.

• At a median follow-up of 61.3 months, the median OS was 60.7 months, far exceeding historical expectations.

• Safety remained consistent with prior reports; no new neurotoxicity or safety signals were observed.

KOL insights

"This new evidence shows how a single infusion of CARVYKTI can help patients survive without disease progression much longer than previously thought possible in this setting and without any maintenance or subsequent treatment."– Expert Opinion

“Cilta-cel… is the first potential functional cure for patients with modern-day relapsed/refractory myeloma. The ‘modern day’ is for my colleagues who actually like transplant and will always tell me that 10%–15% of patients do really well post-transplant. But again, for modern-day patients who are triple-class refractory or exposed, I think this is pretty phenomenal.” – Expert Opinion

Conclusion

The heavy-pretreatment multiple myeloma space is more focused on CAR T-cell therapies. In the same segment Bispecific antibodies have also been approved. With this it is common to compare CAR T-cell therapies and the bispecific antibodies. Between CAR-Ts and bispecifics, everyone wants CAR-Ts; yet, CAR-Ts are not without difficulties. Given the high ORR seen among all CAR T-cell therapies and bispecific antibodies the research is continued to understand the sequential treatment for all these agents. Efficacy comparison is only part of the equation. When selecting between bispecific antibodies and CAR T-cell treatments, physicians must take into account the safety characteristics of both treatments. Of all these agents, the risk for CRS and ICANS cannot be disregarded when examining comparative safety and adverse events. 

CARVYKTI became the first and only BCMA-targeted treatment approved by the US FDA for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. As of right now, CARVYKTI is the most lucrative approved CAR-T treatment for multiple myeloma. Sales in the 2024 of CARVYKTI surpassed the historical CAR-T launches. A single infusion of CARVYKTI delivered unprecedented durability in heavily pretreated RRMM patients, with one-third achieving ≥5-year PFS without maintenance—far exceeding historical outcomes. Deep MRD negativity, sustained OS, and a stable safety profile underscore its transformative potential in shifting myeloma treatment from continuous therapy to functional cure.