New five-year follow-up from the phase 2 CARTITUDE-2 study reported that 10 of 20 patients (50%) with early-line relapsed/refractory multiple myeloma were alive and progression-free at least five years after one CARVYKTI (ciltacabtagene autoleucel) infusion, without maintenance or other anti-myeloma treatment.
After a median follow-up of 60.7 months, the five-year overall-survival rate was 69.2%, and median progression-free survival was 60.5 months. Median overall survival had not been reached.
The results add to the 2025 CARTITUDE-1 follow-up, in which 32 of 97 heavily pretreated patients (33%) remained progression-free for at least five years after a single infusion and without further anti-myeloma therapy. In a small 12-patient subset with serial assessments, all were MRD- and imaging-negative at five years or later.
The findings are encouraging evidence of unusually durable, treatment-free remission and possible curative potential for some patients—but they do not establish that CARVYKTI cures multiple myeloma. The newer early-line result is from a small group of 20 patients, and longer follow-up and larger studies are needed.
Sources:
Single infusion of CARVYKTI® (ciltacabtagene autoleucel ...
Myelomtherapie: Fünf-Jahres-Daten von CARTITUDE-1 – ...
Long-Term (≥5-Year) Remission and Survival After Treatment ...
Single infusion of CARVYKTI® (ciltacabtagene autoleucel) ...
Legend Biotech reports 5-year CARVYKTI data in myeloma patients By Investing.com
Single infusion of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel ...
Ciltacabtagene Autoleucel Delivers Lasting Remissions in Relapsed or Refractory Multiple Myeloma
Carvykti delivers five-year remissions in early myeloma - PharmaTimes
Long-Term (≥5 Year) Remission and Survival After Treatment ...