IMS 2022 Express BCMA CAR-T Cell Therapy RRMM Real World Research Data Released! The efficacy and safety are good, and the toxicity in elderly patients has not increased!

Idecabtagene vicleucel (ide-cel), a chimeric antigen receptor T cell (CAR-T) immunotherapy that targets B cell maturation antigens (BCMA), was approved in the United States in 2021 for patients

Researchers from the United States conducted a real-world study that retrospectively analyzed data

Figure 1

Of these, 47% had extramedullary disease and 44% had a pentatreous MM, both higher than the KarMMa trial (a key ide-cel trial) (Table 1

Table 1

Table 2

ide-cel was similar in toxicity to the KarMMa trial in this study, with CRS occurring in 82% of patients and neurotoxicity in 18% of patients (Table 3

Table 3

On day 90, the optimal overall response rate (ORR) for 141 patients was 86 percent, and the ≥ complete response (CR) rate was 42 percent

Figure 2

The results of the multivariate analysis showed that patients who had previously received BCMA targeted therapy and high-risk cytogenetic traits had shorter PFS (Figure 3
).

Figure 3

The above results show that even if most patients do not meet the KarMMa trial enrollment criteria, the safety and efficacy of ide-cel standard therapy in real-world RRMM patients is comparable
to that of the Phase II KarMMa trial.

Previous bcMA-targeted therapy and high-risk cytogenetic features are independent predictors
of poor prognosis in patients with RRMM treated with ide-cel.

【OAB-008】 Efficacy and safety of BCMA CAR-T in the treatment of elderly MM patients

In the KarMMa trial, PFS was comparable in older patients to younger patients
.

However, the efficacy and safety of elderly patients after receiving BCMA CAR-T have not been analyzed, and researchers from the United States have explored
this.

A total of 69 patients (33-77 years) were included in the study, and 15 patients (22%) were ≥70 years
old at the time of CAR-T cell infusion.

The demographic characteristics, physical status, and disease-related features of older patients are similar to those of younger patients (Table 4
).

Table 4

Despite similar body weights, older patients had lower creatinine clearance (median creatinine clearance: 74.
5 vs 108.
7 mL/min, P<0.
01) and were more likely to use low-dose fludarabine for lymphocyte clearance (53% vs 17%, P<0.
01).


The incidence of any level of CRS, any level of ICANS, and persistent neutropenia was similar between the two groups (Table 5
).

Table 5

Hypogammaglobulinemia developed in 93% of elderly patients and 73% of young patients ,p=0.
16),
respectively.

A total of 5 infections occurred, all occurring in
young patients.

Median PFS (95% CI: 10.
6-NR) and median OS (95% CI: NR-NR) were not achieved in older patients, and median PFS and median OS were 13.
9 months (95% CI: 11.
3-NR) and 30.
3 months (95% CI: 24.
8-NR) in younger patients (Figure 4).


+100 days, 2 patients died, both of whom were progressive MM, and both occurred in
young patients.

Figure 4

These results suggest that BCMA CAR-T cell therapy toxicity does not increase
in patients aged ≥70 years, although limited by small sample size and selection bias (more preference is given to older patients with better physical fitness for study).

Hypogamma globulinemia is more common in older patients but does not correspond to a higher risk
of infection.

Low-dose fludarabine lymphocyte clearance did not reduce the efficacy
of BCMA CAR-T cell therapy in elderly patients.

The results suggest that BCMA CAR-T cell therapy can be used as an effective treatment regimen
for elderly patients with RRMM.

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