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    Treatment of Relapsed/Refractory Myeloma (excluding T-cell redirection therapy)

    Category: Treatment of Relapsed/Refractory Myeloma (excluding T-cell redirection therapy)

    Real-world (RW) Burden of Infection Among Triple-class–exposed (TCE) Patients (Pts) With Relapsed/Refractory Multiple Myeloma (RRMM)

    (PA-462) Real-world (RW) Burden of Infection Among Triple-class–exposed (TCE) Patients (Pts) With Relapsed/Refractory Multiple Myeloma (RRMM)

    Thursday, September 18, 2025
    Introduction: Pts with RRMM often require multiple lines of therapy (LOTs); a cumulative immunosuppressive effect of these multiple lines of therapy may contribute to an increased infection risk. Bispecific antibodies (BsAbs) have become key treatment options in later LOTs. While studies of BsAbs have investigated infection rates, RW data on the burden of infection with conventional (non-T-cell–redirecting) therapies is limited. This retrospective, observational study aimed to identify infection risk in pts with TCE (≥1 proteasome inhibitor, ≥1 immunomodulatory drug, and ≥1 anti-CD38 monoclonal antibody) RRMM receiving conventional therapies.

    Methods:

    Pts with TCE RRMM and with ≥4 prior LOTs who had started a subsequent LOT (index LOT) during the study period (Jan 1, 2016-Oct 31, 2024) were identified from the Komodo Research Dataset (KMD) and the All-Payer Claims Data (APCD). Pts enrolled in a trial ≤6 mo prior to index (index LOT start date) or receiving T-cell–redirecting therapies on/post index were excluded. Pt characteristics were collected during the 6-mo baseline period. Pts were followed from the index date to end of continuous enrollment, death, data cut-off, or end of study period. An algorithm requiring a 30-day washout with no infections prior to index was developed to define infection episodes. Infections that led to hospitalization or emergency room visits were considered severe. Meta-analysis was used to synthesize data between KMD and APCD.

    Results:

    2702 KMD and 1755 APCD pts were included (median follow-up, 9.5 and 14.9 mo, respectively). Mean (SD) age was 67.2 (10.6) y for KMD and 69.3 (9.5) y for APCD. Of KMD/APCD pts, 54.0%/52.4% were male and 53.2%/64.2% were White; 29.3%/17.4% had a commercial payer, 9.0%/6.6% had Medicaid, and 61.5%/75.0% had Medicare. Mean (SD) Quan-Charlson Comorbidity Index was 3.2 (3.1)/2.3 (2.8). Pts were heavily pre-treated, with a median index LOT number of 5 in both databases. The most common prior therapies in the TCE classes for KMD/APCD pts were daratumumab (D; 99.3%/99.1%), lenalidomide (83.8%/89.9%), and bortezomib (79.5%/81.6%). The most frequent index LOTs in KMD pts were elotuzumab+pomalidomide (P)±dexamethasone (d; 5.1%), DP±d (6.3%), carfilzomib (K)±d (5.2%), DK±d (4.4%), and KP±d (3.9%). Across KMD and APCD pts, the weighted average (wavg) infection rate for any infection was 63.5% (58.2%, bacterial; 27.4%, viral; 8.2%, fungal); at 26 and 52 wks, the wavg cumulative infection rates for any infection were 49.5% and 66.4%, respectively. The wavg rate of severe infection was 46.1% for any infection (42.5%, bacterial; 17.1%, viral; 4.9%, fungal); at 26 and 52 wks, these wavg cumulative rates for severe infection were 31.5% and 44.9%, respectively.

    Conclusions: These RW data highlight the substantial burden of infection in TCE pts with RRMM receiving conventional (non-T-cell–redirecting) therapies after ³4 prior LOTs, with a high risk of any infection ( >60%) and severe infection ( >45%).