Lesokhin Alexander, Nath Karthik, Shekarkhand Tala, Nemirovsky David, Derkach Andriy, Costa Bruno Almeida, Nishimura Noriko, Farzana Tasmin, Rueda Colin, Chung David, Landau Heather, Lahoud Oscar, Scordo Michael, Shah Gunjan, Hassoun Hani, Maclachlan Kylee, Korde Neha, Shah Urvi, Tan Carlyn Rose, Hultcrantz Malin, Giralt Sergio, Usmani Saad, Shahid Zainab, Mailankody Sham
Memorial Sloan Kettering Cancer Center.
MSKCC.
Res Sq. 2024 Feb 7:rs.3.rs-3911922. doi: 10.21203/rs.3.rs-3911922/v1.
B-cell-maturation-antigen (BCMA)-directed therapies are highly active for multiple myeloma, but infections are emerging as a major challenge. In this retrospective, single-center analysis we evaluated infectious complications after BCMA-targeted chimeric-antigen-receptor T-cell therapy (CAR-T), bispecific-antibodies (BsAb) and antibody-drug-conjugates (ADC). The primary endpoint was severe (grade ≥ 3) infection incidence. Amongst 256 patients, 92 received CAR-T, 55 BsAb and 109 ADC. The incidence of severe infections was higher with BsAb (40%) than CAR-T (26%) or ADC (8%), including grade 5 infections (7% vs 0% vs 0%, respectively). Comparing T-cell redirecting therapies, the incidence rate of severe infections was significantly lower with CAR-T compared to BsAb at 1-year (incidence-rate-ratio [IRR] = 0.43, 95%CI 0.25-0.76, P = 0.004). During periods of treatment-emergent hypogammaglobulinemia, BsAb recipients had higher infection rates (IRR:2.27, 1.31-3.98, P = 0.004) and time to severe infection (HR 2.04, 1.05-3.96, P = 0.036) than their CAR-T counterparts. During periods of non-neutropenia, CAR-T recipients had a lower risk (HR 0.44, 95%CI 0.21-0.93, P = 0.032) and incidence rate (IRR:0.32, 95% 0.17-0.59, P < 0.001) of severe infections than BsAb. In conclusion, we observed an overall higher and more persistent risk of severe infections with BsAb. Our results also suggest a higher infection risk during periods of hypogammaglobulinemia with BsAb, and with neutropenia in CAR-T recipients.
靶向B细胞成熟抗原(BCMA)的疗法对多发性骨髓瘤具有高度活性,但感染正成为一个重大挑战。在这项回顾性单中心分析中,我们评估了靶向BCMA的嵌合抗原受体T细胞疗法(CAR-T)、双特异性抗体(BsAb)和抗体药物偶联物(ADC)治疗后的感染并发症。主要终点是严重(≥3级)感染发生率。在256例患者中,92例接受了CAR-T治疗,55例接受了BsAb治疗,109例接受了ADC治疗。BsAb治疗的严重感染发生率(40%)高于CAR-T(26%)或ADC(8%),包括5级感染(分别为7%、0%和0%)。比较T细胞重定向疗法,1年时CAR-T治疗的严重感染发生率显著低于BsAb(发生率比[IRR]=0.43,95%CI 0.25-0.76,P=0.004)。在治疗出现低丙种球蛋白血症期间,接受BsAb治疗的患者感染率更高(IRR:2.27,1.31-3.98,P=0.004),发生严重感染的时间更短(HR 2.04,1.05-3.96,P=0.036)。在非中性粒细胞减少期间,接受CAR-T治疗的患者发生严重感染的风险较低(HR 0.44,95%CI 0.21-0.93,P=0.032),发生率也较低(IRR:0.32,95% 0.17-0.59,P<0.001)。总之,我们观察到BsAb治疗严重感染的总体风险更高且更持久。我们的结果还表明,在低丙种球蛋白血症期间,BsAb治疗的感染风险更高,而在接受CAR-T治疗的患者中,中性粒细胞减少时感染风险更高。