Introduction: Talquetamab (Talq) is a GPRC5D targeting bispecific antibody recently approved for the treatment of relapsed refractory multiple myeloma (MM) based on the MonumenTAL-1 study. Real World Evidence (RWE) is needed to understand the safety and efficacy of Talq in patients treated outside of a clinical trial as they may have different outcomes and toxicities. Here we report outcomes of 118 patients treated with Talq.

Methods: Patients treated with standard-of-care Talq were included. Data was collected through a retrospective chart review from 01/2023 until 7/2024 from 7 International Myeloma Foundation (IMF) associated MM academic centers.

Results: 118 patients were included in the analysis. The median age was 64, 37% had HR disease, 22% had EMD at presentation. The median LOT was 6, median number of immunotherapies before TAL was 2 (range 1,4) and 71% received prior BCMA therapy. 72% were triple refractory and 44% were penta refractory. 25% (n=60) would not have been eligible for TAL clinical trial due to exclusion criteria and15% had an ECOG of 2 or greater.

18% (n=97) received TAL as an outpatient and the median number of hospital days was 9 (0,37) for inpatients. CRS during Step up Dose (SUD) 1 was present in 30% Gr 1 (57%), Gr2 (11%), Gr 3 (6%), CRS during SUD 2 was present in 31%, Gr 1 (65%), Gr 2 (11%), CRS during SUD 3 when administered was present in 14% , Gr 1 (82%), Gr 2 (6%) and with first full dose was 12% , Gr 1 (71%), unknown (29%). ICANS occurred in 6% (7/97), Gr 1 (14%), Gr 2 (29%), Gr 3 (14%) and unknown in 43% there was no evidence of HLH.

Skin toxicity was present in 62% of patients (n=105/118) with 4% needing dose interruptions and presented as rash (20%), dryness (42%) and itching (20%). Nail toxicity was present in 20% (n=65/118), with 9% needing dose interruptions. Dysgeusia was present in 51% (n=97/118), with 10% needing dose interruptions. Oral toxicity manifest as stomatitis (10%), glossitis (1%), ulcerations (2%), dry mouth (27%), was present in 34% (n=61/118), with 12.5% needing dose interruptions. Infections were present in 34% (n=82/118) and CMV reactivation in 23% while only 1 patient needed treatment for CMV.

The Overall Response Rate (ORR) was 64.9% with a VGPR rate or higher of 43.3% in this population. Updated efficacy data including PFS will be reported at the time of presentation

Conclusions: This is the first largest RWE of the safety and efficacy of Talq in a heavily pretreated population with a high prior BCMA exposure. The ORR is consistent with a prior study by Jakubowiak et al which showed an ORR OF 65.7% after prior T cell engagers. The safety profile - CRS, ICANS, skin and oral toxicities was similar to the MonumenTAL study, CMV reactivation was higher and this may be related to treatment with prior immunotherapies and should be monitored in the future. This report shows that Talq has a similar safety and efficacy profile in the real world when sequenced after prior BCMA therapies.

Disclosures

Janakiram:LEGEND: Honoraria, Research Funding; FATE THERAPEUTICS: Research Funding; BMS: Honoraria, Research Funding; JANNSEN: Honoraria, Research Funding. Tan:Janssen: Honoraria, Research Funding; Sanofi: Honoraria; Takeda: Research Funding. Popat:Pfizer: Honoraria, Research Funding, Speakers Bureau; GSK: Honoraria, Research Funding; Sanofi: Honoraria; Janssen: Honoraria, Speakers Bureau; Abbvie: Honoraria; BMS: Honoraria. Lopez:Pfizer, Janssen, Incity: Research Funding; BMS, Pfizer, Janssen, Amgen, Roche, Kite: Honoraria; BMS, Pfizer, Janssen, Amgen, Roche, Kite: Consultancy. Kastritis:GSK: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Honoraria; Prothena: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Genesis Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Chng:BMS: Honoraria; Janssen: Honoraria; Amgen: Honoraria; Sanofi: Research Funding; GSK: Research Funding. Kapoor:Karyopharm: Research Funding; Loxo Pharmaceuticals: Research Funding; Oncopeptides: Membership on an entity's Board of Directors or advisory committees; Kite: Membership on an entity's Board of Directors or advisory committees; BeiGene: Membership on an entity's Board of Directors or advisory committees, Research Funding; X4 Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Mustang Bio: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees, Research Funding; Ichnos: Research Funding; Regeneron: Research Funding; Bristol Myers Squibb: Research Funding; AbbVie: Membership on an entity's Board of Directors or advisory committees, Research Funding; GlaxoSmithKline: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Amgen: Research Funding; Angitia Bio: Membership on an entity's Board of Directors or advisory committees; CVS Caremark: Consultancy; Keosys: Consultancy. Mian:Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria. Bal:BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy, Research Funding; Beigene: Research Funding; AstraZeneca: Consultancy; Fate Therapeutics: Research Funding; MJH Life Sciences: Honoraria; Janssen: Consultancy. Nooka:ONK Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Aduro Biotech: Research Funding; Arch Oncology: Research Funding; Adaptive Biotechnologies: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sebia: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AstraZeneca: Honoraria, Membership on an entity's Board of Directors or advisory committees; K36 Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Cellectis: Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; GSK: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Cellectar Biosciences: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Genentech: Research Funding; Karyopharm: Research Funding; Kite Pharma: Research Funding; Merck: Research Funding. Lin:Caribou: Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Consultancy, Research Funding; Regeneron: Consultancy; Pfizer: Membership on an entity's Board of Directors or advisory committees; NexImmune: Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy; Celgene: Consultancy, Research Funding; Legend: Consultancy; Janssen: Consultancy, Research Funding; Genentech: Consultancy. Martin:Janssen: Research Funding; Poseida: Research Funding; Sanofi: Research Funding; GSK, Pfizer, Roche: Honoraria; BMS: Research Funding. Krishnan:AbbVie; Adaptive; Arcelx; GSK; Janssen; Roche; and Sanofi: Consultancy; Bristol Myers Squibb: Current holder of stock options in a privately-held company; Johnson & Johnson: Membership on an entity's Board of Directors or advisory committees; City of Hope National Medical Center: Current Employment.

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2024
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