Introduction: The bispecific antibodies teclistamab (TEC) and talquetamab (TAL) have been recently approved in patients with relapsed/refractory multiple myeloma (RRMM).

Methods: We retrospectively evaluated the efficacy and safety outcomes of patients with RRMM treated with the approved schedule of TEC or TAL at 8 Greek centers until 30/06/2024.

Results: 35 patients were included; 24 on TEC (median age 66.5 years, range 44-85, 45.8% females) and 11 on TAL (57 years, 50-60, 18.2% females). 10 (41.7%) and 1 (9.1%) were primary refractory, whereas 13 (54.2%) and 10 (90.9%) were penta-refractory, respectively. The patients had received a median of 5 (range 3-11) and 7 (5-11) prior lines of treatment, respectively. 9 (37.5%) and 6 patients (54.5%) had extramedullary disease (EMD), respectively.

After a median of 8 and 7 cycles (range 3-23 and 2-17), respectively, best responses included 7 (33.4%) complete response (CR) or better, 3 (12.5%) very good partial response (VGPR) and 7 (29.2%) partial response (PR) for TEC and 1 (9.1%) CR or better, 2 (18.2%) VGPR, 2 (18.2) PR, 1 (9.1%) minor response (MR) and 3 (27.3%) stable disease (SD) for TAL. The median time to first response was 36 (range 20-120) and 42 (15-67) days and the median time to best response was 56.5 (range 20-211) and 56 (15-194) days, respectively. 3/7 patients with EMD on TEC responded (42.9%) and 2/6 on TAL (33.3%).

14 patients (58.3%) on TEC are still ongoing treatment in remission, 1 (4.2%) is off treatment but in remission, while 5 (20.8%) have discontinued due to progressive disease (PD) (5%) and 4 (23.6%) have died (3 due to PD, 1 due to COVID-19); two (8.3%) were lost to follow-up. For TAL, 5 patients (45.5%) are still undergoing treatment on remission, whereas 6 (54.5%) have died due to PD.

At a median follow-up of 4.6 months (range 0.2-13.5) for TEC and 7.8 months (1.1, 19.8) for TAL, the median progression-free survival (PFS) was not reached (NR) and was 6.9 (95% CI: 3.87, NA) months, respectively. Median overall survival (OS) was NR for TEC, while it was 11.5 months (95% CI: 7.8, NA) for TAL. There were no significant differences in PFS for each treatment group when stratified by the presence of high-risk cytogenetics, ISS stage, penta-refractory status or extramedullary disease.

Every patient was hospitalized at least for the initial administration of the drug. The median days of hospitalization were 9 (range 2-45) and 10 (9-22), respectively. Five patients on TEC (20.8%) and 3 on TAL (27.3%) were required to be re-admitted, mainly due to infections. The median hospitalization days for re-admitted patients were 5 (range 2-10) and 7 (4-9), respectively.

Eight patients (33.3%) on TEC and 8 patients (72.7%) on TAL developed grade 1-5 infections (mainly bacterial and viral) with the first being at a median of 3 (range 1-15) and 1 (range 1-5) cycles, respectively. Five of infected patients on TEC and the 6 on TAL required hospitalization with a median of 5 (range 4-10) and 7 (range 5-45) days until resolution. There was no association between baseline neutrophil or leukocyte levels and infection occurrence.

Therapy-induced CRS was documented in 15 (62.5%) TEC and 7 (63.6%) TAL patients. There were 5 (20.8%) and 7 (63.6%) incidences of CRS after dose step-up. The median grade for both groups was 1 (range 1-3). The median time to CRS onset for both groups was 1.5 and 1 day (ranges 1-5 and 1-1) and the median time to resolution for both groups was 1 day (ranges 1-5 and 1-2). The main treatment of choice in both cohorts was tocilizumab (40.0% and 42.9%). There was only one case of Immune effector cell-associated neurotoxicity syndrome (ICANS) in the TEC group.

Hypogammaglobulinemia was common even at treatment initiation, as it was present in 16 (66.7%) and 3 (27.3%) patients for TEC and TAL groups, respectively. There were also 10 (41.7%) cases during TEC treatment. After a median of 4 months (range 1-8) on Ig administration, 9 patients (90.0%) recovered. Moreover, there were 7 (29.2%) and 5 (45.5%) cases of grade 3 or 4 neutropenia and 8 (33.3%) and 5 (45.5%) cases of grade 3 or 4 thrombocytopenia, respectively.

Dermatological complications were prevalent mainly in the TAL group, with 3 (12.5%) cases of grade 2 rash and 4 (36.4%) nail changes. There were 3 (12.5%) cases of grade 1-3 rash in the TEC group.

Conclusion: Real-world outcomes confirm the efficacy and safety profile of TEC and TAL in RRMM comparable to clinical trials.

Disclosures

Ntanasis-Stathopoulos:AstraZeneca: Honoraria; Janssen-Cilag: Honoraria; Cellectar Biosciences: Research Funding. Hatjiharissi:Abbvie: Membership on an entity's Board of Directors or advisory committees, Research Funding; Gilead: Honoraria; Genesis: Membership on an entity's Board of Directors or advisory committees. Spanoudakis:GSK: 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; Janssen-Cilag: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees. Douka:Integris Pharma: Honoraria; Janssen: Honoraria; BMS: Honoraria; AbbVie: Honoraria; Astra Zeneca: Honoraria. Fotiou:Sanofi: Honoraria; Janssen: Honoraria. Labropoulou:BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Johnson and Johnson: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Genesis Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Demo: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; WinMedica: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Vianex: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; GSK: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Dalampira:Janssen: Research Funding; Pfizer: Research Funding. Papadopoulou:Janssen: Honoraria; AstraZeneca: Honoraria; Abbvie: Honoraria; Amgen: Honoraria. Christoulas:Amgen: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Astellas: Research Funding; Genesis Pharma: Speakers Bureau; Gilead: Membership on an entity's Board of Directors or advisory committees; GSK: Research Funding; Janssen-Cilag: Research Funding, Speakers Bureau; Laboratories SMB SA: Research Funding; Pfizer: Membership on an entity's Board of Directors or advisory committees; Pharmacyclics: Research Funding; Sandoz: Speakers Bureau; Takeda: Speakers Bureau. Pappa:Genesis Pharma: Honoraria; Roche: Honoraria; Servier: Honoraria; Novartis: Honoraria; Gilead: Honoraria; BMS: Honoraria; AstraZeneca: Honoraria; GSK: Honoraria; Amgen: Honoraria; Sobi: Honoraria; Pfizer: Honoraria; Abbvie: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Celgene: Research Funding. Kastritis:Genesis Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; GSK: 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; Sanofi: Honoraria; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Prothena: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria. Terpos:BMS: Honoraria; AstraZeneca: Honoraria, Other: Travel expenses; EUSA Pharma: Honoraria, Other: Travel expenses; GSK: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Menarini/Stemline: Honoraria; Pfizer: Honoraria; Amgen: Honoraria, Other: Travel expenses, Research Funding; Sanofi: Honoraria, Other: Travel expenses, Research Funding; Takeda: Honoraria, Other: Travel expenses, Research Funding; Novartis: Honoraria; Antengene: Honoraria, Research Funding; Swixx: Honoraria. Dimopoulos:BeiGene Inc: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Consulting fee; GlaxoSmithKline: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Consulting fee; Sanofi: 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, Other: Consulting fee; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Consulting fee; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Consulting fee; Menarini: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Consulting fee; Regeneron: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Consulting fee; Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Consulting fee; Swixx: Honoraria, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen, Abbvie, Takeda, Beigene, BMS, GSK, Janssen, Menarini, Regeneron, Sanofi: Other: Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Gavriatopoulou:GSK: Consultancy, Honoraria; Cellectar Biosciences: Research Funding; BMS: Research Funding; AbbVie: Honoraria; Beigene: Research Funding; Amgen: Consultancy; Karyopharm: Consultancy; Genesis Pharma: Honoraria; Integris: Honoraria; Takeda: Consultancy, Honoraria; Swixx: Honoraria; Janssen Cilag: Honoraria.

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2024
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