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3347 Real-World Evaluation of Teclistamab for the Treatment of Relapsed/Refractory Multiple Myeloma (RRMM)

Program: Oral and Poster Abstracts
Session: 652. Multiple Myeloma: Clinical and Epidemiological: Poster II
Hematology Disease Topics & Pathways:
Research, Clinical Research, Therapies
Sunday, December 10, 2023, 6:00 PM-8:00 PM

Sireesha Asoori, MBBS, MPH1*, Rakesh Popat2*, Joaquín Martínez-Lopez3*, Efstathios Kastritis, MD4*, Larissa Brunaldi5*, Radhika Bansal, MBBS5*, Andre De Menezes Silva Corraes, MD5*, Kwee Yong2, Catriona Mactier, MD2*, Magdalena Corona3*, Adolfo Jesús Sáez Marín, MD3*, Despina Fotiou6*, Meletios A. Dimopoulos6, Saurabh Chhabra, MD, MS7, Sikander Ailawadhi8*, Ricardo Parrondo, MD8, Thomas Martin, MD1, Brian GM Durie, MD9 and Yi Lin, MD, PhD5

1University of California, San Francisco, CA
2University College London, London, United Kingdom
3University of Complutense, Hospital 12 de Octubre, Madrid, Spain
4Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece
5Mayo Clinic Cancer Center, Rochester, MN
6Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece
7Mayo Clinic, Phoenix, AZ
8Mayo Clinic, Jacksonville, FL
9International Myeloma Foundation, Studio City, CA

Introduction: Teclistamab (TEC) is a bispecific BCMA-CD3 directed T-cell antibody (BsAb), recently approved by EMA and FDA. Approval was based on the MajesTEC-1 study showing high overall response rates (≥PR in 63.0%) in heavily pretreated patients with relapsed multiple myeloma (RRMM). Few reports have described Real-World experience despite that TEC can induce unique side effects including cytokine release syndrome (CRS), neurotoxicity (ICANS) and a high incidence of infection (MajesTEC-1: incidence 76.4%; ≥Gr3: 44.8%). Thus, we performed a Real-World analysis of TEC therapy from 7 International Myeloma Foundation (IMF) associated MM academic centers.

Methods: Patients treated with standard-of-care TEC were included. Data was collected until 7/28/2023.

Results: 103 pts were included; median age 63 (range 33-91y); 15 pts. (14.5%) >75 yrs; 56.5% were male, 71.8% Caucasian, 11.6% Hispanic, and 12.6% Asian. Pts received a median of 6 PLT (range 1-16); 75% were triple-class-refractory (n=41/52 (79%), 30/85 (35%) had high-risk cytogenetics/FISH and 32/80 (40%) had 1q21 gain. At least 57/76 (75%) of pts would not have been eligible for MajesTEC-1 (mostly from prior BCMA (n=28 CAR-T, n=14 ADC; n=3 BsAb; n=5 CAR-T+ADC). 14 pts had CrCl <30ml/min with 2 on HD. Median number of hospital days was 8 (n= 72) but 31 patients were treated entirely as outpatients (Mayo clinic (MN, AZ, FL)).

CRS was seen in 52 (50.4%) (all grade 1: except 6 Gr2, 1 Gr4), generally resolved within 24 hrs and was managed with tocilizumab alone (n= 27) or dex alone (n=9) or dex+toci (n=12). CRS was more common with inpatient (56.9%) vs outpatient (35.4%) TEC Rx. CrCl <30 ml, did not appear to alter the incidence or severity of CRS (50%; 1 Gr4). ICANS was infrequent (n=5; 4.85%), 1 pt with Gr 4-Sz requiring HD-steroids and TEC discontinuation). Infections were common, seen in 54 (52.4%) of patients, the majority were viral URI or CMV reactivation (n=26; 3 pts receiving CMV Rx, 1 pt with CMV organ disease). IVIG was given in 43/67 (64%) pts.

The overall response rate for evaluable patients (n=82) was 63%; (sCR/CR 14; VGPR 23; PR 15; MR 2, SD 14; PD 14). In evaluable pts treated with prior BCMA (n=43), the ORR was 53% (sCR/CR 4; VGPR 14; PR 5; 1 MR; SD 10; PD 9). The most common reason for treatment discontinuation was PD (26.2%). 14 pts have died by the time of data cut-off (7/28/23), with the most common cause of death being disease progression.

Conclusions: In this Real-World evaluation of TEC, a high ORR was seen, similar to the MajesTEC-1 study. Responses were rapid and are expected to deepen over time (median f/u 5m). CRS rates were similar to MajesTEC-1 and no new toxicity signal was noted. The rates of infection appear low but may be related to short follow-up. Details regarding the incidence and types of infection and the global use of IVIG will be described. With longer follow-up, additional efficacy/toxicity data will be presented.

Disclosures: Popat: GSK: Consultancy, Honoraria, Research Funding; Abbvie: Honoraria; BMS: Honoraria; Janssen: Honoraria; Roche: Honoraria. Kastritis: Sanofi: Honoraria; Janssen: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; GSK: Honoraria, Research Funding. Dimopoulos: AMGEN, ABBVIE, TAKEDA, BEIGENE,BMS, GSK, JANSSEN, MENARINI, REGENERON, SANOFI: Honoraria.

*signifies non-member of ASH