Notable efficacy for an off-the-shelf immunotherapy[1][2]

TECVAYLI™ (teclistamab) demonstrated notable efficacy for an off-the-shelf immunotherapy, with 58.8% of patients achieving VGPR or better[1][2]

  • After 23 months of follow-up, ORR was 63%[1][2]
  • Of patients who achieved ≥CR (45.5%)[1][2]
  • 81.5% of MRD evaluable patients achieved MRD negativity at any point[1][2]
  • The median time to first response was 1.2 months (range: 0.2–5.5), and the median time to achieved ≥CR was 4.6 months (range: 1.6-18.5)[1][2]

*MRD-negativity was assessed using next-generation sequencing with a threshold of 1 tumour cell per 105 bone marrow cells.[3]

14.1 months was the median follow-up time.[1]

Adapted from Moreau et al. 2022[1]

Efficacy was consistent regardless of cytogenetic risk or extent of prior therapy refractoriness^[1][3]

Adapted from Moreau et al. 2022[3]

*del(17p), t(4;14) and/or t(14;16)[3]
**≥1 PI, ≥1 IMiD and ≥1 anti-CD38 mAb[3]
†≥2 PI, ≥2 IMiD and ≥1 anti-CD38 mAb[3]
^Median follow up of 14.1 months

Responses were rapid and durable in MajesTEC-1[1]

Median progression-free survival (mPFS): 11.3 months (95% CI: 8.8–16.4)[1]
Median follow up of 23 months

PFS

Median duration of response (mDOR): 21.6 months (95% CI: 16.2-NE)[1][2]
Median follow up of 23 months

Duration of response

Adapted from Moreau et al. 2022[1]

mDOR was not mature at the time of publication after censoring of data for 71 patients; median follow-up time was 14.1 months (range: 0.3–24.4)[1]

Median overall survival (mOS): 21.9 months (95% CI: 15.1–NE)[1]
Median follow up of 23 months

OS

*As the MajesTEC-1 trial was a single-armed study without a comparator arm, an indirect treatment comparison was made against LocoMMotion (NCT04035226), a prospective real-world study in a similar patient population[1][5][2]

For further information regarding TECVAYLI including full indications, all adverse effects and data please refer to the Israeli MOH prescribing information: https://israeldrugs.health.gov.il/#!/byDrug

The data in this presentation is based on published clinical studies, please see references at the bottom of the slides/throughout the presentation.