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Expert Interview

Slingshot members are talking to an expert! The topic is:

Discussing the data from the CARTITUDE-4 Trial of Legend's CARVYKTI (ciltacabtagene autoleucel) in multiple myeloma

Ticker(s): LEGN

Who's the expert?

Institution: Washington University St. Louis

  • Professor Department of Medicine Oncology Division Bone Marrow Transplantation & Leukemia at WUSTL
  • Currently treats ~300 patients with multiple myeloma, 25 patients with AML, 10 patients with CMML, and ~15 patients per month with AL Amyloidosis.
  • Clinical research focus on strategies to improve the outcome of patients with multiple myeloma, acute myeloid leukemia, and myelodysplastic syndromes.

Interview Questions
Q1.

CARVYKTI is a BCMA-targeted CAR-T cell therapy. Can you explain how this mechanism of action contributes to its effectiveness in treating multiple myeloma?

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Q2.

The CARTITUDE-4 trial demonstrated a statistically significant and clinically meaningful improvement in overall survival with CARVYKTI. Could you provide more details on the survival benefits observed in this trial?

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Q3.

In the CARTITUDE-4 trial, CARVYKTI was compared to pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd). How did CARVYKTI perform in comparison to these regimens?

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Q4.

Safety results were consistent with the established profile of CARVYKTI, and no new safety signals were identified. What are the key safety considerations and adverse events associated with CARVYKTI treatment?

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Q5.

The trial noted a numerically higher percentage of early deaths in the CARVYKTI arm compared to the control arm. Can you discuss the factors contributing to these early deaths and how they are being addressed?

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Q6.

Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) are significant concerns with CAR-T therapies. How are these toxicities managed in patients receiving CARVYKTI?

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Q7.

CARVYKTI received FDA approval based on the data from the CARTITUDE-4 trial. What are the next steps in the regulatory process, and are there plans for expanding its indications?

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Q8.

Given the results from the CARTITUDE-4 trial, what future research and development plans does Legend Biotech have for CARVYKTI? Are there plans to investigate its use in other hematologic malignancies?

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