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Expert Interview

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

Examining the Phase 2 AGAVE-201 Trial Results for Axatilimab (Niktimvo) in Chronic Graft-Versus-Host Disease from Syndax (SNDX) and Incyte (INCY)

Ticker(s): SNDX, INCY

Who's the expert?

Institution: Huntsman Cancer Institute

  • Assistant Professor in the Transplant and Cellular Therapy Program at Huntsman Cancer Institute
  • Treats 20 patients with chronic GVHD a month
  • Clinical and research expertise is in Blood and Marrow Transplantation and GVHD with particular interest in allogeneic hematopoietic cell transplantation as well as cellular therapies such as CAR-Ts for the treatment of malignant and benign hematologic diseases in adult patients

Interview Questions
Q1.

The AGAVE-201 trial demonstrated that 74% of patients in the 0.3 mg/kg dose cohort achieved a complete or partial response within the first six months of treatment. How meaningful is this response rate for patients with cGVHD, especially those who have failed two or more lines of prior systemic therapy?

Added By: catalin_admin
Q2.

Patients in the 0.3 mg/kg cohort had a median time to response of 1.7 months, with 60% of responders maintaining their response at 12 months. How significant is this rapid and durable response in the management of cGVHD, and what impact could this have on the overall quality of life for patients?

Added By: catalin_admin
Q3.

The study showed notable responses across multiple organs, including fibrosis-dominated organs like the esophagus, joints/fascia, and lungs. Can you discuss the implications of these organ-specific responses for managing the diverse manifestations of cGVHD, particularly those affecting quality of life?

Added By: catalin_admin
Q4.

The AGAVE-201 results were consistent across various patient subgroups, including those who had received prior treatments like ruxolitinib, ibrutinib, or belumosudil. How important is this broad applicability in addressing the unmet needs of patients with refractory cGVHD?

Added By: catalin_admin
Q5.

Niktimvo is the first FDA-approved treatment that specifically targets macrophages involved in both fibrotic and inflammatory processes. How does this novel mechanism of action differentiate Niktimvo from other available therapies, and what does it mean for future treatment strategies in cGVHD?

Added By: catalin_admin
Q6.

The most common adverse events observed in the trial included increased AST and ALT, infections, and fatigue, with grade ≥3 adverse events in 49% of patients. How do these safety results compare to other treatments for cGVHD, and what should clinicians consider when prescribing Niktimvo?

Added By: catalin_admin
Q7.

Niktimvo has been added to the NCCN Clinical Practice Guidelines for cGVHD after the failure of at least two prior therapies. How does this endorsement influence clinical practice, and what impact do you foresee on treatment sequencing for patients with cGVHD?

Added By: catalin_admin
Q8.

There are ongoing studies exploring the use of axatilimab in combination with other agents like ruxolitinib. What potential do you see in these combination strategies for advancing the treatment of cGVHD, and what are the key challenges in bringing these combinations to clinical practice?

Added By: catalin_admin

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