Richard Carvajal, MD

So that your oncology colleagues can better understand your experience, investigational interests, and expertise in cancer immunotherapy and treatment of musical melanoma can you kindly share your current role and affiliations?

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Can you provide an overview of the landscape of immunotherapy for melanoma and its rarer subtypes, with an emphasis on the role of immune checkpoint inhibition, its limitations, and the need for additional immuno-oncology-focused co-therapies?

Richard Carvajal, MD

$Based on current I-O approaches to managing mucosal melanoma, why does this refractory variant of melanoma represent a good model for studying the efficacy and safety of a novel, engineered cytokine fusion protein such as nemvaleukin?$ Video

Based on current I-O approaches to managing mucosal melanoma, why does this refractory variant of melanoma represent a good model for studying the efficacy and safety of a novel, engineered cytokine fusion protein such as nemvaleukin?

Richard Carvajal, MD

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What was it about cytokine-based treatments targeting the IL-2 pathway that suggested they had potential to provide immune system-directed treatment where other therapies had failed? And how did the results from ARTISTRY-1 inform your analysis?

Richard Carvajal, MD

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After taking note of the signals for response in mucosal melanoma that were reported in ARTISTRY-1, how did you proceed with the design for ARTISTRY-6 evaluating the efficacy and safety of this novel cytokine fusion protein in mucosal melanoma?

Richard Carvajal, MD

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What was it about the novel, engineered cytokine fusion protein nemvaleukin that led you to revisit the IL-2-mediated therapeutic space in search of a treatment that would overcome previous limitations with high dose human recombinant IL-2?

Richard Carvajal, MD

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What is it about nemvaleukin’s novel engineering, mechanism-of-action (MOA), as well as its manageable safety profile, that makes it unique among novelly generated cytokines that have been developed in the cancer immunotherapy space?

Richard Carvajal, MD

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How effective has the novel re-engineering of the IL-2 cytokine fusion protein, nemvaleukin, been as far as mitigating side effects and permitting outpatient-based administration and management of this cytokine-based treatment modality?

Richard Carvajal, MD

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Against this backdrop of positive signals for mucosal melanoma observed in ARTISTRY-1, and confirmation that nemvaleukin could be managed effectively and safely in the outpatient environment, how did you approach the design of ARTISTRY-6?

Richard Carvajal, MD

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On the basis of what early clinical data, safety profile, and mechanistic features does the FDA typically approve a drug such as nemvaleukin for fast track designation?

Richard Carvajal, MD

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Moving beyond investigation of nemvaleukin in mucosal melanoma and/or other rare tumor types, how might the cancer immunotherapy community think about advancing studies of nemvaleukin across a wider taxonomy of tumor subtypes?

Richard Carvajal, MD

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What did we learn from pre-clinical animal studies confirming that from an immunobiological, mechanistic perspective, nemvaleukin stimulated CD8+ and natural killer cells while not concommitantly activating the Treg cell axis?

Richard Carvajal, MD