An addendum to the "Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of melanoma" is now available.
In accordance with the Institute of Medicine’s Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs), SITC CPGs undergo periodic evaluation to assess if new evidence necessitates modifications to recommendations, treatment algorithms, or other guideline content. This is done to ensure SITC’s CPGs are up-to-date with cutting-edge thinking and incorporate the leading expert guidance in cancer immunotherapy care – a vital service to treating clinicians and those along the whole cancer care continuum.
Addendum v3.2 Summary
The information below provides an overview of addendum v3.2 to the "Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of melanoma" published in Journal for ImmunoTherapy of Cancer (JITC). This addendum integrates prior rapid updates with practice-changing data and approvals. The SITC Melanoma CPG Expert Panel has updated the recommendations in this guideline to address the following:
- On October 13, 2023, the US Food and Drug Administration (FDA) granted approval to nivolumab for the treatment of resected stage IIB/C melanoma in the adjuvant setting for patients 12 and older. Approval of nivolumab in this setting was based on significant improvement of recurrence-free survival (RFS) in the phase III CheckMate 76K trial (NCT04099251), which enrolled patients with completely resected stage IIB/C melanoma.
- On February 16, 2024, the US FDA granted an accelerated approval to lifileucel for the treatment of unresectable or metastatic melanoma in adult patients who have been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody, and if BRAFV600 positive, a BRAF inhibitor (BRAFi) with or without a MEK inhibitor (MEKi). Lifileucel is a first of its kind autologous tumor-infiltrating lymphocyte (TIL) cell therapy.
- Practice-changing data demonstrating the efficacy of neoadjuvant nivolumab and ipilimumab followed by surgery in patients with resectable stage III melanoma were reported from the NADINA trial (NCT04949113). The phase III randomized trial assessed neoadjuvant nivolumab and ipilimumab followed by surgery (with adjuvant therapy for those with a partial or non-response) compared to adjuvant nivolumab in patients with resectable stage III melanoma showed longer event-free survival (EFS) with the neoadjuvant regimen.
For More Information
- SITC Melanoma CPG – Overview of all available updates and companion guideline educational offerings for this guideline
- SITC Guidelines Program – Listing of all published guidelines in the SITC CPG catalogue
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- Questions – Contact a member of the SITC guideline development staff at scientificresources@sitcancer.org