The Society for Immunotherapy of Cancer (SITC) recently released focused updates to two of its clinical practice guidelines. This edition of our Guidelines Spotlight series will examine the key changes that you need to be aware of. 

Immunotherapy for the Treatment of Gynecologic Cancer

Version 1.1 – Updated on May 24, 2024

Guideline Update Comments:

The main driver for this gynecological cancer guidelines update was two new FDA approvals. First, the FDA approval of dostarlimab (Jemperli / GlaxoSmithKline) with carboplatin and paclitaxel and dostarlimab for dMMR or MSI-H primary advanced or recurrent endometrial cancer in July 2023. Second, the January 2024 FDA approval for pembrolizumab (Keytruda / Merck) with chemoradiotherapy for stage III-IVA cervical cancer.

Key Changes:

  • For patients with FIGO 2014 stage III-IVA cervical cancer, pembrolizumab plus chemoradiotherapy is recommended. (New Recommendation)
  • For first-line treatment of recurrent or metastatic endometrial cancer, carboplatin plus paclitaxel with or without trastuzumab (if HER2+ serous endometrial cancer) was the standard of care at the time of guideline publication (LE:2). Anti-PD-1 ICIs in combination with carboplatin plus paclitaxel demonstrated statistically significant and clinically meaningful improvements in PFS over chemotherapy alone for the treatment of previously untreated stage III or IV or first recurrent (after prior neoadjuvant or adjuvant chemotherapy) endometrial cancer. The observed benefit was regardless of MMR status (LE:2). (Revised Recommendation)

Immunotherapy for the Treatment of Melanoma

Version 3.0 – Updated on May 20, 2024

Guideline Update Comments:

The primary reason for the melanoma guideline updating is the February 2024 accelerated FDA approval granted to lifileucel (Amtagvi / Iovance Biotherapeutics) for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. 

Key Changes:

  • For patients with brain metastases that are treated and stable, referral for liflileucel can be considered. Patients with active brain metastases are ineligible for liflileucel/TIL therapy, unless done as part of a clinical trial. (New Recommendation)
  • For all patients with advanced melanoma whose disease has progressed on any anti-PD-1-based ICI therapy without an anti-CTLA-4 agent, there is no clear standard of care subsequent line therapy and thus treatment with ipilimumab plus nivolumab (LE:2), BRAF-targeted agents (if appropriate) if not already done (LE:2), lifileucel (LE:3), or enrollment in clinical trials evaluating strategies including adoptive cell therapies, novel combinations, and other strategies, should be strongly encouraged in shared decision-making with the patient. (Revised Recommendation)
  • For all patients with advanced melanoma whose disease has progressed on anti-PD-1 therapy and clinical trial enrollment is not feasible, dual ICI therapy, adoptive cell therapy with lifileucel (LE:3), or BRAF-targeted therapy (if appropriate) should be considered, with choice of therapy taking anticipated toxicities and phenotype of resistance (primary versus secondary) into account. (Revised Recommendation)
    • For patients whose best response is PD or <6 months of SD following at least 6 weeks of therapy with a single anti-PD-1 agent (ie, primary anti-PD-1 ICI resistance), combination ipilimumab plus nivolumab (LE:2) or treatment with lifileucel (LE:3) is preferred and ipilimumab monotherapy (LE:2) or ipilimumab plus pembrolizumab (LE:3) can be considered. (Revised Recommendation)
    • For patients who initially benefited from anti-PD-1-based monotherapy for at least 6 months, discontinued therapy, and then ultimately progressed, re-induction with single-agent anti-PD-1 can be considered on progression of disease (LE:3). (Revised Recommendation)
  • For patients with metastatic mucosal melanoma, early use of lifileucel (LE:3) or another adoptive cell therapy should be considered. (New Recommendation)

SITC has been very active in terms of clinical guideline publication during the first half of 2024. These most recent focused guidelines update follow on the heels of two other updates in March 2024 for their guidelines on Immunotherapy for the Treatment of Breast Cancer and Immunotherapy for the Treatment of Nonmelanoma Skin Cancer. There was also a recent June 2024 SITC guideline, co-authored by the Association for Molecular Pathology and the College of American Pathologists, on Tumor Mutational Burden Assay Validation and Reporting. 

We’ll look forward to additional cancer immunotherapy guidelines from SITC in the coming months, and throughout the remainder of 2024. Until then, sign up for alerts and stay informed on our next edition of our Guidelines Spotlight Series!