Efficacy and safety of nivolumab + relatlimab (NIVO+RELA) versus nivolumab + ipilimuab (NIVO+IPI) in the first-line (1L) treatment of advanced melanoma: updated data from an indirect treatment comparison.
Abstract Introduction An indirect comparison between NIVO + RELA and NIVO + IPI, 2 approved immunotherapy combination treatment options for patients with advanced melanoma, was previously conducted using individual patient data from the pivotal RELATIVITY-047 (RELA-047; NIVO + RELA vs. NIVO) and CheckMate 067 (CM-067; NIVO + IPI or NIVO vs. IPI) clinical trials. Here, we present the results obtained from the updated 3-year data from the RELA-047 trial. Materials and methods Inverse probability of treatment weighting was used to adjust for imbalances between patient baseline characteristics across the 2 trials. Database freezes were selected to best align follow-up duration in RELA-047 (median 34 months) and CM-067 [...]
Impact of an online risk prediction tool for sentinel node metastasis on clinical decision-making in melanoma care: A mixed methods study.
Abstract Background The decision to perform a sentinel lymph node biopsy (SLNB) procedure can be guided by risk prediction tools. We aimed to investigate the impact of an online risk prediction tool for sentinel node metastasis on clinical decision-making. Methods We conducted a mixed methods study using an online questionnaire and semi-structured interviews between April 2022 and March 2023. Australian clinicians and patients/carers who were using the Melanoma Institute Australia risk prediction tool were invited to participate. Results Sixty-one participants completed the questionnaire (52 clinicians including 36 general practitioners of whom 32 worked at skin cancer clinics; 14 surgeons; [...]
Nivolumab vs. Placebo in the Adjuvant Treatment of Patients with Stage IIB/C Melanoma: 3-Year Results of the CheckMate 76K (CM 76K) Study.
Abstract Introduction Patients (pts) with resected stage IIB/C melanoma have a high risk of recurrence, similar to that of pts with resected stage IIIB melanoma. The CM 76K trial ( NCT04099251 ) demonstrated a significant reduction in the risk of recurrence or death with nivolumab (NIVO) compared with placebo (PBO) in pts with stage IIB/C melanoma who underwent complete resection. Updated data with 3 years of follow-up are presented here. Materials and methods Pts aged ≥ 12 years without evidence of residual disease after resection were stratified according to T category and randomized 2:1 to receive NIVO IV 480 mg or PBO every 4 [...]
European consensus-based interdisciplinary guideline for melanoma. Part 2: Treatment – Update 2024
Abstract A unique collaboration of multi-disciplinary experts from the European Association of Dermato-Oncology (EADO), the European Dermatology Forum (EDF), and the European Organization of Research and Treatment of Cancer (EORTC) was formed to make recommendations on cutaneous melanoma diagnosis and treatment, based on systematic literature reviews and the experts' experience. Cutaneous melanomas are excised with one to two-centimeter safety margins. For a correct stage classification and treatment decision, a sentinel lymph node biopsy shall be offered in patients with tumor thickness ≥ 1.0 mm or ≥ 0.8 mm with additional histological risk factors, although there is as yet no [...]
European consensus-based interdisciplinary guideline for melanoma. Part 2: Treatment – Update 2024.
Abstract A unique collaboration of multi-disciplinary experts from the European Association of Dermato-Oncology (EADO), the European Dermatology Forum (EDF), and the European Organization of Research and Treatment of Cancer (EORTC) was formed to make recommendations on cutaneous melanoma diagnosis and treatment, based on systematic literature reviews and the experts' experience. Cutaneous melanomas are excised with one to two-centimeter safety margins. For a correct stage classification and treatment decision, a sentinel lymph node biopsy shall be offered in patients with tumor thickness ≥ 1.0 mm or ≥ 0.8 mm with additional histological risk factors, although there is as yet no [...]
The Impact of Preoperative Facial Nerve Weakness and Facial Nerve Outcomes in the Management of Patients With Parotid Metastases of Cutaneous Squamous Cell Carcinoma
Abstract Background: Cutaneous squamous cell carcinomas (cSCC) metastasizing to the parotid gland can cause facial nerve (FN) dysfunction secondary to direct invasion, perineural spread, or surgical ablation. This study aims to characterize the prevalence of preoperative FN involvement in metastatic cSCC to the parotid and identify risk factors resulting in FN sacrifice. Methods: Patients with parotid metastases from cSCC, treated surgically with parotidectomy with curative intent were identified through a retrospective cohort analysis of a prospectively maintained Sydney Head and Neck database from 1992 to 2021. Results: Of 408 patients identified, 39 (10%) were found to have preoperative FN weakness, of which [...]
The Impact of Preoperative Facial Nerve Weakness and Facial Nerve Outcomes in the Management of Patients With Parotid Metastases of Cutaneous Squamous Cell Carcinoma.
Abstract Background: Cutaneous squamous cell carcinomas (cSCC) metastasizing to the parotid gland can cause facial nerve (FN) dysfunction secondary to direct invasion, perineural spread, or surgical ablation. This study aims to characterize the prevalence of preoperative FN involvement in metastatic cSCC to the parotid and identify risk factors resulting in FN sacrifice. Methods: Patients with parotid metastases from cSCC, treated surgically with parotidectomy with curative intent were identified through a retrospective cohort analysis of a prospectively maintained Sydney Head and Neck database from 1992 to 2021. Results: Of 408 patients identified, 39 (10%) were found to have preoperative FN weakness, of which [...]
Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma
Abstract Purpose: In the phase III CheckMate 067 trial, durable clinical benefit was demonstrated previously with nivolumab plus ipilimumab and nivolumab alone versus ipilimumab. Here, we report 6.5-year efficacy and safety outcomes. Patients and methods: Patients with previously untreated unresectable stage III or stage IV melanoma were randomly assigned 1:1:1 to receive nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks (four doses) followed by nivolumab 3 mg/kg once every 2 weeks (n = 314), nivolumab 3 mg/kg once every 2 weeks (n = 316), or ipilimumab 3 mg/kg once every 3 weeks (four doses; n = 315). Coprimary [...]
Impact of personalized response-directed surgery and adjuvant therapy on survival after neoadjuvant immunotherapy in stage III melanoma: Comparison of 3-year data from PRADO and OpACIN-neo.
Abstract Background: Pathologic response following neoadjuvant immune checkpoint blockade (ICB) in stage III melanoma serves as a surrogate marker for long-term outcomes. This may support more personalized, response-directed treatment strategies. Methods: The OpACIN-neo and PRADO trials were phase 2 studies evaluating neoadjuvant treatment with ipilimumab and nivolumab in stage III melanoma. In OpACIN-neo, all patients underwent therapeutic lymph node dissection (TLND) without subsequent adjuvant therapy. In contrast, PRADO explored a response- directed strategy, where patients achieving a major pathologic response (MPR) omitted TLND and adjuvant therapy, while those without a pathologic response (pNR) received TLND and adjuvant therapy. Here, we provide [...]
Relapse-free survival with adjuvant dabrafenib/trametinib therapy after relapse on a prior adjuvant CPI in BRAF V600-mutated stage III/IV melanoma.
Abstract Background: In BRAF-mutated high-risk melanoma, targeted therapy (BRAF/MEK inhibitors) and checkpoint inhibitor (CPI) immunotherapy have durable benefits as first-line (1L) adjuvant therapy. Based on differing action mechanisms of BRAF/MEK inhibitors and CPI immunotherapies, there is interest in evaluating the activity of 2L adjuvant targeted therapy in decreasing the risk of subsequent recurrence after repeat resection following relapse on/after 1L adjuvant CPI. Patients and methods: This was a retrospective review of BRAF V600-mutated resected stage III/IV melanoma patients in the United States, Australia, and The Netherlands who received 1L adjuvant CPI immunotherapy, relapsed locoregionally/distantly, were again resected to no evidence of [...]