6 juni 2023: Bron: ASCO 2023

In de week van 2 t/m 6 juni was er weer  ASCO 2023. Hier een aantal aanbevolen abstracten gerelateerd aan melanomen door vooraanstaande artsen en oncologen wereldwijd.

Aanbevolen door Dr. Alexander van Akkooi, voorzitter van Melanoma Surgical Oncology aan het Melanoma Institute Australia en Associate Editor of PracticeUpdate Oncology

Klik op de nummers van de abstracten om deze te lezen of te downloaden:

Saturday, June 3, 2023; 8:00 AM–9:30 AM CDT
Clinical Science Symposium
The Promise of Neoadjuvant Immunotherapy Across Solid Tumors

101 The impact of response-directed surgery and adjuvant therapy on long-term survival after neoadjuvant ipilimumab plus nivolumab in stage III melanoma: Three-year data of PRADO and OpACIN-neo. ILM Reijers

Take-Home Message

  • This study investigated the relapse-free and distant metastasis–free survival outcomes of a personalized approach to treatment following neoadjuvant ipilimumab plus nivolumab based on pathologic response/non-response among patients with stage III melanoma. This particular study shows the utility of the neoadjuvant platform; it allows quick comparisons of how the extent of surgery probably can be safely reduced in the major pathologic responders and how the non-responders seem to benefit from getting adjuvant therapy (and switching to BRAF/MEK if they are BRAF-mutant).
  • Patients who achieve a major pathologic response to neoadjuvant ipilimumab/nivolumab have high survival rates, and subsequent lymph node dissection and adjuvant systemic therapy do not seem to affect relapse-free and distant metastasis–free survival one way or the other. On the other hand, in patients with a pathologic non-response to neoadjuvant therapy, adjuvant systemic therapy with the addition of ongoing anti-PD-1 therapy or with a switch to BRAF/MEK inhibitors seems to improve survival.

Saturday, June 3, 2023; 1:15 PM–4:15 PM CDT
Poster Session
Melanoma/Skin Cancers

9546 Neoadjuvant T-VEC + nivolumab combination therapy for resectable early metastatic (stage IIIB/C/D-IV M1a) melanoma with injectable disease: NIVEC trial. LP Zijlker, W van Houdt, E Stahlie, et al

Take-Home Message

  • This single-arm prospective phase II trial showed a significantly higher efficacy of the combination of neoadjuvant T-VEC plus nivolumab (65% major pathologic response = pCR + near-pCR) than either one has shown before as single agent. 

Monday, June 5, 2023; 3:00 PM–6:00 PM CDT
Oral Abstract Session
Melanoma/Skin Cancers

9501 Significant durable response with fianlimab (anti-LAG-3) and cemiplimab (anti-PD-1) in advanced melanoma: Post adjuvant PD-1 analysis. O Hamid, K Lewis, A Weise, et al

Take-Home Message

  • The clinical activity and safety of combination anti–LAG-3 fianlimab and anti–PD-1 cemiplimab was analyzed using phase I data from patients with advanced melanoma. The study enrolled 98 patients; the median treatment duration with fianlimab + cemiplimab was 33 weeks. In total, 23.5% of the participants had received prior adjuvant/neoadjuvant-adjuvant systemic therapy for melanoma, including 13.3% treated with nivolumab or pembrolizumab. Treatment-related adverse events were common and caused 16.3% of participants to discontinue treatment. The overall ORR was 61.2%, and median duration of response was not reached.
  • The combination of fianlimab + cemiplimab demonstrated high clinical activity in patients with advanced melanoma. The results show the efficacy of the combination of anti–PD-1 and anti–LAG-3 in patients who have previously been exposed to (adjuvant) anti–PD-1, which is higher than might have been imagined; but, it is early days, as the number of patients in that specific cohort is small.

9502 Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: 2-year results from RELATIVITY-047. HA Tawbi, F Hodi, E Lipson, et al

Take-Home Message

  • This is an important landmark update of a pivotal phase II/III clinical trial which shows that the incremental benefit of the combination of nivolumab plus relatlimab versus single-agent nivolumab holds after longer follow-up for all relevant clinical endpoints: ORR, PFS, OS, etc.

LBA9503 Distant metastasis-free survival results from the randomized, phase 2 mRNA-4157-P201/KEYNOTE-942 trial. MA Khattak, J Weber, T Meniawy, et al

Take-Home Message

  • While the phase III trial is being set up and conducted, everybody is eagerly awaiting more/updated data from this phase II trial, which was initially presented at AACR and showed a significant incremental benefit for the combination of an adjuvant personalized vaccine plus pembrolizumab versus adjuvant single-agent pembrolizumab.

9504 Association of biomarkers (BMs) with efficacy of adjuvant nivolumab (NIVO) vs placebo (PBO) in patients with resected stage IIB/C melanoma (CA209-76K). GV Long, JM Kirkwood, C Hoeller, et al

Take-Home Message

  • CheckMate 76K is a landmark phase III adjuvant trial of nivolumab for high-risk resected stage IIB/C melanoma. In this discussion, we will hear the biomarker data, which, hopefully, will help us to better select who does and who does not benefit from adjuvant nivolumab. The investigators analyzed the association between selected biomarkers and recurrence-free survival in patients with early-stage melanoma receiving nivolumab versus placebo. The benefit of nivolumab was seen across all biomarker subgroups, and IFNγ-sig, TMB, % CD8+ T cells, and lower CRP levels were associated with a longer recurrence-free survival compared with placebo.

  • None of the biomarkers assessed were prognostic of recurrence-free survival in the placebo arm of the study. On the other hand, prolonged recurrence-free survival was evident in the nivolumab arm across all levels of biomarkers, regardless of BRAF mutation status.

LBA9505 Pembrolizumab versus placebo as adjuvant therapy in stage IIB or IIC melanoma: Final analysis of distant metastasis-free survival in the phase 3 KEYNOTE-716 study. JJ Luke, P Ascierto, M Khattak, et al

Take-Home Message

  • This is another important update of a landmark phase III adjuvant trial of pembrolizumab in resected high-risk stage IIB/C melanoma.

9506 Non-comparative, open-label, international, multicenter phase I/II study of nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with recurrent/metastatic Merkel cell carcinoma (MCC) (CheckMate 358). S Bhatia, S Topalian, W Sharfman, et al

Take-Home Message

  • This is an interesting phase I/II trial examining the combination of ipilimumab and nivolumab in patients with Merkel cell carcinoma.
  • Although it is a nonrandomized design, this study is likely the first and largest to be conducted so far and, unfortunately, seems to show a lack of incremental benefit for the combination in this specific patient population.

9507 Towards organ preservation and cure via 2 infusions of immunotherapy only, in patients normally undergoing extensive and mutilating curative surgery for cutaneous squamous cell carcinoma: An investigator-initiated randomized phase II trial—The MATISSE trial. C Zuur, S Breukers, M Machuca-Ostos, et al

Take-Home Message

  • This is another unique neoadjuvant immunotherapy trial for a difficult-to-treat population of patients with advanced cutaneous squamous cell carcinoma.
  • Results show a high rate of major pathologic response (MRP = pCR + near-pCR) and the ability to safely avoid (morbid) surgery altogether. 

9508 Temozolomide plus cisplatin versus toripalimab (anti-PD-1) as adjuvant therapy in resected mucosal melanoma. B Lian, H Tian, L Si, et al

Take-Home Message

  • This unique study compared the classic standard-of-care adjuvant chemotherapy with temozolomide with modern immunotherapy in the niche of mucosal melanoma.
  • In this particular case, the classical approach is still, unexpectedly, by far superior.

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