Marco Donia, Professor at University of Copenhagen (Københavns Universitet), shared a post on LinkedIn:
“Melanoma at ASCO 2026: a mature field moving toward precision.
No new standard of care, and in a mature field that is the point. The work is refinement: who to intensify, who to spare, how to sequence, how to deliver.
Key Highlights
Personalized vaccines (phase 3 decisive)
- KEYNOTE-942, 5-yr: intismeran autogene + pembro, resected stage IIIB-IV, randomized phase II. 5-yr RFS 68.8% vs 49.1% (HR 0.51, 95% CI 0.29-0.89), DMFS HR 0.41 (0.20-0.84), OS immature.
Neoadjuvant (how much intensification?) - NeoINR (ipi+nivo+rela, macroscopic III-IV/M1a, single-arm II): pCR 63.2%, MPR 73.7%, 1-yr EFS 95.5%; one grade 5 myocarditis.
pCR sits above ipi/nivo (NADINA 47%) and pembro (S1801 ~40%), and matches nivo/rela (57%). - NeoReNi II (nivo+rela, high-risk stage II): MPR 65%, pCR 60%, no grade 4/5. Stage II raises the overtreatment bar.
- Daromun (intralesional L19IL2+L19TNF vs surgery, randomized phase III, pretreated IIIB/C, 36.8-mo update): RFS HR 0.55 (0.38-0.78), DMFS HR 0.53 (0.33-0.83), EFS HR 0.71 (0.51-0.98). A different axis: the option after ICI failure or ineligibility, not more intensification.
Uveal (beyond tebentafusp) - OptimUM-02 (daro+crizo vs IC, 1L HLA-A2-negative): PFS 6.9 vs 3.1 mo (HR 0.42), ORR 37.1% vs 5.8%, OS immature. Potential new standard (none before).
- TIL (n=32): ORR 22%, responses only in tumor-reactive products (37% vs 0%), predicted by a transcriptomic score, UMIS (ORR 44% vs 8%).
Sequencing (reconcile, do not conclude) - COWBOY (6-wk BRAF/MEK then ipi/nivo vs upfront ipi/nivo, BRAF V600, LDH>ULN, n=71): PFS 4.4 vs 25.0 mo, OS 13.5 mo vs NR.
This contradicts EBIN (12-wk sandwich, PFS 9 vs 9 mo) and SECOMBIT arm C (8-wk sandwich comparable to IO-first). Ipi/nivo upfront stays the standard when feasible. - RP1+nivo (anti-PD-1-failed, IGNYTE, 3-yr): ORR 33.6%, 3-yr OS 47.8%; durable, phase III pending.
Cell therapy (from activity to access)
- The contest is IL-2-free TIL (OBX-115, GC-101/MIZAR-003) vs low-dose IL-2 PRAME TCR-T (anzu-cel).
I spoke at a ASCO Melanoma Cell Therapy Symposium, summary at: https://lnkd.in/e4eiAvy8
Take-Home
- Selection, sequencing, access, not a new standard.
- Uveal: a real HLA-A2-negative option, plus a biomarker to pick TIL candidates.
- Most data are phase II/surrogate: little changes practice today.
Open Questions
Reconcile COWBOY with EBIN and SECOMBIT arm C: does induction duration (6 vs 8–12 wks) matter?
Neoadjuvant: does the triplet beat the doublet, and how far into stage II before overtreatment?
Sources in the first comment.
Congratulations to all investigators, teams, and thanks to patients in the trials.
Post written with Yago Garitaonaindia, ASCO26 Featured Voice.”
Title: Individualized neoantigen therapy intismeran autogene (intismeran) plus pembrolizumab (pembro) in resected melanoma: 5-year update of the KEYNOTE-942 study.
Authors: Matteo S. Carlino, Adnan Khattak, Tarek Meniawy, George Ansstas, Matthew H. Taylor, Kevin B. Kim, Meredith McKean, Georgina V. Long, Ryan J. Sullivan, Mark B. Faries, Thuy Tran, Charles L. Cowey, Andrew L. Pecora, Theresa Medina, Victoria Atkinson, Clemens Krepler, Thomas Jemielita, Huzhang Mao, Mariana Faria-Urbina, Janice M. Mehnert
Read the Full Article.
Other articles featuring Marco Donia.