Moderna and Merck's personalized mRNA cancer vaccine, intismeran autogene, showed promising Phase 3 results in preventing melanoma recurrence. Combined with Keytruda, it cut recurrence risk by half and reduced spread by 59% in earlier data. The treatment could reach patients within two years pending regulatory approval.
Merck and Moderna's personalized mRNA cancer vaccine combined with Keytruda significantly reduced melanoma recurrence risk in a Phase 3 trial. The FDA has not yet approved the vaccine, with potential availability expected by early 2027.
A phase one trial of RSO-021 achieved disease control in 67% of relapsed mesothelioma patients. Other advances include daraxonrasib for NRAS-driven melanoma, an aneuploidy biomarker for PARP inhibitor response in childhood cancers, and new research into a cancer target and cholangiocarcinoma treatment.
The FDA has cleared an IND for Amphista's novel BRD9 degrader AMX-883 for AML, approved Lantheus' new prostate cancer imaging agent Pylarify TruVu, and accepted Biofrontera's sNDA for Ameluz PDT in superficial basal cell carcinoma. These regulatory milestones span hematologic and solid tumor areas, addressing significant unmet medical needs.
The C-POST trial shows adjuvant cemiplimab improves disease-free survival in high-risk cutaneous squamous cell carcinoma, with a hazard ratio of 0.32. Meanwhile, an international Phase III study is testing cemiplimab before surgery in advanced cases. Cemiplimab is FDA-approved for advanced skin cancer but not yet for pre-surgical use.
Ultragenyx received FDA clearance for UX016 in GNE myopathy, with a Phase 1/2 study planned for 2026. Soligenix's confirmatory HyBryte trial for CTCL has 66 of 80 patients enrolled, and an interim analysis is expected in early 2026.
Immunotherapy is increasingly used in earlier cancer stages before or after surgery across seven tumor areas. Research shows neoadjuvant and adjuvant immunotherapy can reduce recurrence risk and improve immune recognition of tumor cells. However, challenges remain including side effects, costs, and determining which patients benefit most from earlier treatment.
Study finds advanced melanoma patients with sufficient vitamin D levels showed better response rates and longer survival when receiving anti-PD-1 immunotherapy compared to those with low vitamin D status.
Pharmac has proposed expanding access to melanoma treatments and funding two new therapies for chronic lymphocytic leukaemia. Medical researchers also highlight that New Zealanders lack access to CAR T-cell therapy domestically.
Whole genome sequencing, comprehensive genomic profiling, and spatial multiomics are transforming precision medicine from research tools to clinical applications in oncology, rare diseases, and neonatal care, enabling faster diagnoses and personalized treatments.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07670403 |
Digital Phenotyping of Psychological Distress in Skin Cancer Patients |
COMPLETED | |
| NCT07624981 |
Validation of Clinical Biomarkers Using Spatial Transcriptomics and Development of a Diagnostic Test to Characterize the Progression Potential of Cutaneous Precancerous Lesions |
ACTIVE_NOT_RECRUITING | |
| NCT07510061 |
Title: ICARUS - Psycho-physiological Profiling of Low and High Heat-resilient Individuals |
RECRUITING | NA |
| NCT07436390 |
IFN-Gamma Expression as a Predictor of Response to Immune Checkpoint Inhibitors in First-Line Metastatic Melanoma |
COMPLETED | NA |
| NCT07429123 |
Using an Artificial Intelligence Medical Device to Help Primary Care Practitioners Identify and Manage Skin Conditions (Tumor, Inflammatory, and Infectious Diseases) in Adult Patients at Pozuelo and Majadahonda Health Centers |
COMPLETED | |
| NCT07426484 |
Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy |
RECRUITING | PHASE4 |
| NCT07422805 |
Circulating Tumor DNA in Melanoma Patients |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT07422779 |
Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia |
RECRUITING | NA |
| NCT07406022 |
Optical Characterization and Multi-modality, Multi-scale Modeling of Human Skin Applied to Cancer Diagnosis. |
RECRUITING | |
| NCT07349940 |
Early Detection of Skin Tumors Using a Telemedicine Tool in Primary Care |
RECRUITING | NA |
