ArticleActa oncologica (Stockholm, Sweden)2025
Feasibility and outcome of genomics-guided treatment selection in advanced cancer - the MEGALiT explorative clinical trial.
Article in Acta oncologica (Stockholm, Sweden), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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4 citing papers in PubMed.
- Exceptional response to alpelisib in a heavily pretreated patient with metastatic breast cancer carrying a PIK3CA mutation outside SOLAR-1 eligible mutations: a case report.Acta oncologica (Stockholm, Sweden) · 2026Article
- Retrospective analysis of real-world clinical use of comprehensive genomic profiling in solid tumors in Finland 2017-2020.ESMO real world data and digital oncology · 2026Article
- FOCU.SE trial: a nationwide Swedish drug repurposing protocol and research framework.Acta oncologica (Stockholm, Sweden) · 2026Article
- The promises of precision medicine - voices from the Nordics.Acta oncologica (Stockholm, Sweden) · 2025Article
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Abstract
backgroundPrecision cancer medicine (PCM) is key to advancing cancer treatment beyond the standard of care. We performed an explorative clinical trial, MEGALiT, to investigate the feasibility, safety, and clinical benefit of genomics-based PCM in advanced cancer.
methodsMEGALiT recruited adult patients with advanced solid tumors refractory to standard treatment. Tumor DNA from newly acquired biopsies or ctDNA were analyzed for alterations targetable with the PD-L1 inhibitor atezolizumab, the MEK inhibitor cobimetinib, the mTOR inhibitor everolimus, or the PARP-inhibitor niraparib. Any other 'in study' treatment was left to the discretion of the physician.
resultsOutcome data are reported for 153 patients. The median age was 65 years and the most common diagnoses were colorectal, prostate, and ovarian cancer. The median time from study inclusion to the Molecular Tumor Board was 35 days for tumor sampling by biopsy and 21 days by ctDNA. Of the 44 patients allocated to a study drug, 38 started treatment. The median follow-up was 1.9 years. Of the patients on a study drug and evaluable for tumor response, 6% (2/32) had partial remission, and 25% (8/32) had disease control at 16 weeks. Median overall survival for patients starting a study drug was longer, 7.4 months, compared to 2.7 months for the 61 untreated patients (HR 0.43; log-rank p < 0.0001), but shorter than for the 50 patients receiving treatment of physician's choice, 11.8 months (HR 0.55; log-rank p = 0.012). No significant procedure- or drug-related severe adverse events were observed.
interpretationGenomics-guided treatment selection in advanced cancer is feasible and safe. However, evidence of patient benefit warrants further investigation.
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