Nare Hovhannisyan, Radiation Oncology Resident at National Center of Oncology of Armenia and Publishing Editor at OncoDaily, shared a post on LinkedIn:
”Key Takeaways from Diogo Martins Branco’s Lecture at the ESMO – European Society for Medical Oncology Advanced Courses.
1. Tumor-agnostic approvals have grown rapidly, but most have been driven by non-randomized, non-comparative trials, making ORR the central endpoint.
2. The first agnostic approval (MSI-H/dMMR, 2017) set the stage with consistent activity across multiple tumor types.
3. NTRK and RET fusion inhibitors reinforced the paradigm with strong and uniform response rates.
4. A later approval with lower ORR and fewer consistent tumor types raised concerns and highlighted the need for clearer regulatory criteria.
5. The ESMO proposed a screening criterion for tumor-agnostic potential: ORR ≥20% in ≥2 of 3 tumor types, with ≥5 patients per tumor type.
6. 2024 approvals validated the model, strengthening confidence in the proposed cut-offs.
7. A new three-tier tumor-agnostic taxonomy is under development (fully agnostic → tumor-modulated → tumor-restricted).
8. A large systematic review of MGTO trials is underway to refine metrics and support expert consensus.
9. The end goal is a robust, evidence-based framework to classify tumor-agnostic activity and guide future development and approvals.”
More posts featuring Diogo Martins Branco on OncoDaily.
