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The results of discussions will support the prioritisation of actions to fight cancer in EMA's Regulatory Science Strategy to 2028 and the Academia Collaboration Matrix Action Plan. The meetings of the forum are by invitation only.
At this meeting on 16 December 2024, CMF members were invited to propose treatment optimisation research questions and priorities. Several proposals were presented by the EHA, ESMO, and EORTC, including both general study ideas and specific study concepts.
The general study concepts included:
• Identifying very low-risk patient groups that could potentially forgo medical treatment in the adjuvant setting through biomarker-based risk stratification.
• Determining the optimal treatment duration in advanced disease phases when long-term disease control is achieved.
• Exploring low-dose immunotherapy strategies.
Furthermore, the specific study concepts included:
• A de-escalation study on the new T-cell-engaging bispecific antibodies in multiple myeloma.
• A trial on optimising first-line use of Cereblon (CRBN) binders in multiple myeloma.
• Optimising the treatment schedule of a B-cell lymphoma 2 (BCL-2) inhibitor in acute myeloid leukaemia.
• A de-escalation strategy for elderly glioblastoma patients according to the O6-methylguanine-DNA methyltransferase (MGMT) methylation status.
• Optimising the treatment schedule of androgen deprivation therapy in newly diagnosed metastatic prostate cancer.
• Determining the optimal treatment duration of an antibody-drug conjugate in patients with previously untreated advanced urothelial cancer.
• A de-escalation strategy that omits neoadjuvant treatment in unfit and elderly breast cancer patients.
• An intensified first-line treatment strategy for oligometastatic esophagogastric cancer patients.
• A study to determine the optimal duration of immunotherapy for melanoma treatment.
The FDA was invited to provide an overview and share insights from its recently launched guideline on optimising the dosage of human prescription drugs and biologic products in oncology as well as Project OPTIMUS.
This FDA guidance aims to contribute to reforming the dosing paradigm in oncology drug development, recognising that optimisation is critical for ensuring both efficacy and safety. The early adoption of dose optimisation principles is seen as essential, as it enhances decision-making, reduces avoidable toxicity, and improves efficiency and feasibility.