The first day of the CDDF Multi-Stakeholder Workshop on New Modalities in Oncology Drug Development set the stage for insightful discussions on the evolving landscape of oncology treatments. The event brought together experts from regulatory bodies, pharmaceutical companies, academia, and patient advocacy groups to explore the opportunities and challenges associated with innovative treatment modalities. Here are the key takeaways from the first three sessions of the day.
SESSION 1: WHAT IS NEW IN ONCOLOGY
[Poll results]: What are the main considerations when introducing novel modalities of cancer therapies?
[Key Takeaways]
🔶ADCs have diversified as regards their payload, and the class is growing – selection of the payload is a key step towards increasing efficacy, and toxicity is being approached
🔶Diseases can recur due to antigen loss or mutations, and target heterogeneity, which is one of the missions of next-generation T cell engagers, including those targeting two antigens at the same time. Next generations of these molecules will be engineered to diversify antigenic targeting and lowering the risk for known toxicities
🔶Targeted Protein Degradation (TPD) has a high potential to target otherwise unreachable targets by “hijacking” the endogenous cellular protein homeostasis machinery, bringing a tumor-related protein in close proximity to it. “Molecular glues” create a neomorphic surface which can also target otherwise unreachable proteins
🔶Naturally, we are going towards trying out various combinations as we want to approach our ultimate goal: Curing metastatic cancer in patients
🔶Some novel modalities, like TPD drugs or molecular glues, can be dosed orally or via long-acting formulations, also implying patient convenience and an established regulatory framework. AI and machine learning can be helpful in advancing this field further
🔶Some of these new modalities may have further advantages like scalability and reduced cost of production, and being applicable to patients in an outpatient setting, and to multimorbid patients by tailoring doses
[Next steps]
🔶It will be important to develop these medicines having challenges in mind (dose optimization, high cost of development, development of resistance and heterogenous metastasis in patients etc)
🔶Further research helps identifying targets and mechanisms not considered before, and helps identifying and mitigating anticipated risks
SESSION 2: RADIOPHARMECEUTICALS
[Poll results]: What innovation in radiopharmaceuticals are you the most excited about?
[Key Takeaways]
🔶Continued regulatory guideline advancements are needed for the different approval pathways and better patient access to radiopharmaceuticals
🔶Advances in radiopharmaceuticals show great promise especially in NET and prostate tumors with many key learnings – opportunities in supply and patient access remain
🔶Healthcare systems across EU need greater harmonisation including facility and personnel training, and supply chain infrastructure enhancements. Patients want to see an integrated, accessible service that brings all relative clinical teams together
🔶Sequencing and combination strategies of radiopharmaceuticals remain an area of great focus, with drivers to potentially treat earlier, especially in prostate cancer
[Next steps]
🔶A lot of work and advances with the development of radiopharmaceuticals have taken place, however much work is required and continued discussions among regulators, HTAs, patients, academics, and industry is essential for sustained progress
SESSION 3: PERSONALISED VACCINES IN ONCOLOGY
[Poll results]: What do you see as the main opportunity or challenge for a personalized vaccine?
[Key Takeaways]
🔶Cancer vaccines are a promising new therapy but questions remain about the target selection, therapeutic window and delivery
🔶It will truly be important to implement shared decision making with patients to increase trust and uptake
🔶It is important to consider early how the treatment will be delivered in the real-world vs clinical trial (from HTA Perspective)
🔶Despite these challenges it will be feasible to follow through the regulation process with all stakeholders on board