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Innovative directions in oncology drug development
Select a subject below to learn more
Hallmarks of innovation
Key attributes for novel anti-cancer drugs may increase their chances of eventually moving the needle in patient care.
Finding the next “big leap forward” will require a mechanistic focus on the tumor microenvironment beyond T cells.
Hallmarks of innovation
What to look for?
A good biomarker vastly increases chances of clinical success
Clearly defined niche applications are an asset, not a limitation.
For companion diagnostics, look for validated predictive value and a reproducible assay.
An innovative drug platform may have potential for broad application
Nearly all spaces in oncology are getting too competitive for “me toos,” unless the drug has design elements that are truly a step forward for the MOA.
Think beyond the lead product or indication, a well-designed new platform may have the potential to be applied to other MOAs.
For existing platforms, look for meaningful design improvement on existing technology.
Novel, mechanistically sound solution to a global unmet need
Look for a biologic rationale/story that clearly distinguishes the design or approach from prior successes and failures.
Look for combination regimens that are chosen for their mechanistic synergy, supported by data that shows component effects.
Consider whether the suite of preclinical and early clinical data that establishes a dose with biologic effect (beyond MTD). Data in at least one in vivo model is a bonus.
Ensure the registrational development program is designed for global relevance.
Now a fixture in most companies’ pipelines.
Unclear what the next “big leap forward” will be.
A MOA with suffcient clinical precedent and wide research interest
The field of immunotherapy needs a mechanistic focus on the tumor microenvironment beyond T cells; eg, approaches to target NK cells, APCs, MDSCs, or macrophages (cells or related pathways).
Emerging advances are hoped to continually improve CAR-T technology or off-the-shelf alternatives like bispecific T-cell engagers.
Novel immune agonist MOAs or CAR-Ts in solid tumors will need to go the extra mile to differentiate from prior failures.
Improvements in ADC, radioligand, and oncogenic targeting technology are making cancer therapy more personalized than ever.
Advances in technology might have improved our ability to predict efficacy or detect residual disease.
Serial resistance is a problem and an opportunity
Communication gaps re: actionability and need to test
Differentiated MOA, technology, or platform
There is still room for more effective targeting of known driver pathways (eg, KRAS, HER2, BTK).
Novel approaches to target novel oncogenic drivers, pan-cancer markers or defects, or elements of synthetic lethality (beyond the PARPs) have the strongest potential to address biologic unmet needs.
Improving the tolerability of bi- or tri-specifics will help make these approaches more broadly applicable.
High interest driven by clinical and value gains
Technology advances might have improved feasibility
Validated to predict efficacy or detect residual disease; few feasibility barriers
Companies with the most impactful focus are working on ways to identify:
- Acquired resistance to oncogenic targeting or immunotherapy
- Residual disease in a validated, accurate, and reproducible way (eg, ctDNA, exosomes)
Emerging technology should provide novel, feasible improvements to:
- NGS or –omics
- Tissue biopsy alternatives
Innovation directions in oncology drug development: Download our PDF to learn more.Download PDF
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