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Published on: December 9, 2015
Novel Therapeutic Interventions Early in the Disease Trajectory: Drug Development Beyond the Refractory Setting
Navid Hafez1, Hope S Rugo2, Margaret A Tempero2
1Yale Cancer Center, New Haven, Connecticut. navid.hafez@yale.edu.
Abstract:
The 2019 Accelerating Anticancer Agent Development Workshop assembled a panel of experts for an in-depth discussion session to present "novel therapeutic interventions early in the disease trajectory." The panel reviewed the limitations of evaluating investigational cancer therapeutics solely in advanced metastatic and relapsed/refractory disease settings, and recommended strategies for drug evaluation earlier in the disease course, including in the first line in combination with standard chemotherapy, and in the maintenance and neoadjuvant disease settings. Advantages of earlier drug evaluation were discussed, including expanding the population of evaluable patients, earlier response assessment via surrogate endpoints, earlier clinical benefit in the disease course, tailoring of therapies based on response, and furthering our understanding of biomarker-driven therapies.
Insights
Early cancer drug evaluation is recommended to improve patient outcomes and therapeutic development. Assessing novel anticancer agents earlier in the disease course offers significant advantages for patient populations and treatment strategies.
Area of Science:
- Oncology
- Drug Development
- Clinical Trials
Background:
- Current limitations in evaluating investigational cancer therapeutics primarily in advanced disease settings.
- Need for novel therapeutic interventions early in the disease trajectory.
Purpose of the Study:
- To discuss and recommend strategies for evaluating anticancer agents earlier in the disease course.
- To highlight the advantages of early drug evaluation in cancer treatment.
Main Methods:
- Convened a panel of experts at the 2019 Accelerating Anticancer Agent Development Workshop.
- Facilitated an in-depth discussion on novel therapeutic interventions and drug evaluation strategies.
Main Results:
- Recommended evaluating drugs earlier, including in first-line therapy, maintenance, and neoadjuvant settings.
- Identified benefits such as expanded patient populations and earlier response assessment using surrogate endpoints.
Conclusions:
- Early evaluation of anticancer agents enhances treatment tailoring and understanding of biomarker-driven therapies.
- Shifting drug evaluation to earlier disease stages promises improved clinical benefit and patient outcomes.
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