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Navigating oncology development decisions for long-term success

Oncology clinical development is often at the leading edge of innovative approaches to study designs through the use of novel approaches to enhanced patient care and clinically relevant endpoints.1,2 Oncology has made substantial progress in the last 10 years. However, recently reported success rates across oncology phases 1 to 3 are still below 50%, with the transition from phase 2 to 3 especially low at 25%.3 A more strategic assessment of clinical development influencing factors at key decision-making points can help to close these gaps and build on the industry’s successes. 

Factors for continuous focus

Some of the critical factors, including dose, schedule, safety and efficacy, need continuous reassessment across development phases. The FDA’s recent emphasis on dose and schedule selection aims to establish clearer understandings of a treatment’s safety and tolerability earlier in development, especially regarding toxicities that may impact patients’ quality of life and overall survival.4 Therefore, future oncology submissions to regulators will require a continuous assessment of these components from early to late-stage development to support a successful submission package.

Patient and indication selection

The time point for indication selection is important to optimise the downstream impacts, including those to patient populations and timelines. A strategic approach to indication selection allows for consideration of possible efficacy and safety signals in multiple indications before narrowing scope and minimises the necessary timelines for phase 1 dose escalation execution. Diverse patient populations are also important here to demonstrate the drug’s ability to meet real-world medical needs in more truly representative patient groups. Generating evidence of patient benefit, and demonstrating a patient-centric approach will also impact registrational potential. 

Program and portfolio prioritisation

Setting the overall oncology program up for success includes carefully plotted go/no-go points throughout phases 1 to 2 that, if successfully crossed, make a solid base for clearly defined thresholds in phase 3. These early inflection points are also important for pipeline prioritisation and understanding biomarker availability. In later stages, the focus shifts to include considerations on the future medical landscape to prioritise resources and support the portfolio products that demonstrate high registrational potential. At this point, sponsors should consider pivotal and supportive study data needs, in vitro diagnostic packages, and real-world evidence plans to inform strategic program direction. 

The benefits of timely goals and strategies to navigate critical decision-making on the clinical protocol level can be expanded across the portfolio to facilitate time and cost-efficiencies.  

Conclusion

Mapping clear inflection points for data-driven decisions will inform efficient drug development. Careful consideration of the influencing factors above will help define the optimal pathway through early to late development and prepare sponsors to meet regulator, provider and patient needs throughout the process.

To learn how wecan help optimise your oncology drug development to meet regulator, provider and patient needs throughout the process, please contact us.

This article was first published on Clinical Oncology Daily on 1 June 2024.

 

References

1 Verweij, J., Hendriks, H.R. & Zweirzina, H. Innovation in oncology clinical trial design. Cancer Treatment Reviews. Volume 74, P15-20, March 2019.

2 Huber, M., & Huber, B. (2019). Innovation in Oncology Drug Development. Journal of oncology. 2019, 9683016.

3 New Clinical Development Success Rates 2011-2020 Report. BIO, QLS Advisors, Informa UK Ltd. February 2021.

4 Project Optimus: Reforming the dose optimization and dose selection paradigm in oncology. U.S. Food & Drug Administration.

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