Is Your NSCLC Asset Ready to Create Value Post-FDA Approval? | 2024 Update
The landscape of advanced non-small cell lung cancer (NSCLC) treatment continues to evolve at a rapid pace, presenting both opportunities and challenges for product development teams looking to break out in the highly competitive market.
The landscape of advanced non-small cell lung cancer (NSCLC) treatment continues to evolve at a rapid pace, presenting both opportunities and challenges for product development teams looking to break out in the highly competitive market.
NSCLC treatment has become highly personalized as a result of the identification of specific genetic mutations and biomarkers within cancer cells. The FDA’s guidance on improving clinical trial diversity continues to evolve and reimbursement challenges continue to underscore the need for improved clinical trial design, funding and patient awareness. Against this backdrop of ongoing transformation, our experts revisit and refine these value considerations to reflect on the creativity necessary to deliver NSCLC innovative therapies to patients at a rapid pace:
- How have you improved clinical trial enrollment diversity? Addressing diversity extends beyond ensuring representation within trials; it also involves ensuring equal access to commercially available drugs for underrepresented populations. Nonetheless, efforts to enhance diversity in clinical trials must be prioritized to ensure equitable access to innovative treatments. Strategies to enhance clinical trial diversity include broadening eligibility criteria, being mindful of cultural sensitivities in trial materials, overcoming barriers to participation and proactive diversity planning in study delivery.
- How has your companion diagnostic strategy evolved? With the continued fragmentation of the market, there is a growing need to educate healthcare professionals about the relevance of specific genetic markers in the selection of more targeted and effective treatments and to provide them with relevant diagnostic tests. As treatment pathways become increasingly personalized, the integration of companion diagnostics into clinical practice becomes essential to optimize patient outcomes. Development of tech-enabled companion diagnostics (CDx) is crucial for guiding treatment decisions in NSCLC. Researchers are gaining valuable insights into functional phenomics data, paving the pathway for highly predictive biomarkers with significant clinical impact.
- How is your team balancing the need to build the case for approval, with cases for use and cases for reimbursement? Especially in assets with more complex paths to approval, asset developers may spend the bulk of their time meeting case for approval objectives. But understanding and solving for all three cases -- approval, use and reimbursement -- earlier in the lifecycle can help to accelerate the asset's overall development timeline and retain its core product differentiation as front and center in an ever-shifting market. The data required by the FDA versus what will be required by healthcare providers (HCPs) may be completely different. Asset developers need to balance all three perspectives when thinking about design, populations, endpoints, magnitude and comparators. In securing and addressing use and authorization cases earlier in the product's lifecycle, asset developers will be able to hit the ground running with a clearer understanding of the overall market.
- What are your plans following the treatment of NSCLC? Many of the assets currently in development for NSCLC target pathways that are also relevant to other types of cancer. It's essential to start planning for the entire lifecycle of a product early in its development phase. In markets as competitive and extensively studied as NSCLC, it's crucial to maintain focus and move swiftly. Developers of assets must stay ahead of the competition in key markets to ensure that the asset provides maximum value to both patients and investors. By prioritizing lifecycle planning early on, developers will have a clear understanding of their trajectory, how they will achieve their goals, and the value the asset will bring to patients and investors across various indications and markets.
The refinement of key questions in NSCLC therapies in 2024 underscores the dynamic nature of lung cancer therapy studies and the imperative to adapt strategies to meet the evolving challenges of the market. Ultimately, these efforts can accelerate the development of innovative treatments and improve patient care and access to underserved populations, contributing to the ongoing battle against one of the world's largest growing cancers.
Contributors
Waynne Waterfield | Managing Director, Consulting
Jane Bentley, PhD | Vice President, Oncology Therapeutic Strategy and Innovation
Rita Jan, MD | Senior Medical Director, Medical Management
