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Is Your NSCLC Asset Strategy Set Up to Create Value Post-FDA Approval?

Over the last decade, advanced non-small cell lung cancer (NSCLC) treatment has moved from platinum-based chemotherapy to personalized medicine. This rapid shift in the NSCLC treatment landscape is challenging for asset developers to navigate. Given the fluidity in the market, how can teams build towards more differentiated NSCLC therapies and simultaneously strive for more efficient and effective clinical strategies?

To better understand the rapid evolution in the NSCLC market – and its continued potential for shake-up –  our commercial and clinical experts have issued a series of questions meant to help product development teams see around corners to build and simultaneously strive for more efficient and effective clinical strategies.

  1. How much is the future market factoring into your asset's development plan? The oncology treatment market is rapidly shifting, and assets in Phase II or III development have several years of trials before applying for FDA approval, let alone commercial launch. Dynamics today may be completely different four to five years out. Consequently, advanced NSCLC asset teams must understand how the market may evolve and the attributes a new product must have to be differentiated in that future state.
  2. How is clinical trial diversity impacting your asset's development? The shifts in the market have reduced the target population sizes and types needed for rigorous clinical testing of advanced NSCLC products. In parallel, the FDA released its latest guidance on improving diversity amongst clinical trial participants. This guidance encourages biopharma teams to plan on how to attract and expand diverse clinical recruits to meet stricter objectives at the approval stage. Drug makers in the NSCLC space have had to react to this change already, having recently pulled an NSCLC monotherapy from FDA consideration after the agency's feedback reported a lack of diversity among trial participants. This means now, more than ever, the structure and design of a pivotal trial play a significant role when developing, launching and commercializing a new therapeutic, especially in addressing trial diversity.
  3. How is your team balancing building cases for approval, 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 accelerate the asset's overall development timeline and keep its core differentiation as a product front and center in an ever-shifting market. Data the FDA needs versus what will be required by healthcare providers (HCPs) could be completely different. Asset developers need to balance all three perspectives when thinking about design, populations, endpoints, magnitude, comparators, and more. This wide-lens perspective has already impacted the market: a recent NSCLC therapy launched with slower-than-anticipated sales since its release. While several factors contributed to this slowdown, early provider feedback suggests that healthcare providers (HCPs) had concerns with dosing and continued to follow other pathways. In securing and addressing use and authorization cases earlier in the product's lifecycle, asset developers can hit the ground running with a clearer understanding of the overall market.
  4. What does your CDx strategy look like? Thinking through your companion diagnostics (CDx) strategy earlier in the lifecycle process can help with the development and commercialization processes in competitive markets like NSCLC. Ease of access the appropriate CDx test can have profound implications on trial enrollment and market adoption of the asset.

Once Phase III trials begin, there is no turning back. Asset development teams should have the ability to harness various endpoints in the clinical lifecycle process to strengthen and accelerate an asset's chances for approval and introduction into the market. Talk with our experts to explore ways to accelerate your NSCLC timeline and bring your asset to market in this highly competitive space.



Michael Smith

Senior Vice President | Syneos Health

Waynne Waterfield

Managing Director, Consulting | Syneos Health

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