Smart-to-Market Approach

Speed to market matters, but winning when you get there is what really counts.

Situation

  • A promising compound was in early-stage clinical development in several oncology indications.
  • A mechanistically similar drug was further along in development, and if approved, would be the first drug with that mechanism of action on the market for the same several indications.
  • As second-to-market, the client would lose out on a significant market opportunity.
  • Health Advances was asked to determine what strategy the company should pursue for this asset.

Critical Questions to Address

  • Which indication provides the greatest opportunity for clinical trial success with this mechanism of action?
  • What clinical trial design offers the most efficient proof-of-concept?
  • Are there rational combination approaches that are more likely to succeed than the monotherapy alone?

Health Advances Approach

Health Advances conducted thorough investigations into mechanistic implications, previous clinical trials of similar compounds, and novel trial approaches.

Results

  • Health Advances identified two cancers as the best opportunities for development based on the probability of trial success and the ability to test the approach quickly.
  • Development in one tumor type with a small patient population and high unmet need is supported by the highest quantitative response rates and qualitative magnitude of the responses produced by a similar mechanistic approach.
  • Three-arm trial examining the impact of the most rational combination therapy vs. monotherapy would establish proof of concept.
  • Rational biomarker approach is needed to identify most responsive proper patient population.
  • The other development option offers a novel neoadjuvant setting trial design that would efficiently validate the drug’s efficacy and potentially lead to accelerated approval in a large patient population.
  • By performing a comprehensive analysis of the oncology clinical trial landscape and supportive scientific rationale, Health Advances determined that intelligent indication selection and trial design would reward the client more than speeding through clinical development toward regulatory approval.