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Portfolio Decisions in Early Development:

Oncology and Non-Oncology Diseases Oncology drug development program transitions in the 2006-2015 period accounted for 31% of the 9,985 total transitions. With the lowest LOA from Phase I (5.1%, n=3,163), Oncology had an outsized effect on the overall industry success rate. To further understand this contribution, we compared phase transition success rates and LOA for non-oncology development programs against oncology development programs alone. Figure 6 shows Phase success rates and LOA from Phase I for oncology and non-oncology development programs. The LOA from Phase I across non-oncology indications was twice that for oncology alone, at 11.9% (n=6,822). Looking at individual phase transition success rates, it is clear that Phase III transition success rates were the reason Oncology ended up with the lowest overall success across our 14 disease categories. Oncology Phase III success was 23% lower than Non-Oncology disease areas. Phase Success Advanced or Suspended Phase Success Advanced or Suspended Phase Success Advanced or Suspended Phase Success Advanced or Suspended Phase Success Oncology 1222 62.8% 1416 24.6% 349 40.1% 176 82.4% Non-Oncology 2360 63.5% 2446 34.3% 1142 63.7% 874 85.9% LOA n Likelihood of Approval Phase LOA LOA n Phase LOA LOA n Phase LOA LOA n Phase LOA Oncology 3163 5.1% 1941 8.1% 525 33.0% 176 82.4% Non-Oncology 6822 11.9% 4462 18.7% 2016 54.7% 874 85.9% Phase I to Phase II Phase II to Phase III Phase III to NDA/BLA NDA/BLA to Approval Phase I to Approval Phase II to Approval Phase III to Approval NDA/BLA to Approval 34.3% 63.7% 85.9% 11.9% 24.6% 63.5% 62.8% 40.1% 82.4% 5.1% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Phase I to Phase II Phase II to Phase III Phase III to NDA/BLA NDA/BLA to Approval Phase I to Approval Pro b a bility of S ucc e s s Non-Oncology Oncology Probability of Success Oncology vs. Non-Oncology Figure 6. Oncology vs. Non-Oncology phase transition success rates and LOA. Top: Chart of LOA from Phase I. Bottom: Table of phase transition success rates and LOA for Oncology vs. Non-Oncology indications, with corresponding n values. ‘Advanced or Suspended’ refers to the total number of transitions used to calculate each success rate, with the n value noted in the text. The LOA n value is the total ‘Advanced or Suspended’ transitions of all phases used to calculate LOA. ‘Phase Success’ is the probability of successfully advancing to the next phase, whereas ‘Phase LOA’ is the probability of FDA approval for drugs in this phase of development.