In our previous analyses (2023[1] and 2024[2]), we tracked two oncology development cohorts using a Kaplan–Meier framework to visualize how quickly programs reach a terminal outcome—either an FDA approval or a discontinuation. We highlighted the growing use of expansion cohorts in FIH studies, and identified that commercial sponsors tend to move programs through development more efficiently, reflecting both stronger operational resourcing and portfolio discipline.
Since then, both cohorts have continued to mature:
- 2012 cohort: 75 assets with FIH U.S. trials initiated in 2012
- 2017 cohort: 76 assets with FIH U.S. trials initiated in Q3–Q4 2017
We again apply a Kaplan-Meier framework to assess how quickly development efforts have continued to reach a terminal outcome (approval or discontinuation). The resulting Kaplan Meier curves provide a compact way to assess operational efficiency and portfolio turnover across sponsor types.
The 2017 cohort continues to mature slightly faster
Now in its 13th year, the 2012 cohort is relatively mature, with only 14 of the original 75 assets (19%) still in development, and with 55 discontinuations and 6 approvals. The 2017 cohort is less mature, with about 33% still in development, but speed of programs reaching their final outcomes is slightly faster than of the 2012 cohort (Exhibit 1). This is consistent with our findings from the 2024 update.
Exhibit 1: K-M analysis of the 2012 vs 2017 cohort showing programs progression to final outcome (discontinuation or 1st approval) over time
The strongest predictor of speed to outcome is the type of sponsor
Similar to our 2024 findings, we see that commercial sponsors discontinue programs significantly faster than their early-stage counterparts in both the 2012 and 2017 cohorts (Exhibit 2).
Exhibit 2: K-M analysis of programs by sponsor type
Conclusion
The further maturation of the 2012 and 2H2017 cohort reinforces our earlier observations: oncology programs continue to reach final outcomes more efficiently, particularly when backed by commercial sponsors. The Kaplan-Meier approach remains a valuable lens for understanding how organizations translate R&D investment into timely outcomes. As pipelines grow more complex, such analyses can help benchmark productivity and strategic agility across the oncology landscape and beyond.
Finally, the asymptotic probability of technical and regulatory success appears to be stuck at around 10% for a drug reaching first in human status in the US (though it is still a bit early to tell for the 2017 cohort). Until we find a better way to pick clinical candidates, the ability to weed out the duds quickly will be a crucial driver of productivity.
[1] Trends and strategy in oncology development, Zhang, Brauner, & Herant (2023)
[2] A Kaplan-Meier view of oncology development, Zhang, Brauner, & Herant (2024)