Olaratumab (Eli Lilly, Lartruvo)
Randomized Phase 2, advanced soft-tissue sarcoma · The Lancet, 2016
This Phase 2 was the basis for accelerated approval. The disproportionate overall-survival claim (26.5 vs 14.7 months) carried the valuation and the EU filing.
- criticalA statistically impossible result: an 18.2% objective response rate reported with 95% CI 29.6–29.8 — an interval that excludes its own point estimate.
- criticalAn independent-review PFS hazard ratio of 0.670 with 95% CI 0.04–1.12 — a lower bound implausible for 133 patients. The journal later corrected it to 0.40–1.12; Kaimen Rigor flagged it from the text alone.
- seriousFour reported percentages disagree with their own counts (e.g. neutropenia “25 [39%]” against N=65), plus no data-availability statement and unidentified assay reagents.
What happened next: Confirmatory Phase 3 ANNOUNCE (JAMA 2020, n=509) found no overall-survival benefit (HR 1.05). The FDA revoked the Lartruvo license and the EMA withdrew authorisation; olaratumab is no longer approved.
Kaimen Rigor read only the 2016 paper text — it never saw the ANNOUNCE result or the journal’s correction.