Case Studies

The warning was already in the early paper.

Assets that failed in the clinic, traced back to the pivotal early paper. Kaimen Rigor was run retrospectively on each early paper, without access to the later outcome. Each is a timeline: the defect in the early paper, then the Phase 3 readout that followed.

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Three assets, three trails that ended in failure

Olaratumab

advanced soft-tissue sarcomaEli Lilly · NCT01185964Flagship · fully disclosed

2016Early paper

Phase 2 · randomized · The Lancet · Not retracted

1★

4 years later

2020 Failed

Phase 3 · ANNOUNCE

Failed to confirm the survival benefit; accelerated approval was withdrawn.

What Kaimen Rigor caught in the 2016 paper

seriousA statistically impossible result: a reported confidence interval that excludes its own point estimate
An 18.2% objective response rate reported with 95% CI 29.6–29.8; a second hazard ratio carried an implausible 95% CI 0.04–1.12.
mediumReported percentages that do not match their own counts
Four rate statements disagree with their numerators/denominators (e.g. “39%” against 25/65).

See the full report

Review based on the open-access author manuscript in PubMed Central (PMC5647653).

Sources

Pivotal Phase 2 — The Lancet, 2016 Tap WD, Jones RL, Van Tine BA, et al. Lancet 2016;388:488–97.
Reviewed text — PMC author manuscript The exact full text Kaimen Rigor reviewed: author manuscript in PubMed Central (PMC5647653).
Correction — Department of Error The Lancet 2016;388:464. Corrections applied to the online and print versions, 28 July 2016.
Confirmatory Phase 3 — ANNOUNCE, JAMA 2020 Tap WD, Wagner AJ, Schöffski P, et al. JAMA 2020;323(13):1266–76.
FDA biologics license revoked — Federal Register Eli Lilly and Co.; Announcement of the Revocation of the Biologics License for LARTRUVO. Federal Register, 17 July 2020. Accelerated approval withdrawn at Lilly’s request after ANNOUNCE.
Marketing authorisation withdrawn — EMA European Medicines Agency. Lartruvo (olaratumab): withdrawal of the marketing authorisation.

Antibody-drug conjugate

Asset withheldsmall-cell lung cancer

2017Early paper

Phase 1 · first-in-human · The Lancet Oncology · Not retracted

1★

2 years later

2019 Failed

Phase 3

Stopped early for worse survival; the asset was discontinued.

What Kaimen Rigor caught in the 2017 paper

seriousEfficacy rests on a surrogate endpoint with no demonstrated link to clinical benefit
seriousTwo cited references that resolve to nothing in any registry
lowA result sentence duplicated verbatim between the Abstract and the Results

Full report and asset name on a demo

Monoclonal antibody

Asset withheldosteogenesis imperfecta

2024Early paper

Phase 2b · Journal of Bone and Mineral Research · Not retracted

1★

1 year later

2025 Failed

Phase 3

Both pivotal Phase 3 trials missed their primary fracture-reduction endpoint; only bone-density secondaries improved (Dec 2025).

What Kaimen Rigor caught in the 2024 paper

seriousEfficacy rests on a bone-density surrogate after the trial missed its own primary endpoint
seriousThe placebo arm was dissolved mid-study, leaving no concurrent control
mediumWeak transparency: data on request only, no reagent identifiers or named statistical software

Full report and asset name on a demo

None of these papers was retracted. Kaimen Rigor caught every defect from the paper text itself.

We grade the paper, not the outcome

Kaimen Rigor never sees the trial result. Beside disease- and target-matched controls that succeeded, the failed assets sit at 1★, the controls higher, except where a success was itself reported poorly.

Failed assets

1.0★ all three

Each floored by a concrete, text-level defect in the early paper.

Matched controls

2.92★ avg

6 disease/target-matched programs that succeeded.

The tell that it’s honest: A Phase 3 success that still scored low; Kaimen Rigor grades the paper, not the outcome. Kaimen Rigor never sees the trial outcome. It measures evidence quality in the text and lets the reader draw the risk conclusion.

What “early paper” means

The pivotal Phase 1/2 or target-engagement paper a diligence team read before committing. The later phase records the outcome only; it is never what Kaimen Rigor reviews.

How the star works

A deduction model: every paper starts at 5★ and loses stars for concrete, named findings. A single critical defect can floor it at 1★, so one serious problem is never averaged away.

The honest limit

Rigor is not outcome. A well-reported study can still fail; a sloppy paper can still describe a drug that works. The claim is narrow: Kaimen Rigor surfaces the defects that make early data unsafe to bank on. A triage signal, not a verdict.

Why this matters

Build on science robust enough to stake your decision on.

The cost of unreproducible early evidence isn’t just capital. It’s patient-years and delayed medicines. Kaimen Rigor surfaces the weak evidence early, so the programs that move forward are the ones built on science that holds.

See the full reports

Schedule a demo to see every asset, finding, and live Kaimen Rigor review

For BD, licensing, and diligence teams: we walk the full case studies with you.

Request a demo See two real Kaimen Rigor reviews

Case Studies

The warning was already in the early paper.

Request a demo

Three assets, three trails that ended in failure

Olaratumab

advanced soft-tissue sarcomaEli Lilly · NCT01185964Flagship · fully disclosed

2016Early paper

Phase 2 · randomized · The Lancet · Not retracted

1★

4 years later

2020 Failed

Phase 3 · ANNOUNCE

Failed to confirm the survival benefit; accelerated approval was withdrawn.

What Kaimen Rigor caught in the 2016 paper

seriousA statistically impossible result: a reported confidence interval that excludes its own point estimate
An 18.2% objective response rate reported with 95% CI 29.6–29.8; a second hazard ratio carried an implausible 95% CI 0.04–1.12.
mediumReported percentages that do not match their own counts
Four rate statements disagree with their numerators/denominators (e.g. “39%” against 25/65).

See the full report

Review based on the open-access author manuscript in PubMed Central (PMC5647653).

Sources

Pivotal Phase 2 — The Lancet, 2016 Tap WD, Jones RL, Van Tine BA, et al. Lancet 2016;388:488–97.
Reviewed text — PMC author manuscript The exact full text Kaimen Rigor reviewed: author manuscript in PubMed Central (PMC5647653).
Correction — Department of Error The Lancet 2016;388:464. Corrections applied to the online and print versions, 28 July 2016.
Confirmatory Phase 3 — ANNOUNCE, JAMA 2020 Tap WD, Wagner AJ, Schöffski P, et al. JAMA 2020;323(13):1266–76.
FDA biologics license revoked — Federal Register Eli Lilly and Co.; Announcement of the Revocation of the Biologics License for LARTRUVO. Federal Register, 17 July 2020. Accelerated approval withdrawn at Lilly’s request after ANNOUNCE.
Marketing authorisation withdrawn — EMA European Medicines Agency. Lartruvo (olaratumab): withdrawal of the marketing authorisation.

Antibody-drug conjugate

Asset withheldsmall-cell lung cancer

2017Early paper

Phase 1 · first-in-human · The Lancet Oncology · Not retracted

1★

2 years later

2019 Failed

Phase 3

Stopped early for worse survival; the asset was discontinued.

What Kaimen Rigor caught in the 2017 paper

seriousEfficacy rests on a surrogate endpoint with no demonstrated link to clinical benefit
seriousTwo cited references that resolve to nothing in any registry
lowA result sentence duplicated verbatim between the Abstract and the Results

Full report and asset name on a demo

Monoclonal antibody

Asset withheldosteogenesis imperfecta

2024Early paper

Phase 2b · Journal of Bone and Mineral Research · Not retracted

1★

1 year later

2025 Failed

Phase 3

Both pivotal Phase 3 trials missed their primary fracture-reduction endpoint; only bone-density secondaries improved (Dec 2025).

What Kaimen Rigor caught in the 2024 paper

seriousEfficacy rests on a bone-density surrogate after the trial missed its own primary endpoint
seriousThe placebo arm was dissolved mid-study, leaving no concurrent control
mediumWeak transparency: data on request only, no reagent identifiers or named statistical software

Full report and asset name on a demo

None of these papers was retracted. Kaimen Rigor caught every defect from the paper text itself.

We grade the paper, not the outcome

Failed assets

1.0★ all three

Each floored by a concrete, text-level defect in the early paper.

Matched controls

2.92★ avg

6 disease/target-matched programs that succeeded.

What “early paper” means

The pivotal Phase 1/2 or target-engagement paper a diligence team read before committing. The later phase records the outcome only; it is never what Kaimen Rigor reviews.

How the star works

A deduction model: every paper starts at 5★ and loses stars for concrete, named findings. A single critical defect can floor it at 1★, so one serious problem is never averaged away.

The honest limit

Why this matters

Build on science robust enough to stake your decision on.

See the full reports

Schedule a demo to see every asset, finding, and live Kaimen Rigor review

For BD, licensing, and diligence teams: we walk the full case studies with you.

Request a demo See two real Kaimen Rigor reviews