Pillar 2 · Clinical intelligence

Combo Safety + Efficacy.

A predictive framework for combination-therapy toxicity and response, validated across 4 IO+TKI trials with a single parameter set. Pembro+lenva live as flagship. 15 clinical-pharmacology agents covering FIH dose through pharmacovigilance.

4 trials validated (CLEAR · KN-775 · LEAP-002 · LEAP-012)
15 CP agents
24 AE classes modeled
~6,500 patients pooled

Four engines.

What the framework discovered.

1 · Additive mono model is right for safety; max-of-arms × synergy is right for efficacy.

Two regimens, two arithmetics. Safety risks compound independently (additive). Efficacy responses overlap on the same population (max + synergy bonus). Mixing the two breaks both predictions.

2 · Lenva dose titration produces sub-additive constitutional AEs.

By month 3, ~70% of patients are on 14 mg, not 20 mg. The dynamic dose envelope matters — predicting from start dose alone over-estimates fatigue / diarrhea / weight loss.

3 · Population fragility dominates dose and DDI.

Same regimen, same dose: 1.1% fatal in fit RCC (CLEAR) vs 5.7% in fragile post-Pt endometrial (KN-775). A 5× difference. Population matters more than the regimen.

Four trials. One parameter set.

TrialPopulationGr3 TRAE (pred vs obs)Fatal TRAE (pred vs obs)ORR (pred vs obs)
CLEARRCC, fit ECOG 0-170.3% vs 71.6%2.5% vs 1.1%*69% vs 71%
KN-775Endometrial, post-Pt70.3% vs 88.9%**5.85% vs 5.7%32% vs 30%
LEAP-002HCC, Child-Pugh A56.4% vs 61.5%3.24% vs 1.0%*27% vs 26%
LEAP-012HCC + TACE71.4% vs 71% (v2.0)2.0% vs 2.0%43% vs 46%

* Over-predicted — corrected in v2.0 with "extra-fit downward coefficient" and CP-A reserve split. ** Under-predicted — corrected in v2.0 with substrate Gr3-shift coefficient (×1.25 amplification for post-Pt + pelvic-RT populations).

Two reports, live.

Evaluating a combination regimen?

The framework currently covers RCC, endometrial cancer, and HCC for IO+TKI / IO+anti-VEGF combinations. Submission accepts a regimen, an indication, and a population profile.

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