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Envafolimab subcutaneous population PK

A subcutaneous population PK model representing envafolimab absorption, systemic concentration, renal-function covariates, and time-varying clearance.

Model-informed drug development of envafolimab, a subcutaneously injectable PD-L1 antibody, in patients with advanced solid tumors ↗

The Oncologist

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MODEL IN MOTION 18 sec

How do weekly and every-two-week envafolimab regimens differ?

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Final model 150 mg QW for 20 weeks

How do dosing interval, renal function, and time-varying clearance change envafolimab exposure?

0–140 day

Scenario details

Final model 150 mg QW for 20 weeks

How do dosing interval, renal function, and time-varying clearance change envafolimab exposure?

Readouts

Envafolimab concentration · Unit unavailable
Envafolimab concentration over the selected simulation window.
Exposure (AUC) · mg*day/L
Exposure (AUC) over the selected simulation window.
Individual clearance · Unit unavailable
Individual clearance over the selected simulation window.
Absorption rate constant · Unit unavailable
Absorption rate constant over the selected simulation window.

Study purpose

  • How do dosing interval, renal function, and time-varying clearance change envafolimab exposure?

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Model parameter

Absorption rate constant governing entry from the administration site.

1/hr

Suggested: 0.00735–0.0221. You can explore beyond this range.

0.0147 → —

Typical clearance governing removal of modeled material from the relevant compartment.

L/hr

Suggested: 0.0239–0.0717. You can explore beyond this range.

0.0478 → —

Apparent distribution volume coefficient used by the released system of model equations.

L

Suggested: 7.75–23.3. You can explore beyond this range.

15.5 → —

Time to half-maximal change coefficient used by the released system of model equations.

day

Suggested: 17–51. You can explore beyond this range.

34 → —

Creatinine clearance coefficient used by the released system of model equations.

mL/min

Suggested: 47.6–143. You can explore beyond this range.

95.14 → —
Simulation time
day
day
140 → 168

Time between reported samples.

day
0.25 → 1

2 changes · Variation 1

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Biology

A subcutaneous envafolimab dose enters a depot, is absorbed into central systemic exposure, and undergoes clearance modulated by renal function, elapsed time, and a country factor. Central concentration accumulates as exposure.

How do subcutaneous absorption and time-varying clearance shape envafolimab exposure?A subcutaneous envafolimab dose enters a depot, is absorbed into central systemic exposure, and undergoes clearance modulated by renal function, elapsed time, and a country factor. Central concentration accumulates as exposure.BIOLOGY OVERVIEWHow do subcutaneous absorption and time-varying clearance shape envafolimabexposure?Subcutaneous dose: Envafolimab inputSubcutaneous doseEnvafolimab inputSC depot: First-order absorptionSC depotFirst-order absorptionSystemic exposure: Central envafolimab amountSystemic exposureCentral envafolimab amountClearance drivers: Renal function, time, countryClearance driversRenal function, time, countryTime-varying clearance: Central concentration lossTime-varyingclearanceCentral concentration lossCumulative exposure: Central concentration integralCumulativeexposureCentral concentration integralPRIMARY READOUTSEnvafolimab concentrationEnvafolimab concentrationCumulative exposureCumulative exposureIndividual clearanceIndividual clearanceAbsorption rateAbsorption rate

Solid arrows show modeled movement or change; two-headed arrows show reversible exchange; dashed arrows show modulation without material transfer.

Model scope: PD-L1 binding or occupancy, tumor immunity, efficacy, peripheral distribution, and target-mediated disposition are not represented.

Modeled relationships (5)
  • Subcutaneous dose → SC depot: SC input (flow)
  • SC depot → Systemic exposure: absorption (flow)
  • Systemic exposure → Time-varying clearance: CL(t) (loss)
  • Clearance drivers → Time-varying clearance: modifies CL (modulation)
  • Systemic exposure → Cumulative exposure: integrates C (production)

Modeled relationships: Subcutaneous dose to SC depot: SC input (flow); SC depot to Systemic exposure: absorption (flow); Systemic exposure to Time-varying clearance: CL(t) (loss); Clearance drivers to Time-varying clearance: modifies CL (modulation); Systemic exposure to Cumulative exposure: integrates C (production).

Primary readouts: Envafolimab concentration; Cumulative exposure; Individual clearance; Absorption rate.

Model details

9 parameters · 4 states · 4 equations · 11 derived outputs

Classification & API access
Therapeutic
Envafolimab
Modality
Monoclonal antibody
Target
PD-L1 / CD274
Disease / scope
PD-L1-positive solid tumors
ParameterDefaultUnitDescription
Clearance creatinine clearance powercl_crcl_power0.475—Clearance creatinine clearance power governing removal of modeled material from the relevant compartment.
Country factorcountry_factor1—Country factor coefficient used by the released system of model equations.
Creatinine clearancecrcl_ml_min95.14mL/minCreatinine clearance coefficient used by the released system of model equations.
Creatinine clearance referencecrcl_ref_ml_min95.14mL/minCreatinine clearance reference coefficient used by the released system of model equations.
Maximum effectemax-0.439—Maximum effect defining the limiting magnitude of the corresponding pharmacodynamic effect.
Absorption rate constantka_hr0.01471/hrAbsorption rate constant governing entry from the administration site.
Time to half-maximal changet50_day34dayTime to half-maximal change coefficient used by the released system of model equations.
Typical clearancetheta_cl_l_hr0.0478L/hrTypical clearance governing removal of modeled material from the relevant compartment.
Apparent distribution volumev_l15.5LApparent distribution volume coefficient used by the released system of model equations.

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