Copanlisib population pharmacokinetics from phase I-III studies and exposure-response relationships in combination with rituximab.

Testing copanlisib exposure variables on the RBCM for PFS in copanlisib‐treated patients only demonstrated a statistically significant, positive ER relationship for PFS for all three time‐varying copanlisib exposure estimates ( C avg,2wk : p = 0.002; C avg,4wk : p = 0.004; C avg,8wk : p = 0.002), along with a borderline significant ( p = 0.023) relationship for copanlisib exposure expressed as time‐invariant AUC (0–168)nd (Figure 3b ), indicating that higher exposure in copanlisib‐treated patients was associated with prolonged PFS.

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Of note, a nonsignificant trend for exposure–safety relationship was reported for copanlisib in the phase II CHRONOS‐1 monotherapy trial at the primary data cutoff. 32 The current analysis provides further elucidation of exposure–safety relationships in the larger phase III CHRONOS‐3 trial, supporting no significant relationships.

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