What is the rationale for zolbetuximab infusion rates?

Published
Zolbetuximab infusion rates follow SPOTLIGHT/GLOW protocols: starting at a slow rate and building up as tolerated over minimum two hours

The recommended infusion rates are based on guidance provided in the clinical trial protocols for the zolbetuximab Phase 3 trials, SPOTLIGHT and GLOW.1

  • Per the protocols, it was required to administer the total volume of zolbetuximab by intravenous infusion over a minimum of two hours.2,3 
  • The maximum rate represents the rate that the total volume can be completed in two hours.1 The initial and subsequent infusion rates are fractionations of the total volume to start at a slow rate and build up as tolerated.

In the Phase 3 trials, the infusion rate for the first infusion (or loading dose) was numerically higher in mg/m2/hour than for the second and subsequent infusions.1 However, the initial fractionation of total infusion volume as the starting infusion rate was the same for all infusions. The percentage of total infusion solution volume infused in the first 30-60 minutes was consistent in the first and subsequent infusions. The first infusion was a higher dose and subsequently larger total volume of infusion.

  • The same principle applies for the 400mg/m2 and 600 mg/m2 doses for their respective dosing frequency.1 

  • The recommended zolbetuximab dosage is a single loading dose of 800 mg/m2 followed by maintenance doses of 600 mg/m2 every three weeks or 400 mg/m2 every two weeks.4
  • Specific data examining rates of adverse events at specific infusion rates is not available.1 

  1. Data on File.

  2. Shah MA, Shitara K, Ajani JA, et al. Supplement to: Zolbetuximab plus CAPOX in CLDN18.2- positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat. Med. 2023;29(8):2133-2141. Available at: https://doi.org/10.1038/s41591-023-02465-7.

  3. Shitara K, Lordick F, Bang YJ, et al. Supplement to: Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023;401(10389):1655-1668. Available at: https://doi.org/10.1016/s0140-6736(23)00620-7.

  4. Shitara K, Lordick F, Bang YJ, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023;401(10389):1655-1668. Available at: https://doi.org/10.1016/s0140-6736(23)00620-7. 

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