TUMOR-TARGETED SUPERANTIGENS - Fusion Protein Technologies for Biopharmaceuticals: Applications and Challenges - page 363

MTD for naptumomab estafenatox in combination with
docetaxel. Secondary endpoints included pharmacokinetics,
immunological responses, changes in anti-SAg (anti-
SEA/E-120) levels, and effects on tumor disease. Patients

were treated with a 5-min bolus injection of naptumomab
estafenatox for four consecutive days followed by 75 mg/m 2
docetaxel on day 5. Three weeks later, this procedure

was repeated (Figure 24.6). Three patients received

FIGURE 24.6 Naptumomab estafenatox was investigated in combination with docetaxel in a Phase I
study with 13 NSCLC patients (COMBO). (A) Study treatment scheme. (B) Immunohistochemical
staining (brown) for T lymphocytes (anti-CD3) of paraffin sections of liver metastasis from samples
taken pretreatment and day 3 of the second cycle of 22 m g/kg naptumomab estafenatox treatment froma
patient with a PR (pt#10-02). This patient had previously received three treatment regimes (including
docetaxel), but had a PR after COMBO treatment. (C) CT scans pretreatment and 6 months after
naptumomab estafenatox treatment start of pt#10-02. (D) Anti-SEA/E-120 antibody concentrations of
individual patients at baseline (day 1) and after 3-4 weeks (Day 20/28); left: populationMONO n ¼ 35;
right: population COMBO n ¼ 11; red lines depict median quartiles. (E) Best overall tumor response
according to RECIST criteria at days 56 and 115 of evaluable patients depicted as a waterfall plot.
Source: Reprinted from Reference 39 with permission from American Society of Clinical Oncology.