TUMOR-TARGETED SUPERANTIGENS - Fusion Protein Technologies for Biopharmaceuticals: Applications and Challenges - page 361

FIGURE 24.4 (A) Kaplan-Meier plot showing survival of the RCC patients treated with anatu-
momab mafenatox in a Phase IIa study (n ¼ 43). Matched simulated control population with equivalent
MSKCC prognostic criteria characteristics is represented by the dotted line. (B) Kaplan-Meier plot
showing survival of the RCC patients treated with anatumomab mafenatox in a Phase IIa study (solid
gray and dashed black) or naptumomab estafenatox in a Phase I study (solid black; n ¼ 11). Subgroups
of patients receiving high (solid gray) versus low (dashed black) exposure of anatumomab mafenatox
are depictedwhere the high exposure group received a total dose/anti-SEAof > 15.3 during the 4 days of
the first cycle. (C) Kaplan-Meier plot showing survival of the RCC patients treated with anatumomab
mafenatox in a Phase IIa study. Subgroups of patients receiving high (black) versus low (gray) exposure
of anatumomab mafenatox and responding with high (solid) versus low (dashed) IL-2 are depicted.
(D) Kaplan-Meier plot showing survival of the PC (dashed black; n ¼ 8), RCC (solid gray; n ¼ 11), and

NSCLC (solid black; n ¼ 20) patients in the Phase I MONO study with naptumomab estafenatox.

Source: Reprinted by permission from Macmillan Publishers Ltd on behalf of Cancer research UK,
Reference 38.

anti-SAg (anti-SEA/E-120) antibody titers. The recommended
Phase II dosewas set to 15 m g/kg/day for patientswithRCC and
22 m g/kg/day for patients with NSCLC and PC.
As part of the immune activation, increased systemic
levels of IL-2, IFN- g , and IL-10 were observed 3 h after TTS

treatment, and there was a correlation between dose and
cytokine induction. It can be assumed that the cytokine
responses may be used as parameters for beneficial pharma-
cologic effect (see Figure 24.4 and [38]), and we have
therefore evaluated the cytokine responses in all patients