Safety Profile
The emerging safety data for nimotuzumab suggest an improved side-effect profile compared to currently approved EGFR-targeting antibodies and small molecules.
Safety Profiles of Leading Anti-EGFR Products Compared to Nimotuzumab Safety Profile
|
|
Nimotuzumab |
Erbitux® |
Vectibix® |
BSC |
|
Rash/Skin Reactions - grades 3 and 4 |
<1% |
25%d |
62%e |
0% |
|
Rash/Skin Reactions - all grades |
9% |
87% |
90% |
6% |
|
Pruritus |
<1% |
16% |
57% |
2% |
|
Hypomagnesemia - all grades |
<1% |
50% |
39% |
2% |
|
Nausea |
22% |
49% |
23% |
16% |
|
Diarrhea |
9% |
19% |
21% |
11% |
|
Constipation |
14% |
35% |
21% |
9% |
|
Vomiting |
14% |
29% |
19% |
12% |
Events highlighted in orange above are common side-effects of anti-EGFR antibodies.
a Information from four completed clinical trials. Data collection ongoing.
b Information obtained from Erbitux® and Vectibix® product labels and company websites.
c BSC = best supportive care
d June 6, 2008 FDA Action Letter on cetuximab
e STEPP trial - 2008 - 29% post-preemptive treatment
In the more than 9,000 patients treated with nimotuzumab worldwide to date in numerous cancer indications, there have been very few reports of Grade 3/4 acneform rash and rare occurrences of the other severe toxicities frequently reported with other EGFR-targeting agents. The absence of acneform rash to date and the rare instances of any of the other debilitating side-effects holds the potential for nimotuzumab to become best-in-class for this important family of EGFR-targeting agents.