A Trial Exploring the Efficacy of EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)

The purpose of this research is to determine if EMD 1201081 in combination with cetuximab is
more efficient than cetuximab alone to control the cancer.

EMD 1201081 is an immune modulatory oligonucleotide (IMO) containing phosphorothioate
oligodeoxynucleotide and acts as an agonist of Toll-like receptor 9 (TLR9).

EMD 1201081 has been studied in six clinical trials in over 170 subjects either as a
monotherapy or in combination with chemotherapeutic agents or targeted therapies. Two
studies have been conducted in healthy volunteers. In the other five studies, patients with
advanced solid tumors, renal cell carcinoma, non-small cell lung cancer and colorectal
cancer have been treated with EMD 1201081. Two studies are still ongoing. Future clinical
development of EMD 1201081 will focus on colorectal cancer (CRC) and squamous cell cancer of
the head and neck (SCCHN).

Subject of this application is the phase II study EMR 200068-006 in recurrent or metastatic
squamous cell cancer of the head and neck (R/M SCCHN) in which patients with recurrent or
metastatic squamous cell cancer of the head and neck will be treated with cetuximab plus EMD
1201081 or cetuximab alone. The study will be conducted as a multicenter study in several EU
Member States and the USA.

EMD 1201081 in combination with cetuximab will be evaluated for antitumor activity in
subjects by examining its effects on accepted clinical endpoints. Progression-free survival
will be evaluated in subjects treated with EMD 1201081 plus cetuximab compared to cetuximab
alone in cetuximab-naïve subjects with recurrent and/or metastatic SCCHN who have progressed
on a cytotoxic therapy.

Cetuximab, approved in colorectal cancer and SCCHN in combination with platinum-based
chemotherapy and SCCHN in combination with radiotherapy in the EU, will be provided as
Investigational Medicinal Product (IMP) in this study. Commercially available Cetuximab will
be provided in the US.