XBiotech, a developer of True Human therapeutic antibodies, has inked an agreement with the NCIC Clinical Trials Group (NCIC CTG), a Canadian cooperative cancer trials group, to develop a phase II study to assess Xilonix in combination with Tarceva for treatment of non-small cell lung cancer (NSCLC).
The proposed study, which will enroll 75 patients, is projected to launch in Canada in the second quarter of 2016.
Michael Stecher, M.D., the company’s medical director, said, “This program represents the second oncology indication we will be pursuing with the Xilonix antibody. We believe that the potential synergy between IL-1 alpha antagonism and EGFR inhibitors makes this a highly attractive combination therapy in non-small cell lung cancer, where safe and effective therapies are urgently needed.”
The NCIC CTG study is a follow up of results from a subset of the NSCLC patients treated in an all comers oncology study of Xilonix conducted at MD Anderson Cancer Center in Houston, which were published in Investigational New Drugs in March. Those results highlighted the potential for combination therapy in NSCLC patients treated with EGFR inhibitors.
In the MD Anderson study, NSCLC patients had metastatic, refractory disease at baseline and were treated with Xilonix monotherapy until disease progression. Patients that had received prior treatment with Tarceva appeared to have considerably better outcomes than those that had not received Tarceva.
In the study, radiographic evidence of tumor response, changes in lean body mass and quality of life were assessed and patients were followed for 24 months for survival analysis. Radiographic evidence of anti-tumor effect was observed, and improvements in lean body mass and quality of life were observed. Furthermore, stratification by prior therapies revealed a median overall survival for patients treated with anti-EGFR therapy of 9.4 months compared to only 4.8 months for non-pretreated patients.