Sanofi THOR-707 and Merck Keytruda to be evaluated for cancer combotherapy

Under the agreement, Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. 

THOR-707 is currently being evaluated by Sanofi in an ongoing Phase 1 open-label, multi-center, dose escalation and expansion trial.  This study is designed to evaluate the safety and tolerability of THOR-707, and to determine its recommended Phase 2 dose alone and in combination with anti-PD-1 and anti-EGFR antibodies. 

In addition to testing THOR-707 in combination with KEYTRUDA, Sanofi is separately evaluating the activity of this novel biologic in combination with other anti-PD-1 antibodies, including Libtayo® (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors. 

THOR-707 demonstrated in preclinical studies the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as single agent as well as in combination with an anti-PD1 mAb.

It is the first molecule from the Synthorin platform, Sanofi’s unique expanded genetic alphabet platform, which has the potential to create a new generation of precision medicines for oncology and autoimmune disease. 

Novocure to collaborate with Merck to evaluate Tumor Treating Fields with KEYTRUDA in NSCLC

The two companies plan to conduct a phase 2 pilot study of Tumor Treating Fields concomitant with KEYTRUDA for first-line treatment of intrathoracic advanced or metastatic, PD-L1 positive NSCLC. The study is designed to enroll approximately 66 patients in the United States and is expected to begin in the second half of 2020. Objective response rate (ORR) is the primary endpoint of the study. Secondary endpoints include overall survival, progression free survival (PFS), PFS at six months, one-year survival rate, duration of response, disease control rate at 18 weeks and safety.

William Doyle, Novocure’s Executive Chairman said: “Multiple preclinical studies suggest that the use of Tumor Treating Fields together with anti-PD-1 therapy can potentially augment the immune response resulting in improved tumor control. We look forward to generating clinical data demonstrating the effect of Tumor Treating Fields concurrent with KEYTRUDA in first-line NSCLC.”

Novocure aims to extend survival in some of the most aggressive forms of cancer through the development and commercialization of Tumor Treating Fields.