Daiichi Sankyo Company, Limited has announced the first patient has been dosed in a phase 1 study assessing the safety and tolerability of DS-1062, an investigational TROP2-targeting antibody drug conjugate (ADC), in patients with unresectable advanced non-small cell lung cancer (NSCLC) who are refractory to or have relapsed following standard treatment or for whom no standard treatment is available.
With the discovery of driver genes and introduction of targeted therapies, there has been improvement in patient outcomes for certain types of NSCLC. However, for patients with unresectable advanced NSCLC, there is still a need for new therapeutic strategies as the five-year survival rates for patients with advanced stages of NSCLC are low.
DS-1062 is designed to target and deliver chemotherapy inside cancer cells expressing trophoblast cell-surface antigen 2 (TROP2), which is overexpressed in many cancers including NSCLC. Overexpression of TROP2 is a driver in cancer growth and has been associated with decreased patient survival, increased tumor aggressiveness, metastasis, and drug resistance in several tumor types.
“We are initially focusing on evaluating DS-1062 in patients with advanced NSCLC with potential expansion into other tumor types depending on the results of this early critical test in a study designed to provide evidence supporting unique properties of this particular TROP2 ADC construct,” said Antoine Yver, MD, MSc, executive vice president and Global head, Oncology Research and Development, Daiichi Sankyo. “With the initiation of this study of DS-1062, we move our third ADC into the clinic and continue to investigate the potential of the smart delivery of chemotherapy in various cancers including lung, breast and gastric cancer.”
The phase 1, open-label study will investigate the safety and tolerability of DS-1062 in patients with unresectable advanced NSCLC who are refractory to or have relapsed following standard treatment or for whom no standard treatment is available. The first part of the study (dose escalation) will assess the safety and tolerability of increasing doses of DS-1062 to determine the maximum tolerated dose and recommended dose for expansion. The second part of the study (dose expansion) will evaluate the safety and tolerability of DS-1062 at the recommended dose for expansion. Study endpoints include safety, pharmacokinetics, objective response rate, duration of response, disease control rate, time to response, progression-free survival, overall survival, biomarker analysis and immunogenicity. This portion of the study is expected to enroll approximately 40 patients with unresectable advanced NSCLC in the United States and Japan.
Following the outcome of both the dose escalation and dose expansion parts of the study in patients with unresectable advanced NSCLC, there may be two additional expansion cohorts opened for other solid tumors where high expression of TROP2 is frequently observed.