Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that the first patient has been dosed in a global phase 2 study evaluating the efficacy and safety of DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), in patients with unresectable and/or metastatic non-squamous HER2-overexpressing or HER2-mutated non-small cell lung cancer (NSCLC) that has progressed after one or more prior therapies.
The introduction of targeted therapies and checkpoint inhibitors in recent years has improved the treatment landscape for metastatic NSCLC patients, who previously had limited options beyond systemic chemotherapy.1,2 However, for those who are not eligible for available treatments, or whose cancer continues to progress, new approaches are needed to help manage the disease.1 HER2 overexpression has been reported in rates ranging from 4 to 35 percent of NSCLC, depending on the published series and methods, and is associated with poor disease prognosis and shortened overall survival.1,3 HER2 mutations have more recently been identified as distinct molecular targets for NSCLC and have been reported in up to 5 percent of NSCLC.4,5 Currently no therapy is specifically approved for HER2-overexpressing or HER2-mutated non-small cell lung cancer.
“There is renewed interest in exploring alterations in the HER2 pathway as treatment targets for NSCLC and clinical research suggests a potential role for a HER2-targeting ADC agent,” said Gilles Gallant, BPharm, PhD, Vice President, Global Team Leader DS-8201, Oncology Research and Development, Daiichi Sankyo. “DS-8201 is specifically designed to target and deliver chemotherapy inside HER2-expressing cancer cells, and we are advancing it to phase 2 in non-small cell lung cancer as part of our broad program in multiple types of HER2-expressing tumors.”
About the DS-8201 NSCLC Study
The global, multicenter, phase 2, open-label, two-cohort study is investigating the safety and efficacy of DS-8201 in patients with HER2-overexpressing and/or HER2-mutated unresectable and/or metastatic non-squamous NSCLC that has progressed after one or more systemic therapies (including chemotherapy, molecular targeted therapy or immunotherapy). Cohort 1 will enroll approximately 40 patients with HER2-overexpressing (defined as IHC 3+ or IHC 2+), unresectable and/or metastatic non-squamous NSCLC, and Cohort 2 will enroll approximately 40 patients with HER2-mutated, unresectable and/or metastatic non-squamous NSCLC.
The primary endpoint is objective response rate. Key secondary endpoints include efficacy (duration of response, disease control rate, progression free survival, overall survival and investigator-assessed objective response rate), safety, and pharmacokinetic endpoints. Exploratory efficacy endpoints include time to response as well as biomarker endpoints for mechanisms of response and resistance. This study is expected to enroll the approximately 80 patients at 20 sites in North America, Japan, and Europe. For more information about the study, visit ClinicalTrials.gov.