Daiichi Sankyo announced that the first patient has been dosed in a first-in-human phase 1/2 trial evaluating DS3790 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. DS3790 is a specifically engineered, potential first-in-class CD37 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo. CD37 is a transmembrane protein that plays a role in regulating cell survival and is overexpressed on malignant B-cells, making it a promising therapeutic target.
Currently, there are no CD37 directed therapies approved for any type of cancer. The multicenter, open-label, multi-cohort, first-in-human phase1/2 trial will assess the safety and efficacy of DS3790 in patients with Relapsed or refractory B -cell non-Hodg kin lymphoma. The first part of the trial (dose escalation) is evaluating DS3790 as a monotherapy to determine the recommended dose for expansion.
The second part of the trial (dose expansion) will consist of multiple expansion cohorts to further evaluate DS3790 as a mon monotherapy. Following the assessment of preliminary safety and efficacy in the monotherapy part of the trial, subsequent cohorts will evaluate DS3790 in combination with other targeted therapies in both dose escalation and dose expansion phases. The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events, as well as efficacy endpoints including overall response, disease control rate, duration of response, time to response, progression-free survival and overall survival.
Pharmacokinetics and biomarker endpoints also will be assessed. The trial is expected to enroll approximately 420 patients across multiple sites globally, including Asia, Europe and North America. The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sank Tokyo.
The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU®? and DATROWAY®?, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), rudotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed andcommercialized globally with Merck & Co., Inc, Rahway, NJ, USA.
DS-39 and DS3790 are being developed by Daiichi Sankyo; An additional ADC being developed by Daiichi Sanksyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxTEcan, rudotatug deroxtecan, patritumab deruxTEcan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.
