Daiichi Sankyo Launches First Clinical Trial for DS3790 in Hematology

Daiichi Sankyo has commenced the first-in-human clinical trial for its investigational drug DS3790, targeting patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The initial patient was dosed on February 4, 2026, marking a significant milestone in the development of this potential first-in-class antibody drug conjugate (ADC), which targets the CD37 protein.

CD37 is a transmembrane protein known for its role in regulating cell survival and is highly expressed on malignant B-cells. This characteristic makes it a promising therapeutic target, especially as there are currently no approved therapies that specifically target CD37 in any type of cancer. The development of DS3790 reflects Daiichi Sankyo’s commitment to addressing unmet medical needs in oncology.

Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, emphasized the importance of this trial, stating, “The initiation of this trial of DS3790 with its novel CD37 target marks a significant milestone as our first DXd antibody drug conjugate in hematology.” With this drug, Daiichi Sankyo expands its ADC portfolio to seven agents, all developed using proprietary technology aimed at creating innovative cancer therapies.

Details of the Clinical Trial

The phase 1/2 trial is a multicenter, open-label study designed to evaluate the safety and efficacy of DS3790 in patients suffering from relapsed or refractory B-cell non-Hodgkin lymphoma. The first segment of the trial will focus on dose escalation, where DS3790 will be administered as a monotherapy to establish the recommended dose for subsequent expansions.

Following this, the second part will consist of several cohorts assessing DS3790 in combination with other targeted therapies. Researchers will monitor a range of safety and efficacy endpoints, including dose-limiting toxicities, overall response rates, disease control rates, and progression-free survival. The trial aims to enroll approximately 420 patients across multiple global sites, including regions in Asia, Europe, and North America.

Understanding CD37 and Its Role

CD37’s overexpression in various B-cell malignancies makes it an attractive target for new therapies. B-cells, a type of white blood cell, are vital for immune response but can become dysfunctional and proliferate uncontrollably in cancers. As such, targeting CD37 could provide a new avenue for treatment in a field where options remain limited.

In 2021, there were over 604,000 diagnoses of non-Hodgkin lymphoma worldwide, leading to approximately 267,000 deaths. B-cell non-Hodgkin lymphoma accounts for over 85% of these cases, with a five-year survival rate of around 74%. Despite advancements in targeted therapies, patients with relapsed or refractory forms of this disease still face significant challenges in treatment durability and long-term survival.

About DS3790 and Daiichi Sankyo’s ADC Portfolio

DS3790 is constructed using Daiichi Sankyo’s proprietary DXd ADC technology. It combines a humanized anti-CD37 IgG1 monoclonal antibody with a topoisomerase I inhibitor payload, linked through cleavable tetrapeptide linkers. This innovative design enhances the therapeutic potential of the ADC in targeting cancer cells while minimizing damage to healthy tissues.

Daiichi Sankyo’s ADC portfolio includes eight ADCs currently in clinical development, with each product based on in-house technology. Among these, ENHERTU and DATROWAY are being co-developed globally with AstraZeneca, while other investigational drugs are being developed in collaboration with Merck & Co., Inc. and Daiichi Sankyo itself.

Daiichi Sankyo, with over 120 years of experience, continues to strive for advancements in healthcare, focusing on discovering and delivering new standards of care in oncology and other areas with high unmet medical needs. For further details about the ongoing trial, interested parties can visit ClinicalTrials.gov.

For more information about Daiichi Sankyo’s initiatives, please visit their official website at www.daiichisankyo.com.