Daiichi Sankyo’s first in-human Phase I study of DS-1062 (Antibody Drug Conjugate) in TNBC and NSCLC.

Press Release : July 10, 2020
Daiichi Sankyo’s first in-human Phase I study of DS-1062 (Antibody Drug Conjugate) in TNBC and NSCLC.

Daiichi Sankyo’s DS-1062 is a TROP2-directed antibody drug conjugate (ADC), designed using Daiichi Sankyo’s proprietary DXd ADC technology with the highest development stage of Phase I. 

We, Mellalta Meets, unveil the Daiichi’s strategies with our Competitive intelligence team, as below 

Daiichi Sankyo DS-1062 (Datopotamab Deruxtecan) Strategy 

It’s been only a month when Daiichi Sankyo announced Clinical Research Collaboration to Evaluate DS-1062 in Combination with KEYTRUDA (pembrolizumab) in Metastatic Non-Small Cell Lung Cancer. The clinical trial has not been registered at the Clinical Trials.gov 

The Trial is a multicenter, two-part, open-label, non-randomized, phase 1b study of DS-1062 in combination with KEYTRUDA in patients with advanced or metastatic NSCLC without actionable genomic alterations and previously treated with platinum-based chemotherapy with or without immunotherapy. 

DS-1062 is currently in the Phase I trial for unresectable advanced NSCLC. And following the promising preliminary results reported with DS-1062 at ASCO2020 in patients with non-small cell lung cancer, Daiichi Sankyo has expanded the study to include patients with triple negative breast cancer. 

This Phase I study is the first open-label, two-part, multicenter human study designed to assess the safety, tolerability, and preliminary efficacy of DS-1062 in patients with unselected TROP2 advanced solid tumors, who are refractory or relapse of standard treatment or for whom there is no standard treatment is available. 

As presented at ASCO 2020, in the first-in-human Phase I study of DS-1062, treatment was well tolerated up to 8 mg/kg, and a dose effect on antitumor activity was observed over 2.0-10.0 mg/kg in heavily pretreated pts with prior progression on standard treatment. 

Daiichi Sankyo’s CLAIMS 

  • TROP2 (trophoblast cell surface antigen 2) is highly expressed in NSCLC [TRUE] 
  • TROP2 overexpression is associated with decreased patient survival [TRUE] 
  • It is recognized as a promising molecular target for therapeutic development [TRUE] 
  • No TROP2-directed therapy is currently approved for the treatment of NSCLC. [TRUE but will FACE HIGH Competition with BREAKTHROUGH DRUG] 

There are many Competitor companies exploring their antibody drug conjugate in non-small cell lung cancer (NSCLC) 

 Sacituzumab govitecan (IMMU-132), the TROP 2 antibody developed by Immunomedics received the ADC Fast Track designation for patients with TNBC and for patients with small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC). The drug has also received Breakthrough designation from FDA for TNBC. Dedicated Drug Page https://trodelvy.com/ 

 BAT8003, another Trop2-targeted antibody-drug conjugate being developed by Biothera (Guangzhou, China), for Trop2-positive advanced solid tumors, including breast cancer, non-small cell lung cancer and urothelial carcinoma. 

What separates DS-1062 from Sacituzumab govitecan / IMMU-132? 

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Notes to editors

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