DATROWAY® Shows Continued Promising Tumor Response in Combination Regimens for Early and Advanced NSCLC

• Results from the TROPION-Lung02 and TROPION-Lung04 Phase 1b trials support the use of the DATROWAY combination therapy developed by Daiichi Sankyo and AstraZeneca with immunotherapy as a first-line treatment for advanced or metastatic NSCLC.
• The TROPION-Lung02 results include the first exploratory quantitative continuous scoring (QCS) analysis of DATROWAY in a first-line setting.
• NeoCOAST-2 Phase 2 results continue to show the potential of DATROWAY combined with durvalumab and single-agent platinum chemotherapy in the neoadjuvant setting.

TOKYO & BASKING RIDGE, N.J. — In a promising development for non-small cell lung cancer (NSCLC) treatment, new data from three clinical trials demonstrate the therapeutic potential of DATROWAY (datapotamab deruxtecan) in combination with various immunotherapies. These findings, presented at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting, suggest that DATROWAY could significantly improve outcomes for NSCLC patients across multiple stages of the disease. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC), discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

“These trials continue to reinforce the prospect that DATROWAY can become an important component of immunotherapy-based combination regimens for the treatment of select non-small cell lung cancer patients,” said Ken Takeshita, MD, Global Head of R&D, Daiichi Sankyo. “We look forward to further evaluation of these combinations through our robust clinical development programs in order to determine how DATROWAY may help address unmet needs of patients with lung cancer.” adds Takeshita.

“The DATROWAY combination data presented at ASCO, including results with our own durvalumab and rilvegostomig as well as pembrolizumab, reinforces the combinability of this medicine and its potential to change treatment expectations across stages of lung cancer.” remarked Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. Massacesi continued, “Further, the results from the TROPION-Lung02 exploratory biomarker analysis offer additional evidence that the more precise measurement of TROP2, as enabled by our computational pathology platform, can help identify patients with non-small cell lung cancer that are more likely to respond to DATROWAY.”

DATROWAY Plus Pembrolizumab Offers Encouraging Tumor Response as a First-Line Treatment for Advanced NSCLC

Final results from the TROPION-Lung02 phase 1b trial, which investigated DATROWAY in combination with pembrolizumab (Merck’s anti-PD-1 therapy KEYTRUDA®) with or without platinum chemotherapy as a first-line treatment for advanced NSCLC patients without actionable genomic alterations, were unveiled at the conference. In 42 patients who received the DATROWAY and pembrolizumab doublet regimen as a first-line treatment, the objective response rate (ORR) was 54.8%. The DATROWAY, pembrolizumab, and platinum chemotherapy triplet combination in 54 patients resulted in an ORR of 55.6%. The median treatment duration varied, with the doublet regimen showing 9.7 months and the triplet regimen at 5.8 months.

The safety profiles for both the doublet and triplet regimens in TROPION-Lung02 were consistent with previous findings. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 40.5% of patients in the doublet arm and 55.6% in the triplet arm. The most common grade 3 or higher TRAEs for the doublet were increased amylase (14%) and stomatitis (5%), and for the triplet, they were decreased neutrophil count (15%), neutropenia (13%), anemia (13%), increased amylase (9%), fatigue (6%), and nausea (6%).

Key First-Line Efficacy Results from TROPION-Lung02

For the same trial, the researchers performed an exploratory analysis of tissue samples using the QCS method. The analysis revealed that TROP2-NMR biomarker positivity was associated with a trend toward prolonged progression-free survival (PFS) in the patients receiving the doublet (hazard ratio [HR]: 0.50; 95% CI: 0.19-1.29) and triplet (HR: 0.67; 95% CI: 0.33-1.36) regimens. This exploratory analysis further demonstrated a trend toward improved overall survival in the patients treated with the doublet (HR: 0.35; 95% CI: 0.07-1.72) and triplet (HR: 0.71; 95% CI: 0.31-1.59).

Further Promising Data

The first results from cohort 5 of the TROPION-Lung04 phase 1b trial which assessed DATROWAY with rilvegostomig, a PD-1/TIGIT bispecific antibody by AstraZeneca, as a first-line therapy showed a 57.5% ORR among the patients after a median treatment duration of 5.1 months. The findings also included a 95% DCR and objective responses across diverse histological subtypes and all PD-L1 expression levels.

In the NeoCOAST-2 phase 2 platform trial, results from Arm 4, where neoadjuvant DATROWAY was combined with durvalumab and single-agent platinum chemotherapy, yielded a pathologic complete response (pCR) rate of 35.2% and a major pathologic response (mPR) rate of 63%.

These findings offer a strategic outlook on the future design of treatment regimens for NSCLC. Daiichi Sankyo and AstraZeneca are now conducting the TROPION-Lung10 phase 3 trial, further evaluating the efficacy of DATROWAY and rilvegostomig in the first-line treatment of advanced or metastatic nonsquamous NSCLC with PD-L1 levels greater than or equal to 50% and lacking actionable genomic alterations.

The TROP2 protein is widely expressed in most NSCLC tumors. DATROWAY works by attaching to the TROP2 protein, which is found on many NSCLC tumors, thus delivering the medicine directly to the cancer cells.