Datroway (datopotamab deruxtecan-dlnk) / Daiichi Sankyo, AstraZeneca - LARVOL DELTA

TROPION-SWISH: Prophylaxis for datopotamab deruxtecan (Dato-DXd) related oral mucositis/stomatitis in patients (pts) with metastatic or inoperable locally recurrent breast cancer (BC) or locally advanced/metastatic EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) (ESMO 2026) - No abstract available

Clinical • Metastases • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A single-arm, phase II study of datopotamab deruxtecan, carboplatin, and pembrolizumab for treatment-naive brain metastases from non-small cell lung cancer (NSCLC): TROPICAL-1 (LACOG 0823) (ESMO 2026) - No abstract available

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Mechanisms of insensitivity to the datopotamab deruxtecan (Dato-DXd) payload in subgroups of patients with advanced non-small cell lung cancer (NSCLC) in TROPION Lung01 (ESMO 2026) - No abstract available

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

DATO-DAWN: Systemic and intracranial outcomes from the datopotamab deruxtecan Medical Access Program in advanced nonsquamous NSCLC (ESMO 2026) - No abstract available

Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients (pts) with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Exploratory analysis of pts with brain metastases in TROPION-Breast02 (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer: results from the TROPION-Breast01 China cohort. (PubMed, ESMO Open) - "In this China cohort, Dato-DXd demonstrated numerically improved efficacy versus ICC and a manageable safety profile, consistent with the global population, supporting Dato-DXd as a new treatment option for Chinese patients with previously treated metastatic HR+/HER2- breast cancer."

Journal • Breast Cancer • Dental Disorders • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Mucositis • Neutropenia • Oncology • Solid Tumor • Stomatitis • HER-2

TROPION-Lung12: A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features (clinicaltrials.gov) - P3 | N=25 | Active, not recruiting | Sponsor: AstraZeneca | Trial completion date: Jun 2027 ➔ Mar 2027 | Trial primary completion date: Jun 2027 ➔ Jul 2026

Circulating tumor DNA • Monotherapy • Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

LIBRA: A Phase 2, Open-Label Platform Study Evaluating Novel Agent-Based Combinations in Locally Advanced or Metastatic NSCLC (IASLC-WCLC 2026) - P2 | "Approaches targeting angiogenesis and the PD-1/PD-L1 axis have demonstrated benefit in previously treated AGA-positive (the ORIENT-31 and HARMONi-A studies) and AGA-negative (the Lung-MAP S1800A study of ramucirumab [anti-VEGFR2 monoclonal antibody] plus pembrolizumab) advanced NSCLC...Dato-DXd plus ramucirumab and rilvegostomig may further improve efficacy over Dato-DXd monotherapy in patients with EGFR m NSCLC that has progressed on prior EGFR TKIs...Response and progression will be assessed by investigators per RECIST v1.1. Exploratory objectives include assessment of molecular responses based on ctDNA, pharmacodynamic and predictive biomarkers, and multiomics."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • TIGIT

Datopotamab deruxtecan (Dato-DXd) + rilvegostomig (rilve) in patients (pts) with locally advanced or metastatic urothelial cancer (a/mUC): Results from the phase II TROPION-PanTumor03 study (ESMO 2025) - P2 | "We present results from pts with a/mUC who received Dato-DXd + rilve, an Fc reduced anti–PD-1/TIGIT bispecific antibody (anti–TIGIT component derived from COM902 [Compugen]). Methods Pts with histologically documented unresectable a/mUC were enrolled in two eligible populations: 1L population, no prior systemic therapy in the a/mUC setting (progression >12 months after platinum-based neoadjuvant or adjuvant therapy permitted), and ineligible for cisplatin-based chemotherapy (CT); 2L population, had received previous platinum-based CT in the a/mUC setting or progressed <12 months after platinum-based neoadjuvant or adjuvant therapy...Conclusions Dato-DXd in combination with rilve showed encouraging efficacy and a manageable safety profile in pts with a/mUC. Table: 3072MO Incidence of AEs, n (%) Dato-DXd + rilve 1L (n=22) 2L (n=18) TRAEs 21 (95.5) 17 (94.4) Grade ≥3 TRAEs 4 (18.2) 7 (38.9) Any TRAE leading to: Dose reduction of any study treatment 12 (54.5) 4..."

Clinical • Metastases • P2 data • Pan tumor • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • TIGIT

First-line (1L) datopotamab deruxtecan (Dato-DXd) + rilvegostomig in advanced or metastatic non-small cell lung cancer (a/mNSCLC): Results from TROPION-Lung04 (cohort 5). (ASCO 2025) - P1 | "The safety profile for the combination of Dato-DXd + rilvegostomig was consistent with the expected toxicities of each agent and without new safety findings. Dato-DXd + rilvegostomig had encouraging activity as 1L treatment for pts with a/mNSCLC without AGAs, with responses seen in both histologies and across all PD-L1 levels."

Clinical • Metastases • Alopecia • Cardiovascular • Dental Disorders • Fatigue • Gastrointestinal Disorder • Immunology • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock • Solid Tumor • Stomatitis • TIGIT

Exposure-Response Analyses of Datopotamab Deruxtecan (Dato-DXd), a TROP2-Directed Antibody-Drug Conjugate, in Advanced Non-small Cell Lung Cancer. (PubMed, Clin Pharmacol Ther) - "The exposure-safety analysis identified Dato-DXd or DXd exposures as statistically significant predictors for safety endpoints except adjudicated drug-related interstitial lung disease (ILD)/pneumonitis for which no ER relationship was observed. These ER analyses support that the 6 mg/kg Q3W Dato-DXd regimen optimized the benefit-risk profile for patients with advanced nonsquamous NSCLC and identified clinically relevant factors that influence both survival and safety outcomes."

Journal • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): initial results from BEGONIA, a phase 1b/2 study (ESMO-BC 2022) - P1/2 | "Additional enrollment and analysis of translational data is ongoing. Funding : AstraZeneca/Daiichi Sankyo."

Clinical • P1/2 data • Alopecia • Breast Cancer • Dental Disorders • Hematological Disorders • Inflammation • Neutropenia • Oncology • Pneumonia • Solid Tumor • Stomatitis • Triple Negative Breast Cancer

Rates of pathologic complete response (pCR)after neoadjuvant datopotamab deruxtecan (Dato): Results from the I-SPY2.2 trial. (ASCO 2024) - P2 | "Randomization to Block B includes a taxane-based regimen specific to the RPS, and options include S1: paclitaxel; S2 and S3: paclitaxel + carboplatin + pembrolizumab; S4: paclitaxel + carboplatin vs. paclitaxel + carboplatin + pembrolizumab. Dato monotherapy was active, particularly in the HR-HER2- signature, but did not meet the pre-specified threshold for graduation in I-SPY 2.2."

Clinical • Late-breaking abstract • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • DRD • HER-2

Efficacy and safety of datopotamab deruxtecan (Dato-DXd) in patients (pts) with previously-treated EGFR-mutated advanced non-small cell lung cancer (NSCLC): A pooled analysis of TROPION-Lung01 and TROPION-Lung05 (ESMO Asia 2024) - P2, P3 | "Conclusions Dato-DXd elicited encouraging efficacy and manageable safety in previously treated pts with EGFR m NSCLC. These findings suggest a potential clinical role for Dato-DXd in this population with high unmet need."

Late-breaking abstract • Metastases • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Rates of pathologic complete response (pCR) after datopotamab deruxtecan (Dato) plus durvalumab (Durva) in the neoadjuvant setting: Results from the I-SPY2.2 trial. (ASCO 2024) - P2 | "Randomization to Block B includes a taxane-based regimen specific to the RPS, and options include S1: paclitaxel; S2 and S3: paclitaxel + carboplatin + pembrolizumab; S4: paclitaxel + carboplatin vs. paclitaxel + carboplatin + pembrolizumab. Dato+Durva meets threshold for graduation within the RPS S3 subtype based on estimated pCR rate of 72% and warrants further investigation in a larger randomized controlled trial."

Clinical • Late-breaking abstract • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • DRD • HER-2

TROPION-Lung02: Initial Results for Datopotamab Deruxtecan Plus Pembrolizumab and Platinum Chemotherapy in Advanced NSCLC (IASLC-WCLC 2022) - P1, P1b | "Dato-DXd with pembrolizumab, ± platinum chemotherapy, demonstrates a tolerable safety profile and has notable activity in frontline and relapsed/refractory settings. To our knowledge, this is the first reported clinical experience of a TROP2 ADC in combination with checkpoint inhibitors and platinum chemotherapy in NSCLC."

IO biomarker • Dental Disorders • Fatigue • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Stomatitis • PD-L1 • TROP2

Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Updated results from BEGONIA, a phase Ib/II study (ESMO 2023) - P1/2 | "Translational data analysis is ongoing. Funding: AstraZeneca/Daiichi Sankyo."

Clinical • IO biomarker • Metastases • P1/2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • TACSTD2

Efficacy, safety, and biomarker analysis of datopotamab deruxtecan in advanced non-small cell lung cancer: ICARUS-LUNG01 phase 2 study. (PubMed, Cancer Cell) - "Conversely, the activation of immune-related pathways was associated with treatment response. Validation of these findings in phase III studies will be essential to define biomarkers, ultimately enabling more precise identification of patients most likely to benefit from Dato-DXd."

Biomarker • Journal • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

“A full HTA is recommended to assess the clinical effectiveness and cost-effectiveness of datopotamab deruxtecan (Datroway) compared with the current standard of care.“ (National Centre for Pharmacoeconomics, Ireland)

HEOR • Breast Cancer • Oncology • Triple Negative Breast Cancer

Treatment-Related Toxicities of Antibody-Drug Conjugates in Breast Cancer: A Bayesian Network Meta-Analysis. (PubMed, Cancer Control) - "The protocol was registered in PROSPERO (CRD42024606194).ResultsSeventeen randomized trials including 8,946 patients and five ADCs-trastuzumab emtansine (T-DM1), sacituzumab govitecan (SG), trastuzumab deruxtecan (T-DXd), datopotamab deruxtecan (Dato-DXd), and ARX788-were analyzed. For gastrointestinal toxicities, SG ranked worst for diarrhea (SUCRA 6.0%), whereas T-DXd was associated with higher risks of nausea (2.2%), vomiting (7.9%), and decreased appetite (8.6%). In analyses of SAEs, SG had the highest rates of anemia (11.7%) and neutropenia (8.5%), while gastrointestinal SAEs occurred more frequently with T-DXd.ConclusionsThis network meta-analysis highlights clinically meaningful differences in ADC safety profiles and may help guide individualized toxicity management in breast cancer."

Clinical • Journal • Retrospective data • Review • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia

Enhertu and Datroway Approved in Japan for Two New First-Line Indications for Patients with Metastatic Breast Cancer (Daiichi Sankyo Press Release) - "Enhertu in combination with pertuzumab was approved for the treatment of adult patients with HER2 positive unresectable or recurrent breast cancer. Datroway was approved for the treatment of adult patients with hormone receptor (HR) negative and HER2 negative unresectable or recurrent breast cancer, a subtype commonly referred to as triple negative breast cancer (TNBC)....The approval of Enhertu by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on results from the DESTINY-Breast09 phase 3 trial....The approval of Datroway by Japan’s MHLW is based on results from the TROPION-Breast02 phase 3 trial, which included patients with metastatic TNBC who experienced early relapse following prior treatment and were not candidates for PD-1/PD-L1 inhibitor therapy."

Japan approval • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Triple Negative Breast Cancer

First-in-Human, Phase I Dose-Escalation and Dose-Expansion Study of Trophoblast Cell-Surface Antigen 2-Directed Antibody-Drug Conjugate Datopotamab Deruxtecan in Non-Small-Cell Lung Cancer: TROPION-PanTumor01. (PubMed, J Clin Oncol) - "Promising antitumor activity and a manageable safety profile were seen with Dato-DXd in heavily pretreated patients with advanced NSCLC. Further investigation as first-line combination therapy in advanced NSCLC and as monotherapy in the second-line setting and beyond is ongoing."

Journal • P1 data • Pan tumor • Alopecia • Dental Disorders • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Stomatitis • TACSTD2 • TROP2

Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): updated results from BEGONIA, a phase 1b/2 study (SABCS 2022) - P1/2 | "In this updated analysis with additional patients and longer follow-up, the combination of Dato- DXd + D in 1L a/mTNBC demonstrated a manageable safety profile and compelling high response rates with promising durability. Although subgroups were small, responses occurred irrespective of PD-L1 expression. Further investigation of this treatment combination is warranted."

Clinical • IO biomarker • P1/2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Datopotamab deruxtecan (Dato-DXd) vs docetaxel in previously treated advanced/metastatic (adv/met) non-small cell lung cancer (NSCLC): Results of the randomized phase III study TROPION-Lung01 (ESMO Asia 2023) - P3 | "Dato-DXd was well tolerated, with a manageable safety profile. The trial is continuing until the final OS analysis."

Clinical • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Neoadjuvant durvalumab (D) + chemotherapy (CT) + novel anticancer agents and adjuvant D ± novel agents in resectable non-small-cell lung cancer (NSCLC): Updated outcomes from NeoCOAST-2. (ASCO 2025) - P2 | " Pts were stratified by PD-L1 expression (<1% vs ≥1%) and randomized to neoadjuvant D + platinum-doublet CT + oleclumab (anti-CD73 monoclonal antibody [mAb]) then adjuvant D + oleclumab (Arm 1), neoadjuvant D + platinum-doublet CT + monalizumab (anti-NKG2A mAb) then adjuvant D + monalizumab (Arm 2), or neoadjuvant D + single-agent platinum CT + Dato-DXd (TROP2-directed antibody-drug conjugate [ADC]) then adjuvant D (Arm 4). All arms show that novel perioperative combinations may improve pCR rates and maintain tolerability and feasibility of surgery in resectable NSCLC. The final analysis of pCR and mPR rates in Arm 4 is the first for an ADC in this setting and confirms the encouraging efficacy and manageable safety profile of D + CT + Dato-DXd. Presurgical ctDNA clearance is associated with pathological responses."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KLRC1