Last updated: June 28, 2026
Datroway (datopotamab deruxtecan-dlnk, Dato-DXd, DS-1062) is the second FDA-approved TROP2-directed antibody-drug conjugate on the US market (after Trodelvy / sacituzumab govitecan) and the second Daiichi Sankyo deruxtecan (DXd) linker-payload platform brand alongside Enhertu (trastuzumab deruxtecan, anti-HER2) and patritumab deruxtecan (HER3-DXd). Developed jointly by Daiichi Sankyo and AstraZeneca, Datroway is FDA-approved in 2 indications: HR+/HER2-low or HER2-ultralow metastatic breast cancer (FDA regular approval January 17, 2025, based on TROPION-Breast01 Phase 3) and EGFR-mutant locally advanced or metastatic NSCLC after prior EGFR-TKI and platinum chemotherapy (FDA accelerated approval June 23, 2025, based on TROPION-Lung05 single-arm).
Mechanism of action:Datroway is a humanized IgG1 anti-TROP2 monoclonal antibody (datopotamab) covalently linked via a cleavable tetrapeptide-based linker to deruxtecan (DXd), a derivative of the topoisomerase I inhibitor exatecan. The drug-to-antibody ratio (DAR) is approximately 4, distinguishing it from Trodelvy's CL2A-SN-38 platform with DAR approximately 7-8. The antibody binds TROP2 (trophoblast cell surface antigen 2, encoded by TACSTD2) on tumor cells, the ADC is internalized, the linker is cleaved in the lysosome, and free DXd diffuses to inhibit topoisomerase I and induce DNA damage and apoptosis. The DXd payload also exhibits a bystander effect on neighboring tumor cells regardless of their TROP2 expression, shared with the same DXd platform on Enhertu and patritumab deruxtecan.
Regulatory status:FDA-approved in 2 indications: (1) HR+/HER2-low (IHC 1+ or IHC 2+ ISH-) or HER2-ultralow (IHC 0 with membrane staining) metastatic breast cancer after prior endocrine therapy and at least one chemotherapy regimen — FDA regular approval January 17, 2025, based on TROPION-Breast01 Phase 3 (NCT05104866, n=732, Dato-DXd vs investigator's choice chemotherapy, median PFS 6.9 vs 4.9 months, hazard ratio 0.63); (2) EGFR-mutant locally advanced or metastatic NSCLC after EGFR-directed therapy and platinum-based chemotherapy — FDA accelerated approval June 23, 2025, based on TROPION-Lung05 single-arm Phase 2 (NCT04484142, ORR approximately 36%). The TROPION-Lung01 Phase 3 confirmatory trial vs docetaxel narrowly missed its OS primary endpoint in the overall NSCLC population — the EGFR-mutant indication was carved out from TROPION-Lung05 single-arm data plus TROPION-Lung01 subgroup analyses (see honest framing below). FDA label includes a boxed warning for interstitial lung disease / pneumonitis (deruxtecan-platform class effect shared with Enhertu). Dosing: 6 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity. Baseline ophthalmology examination is required before initiation because of the distinctive Dato-DXd ocular toxicity signal.
Antibody-drug conjugates (ADCs) have transformed metastatic breast cancer over the past five years — Enhertu (T-DXd) reshaped HER2-positive and HER2-low treatment, Trodelvy became the standard 2L+ option in TNBC and HR+/HER2-low. Datroway extends the ADC revolution to two distinctive niches: HR+/HER2-low and HER2-ultralow metastatic breast cancer after prior endocrine therapy and chemotherapy, and EGFR-mutant pretreated NSCLC. The HER2-ultralow (IHC 0 with membrane staining) inclusion is unique to Datroway among FDA-approved TROP2 ADCs — reaching breast cancer patients who would otherwise be classified as HER2-zero and therefore ineligible for HER2-low T-DXd. Approximately a quarter of HER2-zero metastatic breast cancer patients have detectable HER2 membrane staining on careful re-review and are now eligible for Datroway under the HER2-ultralow label.
The TROPION-Breast01 Phase 3 trial randomized 732 patients with HR+/HER2-low or HER2-ultralow metastatic breast cancer who had received prior endocrine therapy and 1-2 chemotherapy regimens for metastatic disease to Dato-DXd 6 mg/kg every 3 weeks vs investigator's choice chemotherapy (capecitabine, eribulin, vinorelbine, gemcitabine). The primary progression-free survival endpoint was met with a hazard ratio of 0.63 (median PFS 6.9 vs 4.9 months) — a clinically meaningful improvement that supported the January 2025 FDA regular approval. Overall survival follow-up continues to mature.
The TROPION-Lung01 OS miss — honest framing. Datroway is also FDA-approved for EGFR-mutant pretreated NSCLC, but the Phase 3 confirmatory trial (TROPION-Lung01, n=604, Dato-DXd vs docetaxel in 2L+ NSCLC) narrowly missed statistical significance for OS in the overall population (median OS 12.4 vs 11.0 months, hazard ratio 0.94, p > 0.05) — although PFS was improved (median PFS 4.4 vs 3.7 months, hazard ratio 0.75) and clinically meaningful OS benefit was observed in the non-squamous histology subgroup (median OS 14.6 vs 12.3 months, hazard ratio 0.84) and in the actionable-genomic-alteration subgroups (EGFR mutation, ALK rearrangement, others) where docetaxel performs especially poorly. The FDA accelerated approval for EGFR-mutant pretreated NSCLC was carved out from TROPION-Lung05 single-arm Phase 2 data plus TROPION-Lung01 EGFR-mutant subgroup analyses rather than from a positive overall-population Phase 3 readout. Datroway is therefore a strong choice in specific biomarker-defined niches but is not a tour-de-force PFS-and-OS winner across the broader TROP2-expressing population — an important nuance for both patients and oncologists evaluating the drug.
Datroway has 2 active FDA approvals: one in metastatic breast cancer (Jan 2025, regular approval) and one in EGFR-mutant NSCLC (Jun 2025, accelerated approval, contingent on confirmatory trial).
1. HR+/HER2-Low or HER2-Ultralow Metastatic Breast Cancer (TROPION-Breast01)
2. EGFR-Mutant Locally Advanced or Metastatic NSCLC after EGFR-TKI and Platinum Chemotherapy (TROPION-Lung05)
★ The HER2-Ultralow Inclusion: Datroway's Unique Breast Cancer Niche
Datroway is the only FDA-approved TROP2 ADC whose breast cancer label includes HER2-ultralow patients — defined as IHC 0 with detectable HER2 membrane staining. This matters because HER2-low patients (IHC 1+ or 2+ ISH-) have two ADC options (Datroway and T-DXd / Enhertu), but HER2-ultralow patients (IHC 0 with membrane staining) currently have only Datroway and T-DXd cross-class options. Trodelvy's HR+/HER2-low label (TROPiCS-02 Feb 2023) requires HER2-low IHC 1+/2+ ISH- and does not extend to HER2-ultralow.
In practice, this means a careful re-review of HER2 IHC in the membrane-staining range is now part of the metastatic HR+/HER2-negative breast cancer workup. Patients whose HER2 was previously called IHC 0 should have the HER2 status re-reviewed with current ASCO/CAP guidance — if detectable membrane staining is present, the patient is HER2-ultralow and is now eligible for Datroway under its FDA label.
The biological basis for the HER2-ultralow Datroway response is the bystander effect of the DXd payload — even tumor cells expressing trace amounts of HER2 may not be the primary target; instead, TROP2 expression on the same or neighboring cells drives drug uptake, and the DXd payload diffuses to kill both TROP2+ and adjacent TROP2-low tumor cells. The combined TROP2 + ultralow HER2 expression pattern appears to mark a subset of HR+ metastatic breast cancer that responds well to TROP2 ADC therapy with a deruxtecan payload.
Curated subset of recruiting interventional Datroway / datopotamab deruxtecan / Dato-DXd trials in the ClinTrialFinder corpus as of June 28, 2026 (approximately 16 recruiting interventional trials total). Trials are grouped by clinical setting and ordered by phase and clinical significance.
Showing a curated subset of recruiting Datroway / datopotamab deruxtecan interventional trials in the ClinTrialFinder corpus as of June 28, 2026 (approximately 16 recruiting interventional trials total). For the latest list: view all recruiting Datroway trials on ClinicalTrials.gov.
Target: TROP2 (trophoblast cell surface antigen 2, encoded by TACSTD2) — a transmembrane glycoprotein normally expressed at low levels on epithelial tissues (skin, breast, lung, pancreas, colon, cornea) and overexpressed in a wide range of carcinomas including breast (TNBC, HR+, HER2-low/ultralow), NSCLC, urothelial, gastric, ovarian, and others. TROP2 expression is detected by immunohistochemistry (IHC) on tumor tissue, but FDA labels for both Datroway and Trodelvy do not require formal TROP2 IHC quantification — activity has been observed across the spectrum of TROP2 expression including TROP2-low tumors, likely due to the bystander effect of the cytotoxic payload.
Linker-payload — the deruxtecan (DXd) platform: Datroway uses a cleavable tetrapeptide-based linker (a glycine-glycine-phenylalanine-glycine sequence) conjugating deruxtecan (DXd), a derivative of the topoisomerase I inhibitor exatecan. The drug-to-antibody ratio (DAR) is approximately 4. Once the ADC is internalized by the tumor cell via TROP2-mediated endocytosis, lysosomal proteases (notably cathepsin B and L) cleave the tetrapeptide linker to release free DXd, which inhibits topoisomerase I, induces DNA double-strand breaks during replication, and triggers apoptosis. Free DXd has a relatively short plasma half-life (limiting systemic exposure) but is membrane-permeable, allowing the bystander effect: free payload released in one tumor cell can diffuse into neighboring tumor cells regardless of their TROP2 expression. This is the same DXd platform used in Enhertu (T-DXd / trastuzumab deruxtecan) against HER2 and in patritumab deruxtecan (HER3-DXd) against HER3.
Why Datroway differs from Trodelvy — the two TROP2 ADCs side by side: Both Datroway and Trodelvy target TROP2 on tumor cells, but the linker, payload, DAR, and clinical profile differ substantially. Trodelvy uses a hydrolyzable CL2A linker with SN-38 (the active metabolite of irinotecan, also a topoisomerase I inhibitor) at DAR approximately 7-8. Trodelvy's defining toxicities are severe neutropenia (boxed warning) and diarrhea — both reflecting the SN-38 payload's overlap with irinotecan-class chemotherapy. Datroway uses a cleavable tetrapeptide linker with DXd (the deruxtecan-platform topoisomerase I inhibitor) at DAR ~4. Datroway's defining toxicities are interstitial lung disease / pneumonitis (boxed warning, a deruxtecan-platform class effect shared with T-DXd), ocular toxicity (dry eye, keratitis — distinctive among ADCs), and stomatitis. The two ADCs are therefore not interchangeable and have different optimal patient populations.
The Daiichi Sankyo deruxtecan family: Datroway is the second Daiichi deruxtecan-platform brand on the US market. The platform's first member, Enhertu (trastuzumab deruxtecan, anti-HER2), is FDA-approved across HER2+ metastatic breast, HER2-low metastatic breast, HER2+ gastric, HER2-mutant NSCLC, and pan-HER2+ solid tumors. Patritumab deruxtecan (HER3-DXd) is the next anticipated Daiichi deruxtecan brand — in late-stage development for EGFR-mutant NSCLC and HER3-expressing solid tumors; HERTHENA-Lung02 and HERTHENA-Breast-03 are the pivotal trials. The platform's shared DXd payload creates the question of cross-resistance: if a patient develops resistance to one DXd-platform ADC, does that resistance generalize across the platform? The TRADE DXd Phase 2 (NCT06533826) head-to-head test of Dato-DXd vs T-DXd in ADC-refractory breast cancer is the first formal answer to this question and is one of the most important trials in the Datroway landscape.
For a patient with HR+/HER2-negative metastatic breast cancer, the choice of ADC after endocrine and 1L chemotherapy progression depends on a careful HER2 IHC re-review. The current decision tree:
In practice: a careful re-review of HER2 IHC in the borderline IHC 0 / membrane-staining range is now part of the metastatic HR+ breast cancer workup. Patients previously called HER2 IHC 0 should have HER2 status re-reviewed with current ASCO/CAP guidance — if detectable membrane staining is present, the patient is HER2-ultralow and is eligible for Datroway under its FDA label. See the Breast Cancer trials page for the full HR+ / HER2-low / HER2-ultralow / HER2-zero metastatic breast trial landscape.
Datroway is one of two FDA-approved TROP2 ADCs and one of multiple FDA-approved ADCs for HR+/HER2-low/ultralow metastatic breast cancer. Sequencing decisions depend on HER2 IHC status, prior ADC exposure, and toxicity considerations.
⚠ FDA Boxed Warning: Interstitial Lung Disease (ILD) / Pneumonitis
Datroway carries an FDA boxed warning for interstitial lung disease (ILD) and pneumonitis — a class effect of the deruxtecan platform shared with Enhertu (T-DXd) and patritumab deruxtecan. ILD was reported in approximately 5-9% of Datroway patients across the TROPION-Breast01 and TROPION-Lung01 trials, with rare fatal cases. ILD typically presents with cough, dyspnea, fever, hypoxia, or new ground-glass opacities on imaging.
Management protocol: (1) Baseline chest imaging before starting Datroway. (2) Prompt evaluation of any new or worsening respiratory symptom — cough, dyspnea, fever, hypoxia — with chest CT and pulmonologist consultation. (3) Dose hold for Grade 1 ILD until resolution; resume at the same dose if Grade 1 resolves promptly. (4) Permanent discontinuation for Grade 2 or higher ILD with concurrent corticosteroids (typically prednisone 0.5-1 mg/kg/day with taper). The Datroway ILD management algorithm follows the same principles as the T-DXd ILD management algorithm developed by Daiichi-AstraZeneca and validated across the deruxtecan platform.
Patients with pre-existing lung disease (interstitial lung disease, pulmonary fibrosis, severe COPD, prior chest radiation with residual fibrosis) are at higher ILD risk and should have Datroway risk-benefit reviewed carefully; the TROPION-Breast01 and TROPION-Lung trials generally excluded patients with active or prior clinically significant ILD.
Ocular toxicity — dry eye, keratitis, blurred vision, conjunctivitis — is a distinctive Datroway safety signal not seen at this magnitude with other approved TROP2 or HER2 ADCs. Reported in approximately 40-60% of patients across pivotal trials (most Grade 1-2; Grade 3+ ~5%). The mechanism is thought to reflect TROP2 expression on the corneal epithelium — the same target the ADC is designed to engage on tumor cells.
Management: (1) Baseline ophthalmology evaluation before starting Datroway is required — complete eye examination, refraction, slit-lamp, dry eye assessment. (2) Prophylactic artificial tears / preservative-free lubricating drops are recommended from the first dose — routine use (e.g. 4-6 times daily) rather than rescue-only. (3) Routine ophthalmology follow-up during treatment, especially after Cycle 1 and every 2-3 months. (4) Dose holds and modifications per protocol for Grade 2 or higher ocular events; refer to ophthalmology for management of keratitis or persistent severe dry eye. (5) Counsel patients to report any new visual symptom — blurred vision, eye pain, foreign body sensation, persistent dryness — promptly to the oncology team.
Stomatitis (oral mucositis) is common with Datroway, reported in approximately 50-60% of patients across pivotal trials (most Grade 1-2; Grade 3+ ~5-7%). The mechanism is multifactorial and includes TROP2 expression on oral epithelium and the DXd payload's general epithelial toxicity. Stomatitis can be dose-limiting in some patients and is the basis for the TROPION-DM Phase 2 trial (NCT06974604) testing prophylactic dexamethasone mouthwash. The TROPION-DM intervention mirrors the use of steroid mouthwash for everolimus-related stomatitis, a similar epithelial-toxicity mechanism. Standard supportive care includes good oral hygiene, ice chips during infusion, magic mouthwash (lidocaine + diphenhydramine + antacid) for symptomatic relief, and dose holds or reductions for Grade 3+ events.
Because Datroway is administered every 3 weeks until disease progression or unacceptable toxicity, patients on continued therapy require regular monitoring of ILD risk (chest imaging on clinical suspicion), ocular health, oral mucosa, and CBC + LFT. The drug's response in HR+/HER2-low/ultralow metastatic breast typically manifests as PFS prolongation rather than deep RECIST responses — most patients have stable disease or partial response over many months, with progression eventually due to disease evolution rather than cumulative toxicity. Discontinuation typically follows clinical progression, severe ILD, or refractory ocular / stomatitis events.
What is Datroway (datopotamab deruxtecan, Dato-DXd)?
Datroway (brand name Datroway, USAN datopotamab deruxtecan-dlnk, development code DS-1062 / Dato-DXd) is a TROP2-directed antibody-drug conjugate (ADC) developed jointly by Daiichi Sankyo and AstraZeneca. It consists of a humanized IgG1 anti-TROP2 monoclonal antibody covalently linked via a cleavable tetrapeptide-based linker to deruxtecan (DXd), a derivative of the topoisomerase I inhibitor exatecan, with a drug-to-antibody ratio of approximately 4. Datroway is the second FDA-approved TROP2 ADC (after Trodelvy / sacituzumab govitecan) and the second Daiichi Sankyo deruxtecan-platform brand on the US market, alongside Enhertu (trastuzumab deruxtecan, anti-HER2) and patritumab deruxtecan (HER3-DXd). Datroway received FDA regular approval on January 17, 2025 for HR+/HER2-low (IHC 1+ or 2+ ISH-) or HER2-ultralow (IHC 0 with membrane staining) metastatic breast cancer after prior endocrine therapy and at least one chemotherapy regimen — based on the TROPION-Breast01 Phase 3 trial (NCT05104866) of Dato-DXd vs investigator's choice (median PFS 6.9 vs 4.9 months, hazard ratio 0.63). Datroway received FDA accelerated approval on June 23, 2025 for EGFR-mutant locally advanced or metastatic NSCLC after EGFR-directed therapy and platinum-based chemotherapy — based on the TROPION-Lung05 single-arm Phase 2 trial (NCT04484142) demonstrating an objective response rate of approximately 36%.
Which patients qualify for Datroway?
Datroway has two FDA-approved indications with distinct eligibility criteria. (1) HR+/HER2-low or HER2-ultralow metastatic breast cancer: adults with unresectable or metastatic breast cancer that is hormone receptor-positive (ER+ and/or PR+) and HER2-negative — defined as either HER2-low (IHC 1+ or IHC 2+ in situ hybridization negative) or HER2-ultralow (IHC 0 with detectable membrane staining) — who have received prior endocrine therapy and at least one chemotherapy regimen for metastatic disease. This is distinct from the T-DXd / Enhertu HER2-low label (which requires IHC 1+ or 2+ ISH-) and from the Trodelvy HR+/HER2-low label (which similarly requires HER2-low but uses a different ADC platform). HER2-ultralow patients (IHC 0 with membrane staining) currently have Datroway and T-DXd as cross-class options. (2) EGFR-mutant pretreated NSCLC: adults with locally advanced or metastatic NSCLC harboring an EGFR mutation (exon 19 deletion or L858R most commonly) who have received both prior EGFR-directed targeted therapy (osimertinib or earlier TKIs) AND prior platinum-based chemotherapy. This is the post-TKI, post-platinum chemotherapy setting — a niche population with limited approved options. Both indications require formal pathology confirmation of receptor / mutation status; HER2 IHC scoring should be performed with current ASCO/CAP guidance, including the IHC 0 with membrane staining HER2-ultralow assessment. Datroway is not currently approved for TNBC (Trodelvy is preferred there based on the ASCENT Phase 3) or for HER2-positive breast (T-DXd / Enhertu is preferred based on DESTINY-Breast trials). Baseline ophthalmology evaluation is required before initiating Datroway because of the drug's distinctive ocular toxicity signal.
How does Datroway differ from Trodelvy (the other FDA-approved TROP2 ADC)?
Datroway and Trodelvy share the same TROP2 target on tumor cells but differ in three important ways. (1) Linker-payload platform: Trodelvy uses a hydrolyzable CL2A linker with SN-38 (the active metabolite of irinotecan, a topoisomerase I inhibitor) at a drug-to-antibody ratio of approximately 7-8. Datroway uses a cleavable tetrapeptide-based linker with deruxtecan (DXd), an exatecan derivative — also a topoisomerase I inhibitor — at a drug-to-antibody ratio of approximately 4. Both payloads inhibit the same enzyme (topoisomerase I), but the linker chemistry, DAR, and bystander activity differ, leading to different on-tumor pharmacology and different off-target toxicity. (2) Indication footprint: Trodelvy is FDA-approved for TNBC (Apr 2020 + ASCENT Apr 2021 full approval), HR+/HER2-low metastatic breast (Feb 2023 TROPiCS-02), and previously urothelial (Apr 2021, voluntarily withdrawn Apr 2025 after TROPiCS-04 missed). Datroway is FDA-approved for HR+/HER2-low OR HER2-ultralow metastatic breast (Jan 2025 TROPION-Breast01) and EGFR-mutant pretreated NSCLC (Jun 2025 TROPION-Lung05). The HER2-ultralow inclusion is unique to Datroway among approved TROP2 ADCs; the EGFR-mutant NSCLC indication is also unique to Datroway. (3) Safety profile: Trodelvy's defining toxicities are severe neutropenia (boxed warning) and diarrhea — both reflecting the SN-38 payload's overlap with irinotecan-class chemotherapy. Datroway's defining toxicities are interstitial lung disease / pneumonitis (boxed warning, a class effect of the deruxtecan platform shared with T-DXd / Enhertu), ocular toxicity (dry eye, keratitis, blurred vision — distinctive among ADCs and a Dato-DXd class-specific signal), and stomatitis (oral mucositis, the basis for the TROPION-DM dexamethasone mouthwash trial). The TRADE DXd Phase 2 (NCT06533826) directly tests Dato-DXd vs T-DXd head-to-head in ADC-refractory breast cancer — a question of whether the deruxtecan platform exhibits cross-resistance across its anti-HER2 (T-DXd) and anti-TROP2 (Dato-DXd) members.
What are the main side effects of Datroway?
Datroway has a distinctive safety profile centered on three signals. (1) Interstitial lung disease (ILD) / pneumonitis — class effect of the deruxtecan platform shared with T-DXd / Enhertu. Reported in approximately 5-9% of patients in the TROPION-Breast01 and TROPION-Lung01 trials, with rare fatal cases. This is the basis for an FDA boxed warning on the Datroway label. ILD management requires high vigilance: baseline chest imaging, prompt evaluation of any new or worsening respiratory symptoms (cough, dyspnea, fever), and dose holds or permanent discontinuation per ASCO / manufacturer ILD-management algorithms. (2) Ocular toxicity — dry eye, keratitis, blurred vision, conjunctivitis. This is distinctive among ADCs (no other approved TROP2 or HER2 ADC has this signal at this magnitude) and is thought to reflect TROP2 expression on the corneal epithelium. Baseline ophthalmology evaluation is required before initiating Datroway; routine ophthalmology monitoring during treatment is recommended; patients should use artificial tears / preservative-free lubricating drops prophylactically. (3) Stomatitis — oral mucositis, common and dose-limiting in some patients. The TROPION-DM Phase 2 trial (NCT06974604) is testing prophylactic dexamethasone mouthwash to prevent or attenuate Dato-DXd-related stomatitis, mirroring the use of steroid mouthwash for everolimus-related stomatitis. Other common adverse events: nausea, fatigue, alopecia, neutropenia (less severe than Trodelvy's neutropenia), constipation, decreased appetite, and transient liver enzyme elevations. See the Breast Cancer trials page for the full HR+/HER2-low metastatic breast landscape and the NSCLC trials page for EGFR-mutant treatment options.
What is the TROPION-Lung01 OS miss — and what does it mean for Datroway?
TROPION-Lung01 (NCT04656652) was the Phase 3 confirmatory trial of Dato-DXd vs docetaxel in 2L+ previously-treated metastatic NSCLC. The trial enrolled 604 patients and reported its primary OS endpoint readout in 2024 — the Dato-DXd arm narrowly missed statistical significance for OS in the overall population (median OS 12.4 vs 11.0 months, hazard ratio 0.94, p > 0.05), although progression-free survival was improved (median PFS 4.4 vs 3.7 months, hazard ratio 0.75). Pre-specified subgroup analyses showed clinically meaningful benefit in the non-squamous histology subgroup (median OS 14.6 vs 12.3 months, hazard ratio 0.84) and in patients with actionable genomic alterations (EGFR mutation, ALK rearrangement, others) where docetaxel performs especially poorly. The TROPION-Lung01 readout is the honest framing required when discussing Datroway in NSCLC: the drug is NOT a tour-de-force PFS-and-OS winner across the broader TROP2-expressing NSCLC population (where docetaxel remains a reasonable and inexpensive comparator). The FDA accelerated approval for EGFR-mutant pretreated NSCLC (June 23, 2025) was carved out from the TROPION-Lung05 single-arm Phase 2 (NCT04484142, ORR ~36% in EGFR-mutant post-TKI post-platinum) plus the TROPION-Lung01 EGFR-mutant subgroup analysis, rather than from a positive overall-population Phase 3 readout. Continued approval is contingent on a confirmatory trial demonstrating clinical benefit. Several recruiting trials test Dato-DXd in earlier NSCLC lines and biomarker-defined subgroups: NCT07291037 Dato-DXd vs docetaxel in previously-treated TROP2-positive NSCLC (TROP2 enrichment); NCT06350097 TROPION-Lung10 1L osimertinib +/- Dato-DXd in EGFR-mutant NSCLC; NCT06357533 TROPION-Lung08 1L Dato-DXd + rilvegostomig (the AstraZeneca / Daiichi PD-1/TIGIT bispecific).
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