ifinatamab deruxtecan (DS-7300) / Daiichi Sankyo, Merck (MSD) - LARVOL DELTA

Upcoming treatments (EADV 2026) - "Cytokines are small, low-molecular-weight proteins (~5–25 kDa) that serve as critical chemical messengers for cell-to-cell communication within the immune system. Produced by a wide range of cells, including immune cells (such as T cells, B cells, macrophages, and natural killer cells) and non-immune cells (such as endothelial, fibroblast, and epithelial cells), they regulate immunity, inflammation, and hematopoiesis.Key Approved Monoclonal AntibodiesPembrolizumab (Keytruda): Blockade of the PD-1 immune checkpoint for multiple solid tumors including melanoma and non-small cell lung cancer.Trastuzumab (Herceptin): Targeting of the HER2 receptor in HER2-positive breast cancers.Lecanemab (Leqembi): Clearance of brain amyloid-beta plaques for early-stage Alzheimer's disease.Blinatumomab (Blincyto): Bispecific T-cell engager utilized for B-cell precursor acute lymphoblastic leukemia.Emerging Formats and Pipeline DrugsBispecific and Multispecific Antibodies: Engineered to..."

Acute Lymphocytic Leukemia • Alzheimer's Disease • Breast Cancer • Chronic Spontaneous Urticaria • CNS Disorders • Dermatology • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Leukemia • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Pruritus • Solid Tumor • Urticaria • HAVCR2 • HER-2 • LAG3 • TIGIT

IDeate-Prostate01: A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN VERSUS DOCETAXEL IN PARTICIPANTS WITH PREVIOUSLY TREATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (SUO 2025) - P3 | "Recruitment is ongoing. "

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

Current Treatment on Heavily Treated ES-SCLC and Role of I-DXd (IASLC-WCLC 2026) - "Sponsored by Merck (MSD)."

Lung Cancer • Small Cell Lung Cancer • Solid Tumor

Clinical and Biomarker Data from A Phase 1/2 Trial of IFINATAMAB DERUXTECAN (i-DXD; DS-7300) in Advanced Solid Tumors (JSMO 2024) - No abstract available

Biomarker • Clinical • Metastases • P1/2 data • Oncology • Solid Tumor

Ifinatamab Deruxtecan (I-DXd) in Extensive-Stage Small Cell Lung Cancer: Primary Analysis of the Phase 2 IDeate-Lung01 Study (IASLC-WCLC 2025) - P2 | "These results demonstrate the remarkable efficacy of I-DXd 12 mg/kg in patients with pretreated ES-SCLC, a population for whom there is a substantial unmet need, with clinical benefit observed regardless of platinum sensitivity or prior treatments. I-DXd 12 mg/kg had a manageable safety profile that was consistent with prior data, with no new safety signals observed."

P2 data • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock • Small Cell Lung Cancer • Solid Tumor • CD276

Ifinatamab Deruxtecan (I-DXd) in Extensive-Stage Small Cell Lung Cancer (ES-SCLC): IDeate-Lung01 Updated Results (ESMO 2026) - No abstract available

Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Ifinatamab Deruxtecan (I-DXd) in Extensive-Stage Small Cell Lung Cancer (ES-SCLC): Interim Analysis of Ideate-lung01 (IASLC-WCLC 2024) - P2, P3 | "No new safety signals were observed; TEAEs were more frequent in the 12 mg/kg cohort. Twelve mg/kg was selected as the optimal I-DXd dose for the extension part of IDeate-Lung01 and for the Phase 3 IDeate-Lung02 study (NCT06203210)."

Fatigue • Gastrointestinal Disorder • Hematological Disorders • Interstitial Lung Disease • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • CD276

Preclinical development of ABL206, a novel bispecific antibody-drug conjugate targeting B7-H3 and ROR1. (PubMed, MAbs) - P1 | "ABL206 consistently outperformed clinical-stage benchmark monospecific ADCs, ifinatamab deruxtecan (I-DXd) and zilovertamab vedotin, and effectively induced regression in I-DXd-pretreated regrowing tumors. Furthermore, ABL206 exhibited excellent in vitro plasma stability, a robust pharmacokinetic profile in rodents and non-human primates, and a favorable safety profile with the highest non-severely toxic dose (HNSTD) of 60 mg/kg in cynomolgus monkeys. Collectively, these data provide a comprehensive preclinical proof-of-concept for ABL206, supporting its advancement into a Phase 1 clinical trial for patients with advanced solid tumors (NCT07612176)."

Journal • Preclinical • Oncology • Solid Tumor • ROR1

Ifinatamab Deruxtecan in Patients With Extensive-Stage Small-Cell Lung Cancer: Primary Analysis of the Phase 2 IDeate-Lung01 Trial. (PubMed, J Clin Oncol) - "I-DXd 12 mg/kg Q3W showed promising efficacy in patients with previously treated ES-SCLC. The observed safety profile was consistent with previous reports, with no new safety signals identified."

Journal • P2 data • Hematological Disorders • Interstitial Lung Disease • Lung Cancer • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • CD276

A phase Ib/II study of gocatamig (MK-6070; HPN328) and ifinatamab deruxtecan for relapsed/refractory extensive-stage small cell lung cancer (ES-SCLC) (ESMO 2025) - P1/2 | "Secondary objectives are to evaluate duration of response and progression-free survival by investigator assessment per RECIST v1.1 (part 1) and to characterize the pharmacokinetics and immunogenicity of gocatamig plus I-DXd combination therapy (part 1), I-DXd monotherapy (part 1), and gocatamig monotherapy (part 2). The 6070-002 study will enroll participants in Australia, Chile, China, Israel, Japan, South Korea, Spain, Türkiye, the United States of America, and other sites as the expansion gets underway."

P1/2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Phase 1b/2, Open-Label Study Evaluating Gocatamig and Ifinatamab Deruxtecan for Extensive-Stage Small-Cell Lung Cancer (IASLC-WCLC 2026) - P1/2 | "For arms 2-4 (induction and maintenance), ⁓120 participants will be randomized 1:1:1 to gocatamig plus I-DXd induction and maintenance (arm 2); gocatamig plus I-DXd induction for 4 cycles followed by gocatamig plus atezolizumab 1200 mg maintenance (arm 3); or carboplatin AUC5 mg/mL/min plus etoposide 100 mg/m 2 (days 1-3) plus atezolizumab Q3W induction for 4 cycles then atezolizumab Q3W maintenance (arm 4). Secondary endpoints include disease control rate, duration of response, and PFS per RECIST v1.1 by BICR, OS, pharmacokinetic profile parameters (AUC, C max , and C trough ), and immunogenicity evaluation. Enrollment began in January 2026 and is ongoing across 63 planned global sites."

Clinical • P1/2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276 • DLL3

Intracranial activity of ifinatamab deruxtecan (I-DXd) in patients (pts) with extensive-stage (ES) small cell lung cancer (SCLC) and baseline (BL) brain metastases (BM): Primary analysis of IDeate-Lung01 (ESMO 2025) - P2 | "Table: 2760MO All pts with BL BM (N=65) No prior brain RT for BL BM (n=26) With prior brain RT for BL BM (n=39) BL brain TL (n=29) CNS ORR, n (%) 30 (46) 15 (58) 15 (38) 19 (66) 95% CI 34–59 37–77 23–55 46–82 CNS best overall response, n (%) Complete response 20 (31) 12 (46) 8 (21) 9 (31) Partial response 10 (15) 3 (12) 7 (18) 10 (34) Stable disease 29 (45) 9 (35) 20 (51) 9 (31) Progressive disease 1 (2) 0 1 (3) 0 Not evaluable 5 (8) 2 (8) 3 (8) 1 (3) CNS disease control rate, n (%) 59 (91) 24 (92) 35 (90) 28 (97) CNS duration of response, median (95% CI), months 6.2 (4.0–7.9) 6.7 (3.1–not estimable) 5.1 (3.0–7.9) 5.7 (3.1–7.1) CNS time to response, median (range), months 1.4 (0.9–8.5) 1.3 (1.1–2.8) 1.4 (0.9–8.5) 1.3 (0.9–3.0) Conclusions I-DXd demonstrated encouraging CNS activity in pts with ES-SCLC and BL BM regardless of prior RT for BL BM. The safety profile was manageable, similar between pts with and without BL BM, and consistent with the overall 12 mg/kg..."

Clinical • Brain Cancer • CNS Tumor • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

Ifinatamab Deruxtecan (I-DXd; DS-7300) in Patients with Refractory SCLC: A Subgroup Analysis of a Phase 1/2 Study (IASLC-WCLC 2023) - P2 | "I-DXd demonstrated robust and durable efficacy in this subset of patients with heavily pretreated SCLC. Likewise, it was tolerable with manageable toxicity. A phase 2 study (NCT05280470) of patients with second- or third-line extensive stage SCLC only is currently ongoing."

Clinical • IO biomarker • P1/2 data • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

KEYMAKER-U01 substudy 01A: Phase 1/2 study of pembrolizumab plus ifinatamab deruxtecan (I-DXd) or patritumab deruxtecan (HER3-DXd) with or without chemotherapy in untreated stage IV non–small-cell lung cancer. (ASCO 2025) - P1/2 | "KEYMAKER-U01 substudy 01A (NCT04165070) is a phase 1/2, two-part, rolling arm, open-label study assessing the efficacy and safety of pembrolizumab plus an investigational agent (part A: vibostolimab, boserolimab, MK-4830, and MK-0482; part B: I-DXd and HER3-DXd), with or without chemotherapy in untreated stage IV NSCLC...In Arms 5 and 6, participants will receive I-DXd plus pembrolizumab 200 mg Q3W (Arm 5) or I-DXd plus pembrolizumab with 4 cycles of carboplatin area under the curve 5 or 6 mg/ml/min (Arm 6); I-DXd dose will be at 8mg/kg...The primary endpoint is incidence of dose-limiting toxicities until the start of cycle 2, and AEs and treatment discontinuations due to AEs until 40 days after last treatment (90 days for serious AEs); secondary endpoints include ORR and DOR, both per RECIST v1.1 by BICR, and pharmacokinetic parameters, including maximum concentration (Cmax) and maximum trough concentration (Ctrough) of I-DXd and HER3-DXd. Enrollment will be..."

IO biomarker • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ERBB3 • HER-2 • ROS1

IDeate-Prostate02: A phase 1/2, open-label umbrella substudy of ifinatamab deruxtecan-based treatment combinations or as monotherapy in participants with previously treated metastatic castration-resistant prostate cancer. (ASCO-GU 2026) - P1/2 | "Two monotherapy arms, each with ~80 to ~120 participants, will enroll participants into the Efficacy Phase; Arm 1: docetaxel and Arm 2: I-DXd. Two I-DXd combination arms will enroll participants into the Safety Lead-in (n~10), followed by Efficacy (n~50) phases: Arm 3: I-DXd+MK-5684, and Arm 4: I-DXd+ARPI...Previously presented at 26th Annual Meeting of the Society of Urologic Oncology; December 2–5, 2025; Phoenix, AZ. bid, twice daily; IV, intravenously; po, orally; q3w, every 3 weeks; qd, once daily."

Clinical • First-in-human • Metastases • Monotherapy • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

IDeate-Prostate02: A PHASE 1/2, OPEN-LABEL UMBRELLA SUBSTUDY OF IFINATAMAB DERUXTECAN-BASED TREATMENT COMBINATIONS OR AS MONOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY TREATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (SUO 2025) - P1/2 | "Two monotherapy arms (Arm 1 [docetaxel] and Arm 2 [I-DXd]) will enroll participants into the Efficacy Phase, and 2 I-DXd combination arms (Arm 3: I-DXd+MK-5684; and Arm 4: I-DXd+ARPI [abiraterone acetate or enzalutamide; prior treatment dependent]) will enroll into the Safety Lead-in, followed by Efficacy Phase. Recruitment is ongoing. "

Clinical • Metastases • Monotherapy • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

DS-7300 (B7-H3 DXd antibody-drug conjugate [ADC]) shows durable antitumor activity in advanced solid tumors: Extended follow-up of a phase I/II study (ESMO 2022) - P1/2, P2 | "Conclusions DS-7300 continues to demonstrate evidence of durable antitumor activity in heavily pretreated pts with SCLC, sqNSCLC, and mCRPC. These data support further clinical development of DS-7300, including a Ph 2 dose-optimization study in SCLC (NCT05280470) with starting dose levels of 8 mg/kg and 12.0 mg/kg."

P1/2 data • Endometrial Cancer • Esophageal Squamous Cell Carcinoma • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD276

Results of a phase 1/2 study of MHB088C: A novel B7H3 antibody-drug conjugate (ADC) incorporating a potent DNA topoisomerase I inhibitor in recurrent or metastatic solid tumors. (ASCO 2024) - "Preclinical studies demonstrated robust binding affinity, superior internalization rates, powerful tumor killing activities (3~10 times more potent than the DS-7300a analog in CDX models) and a favorable safety profile with no unique toxicities observed in the GLP study as compared to other B7H3 ADCs and no occurrences of interstitial lung disease (ILD). MHB088C exhibited a manageable safety profile, with striking efficacy in SCLC pts. The dose optimization and expansion study is continuing to establish the RP2D for MHB088C."

Metastases • P1/2 data • Anemia • Febrile Neutropenia • Hematological Disorders • Interstitial Lung Disease • Lung Cancer • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • CD276

Ifinatamab Deruxtecan (I-DXd) in Extensive-Stage Small Cell Lung Cancer (ES-SCLC): Extended Safety Analysis of IDeate-Lung01 (IASLC-WCLC 2026) - "Conclusions : Gastrointestinal and hematologic events were among the most frequently reported TRAEs, and ILD/pneumonitis is an important identified risk with I-DXd 12 mg/kg. The safety profile was generally manageable via appropriate treatments through routine clinical practice, including protocol-specified guidelines for prophylaxis."

Clinical • Inflammation • Interstitial Lung Disease • Lung Cancer • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Patient Quality of Life and Treatment Tolerability (Adverse Events Management) for I-DXd and T-Cell Engagers (IASLC-WCLC 2026) - "Sponsored by Merck (MSD)."

Adverse events • Clinical • HEOR • Lung Cancer • Small Cell Lung Cancer • Solid Tumor

Efficacy and safety of B7-H3-targeted antibody-drug conjugates in previously treated small cell lung cancer: a systematic review and meta-analysis with a contextual comparison to topotecan. (PubMed, Front Immunol) - "In the exploratory contextual comparison, ifinatamab deruxtecan showed numerically favorable efficacy estimates and selected safety outcomes compared with topotecan. https://www.crd.york.ac.uk/PROSPERO, identifier CRD420251237597, version 3.0."

Clinical • Journal • Retrospective data • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

IDeate-Lung02: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=540 | Recruiting | Sponsor: Daiichi Sankyo | Trial completion date: Feb 2029 ➔ Dec 2029 | Trial primary completion date: Apr 2027 ➔ Jan 2028

Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02) (clinicaltrials.gov) - P1/2 | N=680 | Recruiting | Sponsor: Daiichi Sankyo | Phase classification: P2 ➔ P1/2 | N=520 ➔ 680

dMMR • Enrollment change • MSI-H • Pan tumor • Phase classification • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Gallbladder Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Oncology • Oropharyngeal Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • BRAF • EGFR • HER-2 • MSI

Ifinatamab deruxtecan: Topline results from P2 IDeate-Lung01 trial (NCT05280470) for 2L+ extensive stage SCLC in FY2027 (Daiichi Sankyo) - Q1 FY2026 Results

P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer

Ifinatamab deruxtecan: Data from P2 IDeate-Lung01 trial (NCT05280470) for 2L+ extensive stage SCLC at ESMO (Oct 23-27, 2026) (Daiichi Sankyo) - Q1 FY2026 Results

P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer