raludotatug deruxtecan (DS-6000) / Daiichi Sankyo, Merck (MSD) - LARVOL DELTA

Raludotatug Deruxtecan (R-DXd) + Bevacizumab (Bev) in Participants (Pts) With Platinum-Resistant Recurrent Ovarian Cancer (PROC): Results for Cohort B-1 of the Phase 1b/2 REJOICE-Ovarian02 Study (ESMO 2026) - No abstract available

Clinical • P1/2 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

REJOICE-OVARIAN01 AND DS6000-A-U101 STUDIES: BIOMARKER ANALYSIS OF CDH6 AND FRΑ EXPRESSION, AND RALUDOTATUG DERUXTECAN (R-DXD) ANTITUMOR ACTIVITY BY FRΑ STATUS, IN PLATINUM-RESISTANT OVARIAN CANCER (IGCS 2026) - "While the FRα-directed mirvetuximab soravtansine has improved outcomes, only 36% of patients with PROC are eligible. Overall, 184 samples had paired CDH6 and FRα expression data (DS6000-A-U101: n=95; REJOICE-Ovarian01: n=89). Across all samples, 93.5% (n=172) were CDH6-positive and 31.0% (n=57) were FRα-positive (Table 1). The median CDH6 expression on the tumor cell membrane was 77.0% (range, 0–100) and the median FRα expression was 35.0% (range, 0–100)."

Biomarker • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • CDH6 • FOLR1 • PROC

Raludotatug deruxtecan (R-DXd) in patients (pts) with platinum-resistant ovarian cancer (PROC): a subgroup analysis of efficacy and tolerability in Asian pts from the Ph 2 part of REJOICE-Ovarian01 (ESMO Asia 2026) - No abstract available

Clinical • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Raludotatug deruxtecan (R-DXd) in patients (pts) with platinum-resistant ovarian cancer (PROC): an updated analysis of efficacy and tolerability from the Ph 2 part of REJOICE-Ovarian01 (ESMO 2026) - No abstract available

Clinical • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01) (clinicaltrials.gov) - P2 | N=335 | Active, not recruiting | Sponsor: Daiichi Sankyo | N=200 ➔ 335 | Trial completion date: Sep 2027 ➔ Dec 2029 | Trial primary completion date: Sep 2027 ➔ Dec 2029

dMMR • Enrollment change • MSI-H • Pan tumor • pMMR • Trial completion date • Trial primary completion date • Endometrial Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer • MSI

A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04) (clinicaltrials.gov) - P3 | N=802 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • HRD

A Study of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab as Maintenance Therapy in Second-Line Platinum-Sensitive Recurrent Ovarian Cancer (REJOICE-Ovarian03) (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Daiichi Sankyo

New P3 trial • Platinum sensitive • Breast Cancer • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA

Raludotatug deruxtecan monotherapy among patients with previously treated ovarian cancer: Subgroup analysis of a first-in-human phase I study (SGO 2024) - P1, P2/3 | "Across the three dose groups, 40 patients (88.9%) had platinum-resistant disease, 29 (64.4%) had received prior bevacizumab, and 29 (64.4%) had received a prior PARP inhibitor. In unselected, heavily pretreated OVC patients, R-DXd demonstrated a manageable safety profile and encouraging preliminary efficacy, which supports further clinical development in OVC in the ongoing phase 2/3 trial (NCT06161025 [REJOICE-Ovarian01])."

Clinical • Monotherapy • P1 data • Oncology • Ovarian Cancer • Solid Tumor • CDH6

Raludotatug deruxtecan (R-DXd) in patients (pts) with platinum-resistant ovarian cancer (PROC): Primary analysis of the phase II dose-optimization part of REJOICE-Ovarian01 (ESMO 2025) - P2/3 | "Methods Pts with platinum-resistant high-grade serous or endometrioid OC, primary peritoneal, or fallopian tube cancer who received 1–3 prior lines of systemic therapy (LOT), including bevacizumab (bev) and/or PARP inhibitor (PARPi) if eligible, were enrolled in the phase 2, dose-optimization part of REJOICE-Ovarian01 (NCT06161025), irrespective of tumor CDH6 expression by immunohistochemistry. Table: LBA42 4.8 mg/kg n=36 5.6 mg/kg n=36 6.4 mg/kg n=35 Total N=107 ORR by BICR, % (95% CI) 44.4 (27.9–61.9) 50.0 (32.9–67.1) 57.1 (39.4–73.7) 50.5 (40.6–60.3) Best overall response, n (%) CR PR 1 (2.8) 15 (41.7) 2 (5.6) 16 (44.4) 0 20 (57.1) 3 (2.8) 51 (47.7) Disease control rate, % (95% CI) 75.0 (57.8–87.9) 80.6 (64.0–91.8) 77.1 (59.9–89.6) 77.6 (68.5–85.1) Median time to response, weeks (range) 7.1 (5.4–18.7) 6.6 (5.1–18.3) 7.2 (5.3–19.1) 7.1 (5.1–19.1) Any-grade TEAEs, n (%) 35 (97.2) 36 (100) 35 (100) 106 (99.1) Gr ≥3 TEAEs, n (%) 16 (44.4) 20 (55.6) 20 (57.1) 56..."

Clinical • Late-breaking abstract • P2 data • Platinum resistant • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • CDH6

REJOICE-PanTumor01: A phase 2 signal-seeking study of raludotatug deruxtecan (R-DXd) in patients with advanced or metastatic gynecologic or genitourinary tumors. (ASCO 2025) - P1, P2, P2/3 | "PFS and DOR will be analyzed using the Kaplan–Meier method (2-sided 95% CI). Study enrollment began in January 2025."

Clinical • Metastases • P2 data • Pan tumor • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Endometrial Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Solid Tumor • Urothelial Cancer • CDH6

Raludotatug deruxtecan (R-DXd) monotherapy in patients (pts) with heavily pretreated platinum-sensitive ovarian cancer (PSOC): Subgroup analysis of a phase I study (ESMO-GC 2025) - P1 | "Median number of prior lines of therapy was 4 (range, 2–6); 14 pts (77.8%) had received prior bevacizumab and 15 (83.3%) prior PARP inhibitor. Editorial acknowledgement Medical writing support was provided by Natalie Dennis of BOLDSCIENCE, Inc., and was funded by Daiichi Sankyo, Inc. Legal entity responsible for the study Daiichi Sankyo, Inc."

Clinical • Monotherapy • P1 data • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • CDH6

DS6000-A-U101: A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors (clinicaltrials.gov) - P1 | N=179 | Active, not recruiting | Sponsor: Daiichi Sankyo | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Apr 2026 ➔ Dec 2026

First-in-human • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor

Phase I, two-part, multicenter, first-in-human (FIH) study of DS-6000a in subjects with advanced renal cell carcinoma (RCC) and ovarian tumors (OVC). (ASCO 2022) - P1 | "The interim data from dose-escalation of this FIH study showed acceptable tolerability with early signals of efficacy in heavily pretreated pts with advanced RCC and Pt-R OVC, which support further clinical evaluation of DS-6000a in the planned dose-expansion cohorts in advanced RCC and OVC."

Clinical • P1 data • Fatigue • Febrile Neutropenia • Genito-urinary Cancer • Hematological Disorders • Immune Modulation • Inflammation • Neutropenia • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Thrombocytopenia • MUC16 • TOP1

Raludotatug deruxtecan (R-DXd; DS-6000) monotherapy in patients with previously treated ovarian cancer (OVC): Subgroup analysis of a first-in-human phase I study (ESMO 2023) - P1 | "Results As of 03 March 2023, 42 patients with OVC had received R-DXd at 4.8 (n = 7), 6.4 (n = 20), and 8.0 (n = 15) mg/kg: 40 (95%) had platinum-resistant disease, 29 (69%) had received prior bevacizumab, and 26 (62%) had received prior PARP inhibitors. Eleven of 21 GCIG-evaluable patients (52%) had a CA-125 response. Conclusions In heavily pretreated OVC patients without CDH6 preselection, R-DXd demonstrated acceptable safety and encouraging preliminary efficacy, which supports further clinical development in OVC."

Clinical • Monotherapy • P1 data • Oncology • Ovarian Cancer • Solid Tumor • CDH6 • MUC16

Seminal Abstract: RALUDOTATUG DERUXTECAN (R-DXD) IN PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER (PROC): PRIMARY ANALYSIS OF THE PHASE 2, DOSE-OPTIMIZATION PART OF THE REJOICE-OVARIAN01 STUDY (IGCS 2025) - P2/3 | " Patients with platinum-resistant OC (PROC), primary peritoneal, or fallopian tube cancer who received 1–3 prior lines of systemic therapy (LOT), including bevacizumab and/or PARPi if eligible, were enrolled in the Phase 2, dose-optimization part of REJOICE-Ovarian01 (NCT06161025), irrespective of tumor CDH6 expression. R-DXd 5.6 mg/kg was identified as the optimal dose for further evaluation in the Phase 3 study. R-DXd demonstrated promising efficacy and a manageable safety profile in patients with PROC. Table 1 Efficacy 4.8 mg/kg n=36 5.6 mg/kg n=36 6.4 mg/kg n=35 Total N=107 ORR by BICR, % 44.4 (27.9–61.9) 50.0 (32.9–67.1) 57.1 (39.4–73.7) 50.5 (40.6–60.3) (95% CI) Best overall response, n 1 (2.8) 15 (41.7) 2 (5.6) 16 (44.4) 0 20 (57.1) 3 (2.8) 51 (47.7) (%) CR PR Disease control rate, % 75.0 80.6 77.1 77.6 (95% CI) (57.8–87.9) (64.0–91.8) (59.9–89.6) (68.5–85.1) Median time to response, 7.1 6.6 7.2 7.1 (5.1–19.1) weeks (range) (5.4–18.7) (5.1–18.3) (5.3–19.1)..."

Clinical • P2 data • Platinum resistant • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor • CDH6

REJOICE-Ovarian02: A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003) (clinicaltrials.gov) - P1/2 | N=605 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=460 ➔ 605 | Trial completion date: Mar 2029 ➔ Feb 2031

Enrollment change • Platinum resistant • Platinum sensitive • Trial completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor • HRD

A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04) (clinicaltrials.gov) - P3 | N=802 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • HRD

A Clinical Trial of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab in Participants With Ovarian Cancer Who Have Progressed During Treatment With PARP-inhibitors Treatment on First Line Maintenance (MK-5909-008/ENGOT-ov107/GOG-3142 / REJOICE-Ovarian05) (clinicaltrials.gov) - P3 | N=646 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Platinum sensitive • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Raludotatug deruxtecan: Data from dose optimization part of P2 REJOICE-Ovarian01 trial (NCT06161025) for platinum-resistant ovarian cancer at ESMO (23-27, 2026) (Daiichi Sankyo) - Q1 FY2026 Results: Data from bevacizumab combo cohort of P1/2 REJOICE-Ovarian02 trial (NCT06843447) for platinum-resistant ovarian cancer at ESMO (23-27, 2026)

P1/2 data • P2 data • Platinum resistant • Gynecologic Cancers • Oncology • Ovarian Cancer

REJOICE-Ovarian01: Phase 3 part of a phase 2/3 study evaluating raludotatug deruxtecan (R-DXd) versus treatment of physician's choice in patients with platinum-resistant ovarian cancer. (ASCO 2026) - P2/3 | "Patients must have received 1–4 prior lines of therapy (LOT), including bevacizumab (unless ineligible) and mirvetuximab soravtansine for folate receptor α–positive disease (unless not available locally)...Approximately 600 patients will be randomized 1:1 to receive either R-DXd 5.6 mg/kg intravenously every 3 weeks until disease progression per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), lost to follow-up, death, or other reason per protocol, or treatment of physician's choice (TPC; weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan) per local guidelines...Stratified Cox regression models will be fitted to estimate the hazard ratios for PFS and OS. Enrollment in Phase 3 began in December 2025."

Clinical • P2/3 data • P3 data • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor • CDH6 • FOLR1

REJOICE-Ovarian01: A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P2/3 | N=860 | Recruiting | Sponsor: Daiichi Sankyo | Trial completion date: Dec 2029 ➔ Apr 2030

Platinum resistant • Trial completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

REJOICE-Ovarian01: A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P2/3 | N=650 | Active, not recruiting | Sponsor: Daiichi Sankyo | Recruiting ➔ Active, not recruiting

Enrollment closed • Fallopian Tube Cancer • Oncology • Solid Tumor

KEYMAKER-01I: Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I) (clinicaltrials.gov) - P2 | N=144 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P2/3 | N=650 | Recruiting | Sponsor: Daiichi Sankyo | Not yet recruiting ➔ Recruiting

Enrollment open • Fallopian Tube Cancer • Oncology • Solid Tumor

REJOICE-Ovarian01: A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P2/3 | N=710 | Recruiting | Sponsor: Daiichi Sankyo | Active, not recruiting ➔ Recruiting

Enrollment open • Fallopian Tube Cancer • Oncology • Solid Tumor