gocatamig (MK-6070) / Merck (MSD), Daiichi Sankyo - LARVOL DELTA

Updated results from a phase I/II study of gocatamig for small cell lung cancer (SCLC) and other neuroendocrine cancers (ESMO 2025) - P1/2 | "There were no new or unexpected safety findings as of this data cutoff. Investigations of gocatamig at other monotherapy dosing schedules and in combination with other cancer therapies are ongoing."

P1/2 data • Endocrine Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3

Merck Advances Treatment of Bladder and Kidney Cancers with New Data at 2026 ASCO GU Cancers Symposium (Businesswire) - "Late-breaking KEYNOTE-B15 data show KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) significantly improved event-free survival, overall survival and pathologic complete response rates for patients with certain types of bladder cancer; New LITESPARK-022 and LITESPARK-011 data highlight the disease-free survival benefit of WELIREG (belzutifan) plus KEYTRUDA and progression-free survival benefit of WELIREG in combination with LENVIMA (lenvatinib), respectively; Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (pembro) in participants (Pts) with advanced urothelial carcinoma (UC): Results from the Phase 2 2870-002/SKB264-II-06 study; Efficacy and safety of the DLL3 T-cell engager gocatamig in participants (pts) with neuroendocrine prostate cancer (NEPC) and other neuroendocrine neoplasms (NEN)"

Clinical data • Bladder Cancer • Clear Cell Renal Cell Carcinoma • Genitourinary Neuroendocrine Carcinoma • Neuroendocrine Neoplasm • Urothelial Cancer

A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002) (clinicaltrials.gov) - P1/2 | N=242 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Aug 2029 ➔ Feb 2030

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

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

Structural and functional insights into CD3 bispecific antibodies targeting DLL3 in cancer immunotherapy. (PubMed, Med Oncol) - "This study systematically characterized three clinical-stage CD3×DLL3 BsAbs, Tarlatamab (AMG757), BI764532 and HPN328, via structural modeling, T-cell activation assays, cytokine profiling, and tumor cytotoxicity tests. BI764532 demonstrated a balanceed efficacy (ORR 18% in SCLC), while Tarlatamab achieved an ORR range of 13-40% across clinical trials. IS distance and epitope binding are strongly correlated with efficacy and safety of DLL3-targeted BsAbs, providing a critical framework for optimizing T-cell engager design in cancer immunotherapy."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Efficacy and safety of the DLL3 T-cell engager gocatamig in participants (pts) with neuroendocrine prostate cancer (NEPC) and other neuroendocrine neoplasms (NEN). (ASCO-GU 2026) - P1/2 | "Clinical Trial Registry Number: NCT04471727. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • DLL3

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov) - P1/2 | N=232 | Active, not recruiting | Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Interim results from a phase 1/2 study of HPN328, a tri-specific, half-life (T1/2) extended DLL3-targeting T-cell engager, in patients (pts) with neuroendocrine prostate cancer (NEPC) and other neuroendocrine neoplasms (NEN). (ASCO-GU 2024) - P1/2 | "HPN328 is well tolerated and clinically active. MTD determination, dose escalation, and dose optimization are ongoing. Updated safety and efficacy results including recently enrolled NEPC and SCBC pts will be presented."

Clinical • P1/2 data • Trispecific • Bladder Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • DLL3

Impact of Brain Metastases on Safety and Efficacy of MK-6070, a DLL3-Targeting T Cell Engager, in Small Cell Lung Cancer (IASLC-WCLC 2024) - P1/2 | "Introduction : MK-6070 (aka HPN328) is a DLL3-targeting T cell engager being studied in an ongoing phase 1/2 trial in patients (pts) with high grade neuroendocrine tumors associated with DLL3 expression, including small cell lung cancer (SCLC)...This trial is ongoing and data continue to mature. Updated safety and efficacy data including duration of response will be presented."

Clinical • IO biomarker • Brain Cancer • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003) (clinicaltrials.gov) - P1/2 | N=170 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1/2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Progress Continues in Multiple Cancers Across the DXd ADC Portfolio of Daiichi Sankyo (Businesswire) - "Data from...TROPION-PanTumor03, DESTINY-Gastric04, DESTINY-CRC02, DESTINY-PanTumor02 and DS-3939 – further support the strength of the DXd ADC portfolio of Daiichi Sankyo across multiple types of cancer....Updates of progress in lung cancer include a mini oral session reporting updated results from a phase 1/2 trial of gocatamig (2758MO), a DLL3 targeting T-cell engager being jointly developed by Merck, in patients with small cell lung cancer and other neuroendocrine cancers, as well as a poster presentation that will highlight the initial safety results from a phase 1b trial of valemetostat (2023P)..."

Clinical data • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Non-Squamous Non-Small Cell Cancer • Neuroendocrine Tumor • Small Cell Lung Cancer • Urothelial Cancer • HER-2

Preclinical Activity of the DLL3-Targeted T-cell Engager MK-6070 in Neuroendocrine Prostate Cancer. (PubMed, Mol Cancer Ther) - P1/2 | "MK-6070 also demonstrates antitumor activity in mixed tumors, affecting DLL3-negative prostate cancer cells after engagement with surrounding DLL3-expressing tumor cells, supporting a potential bystander effect. Overall, these data demonstrate the promising activity of MK-6070 in NEPC preclinical models including heterogeneous tumors, supporting the clinical development of MK-6070."

Journal • Preclinical • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor • DLL3

Trials-in-Progress Across Daiichi Sankyo’s Oncology Portfolio (Businesswire) - "A trial-in-progress poster will highlight the design of the DESTINY-Endometrial01 phase 3 trial...Three phase 2 trials-in-progress will include the HERTHENA-Breast03 trial (463eTiP)...the REJOICE-GI01 trial (1001TiP)...and, the KEYMAKER-U01 sub-studies 01H/01I (2081eTiP) evaluating ifinatamab deruxtecan, raludotatug deruxtecan or docetaxel in patients with stage IV NSCLC...The design of two additional early phase trials will be shared, including the phase 1/2 trial (2792TiP) evaluating ifinatamab deruxtecan and gocatamig in patients with relapsed/refractory ES-SCLC and a phase 1b trial (977P) of valemetostat..."

pMMR • Trial status • Biliary Tract Cancer • Endometrial Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Renal Cell Carcinoma • Triple Negative Breast Cancer • Urothelial Cancer

Preclinical activity of the DLL3-targeted T cell engager MK-6070 in neuroendocrine prostate cancer. (PubMed, Mol Cancer Ther) - P1/2 | "MK-6070 also demonstrates anti-tumor activity in mixed tumors, impacting DLL3-negative prostate cancer cells after engagement with surrounding DLL3-expressing tumor cells, supporting a potential bystander effect. Overall, these data demonstrate promising activity of MK-6070 in NEPC preclinical models including heterogeneous tumors, supporting the clinical development of MK-6070."

Journal • Preclinical • Genito-urinary Cancer • Genitourinary Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor • DLL3

A Phase 1b/2 Study of Gocatamig and Ifinatamab Deruxtecan for Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer (IASLC-WCLC 2025) - P1/2 | "Secondary objectives are to evaluate duration of response and progression-free survival 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, the Republic of Korea, Spain, Türkiye, and the United States of America."

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

A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002) (clinicaltrials.gov) - P1/2 | N=242 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=138 ➔ 242

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

Harnessing delta-like ligand 3: bridging biomarker discovery to next-generation immunotherapies in refractory small cell lung cancer. (PubMed, Front Immunol) - "The 2024 FDA approval of tarlatamab-a bispecific T-cell engager (BiTE) targeting DLL3 and CD3-marks a pivotal advancement, demonstrating improvement in survival in refractory disease. This review examines three key advances reshaping SCLC management: (1) mechanistic links between DLL3-driven tumorigenesis and PD-L1-mediated immunosuppression, (2) clinical progress in antibody-drug conjugates (ADCs) with next-generation payloads (e.g., FZ-AD005), multispecific BiTEs (e.g., HPN328), and engineered CAR-T/NK cells with enhanced metabolic resilience, and (3) precision strategies combining liquid biopsy for dynamic DLL3 profiling with immuno-PET imaging using [89Zr]Zr-DFO-SC16. Emerging synergies, such as combining DLL3-targeted BiTEs with ICIs to amplify T-cell infiltration or reprogramming CAR-T mitochondrial metabolism, further underscore the potential of multimodal approaches. Together, these developments signal a transformative era in SCLC treatment, where molecular..."

Biomarker • IO biomarker • Journal • Review • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3 • PD-L1

A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002) (clinicaltrials.gov) - P1/2 | N=138 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Oct 2028 ➔ Aug 2029 | Trial primary completion date: Oct 2028 ➔ Aug 2029

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

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov) - P1/2 | N=232 | Recruiting | Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Trial completion date: Jun 2027 ➔ Nov 2027 | Trial primary completion date: Jun 2027 ➔ Nov 2027

Trial completion date • Trial primary completion date • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov) - P1/2 | N=232 | Recruiting | Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Trial completion date: Feb 2026 ➔ Jun 2027 | Trial primary completion date: Feb 2026 ➔ Jun 2027

Monotherapy • Trial completion date • Trial primary completion date • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002) (clinicaltrials.gov) - P1/2 | N=138 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

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

A Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002) (clinicaltrials.gov) - P1/2 | N=138 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1/2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A phase 1/2 trial in progress of MK-6070 (aka HPN328), a DLL3-targeting T cell engager, as monotherapy or combination therapy for advanced cancers associated with DLL3 expression (SITC 2024) - P1/2 | "Enrollment and evaluation of target dose levels and schedules is ongoing in SCLC-specific combination cohorts of MK-6070 IV Q2W with atezolizumab IV Q4W. Cohorts combining the B7 homolog 3 ADC, ifinatamab deruxtecan, with MK-6070 will be enrolling to determine safety and preliminary efficacy in SCLC. Clinical trial information: NCT04471727."

Combination therapy • IO biomarker • Metastases • Monotherapy • P1/2 data • Endocrine Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • CD276 • DLL3

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov) - P1/2 | N=232 | Recruiting | Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | N=162 ➔ 232 | Trial primary completion date: Jul 2025 ➔ Jan 2026

Enrollment change • Metastases • Monotherapy • Trial primary completion date • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3

Daiichi Sankyo and Merck & Co., Inc., Rahway, NJ, USA Enter into Global Development and Commercialization Agreement for MK-6070 (Daiichi Sankyo Press Release) - "Daiichi Sankyo...and Merck & Co., Inc...have expanded their existing global co development and co-commercialization agreement for three investigational DXd antibody drug conjugates to include Merck & Co., Inc., Rahway, NJ, USA’s MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager. The companies will jointly develop and commercialize MK-6070 worldwide, except in Japan where Merck & Co., Inc., Rahway, NJ, USA will maintain exclusive rights. Merck & Co., Inc., Rahway, NJ, USA will be solely responsible for manufacturing and supply for MK-6070.....Under the terms of the agreement, Merck & Co., Inc., Rahway, NJ, USA will receive an upfront cash payment of $170 million and has also satisfied a contingent quid obligation from the original collaboration agreement."

Licensing / partnership • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor