A Phase 1b/2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer

Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body.
A standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy.
* Chemotherapy is a treatment that works to destroy cancer cells or stop them from growing.
* Immunotherapy is a treatment that helps the immune system fight cancer.
Gocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate.
* T-cell engager therapy is a certain type of immunotherapy that uses T-cells to find and destroy cancer cells.
* A T-cell is a type of white blood cell, which are cells that help the body fight infection.
* An antibody drug conjugate (ADC) is a treatment that attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The goals of this study are to learn:
* About the safety of combining gocatamig and I-DXd and if people tolerate them together
* If people who receive gocatamig and I-DXd have ES-SCLC respond, which means the cancer gets smaller or goes away

Start Date29 Jan 2026

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

NCT06780137

/ RecruitingPhase 1/2

A Phase 1b/2 Open-Label Clinical 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

Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment.
The goals of this study are to learn:
* If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated
* If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away

Start Date27 Feb 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

NCT04471727

/ Active, not recruitingPhase 1/2

A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab or Ifinatamab Deruxtecan (I-DXd) in Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch Ligand 3 (DLL3).

This study will investigate the maximum tolerated dose, the recommended dose for expansion (RDE), safety, efficacy, and pharmacokinetics of gocatamig alone, gocatamig with Atezolizumab and gocatamig with I-DXd in participants with advanced cancers associated with expression of Delta-like Canonical Notch Ligand 3 (DLL3).

Start Date14 Dec 2020

Sponsor / Collaborator

Harpoon Therapeutics, Inc.

[+1]

100 Clinical Results associated with Gocatamig

100 Translational Medicine associated with Gocatamig

100 Patents (Medical) associated with Gocatamig

Literatures (Medical) associated with Gocatamig

01 Jul 2026·INTERNATIONAL IMMUNOPHARMACOLOGY

The rise of bispecific antibodies for dual targeting, singular impact: technology and clinical advancements

Review

Author: Eifler, Nora ; Pandey, Abhijeet ; Sommer, Benjamin ; Wankhade, Shrikant ; Podobnik, Barbara ; Fisch, Andreas ; Murthy, Aditya ; Muller, Valerie

Bispecific antibodies (BsAbs) have emerged as a powerful therapeutic modality with the ability to simultaneously engage two distinct targets, enabling novel mechanisms of action that traditional monoclonal antibodies cannot achieve. This dual-targeting capability offers significant advantages in treating complex diseases such as cancer, autoimmune disorders, and infectious diseases by enhancing specificity, improving immune engagement, and reducing resistance mechanisms. The development of BsAbs has been driven by innovations in antibody engineering platforms, including BiTE, TriTAC, CrossMAb, XmAb, Fcab, and κλ-body technologies. These platforms allow the construction of diverse BsAb formats, ranging from compact single-chain variable fragments (scFvs) to full-length IgG-like molecules, each optimized for specific pharmacokinetic and pharmacodynamic profiles. Clinical candidates such as blinatumomab, HPN328, and XmAb14045 demonstrate the therapeutic potential and versatility of BsAbs, several of which have progressed to advanced stages of clinical trials or received regulatory approval. However, BsAb development poses unique challenges, including molecular heterogeneity, complex manufacturing processes, and the need for precise functional characterization. Emerging technologies such as high-resolution mass spectrometry, surface plasmon resonance (SPR), hydrogen‑deuterium exchange (HDX-MS), and AI-assisted modeling are increasingly being adopted to overcome these hurdles. As the field evolves, BsAbs are redefining therapeutic strategies by offering multi-functional approaches within a single molecule. Their ability to orchestrate complex biological interactions with high specificity positions them at the forefront of next-generation biologic. This article explores the technical advancements and clinical milestones that underscore the rising impact of BsAbs in modern medicine.

04 Feb 2026·MOLECULAR CANCER THERAPEUTICS

Preclinical Activity of the DLL3-Targeted T-cell Engager MK-6070 in Neuroendocrine Prostate Cancer

Article

Author: Manzar, Nishat ; Beltran, Himisha ; Balk, Steven P. ; Ku, Sheng-Yu ; Kim, Min Jin ; Garcia, Maria Mica ; Yamada, Yasutaka ; Einstein, David J.

Abstract:

Neuroendocrine prostate cancer (NEPC) is an aggressive variant of prostate cancer with limited therapeutic options. Delta-like ligand 3 (DLL3) is a cell-surface protein and therapeutic target expressed in the vast majority of NEPC tumors. The DLL3-targeted T cell–activating construct MK-6070 (formerly called HPN328) binds to both DLL3 on tumor cells and CD3 on T cells, as well as serum albumin to extend half-life. A phase I/II trial of MK-6070 is currently underway, which includes an NEPC cohort (NCT04471727). In this study, we report the preclinical activity of MK-6070 in prostate cancer models, showing high specificity and antitumor activity in DLL3-expressing NEPC models both in vitro and in vivo, with T-cell activation and tumor infiltration of T cells after treatment. 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.

04 Sep 2024·Molecular cancer therapeutics

HPN328, a Trispecific T Cell–Activating Protein Construct Targeting DLL3-Expressing Solid Tumors

Article

Author: Barath, Manasi ; O’Rear, Jessica ; Yu, Timothy Z. ; Carlin, Kevin ; Aaron, Wade H. ; Hundal, Avneel S. ; Bush, Mabel C. ; Wesche, Holger ; Law, Che-Leung ; Hemmati, Golzar ; Lemon, Bryan D. ; Anand, Banmeet S. ; Santiago, Linda ; Cremin, Michael ; Lin, S.J. ; Molloy, Mary E. ; Valenzuela, Laura B. ; Patnaik, Purbasa ; Yu, Stephen ; Wu, Chi-Heng ; Strobel, Kathryn L. ; Callihan, Evan C. ; Sotelo Rocha, Sony ; Evans, Thomas ; Guerrero, Maria G. ; Lao, Llewelyn ; Laurie, Payton ; Sun, Liping L. ; Austin, Richard J.

Abstract:

Delta-like ligand 3 (DLL3) is expressed in more than 70% of small cell lung cancers (SCLCs) and other neuroendocrine-derived tumor types. SCLC is highly aggressive, and limited therapeutic options lead to poor prognosis for patients. HPN328 is a trispecific T cell–activating construct (TriTAC) consisting of three binding domains: a CD3 binder for T-cell engagement, an albumin binder for half-life extension, and a DLL3 binder for tumor cell engagement. In vitro assays, rodent models, and non-human primates were used to assess the activity of HPN328. HPN328 induces potent dose-dependent killing of DLL3-expressing SCLC cell lines in vitro, concomitant with T-cell activation and cytokine release. In an NCI-H82 xenograft model with established tumors, HPN328 treatment led to T-cell recruitment and anti-tumor activity. In an immunocompetent mouse model expressing a human CD3ε epitope, mice previously treated with HPN328 withstood tumor rechallenge, demonstrating long-term anti-tumor immunity. When repeat doses were administered to cynomolgus monkeys, HPN328 was well tolerated up to 10 mg/kg. Pharmacodynamic changes, such as transient cytokine elevation, were observed, consistent with the expected mechanism of action of T-cell engagers. HPN328 exhibited linear pharmacokinetics in the given dose range with a serum half-life of 78 to 187 hours, supporting weekly or less frequent administration of HPN328 in humans. Preclinical and nonclinical characterization suggests that HPN328 is a highly efficacious, safe, and novel therapeutic candidate. A phase 1/2 clinical trial is currently underway testing safety and efficacy in patients with DLL3-expressing malignancies.

103

News (Medical) associated with Gocatamig

13 Apr 2026

·www.biospace.com

Ifinatamab Deruxtecan Granted Priority Review in the U.S. for Adult Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer who Experienced Disease Progression on or After Platinum-Based Chemotherapy

Based on results from IDeate-Lung01 phase 2 trial, with support from IDeate-PanTumor01 phase 1/2 trial If approved, ifinatamab deruxtecan would be a first-in-class B7-H3 directed DXd antibody drug conjugate for these patients BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) and Merck’s, known as MSD outside of the United States and Canada, (NYSE: MRK) Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd) has been accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck. The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The FDA is also reviewing the BLA under the Real-Time Oncology Review (RTOR) program and Project Orbis, two initiatives of the FDA which are designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is October 10, 2026. The BLA is based on results from the IDeate-Lung01 phase 2 trial, with support from the IDeate-PanTumor01 phase 1/2 trial. Results from the primary analysis of IDeate-Lung01 were presented at the 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25) and published in the Journal of Clinical Oncology . Ifinatamab deruxtecan also was previously granted Breakthrough Therapy Designation by the FDA in August 2025 for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy. “The FDA’s granting of Priority Review for ifinatamab deruxtecan marks a significant milestone in our effort to provide new and innovative treatment options for patients with extensive-stage small cell lung cancer,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “We look forward to continuing to work with the FDA to bring this potential first-in-class B7-H3 directed DXd antibody drug conjugate to patients as quickly as possible.” “Small cell lung cancer remains one of the toughest cancers to treat, with few options if the disease progresses after standard of care treatments,” said Eliav Barr, MD, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. “The FDA’s acceptance of the BLA reinforces the important role that ifinatamab deruxtecan could play in helping to address the needs of patients with extensive-stage small cell lung cancer.” About IDeate-Lung01 IDeate-Lung01 is a global, multicenter, randomized, open-label, two-part phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with ES-SCLC who were previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy. Patients with asymptomatic brain metastases (untreated or previously treated) were eligible to participate. In the first part of the trial (dose optimization), patients were randomized 1:1 to receive ifinatamab deruxtecan (8 or 12 mg/kg) given intravenously once every three weeks. In the second part of the trial (dose expansion), patients received ifinatamab deruxtecan (12 mg/kg) intravenously at the same dosing interval. The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), time to response (TTR), overall survival (OS), pharmacokinetics and safety. Intracranial ORR was assessed by BICR as an exploratory analysis. IDeate-Lung01 enrolled 187 patients in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov . About IDeate-PanTumor01 IDeate-PanTumor01 is a global, multicenter, first-in-human, open-label phase 1/2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists. The phase 1 part of the trial (dose escalation) is assessing the safety and tolerability of increasing doses of ifinatamab deruxtecan to determine the maximum tolerated dose and recommended dose for expansion (RDE). The phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients with squamous non-small cell lung cancer, metastatic castration-resistant prostate cancer or esophageal squamous cell carcinoma. The dose escalation part of the trial is evaluating dose-limiting toxicity and safety. The dose expansion part of the trial is evaluating ORR, DOR, DCR, PFS, OS and safety. Pharmacokinetic endpoints, exploratory biomarker and immunogenicity endpoints also will be assessed. IDeate-PanTumor01 will enroll approximately 250 patients in Asia and North America. For more information about the trial, visit ClinicalTrials.gov . About Small Cell Lung Cancer Approximately 250,000 patients are diagnosed with small cell lung cancer (SCLC) each year globally. 1 There were approximately 27,000 new cases of SCLC in the U.S. in 2025, accounting for about 12% of all lung cancer cases. 2,3 SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate. 4,5 While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment approaches. 6,7,8,9 About B7-H3 B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors that includes PD-1. 10,11 B7-H3 is overexpressed in a wide range of cancer types, including SCLC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target. 12,13,14,15 There are currently no B7-H3 directed medicines approved for the treatment of cancer. About Ifinatamab Deruxtecan Ifinatamab deruxtecan is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Ifinatamab deruxtecan was granted Breakthrough Therapy Designation by the FDA for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy. Ifinatamab deruxtecan has been granted Orphan Drug Designation (ODD) by the U.S. FDA, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of SCLC. Ifinatamab deruxtecan also was granted ODD for the treatment of esophageal cancer by the FDA. About the Ifinatamab Deruxtecan Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan monotherapy and in combination with other cancer medicines across multiple cancers. The program is currently comprised of three phase 3 trials in advanced/metastatic disease, including SCLC ( IDeate-Lung02 ), castration-resistant prostate cancer ( IDeate-Prostate01 ) and esophageal squamous cell carcinoma ( IDeate-Esophageal01 ). About the Daiichi Sankyo and Merck Collaboration Daiichi Sankyo and Merck, known as MSD outside of the United States and Canada, entered into a global collaboration in October 2023 to jointly develop and commercialize ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In  August 2024 , the global co-development and co-commercialization agreement was expanded to include gocatamig (MK-6070/DS3280), which the companies will jointly develop and commercialize worldwide, except in Japan where Merck & Co., Inc., Rahway, N.J., USA will maintain exclusive rights. Merck & Co., Inc., Rahway, N.J., USA will be solely responsible for manufacturing and supply for gocatamig. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU ® and DATROWAY ® , which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc., Rahway, N.J., USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit . Merck’s Focus on Cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 20 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( ). _____________________________ References: Wang Q, et al. Journal of Thoracic Oncology . 2023 Jan;18(1):31-46. National Cancer Institute. SEER Explorer. Cancer Stat Facts: Lung and Bronchus Cancer . Accessed December 2025. U.S. Centers for Disease Control and Prevention. United States Cancer Statistics. Types of Lung Cancer | U.S. Cancer Statistics | CDC . Accessed December 2025. Rudin CM, et al. Nat Rev Dis Primers . 2021;7(1):3. National Cancer Institute. SEER Explorer. Small cell carcinoma of the Lung and Bronchus: 5-year Relative Survival . Accessed January 2026. American Cancer Society. Treatment Choices for Small Cell Lung Cancer, by Stage . Accessed January 2026. Liu SV, et al. J Clin Oncol . 2021;39(6):619-30. Paz-Ares L, et al. ESMO Open . 2022;7(2):100408. von Pawel J, et al. J Clin Oncol . 2014;32:4012-4019. Zhao B, et al. J Hematol Oncol . 2022;15(1):153. Janakiram M, et al. Immunol Rev . 2017;276(1):26-39. Qiu M-j, et al. Front. Oncol . 2021;11:600238. Picarda E, et al. Clin Cancer Res . 2016;22(14):3425-3431. Bendell JC, et al. J Clin Oncol . 2020;39(15 suppl 1). Abstract TPS3646. Kontos F, et al. Clin Cancer Res . 2021;27(5):1227-1235. Contacts Media Contacts: Daiichi Sankyo Global/US: Jennifer Brennan Daiichi Sankyo jennifer.brennan@daiichisankyo.com +1 (908) 900-3183 (mobile) Japan: Daiichi Sankyo Co., Ltd. DS-PR_jp@daiichisankyo.com Investor Relations Contact: DaiichiSankyoIR_jp@daiichisankyo.com Merck Media: Julie Cunningham julie.cunningham@merck.com Michael McArdle michael.mcardle@merck.com Investors: Peter Dannenbaum (732) 594-1579 Steven Graziano (732) 594-1583

Phase 1Phase 2Breakthrough TherapyPriority ReviewClinical Result

25 Mar 2026

·allsci.com

Moonlight Bio prepares potency-enhanced DLL3 CAR-T for first-in-human in SCLC

Moonlight Bio, Inc., a Seattle-based cell therapy company founded in 2023, has registered a Phase I first-in-human clinical trial (NCT07488923) of ML261, an autologous anti-DLL3 CAR T-cell therapy engineered with a CARD11-PIK3R3 fusion transgene, in patients with relapsed or refractory small cell lung cancer and select neuroendocrine carcinomas. The trial, named SPECTRAL-1, is listed as not yet recruiting, with an estimated start date of May 2026 and planned enrollment of 110 participants. ML261 is the first CAR T-cell product to incorporate the CARD11-PIK3R3 potency-enhancement platform in a clinical setting, a technology derived from academic research at Northwestern University and the University of California, published in Nature in February 2024. The Moonlight Bio SCLC program enters a competitive DLL3-targeting landscape but does so with a distinct biological approach that has not previously been tested in humans. SPECTRAL-1 is an open-label, sequential dose-escalation study. The primary endpoint is the incidence of dose-limiting toxicities within a 28-day observation period, while treatment-emergent adverse events, preliminary efficacy, and pharmacokinetics will also be assessed. ML261 is administered as an intravenous infusion of autologous T cells collected via leukapheresis and engineered ex vivo. Eligible participants must have confirmed relapsed or refractory SCLC, gastroenteropancreatic neuroendocrine carcinoma, high-grade neuroendocrine prostate cancer, or extrapulmonary neuroendocrine carcinoma, with documented DLL3 expression, and have received at least one prior line of systemic therapy (excluding prior DLL3 CAR-T). Primary completion is estimated for Q1 2028. The biological rationale for ML261 rests on two elements. First, DLL3 is an inhibitory Notch pathway ligand aberrantly expressed on the surface of neuroendocrine tumor cells — present in approximately 80–90% of SCLC tumors — while largely absent from normal adult tissues. This expression pattern makes it a tumor-selective target. Second, the CARD11-PIK3R3 fusion gene, originally identified as a gain-of-function driver mutation in CD4+ cutaneous T-cell lymphoma by Jaehyuk Choi’s laboratory at Northwestern University, was repurposed by researchers including Kole Roybal at UCSF to enhance CAR T-cell function. The fusion amplifies signaling through the CARD11-BCL10-MALT1 complex, increasing cytokine production, T-cell persistence, and proliferation in preclinical solid tumor models. The modification reduced the CAR T-cell dose required for tumor control and diminished dependence on lymphodepletion preconditioning. Moonlight Bio licensed this technology from its academic originators; both Choi and Roybal serve on the company’s strategic advisory team, alongside Sean Parker of the Parker Institute for Cancer Immunotherapy. ML261 enters a DLL3-targeting field that already includes an approved product. Tarlatamab (Imdelltra, Amgen), a DLL3×CD3 bispecific T-cell engager, received FDA approval for relapsed SCLC and is being studied in Phase 3 trials and in extrapulmonary neuroendocrine carcinomas. HPN328 (Harpoon Therapeutics), a DLL3-targeting tri-specific T-cell engager, is in Phase 1/2 development. Among CAR T approaches, academic-sponsored programs in China — including GC511B and an anti-PD-L1/4-1BB DLL3 CAR T from Sichuan University — are in early-phase testing. ML261 is differentiated by its CARD11-PIK3R3 potency-enhancement platform, which is designed to address the persistent failure of conventional CAR T cells in solid tumors due to T-cell exhaustion and immunosuppressive microenvironments. Whether this translates into clinical benefit over bispecific engagers or unmodified CAR T constructs remains to be determined by SPECTRAL-1 data. Moonlight Bio initiates first-in-human trial of ML261, a potency-enhanced anti-DLL3 CAR T therapy, in relapsed SCLC and neuroendocrine carcinomas. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

ImmunotherapyPhase 1Cell TherapyPhase 3Drug Approval

12 Feb 2026

·www.biospace.com

Merck Advances Treatment of Bladder and Kidney Cancers with New Data at 2026 ASCO GU Cancers Symposium

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 All three studies will be featured in the official ASCO GU Press Program RAHWAY, N.J.--(BUSINESS WIRE)-- $MRK #MRK --Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that data across multiple genitourinary cancers from several approved and investigational medicines will be presented at the 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium from Feb. 26-28. These data, including three studies that will be featured in the symposium’s press program, underscore Merck’s commitment to advancing research across its broad portfolio to improve patient outcomes. “We’re excited to share new results from our portfolio and pipeline for more patients with certain types of bladder and kidney cancers, with new data in muscle invasive bladder cancer and earlier stages of renal cell carcinoma,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “The results we’re presenting at ASCO GU underscore our leadership across the genitourinary cancer landscape and our commitment to advance standards of care for these patients.” Data presentations will feature new findings from Merck’s broad portfolio of cancer medicines, including key data for KEYTRUDA ® (pembrolizumab), WELIREG ® (belzutifan) and LENVIMA ® (lenvatinib), in collaboration with Eisai, as well as new results for the investigational antibody-drug conjugate (ADC) from Merck’s innovative pipeline: sacituzumab tirumotecan (sac-TMT), a TROP2-directed ADC being developed in collaboration with Kelun-Biotech. Key data from Merck’s portfolio and pipeline to be presented at the 2026 ASCO GU Cancers Symposium: First-time data from the Phase 3 KEYNOTE-B15/EV-304 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus Padcev ® (enfortumab vedotin-ejfv) as neoadjuvant and adjuvant treatment (before and after surgery) for patients with muscle-invasive bladder cancer who are eligible for cisplatin (abstract #LBA630, Oral abstract session B: Urothelial carcinoma), which will be featured in the official ASCO GU Press Program. 1 Results from the first interim analysis of the Phase 3 LITESPARK-022 trial evaluating KEYTRUDA in combination with WELIREG, Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as a treatment for patients with clear cell renal cell carcinoma (RCC) following nephrectomy (abstract #LBA418, Oral abstract session C: Renal cell cancer and testicular cancer), which will be featured in the official ASCO GU Press Program. First presentation of data from the Phase 3 LITESPARK-011 trial evaluating WELIREG plus LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, as a treatment for patients with advanced RCC whose disease progressed on or after treatment with anti-PD-1/L1 therapy (abstract #LBA417, Oral abstract session C: Renal cell cancer and testicular cancer), which will be featured in the official ASCO GU Press Program. 2 First-time data presentation for the Phase 2 MK-2870-002 study evaluating sac-TMT plus KEYTRUDA for patients with advanced urothelial carcinoma (abstract #744, Poster session B: Prostate cancer and urothelial carcinoma). 3 Details on abstracts listed above and additional key abstracts for Merck Bladder cancer Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: Randomized, open-label, Phase 3 KEYNOTE-B15 study. M. D. Galsky. 1 Abstract #LBA630, Oral abstract session B: Urothelial carcinoma 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. X. Bian. 3 Abstract #744, Poster session B: Prostate cancer and urothelial carcinoma Pathological outcomes and disease-free survival (DFS) in KEYNOTE-905: Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible. To be determined. 1 Abstract #638, Rapid oral abstract session B: Urothelial carcinoma KEYMAKER-U04 substudy 04B: First-line (1L) enfortumab vedotin (EV) plus pembrolizumab (pembro)-based immune checkpoint inhibitor (ICI) combinations for advanced urothelial cancer (UC). A. Peer. 1 Abstract #634, Rapid oral abstract session B: Urothelial carcinoma SWOG 2427: Single arm Phase II study of bladder preservation with immunoradiotherapy after a clinically meaningful response to neoadjuvant therapy in patients with muscle invasive bladder cancer (BRIGHT). L. K. Ballas. 4 Abstract #TPS913, Trials in progress poster session B: Urothelial carcinoma Kidney cancer Adjuvant pembrolizumab plus belzutifan versus pembrolizumab for clear cell renal cell carcinoma (ccRCC): The randomized Phase 3 LITESPARK-022 study. T. K. Choueiri. Abstract #LBA418, Oral abstract session C: Renal cell cancer and testicular cancer Belzutifan (bel) plus lenvatinib (lenva) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti-PD-(L)1 therapy: Open-label Phase 3 LITESPARK-011 study. R. J. Motzer. 2 Abstract #LBA417, Oral abstract session C: Renal cell cancer and testicular cancer Ascending dose escalation of belzutifan plus palbociclib for previously treated advanced clear cell renal cell carcinoma (ccRCC): Phase 1/2 LITESPARK-024 study Part 1. D. F. McDermott. 5 Abstract #423, Rapid oral abstract session C: Renal cell cancer and testicular cancer KEYMAKER-U03 substudy 03B: Novel investigative regimens for previously treated advanced clear cell renal cell carcinoma (ccRCC). L. Albiges. Abstract #505, Poster session C: Renal cell cancer; adrenal, penile, testicular and urethral cancers Phase 2 trial of belzutifan in participants from China and Japan with von Hippel-Lindau disease-associated tumors: Results from LITESPARK-015 cohort B1. G. Naik. Abstract #494, Poster session C: Renal cell cancer; adrenal, penile, testicular and urethral cancers Prostate cancer Efficacy and safety of the DLL3 T-cell engager gocatamig in participants (pts) with neuroendocrine prostate cancer (NEPC) and other neuroendocrine neoplasms (NEN). H. Beltran. 6 Abstract #182, Poster session A: Prostate cancer 1 In collaboration with Astellas/Pfizer 2 In collaboration with Eisai 3 Led by Kelun-Biotech, conducted in China 4 Sponsored by National Cancer Institute 5 In collaboration with Pfizer 6 In collaboration with Daiichi Sankyo About Merck’s early-stage cancer clinical program Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is evaluating our portfolio of medicines and pipeline candidates in earlier disease states, with more than 30 ongoing registrational studies across multiple types of cancer. About Merck’s research in genitourinary cancers Merck is advancing research aimed at helping transform the treatment landscape and broaden options for people with genitourinary (GU) cancers, including bladder, kidney and prostate cancers. Globally, GU cancers account for an estimated 2.6 million new cancer diagnoses each year, equaling over 1 in 8 of all cancer incidences. Through a robust clinical development program with more than 50 clinical trials evaluating more than 22,000 patients around the world, Merck is investigating the potential of several portfolio medicines and pipeline assets, leveraging multiple novel combination strategies, across various stages of disease, to help address unmet needs in GU cancers. About KEYTRUDA ® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Important Safety Information for KEYTRUDA Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients. Hepatotoxicity and Immune-Mediated Hepatitis KEYTRUDA as a Single Agent KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients. KEYTRUDA With Axitinib KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event. Immune-Mediated Endocrinopathies Adrenal Insufficiency KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypophysitis KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Thyroid Disorders KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients. Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism. Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Immune-Mediated Nephritis With Renal Dysfunction KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients. Immune-Mediated Dermatologic Adverse Reactions KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti–PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. Contacts Media Contacts: Julie Cunningham (617) 519-6264 John Infanti (609) 500-4714 Investor Contacts: Peter Dannenbaum (732) 594-1579 Steven Graziano (732) 594-1583 Read full story here

Phase 3Clinical ResultPhase 2ASCO

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Indication	Highest Phase	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	Phase 2	United States	Merck Sharp & Dohme LLC	27 Feb 2025
Extensive stage Small Cell Lung Cancer	Phase 2	China	Merck Sharp & Dohme LLC	27 Feb 2025
Extensive stage Small Cell Lung Cancer	Phase 2	Japan	Merck Sharp & Dohme LLC	27 Feb 2025
Extensive stage Small Cell Lung Cancer	Phase 2	Argentina	Merck Sharp & Dohme LLC	27 Feb 2025
Extensive stage Small Cell Lung Cancer	Phase 2	Australia	Merck Sharp & Dohme LLC	27 Feb 2025
Extensive stage Small Cell Lung Cancer	Phase 2	Chile	Merck Sharp & Dohme LLC	27 Feb 2025
Extensive stage Small Cell Lung Cancer	Phase 2	Israel	Merck Sharp & Dohme LLC	27 Feb 2025
Extensive stage Small Cell Lung Cancer	Phase 2	South Korea	Merck Sharp & Dohme LLC	27 Feb 2025
Extensive stage Small Cell Lung Cancer	Phase 2	Spain	Merck Sharp & Dohme LLC	27 Feb 2025
Extensive stage Small Cell Lung Cancer	Phase 2	Taiwan Province	Merck Sharp & Dohme LLC	27 Feb 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04471727 (MK-6070-001, ASCO_GU2026)	Phase 1/2	Neuroendocrine Tumors \| Prostate Neuroendocrine Carcinoma DLL3 expression	57	Gocatamig (NEPC)	iatufnvjpf(jqqyitlnas) = mprpcjngza dkjvtvbafc (lljtdjuscs, 3 - 38) View more	Positive	26 Feb 2026
				Gocatamig (other NEN)	iatufnvjpf(jqqyitlnas) = zwomglpgqw dkjvtvbafc (lljtdjuscs, 30 - 63) View more
NCT06780137 (6070-002, ESMO2025)	Phase 1/2	Extensive stage Small Cell Lung Cancer Second line DLL3 \| B7-H3	33	Gocatamig + Ifinatamab deruxtecan	nxrmhrinuq(vfrnwtkztz) = ioricqlkgi wqhzgmuvyk (ptouwddcqp )	Positive	17 Oct 2025
				Ifinatamab deruxtecan	bydgzvnymr(wdpcxsilae) = tgwlwwkogm wxstlngmao (eepeazwuoh )
NCT04471727 (6070-001, ESMO2025)	Phase 1/2	Small Cell Lung Cancer \| Neuroendocrine Tumors DLL3-expressing	73	Gocatamig 12 mg QW	wirugpwowr(cscbpwiccj) = hoanyancjs kysxuhthgn (segbtirgfl ) View more	Positive	17 Oct 2025
				Gocatamig (received at least one 24-mg target dose)	pqhblhxxep(khbxbuistu) = etbabghtpv abkdjyiyxa (acbigncbuo, 36 - 72) View more
NCT04471727 (656, SITC2024)	Phase 1/2	DLL3 positive Small Cell Lung Cancer DLL3 expression	109	MK-6070 monotherapy	jsgoutedor(hksrkxtrkb) = no maximum tolerated target dose has been reached pavmvkqaqv (hxjilfsstb )	Positive	05 Nov 2024
NCT04471727 (WCLC2024) Manual	Phase 1/2	Small Cell Lung Cancer DLL3 expression	49	MK-6070 IV weekly	gouqtqadxn(twrdppxedi) = szgdrehsxz kvaommnihq (bytaojhhqa, 19 - 58) View more	Positive	09 Sep 2024
				MK-6070 Q2W	gouqtqadxn(twrdppxedi) = frbuftlxuf kvaommnihq (bytaojhhqa, 5 - 42) View more
NCT04471727 (ASCO2024) Manual	Phase 1/2	Small Cell Lung Cancer \| Neuroendocrine Tumors DLL3 Expression	86	HPN328 1 mg priming dose with 12 or 24 mg target doses QW or Q2W	gzztdjzpdl(ntjmxsteok) = Treatment-related AEs in ≥ 10% of pts included CRS (59% [30% G1, 26% G2, 3% G3+]), dysgeusia (36%), fatigue (34%), diarrhea (19%), nausea (17%), vomiting (14%), decreased appetite and decreased neutrophil count (13% each), and weight decreased (11%). exgrrcjayl (jvudnpjdhe ) View more	Positive	24 May 2024
NCT04471727 (ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	Small Cell Lung Cancer \| Neuroendocrine Tumors	44	HPN328	enzqesemag(bdrsllufxp) = in >10% of pts included CRS (46%), fatigue (23%), dysgeusia (21%), nausea (18%), pyrexia and vomiting (16% each), and anemia (11%). jmspvedejg (pftsnzmlfn ) View more	Positive	23 Oct 2023
NCT04471727 (ASCO2022) Manual	Phase 1/2	Small Cell Lung Cancer \| Neuroendocrine Tumors	16	HPN 328	ojjeyuglfr(qfonlulsxb) = dsedyfadvv sviqltuafv (mfpdyuonch ) View more	Positive	02 Jun 2022

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