This study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310. The purpose of Part 2 is to see how obrixtamig and ZL-1310 is tolerated when given with another medicine called a checkpoint inhibitor. Another purpose is to check whether the study treatment can stop the cancer from growing and keep it stable. Obrixtamig and ZL-1310 are being developed to help the immune system fight cancer.
In Part 1, participants get obrixtamig and ZL-1310. In Part 2, participants get obrixtamig and ZL-1310 with a checkpoint inhibitor. Part 2 is only open to people with advanced small cell lung cancer. All study treatments are given as infusions into a vein.
The study does not have a fixed duration. Participants can receive study treatment for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.

Start Date28 Oct 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

[+1]

NCT07843940

/ RecruitingPhase 1/2

A Phase Ib/II, Open-label, Safety and Tolerability Trial of Intravenous Obrixtamig in Combination With Pumitamig and Standard of Care (Carboplatin, Etoposide) in Patients With Extensive-stage Small Cell Lung Carcinoma

This study is open to adults with extensive-stage small cell lung cancer. The purpose of this study is to find out how well people with this type of cancer tolerate taking study medicines called obrixtamig and pumitamig. Another purpose is to check whether the combination study treatment can make tumours shrink. Obrixtamig and pumitamig are being developed to help the immune system fight cancer.
Participants are put into 2 groups. One group gets obrixtamig and pumitamig. The other group gets obrixtamig and pumitamig with standard chemotherapy (carboplatin and etoposide). All study treatments are given as infusions into a vein.
This study does not have a fixed duration. Participants can receive obrixtamig and pumitamig for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.

Start Date01 Oct 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

[+1]

NCT07561645

/ Not yet recruitingPhase 2

A Phase II, Single-arm Trial on the Addition of the DLL3xCD3 Bispecific T-cell Engager Obrixtamig (BI 764532) to Standard-of-care Platinum-based First-line Treatment of Advanced Large-cell Neuroendocrine Carcinoma of the Lung

This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.

Start Date01 Sep 2026

Sponsor / Collaborator

Dresden University of Technology

100 Clinical Results associated with Obrixtamig

100 Translational Medicine associated with Obrixtamig

100 Patents (Medical) associated with Obrixtamig

Literatures (Medical) associated with Obrixtamig

01 May 2026·Respiratory Investigation

Emerging therapies and translational advances in small cell lung cancer: Overcoming resistance

Review

Author: Nishii, Yuya ; Yoshida, Tatsuya ; Yamaguchi, Yoh

Small-cell lung cancer (SCLC) is an aggressive neuroendocrine malignancy characterized by rapid proliferation, early metastasis, and poor prognosis. Although initially sensitive to chemotherapy and radiotherapy, most patients relapse rapidly, and long-term survival remains uncommon. Platinum-etoposide has long been the standard first-line therapy, and the recent incorporation of immune checkpoint inhibitors (ICIs) such as atezolizumab (IMpower133) and durvalumab (CASPIAN, ADRIATIC) has modestly improved survival, including a new role for durvalumab as a consolidation therapy in limited-stage SCLC. However, this benefit is restricted to a minority of patients, underscoring the need for novel therapeutic strategies. Emerging approaches include DLL3-directed bispecific T-cell engagers (BiTEs), such as tarlatamab and obrixtamig, which have shown promising efficacy in relapsed disease, and next-generation antibody-drug conjugates (ADCs) targeting DLL3, B7-H3, TROP2, and SEZ6. Additional modalities under investigation include chimeric antigen receptor (CAR) T-cell therapy and radioligand therapy (RLT), which aim to overcome the immunosuppressive tumor microenvironment and resistance to conventional treatments. Future therapeutic efforts will require biomarker-driven strategies that incorporate molecular subtyping (ASCL1, NEUROD1, POU2F3, and YAP1) and immune profiling to facilitate precise treatment selection. Combining ICIs, BiTEs, ADCs, and cellular or radioligand therapies in rational, evidence-based regimens represents a promising avenue to improve outcomes in this historically intractable disease.

20 Sep 2025·JOURNAL OF CLINICAL ONCOLOGY

Phase I Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-Like T-Cell Engager Obrixtamig (BI 764532) in Patients With Delta-Like Ligand 3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas

Article

Author: Arriola, Edurne ; Villaruz, Liza C. ; Fang, Xiaoyan ; Kuboki, Yasutoshi ; Morgensztern, Daniel ; Alese, Olatunji B. ; Bertulis, Julia ; Sanmamed, Miguel F. ; Wermke, Martin ; Studeny, Matus ; Gambardella, Valentina ; Felip, Enriqueta ; Wolf, Jürgen ; Sayehli, Cyrus M. ; Bouzaggou, Mohamed

PURPOSE:

We report phase I results for obrixtamig (BI 764532), a delta-like ligand 3 (DLL3)/CD3 IgG-like T-cell engager, in patients with previously treated DLL3-positive small cell lung cancer (SCLC), extrapulmonary neuroendocrine carcinomas (epNECs), or large cell neuroendocrine carcinoma of the lung (LCNEC-L).

METHODS:

Patients received escalating intravenous obrixtamig doses using four regimens: a fixed dose once every 3 weeks (A); a fixed dose once weekly (B1); a step-up dose once weekly for two weeks and target dose once weekly (B2); and a step-up dose once weekly for 3 weeks, target dose once weekly for 3 weeks, and once every 3 weeks thereafter (B3). The primary objective was maximum tolerated dose (MTD). Secondary objectives included safety, pharmacokinetics, and tumor response (RECIST v1.1).

RESULTS:

As of February 21, 2024, 168 patients received obrixtamig, 72% received ≥2 lines of previous anticancer therapy, and 51% received previous anti–PD-1/PD-L1 therapy. Seven dose-limiting toxicities occurred during MTD evaluation (Regimen A, n = 1; Regimen B2, n = 6). MTD was not reached. The most common treatment-related adverse event was cytokine release syndrome (any grade: 57%; grade ≥3: 3%); most cases occurred early and were reversible. Across all doses, regimens, and tumor types, the overall response rate (ORR) was 23% (95% CI, 17.4% to 30.2%), the median duration of response (DoR) was 8.5 months (95% CI, 6.2 to not reached), and the 6-month DoR rate was 70% (95% CI, 53% to 88%). All patients in Regimens B2/B3 received the minimum effective dose (≥90 μg/kg once weekly or once every 3 weeks), achieving an ORR of 28% (95% CI, 20.7% to 35.9%). With Regimens B2/B3, ORRs were 21% (95% CI, 12.9% to 33.1%), 27% (95% CI, 17.4% to 39.6%), and 70% (95% CI, 39.7% to 89.2%) for SCLC, epNECs, and LCNEC-L, respectively.

CONCLUSION:

The demonstrated tolerability and efficacy of obrixtamig regimens, administered as step-up followed by target doses of 90-1,080 μg/kg (once weekly or once every 3 weeks), in patients with heavily pretreated DLL3-positive tumors support further exploration in SCLC, epNEC, and LCNEC-L.

01 Aug 2022·Future oncology (London, England)

Phase I trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas

Article

Author: Owonikoko, Taofeek K ; Hamed, Zohra Oum’ ; Studeny, Matus ; Wermke, Martin ; Felip, Enriqueta ; Gambardella, Valentina ; Kuboki, Yasutoshi ; Liu, Meiruo ; Morgensztern, Daniel

Poorly differentiated neuroendocrine carcinomas such as small-cell lung cancer (SCLC) have poor survival and high relapse rates. DLL3 is found on these carcinomas and has become a target of increasing interest in recent years. The bispecific DLL3/CD3 T-cell engager BI 764532 has been shown to induce complete tumor regression in a human T cell-engrafted mouse model. Here, we describe the study design of a first-in-human, phase I, multicenter, open-label, non-randomized, dose-escalation study in patients with SCLC or other DLL3-positive neuroendocrine carcinomas. The study will determine the maximum tolerated dose and evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of BI 764532 monotherapy.

News (Medical) associated with Obrixtamig

23 Oct 2026

·www.biospace.com

Zai Lab’s Zocilurtatug Pelitecan (Zoci, Formerly ZL-1310) Demonstrates High Response Rates, Encouraging Durability and Well-Tolerated Safety Profile in First-Line Extensive-Stage Small Cell Lung Cancer

At the recommended Phase 3 dose (RP3D) of 1.6 mg/kg, zoci plus atezolizumab achieved a confirmed objective response rate of 81.8% (27/33) and an estimated 6-month progression-free survival rate of 81.9% (n=33) in 1L ES-SCLC Among patients with at least six-months follow-up (n=15) treated at 1.6 mg/kg zoci plus atezolizumab, median progression-free survival and median duration of response were not yet reached after a median follow-up of 10 months Zoci plus atezolizumab therapy was well-tolerated; Grade > 3 AEs related to zoci occurred in 9.1% (3/33) of patients treated at 1.6mg/kg Global, randomized Phase 3 study in 1L ES-SCLC expected to initiate by year-end 2026 Investor conference call and webcast to discuss data being presented at ESMO 2026 and zoci clinical trial plans scheduled today, October 23 at 8:00 a.m. ET / 8:00 p.m. HKT SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovation-driven, global biopharma company, today shared the first data from a global Phase 1b clinical trial evaluating zocilurtatug pelitecan (zoci, formerly ZL-1310) in combination with atezolizumab with and without carboplatin as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). The data will be presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain. “Despite advances in treatment, extensive-stage small-cell lung cancer remains a devastating disease, with many patients experiencing disease progression within approximately five months of initiating standard first-line treatment,” said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. “The high confirmed response rate, encouraging durability, and well-tolerated safety pro are seeing with a standard chemotherapy-free regimen are particularly compelling. We believe zoci’s combination of efficacy and safety positions it to become an ADC backbone of choice in small-cell lung cancer, including in combination with immunotherapies. We are preparing to initiate a global Phase 3 trial of zoci and an Immuno-Oncology (IO) regimen and continue to evaluate the potential of combinations with T-cell engagers and IO.” Zoci 1.6 mg/kg plus atezolizumab (n=33) Results, as of the September 2026 data cut-off to be shared at ESMO show that among patients who received the zoci 1.6 mg/kg and atezolizumab doublet every three weeks (n=33): Patients achieved a confirmed objective response rate (ORR) of 81.8% (95% CI: 64.5–93.0) by investigator assessment. The six-month progression-free survival (PFS) rate was 81.9%. Among patients with at least six-months follow-up (n=15) treated at 1.6 mg/kg zoci plus atezolizumab: Responses were highly durable, with median progression-free survival (mPFS) not yet reached after a median follow-up of 10 months, indicating the majority of patients continue to benefit from treatment. Ten of these 15 patients (66.7%) remained free from disease progression or death at data cut-off, with median duration of response (mDOR) for these 15 patients also not yet reached. Zoci plus atezolizumab demonstrated a favorable safety pro a chemo plus IO regimen by indirect comparison. The doublet did not have dose-limiting toxicities observed during dose escalation. The most common treatment-emergent adverse events (TEAEs) related to zoci at 1.6 mg/kg and of all grades (≥20%) were anemia (48.5%), nausea (36.4%), leukopenia (30.3%), decreased appetite, ALT increase, neutropenia (27.3% each), and lymphopenia (21.2%). The majority of AEs were Grade 1 or 2 and non-serious. At the 1.6 mg/kg dose, Grade ≥3 AEs related to zoci occurred in 3/33 (9.1%) patients, there were no treatment-related discontinuations and only one Grade 1 interstitial lung disease (ILD) / pneumonitis. Zoci plus atezolizumab and carboplatin (n=13; three dose levels) Patients in the trial who received the triplet regimen of zoci in combination with atezolizumab and carboplatin as first-line therapy (n=13) also demonstrated a high ORR (92.3%), with an mPFS of 8.4 months (95% CI: 3.7-NA) and mDOR of 7.7 months (2.6, NA) across all dose levels, which included two dose levels of zoci and two dose levels of carboplatin. Compared with the doublet regimen, the triplet therapy was associated with more frequent Grade ≥3 TEAEs, including study-drug related hematological AEs, and a higher rate of dose interruptions. Grade ≥3 TEAEs for the doublet 1.6 mg/kg dose was 21.2%; Grade ≥3 TEAEs for the triplet across all doses was 76.9%. Today’s standard of care for first-line SCLC is a checkpoint inhibitor plus chemotherapy, which delivers a 60-70% response rate, an mPFS of about 5 months, and is associated with Grade > 3 treatment-related AEs around 60%. A regimen such as zoci, combined with an IO or other novel agents that are free of platinum chemotherapy, could offer better tolerability, allow longer treatment duration compared to the typical four to six cycles of platinum-based induction chemotherapy, and improve control of brain metastases. “The zoci and atezolizumab doublet demonstrated substantial early antitumor activity with high, durable responses and a favorable safety profile, which are very encouraging results for patients with extensive-stage small cell lung cancer,” said Pedro Rocha, M.D., Ph.D., study investigator and medical oncologist at Vall d’Hebron University Hospital in Barcelona, Spain. “Importantly, this platinum-free regimen may allow patients to stay on treatment longer with potentially fewer side effects. These results support further exploration of zoci in combination regimens. I look forward to seeing how this pro as the clinical program advances.” Based on the data from this trial, Zai Lab is preparing to initiate a global Phase 3 randomized study evaluating a zoci and IO regimen in first-line treatment of ES-SCLC. ESMO 2026 zoci poster details: Title: ZL 1310 (DLL3 ADC) plus Atezolizumab ± Carboplatin in extensive-stage small cell lung cancer: Part 1b/1c results from Study ZL 1310-001 Session Title: SCLC Date/Time: October 26, 2026; 12:00-12:45 CEST Location: Poster Area – Hall 5 Poster Board Number: 3817P Abstract Number: 1569 Details regarding the webcast and conference call are as follows: Date/Time: Friday, October 23, 2026, at 5:00 a.m. PT / 8:00 a.m. ET / 8:00 p.m. HKT Presenters: Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab; Pedro Rocha, M.D., Ph.D., MSc, Medical Oncology Department, Vall d’Hebron University Hospital Registration available at: Webcast presentation (preferred): Dial-in: A replay will be available shortly after the call on the Company’s website at . About Zocilurtatug Pelitecan (zoci, formerly ZL-1310) Zoci is a novel, potential first-in-class antibody-drug conjugate (ADC), that targets Delta-like ligand 3 (DLL3), a validated therapeutic target that is overexpressed in SCLC, making it a promising target for the treatment of these aggressive, lethal and difficult-to-treat malignancies. The DLL3 antigen is generally associated with poor clinical outcomes. Zoci remains on track to become Zai Lab’s first global oncology launch. In addition to the Phase 3 combination trial in first-line extensive stage SCLC that Zai Lab is advancing toward initiation, the Company is also conducting the Phase 3 DLLEVATE study evaluating zoci in previously treated ES-SCLC vs. physician’s choice of chemotherapy, and a Phase 1/2 trial in neuroendocrine carcinomas (NECs) and other DLL3-positive solid tumors. Data presented at AACR 2026 from an ongoing Zai Lab Phase 1 trial of adults with previously-treated ES-SCLC demonstrate that zoci achieved meaningful intracranial efficacy, including in patients who have not received radiotherapy to the brain. Earlier this year, Zai Lab entered into a global clinical trial collaboration with Amgen to evaluate zoci in combination with Amgen’s IMDELLTRA® (tarlatamab-dlle), a DLL3/CD3 bispecific T-cell engager (TCE), for ES-SCLC, and a clinical collaboration with Boehringer Ingelheim to evaluate zoci in combination with obrixtamig, a DLL3/CD3 bispecific TCE, for SCLC and other NECs. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit or follow us at or . Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing zoci, and the potential treatment of extensive-stage small cell lung cancer (ES-SCLC). All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and on the SEC’s website at . Contacts For more information, please contact: Investor Relations: Christine Chiou / Cyan Liu +1 (917) 886-6929 / +86 195 3130 8895 christine.chiou1@zailaboratory.com / cyan.liu@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com

Clinical ResultPhase 3Phase 1AACRADC

22 Oct 2026

·www.fiercebiotech.com

ESMO: Boehringer builds case for late-phase rival to Amgen’s Imdelltra

Boehringer Ingelheim has shared data on its DLL3xCD3 T-cell engager, providing pointers to the prospects of a would-be rival to Amgen’s Imdelltra that entered phase 3 this year. Germany’s Boehringer arrived at the European Society for Medical Oncology Congress in Madrid with updated data from DAREON-9. The phase 1b small cell lung cancer trial is testing the tolerability of Boehringer’s bispecific, obrixtamig, in combination with the chemotherapy drug topotecan. An earlier cut of the data showed that 84% of patients had grade 3 or worse adverse events related to topotecan. At ESMO, Boehringer allayed concerns that patients unable to receive a full dose of topotecan will have significantly worse outcomes. The company split the cohort of 60 second-line SCLC patients based on whether they received a relative dose intensity (RDI) of above or below 80%. RDI is the percentage of the planned chemotherapy dose that a patient actually received. The confirmed overall response rate (ORR) was 72% in the RDI-low subpopulation, compared to 61% in RDI-high patients. Median progression-free survival (PFS) was the same—5.6 months—in both groups. Only the median duration of response favored the RDI-high group, with its 7.3 months numerically beating the 5.6 months of the RDI-low subgroup. Amgen tested its DLL3xCD3 T-cell engager, Imdelltra, as a monotherapy in second-line and later SCLC. In its phase 2 DeLLphi-301 trial. The biotech linked Imdelltra to a 40% ORR and a median PFS of 4.9 months. Amgen’s phase 3 trial, DeLLphi-304, included a chemotherapy control arm that achieved a median PFS of 3.2 months. Boehringer is targeting a different patient population in its phase 3 program. In April, investigators began enrolling first-line SCLC patients to receive obrixtamig in combination with a standard-of-care cocktail featuring Roche’s Tecentriq. The study is one of two phase 3 obrixtamig trials that Boehringer has started this year. The other phase 3 trial, which began in July, is enrolling adults with advanced extrapulmonary neuroendocrine cancer (NEC). Participants are receiving obrixtamig in combination with a standard chemotherapy doublet. Boehringer shared data on obrixtamig in DLL3-expressing NECs at ESMO. The drugmaker generated the data in the phase 1b DAREON-7 study. Boehringer reported a median PFS of 7.7 months in NEC patients who received obrixtamig plus standard-of-care platinum-based chemotherapy as a first-line treatment. Median PFS was 9.5 months in a subgroup of patients with high DLL3 expression. The DLL3-low cohort had a median PFS of 7.6 months. The ORR in the DLL3-high and -low subgroups was 87.5% and 65.0%, respectively. Amgen ran a phase 1 trial in neuroendocrine prostate cancer from 2021 to 2024. However, the biotech’s slate of active Imdelltra clinical trials focuses on SCLC. Ongoing clinical development in NECs is limited to investigator-initiated trials.

Clinical ResultPhase 3Phase 1Phase 2ADC

08 Sep 2026

·www.fiercepharma.com

Amgen’s DLL3-targeted Imdelltra scores overall survival win in first-line small cell lung cancer

In further validation of the DLL3 target pioneered by Amgen’s Imdelltra, the T-cell engager has delivered an overall survival win in first-line small cell lung cancer (SCLC). Imdelltra, used together with AstraZeneca’s Imfinzi, led to a “statistically significant and clinically meaningful” improvement in overall survival (OS) compared with Imfinzi alone as a first-line maintenance treatment for extensive stage SCLC, Amgen announced Tuesday. The Imdelltra regimen also showed superior progression-free survival and objective response rate, with safety consistent with the drugs’ known profiles, the company added. The results from the phase 3 DeLLphi-305 trial could move Imdelltra into earlier treatment of SCLC, which is an aggressive form of lung cancer. SCLC affects about 13% to 15% of more than 2.6 million lung cancer cases diagnosed globally each year, but only about 40% of patients reach second-line therapy, where Imdelltra is currently approved, according to data cited by Amgen. The California company said it will share the data with regulatory authorities and with the medical community at an upcoming conference. In a Sept. 8 statement, Amgen’s R&D chief, Jay Bradner, M.D., said the DeLLphi-305 trial suggests Imdelltra “will further revolutionize the standard for survival earlier in the treatment journey and meaningfully shift the treatment paradigm” for ES-SCLC patients. Despite clinical advances in ES-SCLC, “substantial improvements in survival are rare, underscoring the importance of these findings,” Bradner added. Detailed results will help industry watchers appraise Imdelltra’s commercial opportunity. Recently, Jazz Pharmaceuticals’ Zepzelca improved patients’ OS by 27% when added to Roche’s Tecentriq, also in the first-line maintenance setting of ES-SCLC. Patients who took Zepzelca and Tecentriq lived a median of 13.2 months, versus 10.6 months in the Tecentriq arm. Based on that phase 3 win from the IMforte trial, the Zepzelca-Tecentriq combo secured an FDA approval about a year ago. By comparison, Imdelltra plus PD-L1 inhibitor treatment had shown an unprecedented 25.3-month median OS as first-line maintenance for ES-SCLC in the phase 1b DeLLphi-303 trial. In both IMforte and DeLLphi-305, patients had responded to initial treatment with a PD-L1 inhibitor plus chemotherapy, but had not progressed. Imdelltra got an initial accelerated approval for previously treated SCLC in 2024 and became the first DLL3-targeted agent to reach the market. The go-ahead was converted into a full nod last year based on another OS win from the phase 3 DeLLphi-304 trial. Success of Imdelltra has drummed up interest in DLL3 as a target. In 2024, Merck & Co. bought Harpoon Therapeutics for $680 million and has been working to combine the deal’s DLL3 bispecific, MK-6070, with Daiichi Sankyo-partnered B7-H3-directed antibody-drug conjugate, I-DXd , in SCLC. Roche obtained a DLL3 ADC from Innovent Biologics, and AbbVie got itself a DLL3-directed trispecific T-cell binder from China’s Zejing Biopharmaceutical at the beginning of 2026. Novartis has partnered with Legend Biotech on DLL3 autologous CAR-T, and Boehringer Ingelheim recently advanced its DLL3 T-cell engager, obrixtamig, into phase 3 testing for SCLC.

Clinical ResultPhase 3ADCAcquisitionDrug Approval

100 Deals associated with Obrixtamig

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Neuroendocrine Carcinoma	Phase 3	United States	Boehringer Ingelheim GmbH	10 Jul 2026
Advanced Neuroendocrine Carcinoma	Phase 3	China	Boehringer Ingelheim GmbH	10 Jul 2026
Advanced Neuroendocrine Carcinoma	Phase 3	Japan	Boehringer Ingelheim GmbH	10 Jul 2026
Advanced Neuroendocrine Carcinoma	Phase 3	Argentina	Boehringer Ingelheim GmbH	10 Jul 2026
Advanced Neuroendocrine Carcinoma	Phase 3	Australia	Boehringer Ingelheim GmbH	10 Jul 2026
Advanced Neuroendocrine Carcinoma	Phase 3	Austria	Boehringer Ingelheim GmbH	10 Jul 2026
Advanced Neuroendocrine Carcinoma	Phase 3	Belgium	Boehringer Ingelheim GmbH	10 Jul 2026
Advanced Neuroendocrine Carcinoma	Phase 3	Brazil	Boehringer Ingelheim GmbH	10 Jul 2026
Advanced Neuroendocrine Carcinoma	Phase 3	Canada	Boehringer Ingelheim GmbH	10 Jul 2026
Advanced Neuroendocrine Carcinoma	Phase 3	Chile	Boehringer Ingelheim GmbH	10 Jul 2026

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07544654 (DAREON-NEC-1, ESMO2026)	Phase 3	Neuroendocrine Carcinoma First line DLL3-positive	390	Obrixtamig + carboplatin/etoposide	menastxbev(ldeijieirz) = wgyoyglhlq uruyzlwdbu (lrpjkessqf )	Positive	23 Oct 2026
				Carboplatin/etoposide	menastxbev(ebjcdjeatv) = mzsshlmycm qbgavpfybi (awqqvplauf )
NCT06132113 (DAREON-7, ESMO2026)	Phase 1	Neuroendocrine Carcinoma First line DLL3 expression status	44	Obrixtamig + SoC	keqsyikrwz(pytchpbxau) = kvaqumjptm hkutmehoca (xsgelrzkku ) View more	Positive	23 Oct 2026
				Obrixtamig + SoC (DLL3high)	keqsyikrwz(pytchpbxau) = mfgimqqfrt hkutmehoca (xsgelrzkku ) View more
NCT05990738 (DAREON-9, ESMO2026)	Phase 1	Extensive stage Small Cell Lung Cancer DLL3 \| CD3	60	Obrixtamig + Topotecan	yvrryirfuy(wulraxjkul) = ≤14 days of neutropenia onset (any/G ≥3): 20/5% qogcxyacqf (awnukwfxkz ) View more	Positive	23 Oct 2026
				ObrixtamigTopotecang + Topotecan (Topotecan RDI <80%)
NCT04429087 (CSCO2026)	Phase 1	Neuroendocrine neoplasm of lung DLL3	282	Obrixtamig	vmqiamzjqq(grkjsydith) = jxzlklsrxy ocswxqfehi (ikyskvvpmo ) View more	Positive	11 Sep 2026
				Obrixtamig (DLL3高表达)	vmqiamzjqq(grkjsydith) = sekorwfugb ocswxqfehi (ikyskvvpmo ) View more
NCT06132113 (DAREON-7, CSCO2026)	Phase 1	Neuroendocrine Carcinoma First line DLL3	43	Obrixtamig + Carboplatin/ cisplatin + Etoposide	cfunglcngi(pwfghpvzmt) = mljhugcmjw wsevxitzwj (tusecjcovm ) View more	Positive	11 Sep 2026
NCT06077500 (DAREON-8, CSCO2026)	Phase 1	Extensive stage Small Cell Lung Cancer First line	46	Obrixtamig + standard of care (SoC, carboplatin + etoposide + atezolizumab) induction, followed by obrixtamig + atezolizumab maintenance	fwojflkzzz(beiqzatiki) = ieslaowaoh pvfbbuoxgb (osbvpppxog, 58 - 84) View more	Positive	11 Sep 2026
				Obrixtamig + standard of care (SoC, carboplatin + etoposide + atezolizumab) induction, followed by obrixtamig + atezolizumab maintenance (60 mg)	fwojflkzzz(beiqzatiki) = ejmxgsetbt pvfbbuoxgb (osbvpppxog, 58 - 88)
NCT04429087 (ASCO2026)	Phase 1	Advanced Neuroendocrine Carcinoma DLL3-positive	93	Obrixtamig (DLL3-high)	uubipprjvt(kjdjuoxcms) = The most common treatment-related AEs (TRAEs) were hematological (any grade: 45.2%; grade ≥3: 19.4%) and gastrointestinal (any grade: 35.4%; grade ≥3: 10.2%). Grade ≥3 TRAEs led to dose reductions in 11.8% and interruptions in 29.6% of cycles. There were no treatment-related deaths. qkqxddfmaw (zshwibtwsj )	Positive	29 May 2026
				Obrixtamig (DLL3-low)
NCT05882058 (DAREON-5, AACR2026)	Phase 2	DLL3 high-expressing	50	Obrixtamig (DLL3 high-expressing + extrapulmonary neuroendocrine carcinoma)	jbedrcuwpt(lnemprynkw) = hchnuakcha avaqdttxwh (gtkxgsopmu ) View more	Positive	21 Apr 2026
NCT05882058 (DAREON-5, ASCO_GI2026 \| ASCO_GU2026)	Phase 2	Neuroendocrine Carcinoma DLL3-high expressing	51	Obrixtamig	fbbfjzacgb(ocjlzpaino) = pncrwzadsz vsaxseeudr (zduxmylptg )	Positive	08 Jan 2026
NCT05990738 (DAREON-9, ESMO2025)	Phase 1	Advanced Lung Small Cell Carcinoma	25	Obrixtamig + Topotecan	xveemvhspq(iyncvmtcoa) = ddscdrakdp bhfqjxriaf (gbkrvtkpkm, 70 - 96) View more	Positive	17 Oct 2025

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