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Zai Lab Presents New Data Demonstrating Zocilurtatug Pelitecan (Zoci) Induces Rapid and Robust Intracranial Responses in Small Cell Lung Cancer with Brain Metastases and Promising Activity in Other Neuroendocrine CarcinomasApril 17, 2026 3:01 PM
Business Wire

Zoci, a potential first-in-class DLL3-targeting antibody drug conjugate, showed a 53.7% confirmed intracranial objective response rate (iORR) for small cell lung cancer (SCLC) with brain metastases; at 1.6 mg/kg dose, the confirmed iORR was 62.5% (10/16), including complete responses

Encouraging activity was observed in extrapulmonary neuroendocrine carcinomas (NECs), with a 38.2% confirmed objective response rate

Global Phase 3 trial ongoing in second-line-plus SCLC; first-line SCLC and neuroendocrine carcinoma programs advancing toward registrational phase in 2026

Investor conference call and webcast to discuss data being presented at AACR Annual Meeting 2026 and clinical trial plans scheduled for Monday, April 20, at 5:30 a.m. PT / 8:30 a.m. ET / 8:30 p.m. HKT

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced clinical data indicating zocilurtatug pelitecan (zoci, formerly ZL-1310), a DLL3-targeting antibody-drug conjugate (ADC), provides rapid and robust intracranial responses in patients with previously treated extensive stage small cell lung cancer (ES-SCLC) and brain metastases as measured by independent assessment using modified Response Assessment in Neuro-Oncology for Brain Metastases (mRANO-BM) criteria, as well as promising data in patients with other neuroendocrine carcinomas (NECs). These findings, as well as preclinical data evaluating ZL-6201 (LRRC15 ADC) and ZL-1222 (PD-1/IL-12), will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego.

Results from an ongoing, global Phase 1 trial (NCT06179069) demonstrate that treatment with zoci results in significant intracranial lesion regression and reduced tumor size among patients with ES-SCLC whose cancer metastasized to the brain, a population with poor survival and limited effective treatment options.

“For patients with extensive stage small cell lung cancer who develop brain metastases, a frequent and clinically significant driver of disease progression, the prognosis is poor and existing therapeutic options delays systemic therapy and offer limited efficacy,” said Luis Paz-Ares, M.D. Ph.D., senior investigator and Chair of the Medical Oncology Department at the Hospital Universitario 12 de Octubre and Head of the Lung Cancer Unit at the CNIO (Spanish National Cancer Research Center) in Madrid, Spain. “The data from these ongoing zoci clinical trials are encouraging, demonstrating not only rapid and robust responses across multiple dose cohorts, but also notable activity in patients regardless of prior intracranial radiotherapy. These findings suggest the potential for zoci to provide a novel treatment option for difficult-to-treat cancers with limited therapies, addressing significant unmet needs in this patient population."

Additionally, researchers will share preliminary data from a Phase 1b/2 clinical trial of zoci (NCT06885281) in patients with extrapulmonary neuroendocrine carcinomas (epNECs) and other selected solid tumors. These data indicate that zoci has antitumor activity, with an objective response rate (ORR) of 38.2% in an additional patient population with aggressive malignancies, poor prognosis, and limited treatment options. Notably, there are no approved standard therapies in previously treated epNEC and no targeted therapies in this disease.

Abstract title: Intracranial activity of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer and baseline brain metastasis: Analysis of a Phase 1 trial

Patients with ES-SCLC and baseline brain metastasis were enrolled in a clinical trial with zoci monotherapy administered intravenously every three weeks at varying doses (0.8, 1.2, 1.6, 2, 2.4, or 2.8 mg/kg). The data presented had a median follow-up of 7.9 months. Systemic efficacy was measured with RECIST v1.1 by investigator assessment and intracranial efficacy was assessed with mRANO-BM by blinded independent radiologic committee review.

Among 136 treated patients, 36% had baseline brain metastases.

In all patients with brain metastases and the opportunity to finish at least two post-baseline scans, intracranial objective response rate (iORR) among patients who received zoci was 53.7% (22/41), including seven complete responses. At the 1.6 mg/kg dose, confirmed iORR was 62.5% (10/16), including four complete responses. Fourteen patients were censored after a median follow-up of 9.2 months.

Intracranial tumor reductions occurred across multiple dose levels and responses were observed in both patients with (50%, 13/26) and without (60%, 9/15) prior radiotherapy.

Zoci demonstrated a manageable safety profile, with most treatment emergent adverse events (TEAEs) reported as low grade with minimal discontinuation. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 19.9% (27/136) of the overall population and in 16.4% (9/55) of patients who received 1.6mg/kg. The most common grade ≥3 TRAEs included: neutropenia (9.6%, 13/136), anemia (8.8%, 12/136), thrombocytopenia (3.7%, 5/136), lymphopenia (2.9%, 4/136), and leukopenia (2.9%, 4/136). No intracranial metastasis complications or treatment-related neurologic serious adverse events were reported.

Abstract title: Preliminary results from the Phase 1b/2, open-label, multi-center study of ZL-1310, a DLL3-targeted ADC, in patients with neuroendocrine carcinomas and other selected solid tumors

In another important analysis for patients with high unmet need due to aggressive malignancies with limited treatment options, preliminary results from the multicenter Phase 1b/2 study of zoci in patients with NECs demonstrated clinically meaningful responses. Researchers administered zoci intravenously at 1.6 mg/kg every three weeks until disease progression or unacceptable toxicity, with a data cutoff date of February 18, 2026, representing a median follow up of 3.7 months in the Phase 1b portion of the study. Tumor response was evaluated by investigator-assessed RECIST v1.1 with additional assessments for some NECs.

Of the 46 patients who were pretreated with prior platinum-based chemotherapy and other prior systemic therapies, treatment with zoci decreased tumor sizes within multiple epNEC subtypes with confirmed responses in pretreated patients.

Among response evaluable patients, the overall response rate was 38.2% (13/34) across study cohorts and the overall disease control rate was 55.9% (19/34).

Zoci demonstrated a manageable safety profile; neutrophil count decrease (5.2%, 3/58) was the only Grade ≥3 TRAE occurring in more than one patient.

These findings highlight the potential for zoci across a broad range of DLL3-expressing NECs.

“The zoci data that we will present at AACR, alongside our ZL-6201 and ZL-1222 preclinical data, highlight the breadth, diversity and potential of our global oncology pipeline,” said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. “The rapid progression of zoci into pivotal development, with three registration-enabling studies planned by the end of this year, is a prime example of our strategy to deliver our first global oncology launch. This accelerated progress is made possible by our unique integrated U.S.-China infrastructure, which allows us to evolve drug discovery into life-changing medicines with a focus on speed and quality."

Data from two additional Zai Lab internally developed investigational oncology therapies will also be presented at AACR. Researchers will share promising findings from preclinical studies of ZL-6201, a leucine-rich repeat-containing protein 15 (LRRC15) targeting ADC for the treatment of sarcoma and epithelial tumors with LRRC15 expressing cancer-associated fibroblasts; and, ZL-1222, a potential next generation anti-PD-1 and interleukin-12 (IL-12) signaling attenuated mutein agonist immunocytokine for cancer immunotherapy.

Details regarding the webcast and conference call are as follows:

Date/Time: Monday, April 20, 2026, at 5:30 a.m. PT / 8:30 a.m. ET / 8:30 p.m. HKT

Registration available at:

Webcast presentation (preferred): https://edge.media-server.com/mmc/p/8v9n78fj/

Dial-in: https://register-conf.media-server.com/register/BId10f18579c7947b29fda2857a99f26b9

Presenters: Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab; Luis Paz-Ares, M.D. Ph.D., Chair of the Medical Oncology Department at the Hospital Universitario 12 de Octubre and Head of the Lung Cancer Unit at the CNIO (Spanish National Cancer Research Center), Madrid, Spain; Rohit Thummalapalli, M.D., gastrointestinal medical oncologist, Memorial Sloan Kettering Cancer Center

About Zocilurtatug Pelitecan (Zoci, ZL-1310)

Zoci targets DLL3, a validated therapeutic target for small cell lung cancer that is overexpressed in many neuroendocrine tumors and is generally associated with poor clinical outcomes. Zoci is on track to potentially become Zai Lab’s first global oncology launch, with plans for three registration-enabling studies across 2L+ SCLC, 1L SCLC and extrapulmonary neuroendocrine carcinomas by the end of 2026. Its potential best-in-class safety profile, coupled with compelling systemic and intracranial efficacy, supports its potential role as a new standard of care in previously treated extensive stage small cell lung cancer, as well as a backbone DLL3-targeting antibody drug conjugate in first line combination regimens, including those that reduce the burdens of chemotherapy, such as check point inhibitors and T-cell engagers.

About ZL-6201

Zai Lab is evaluating ZL-6201 as a potential first-in-class LRRC15-targeting antibody drug conjugate for the treatment of multiple solid tumors. LRRC15 is a type I transmembrane protein and an attractive target for cancer therapy because it is overexpressed in various mesenchymal tumors, such as sarcoma, glioblastoma and melanoma, as well as in cancer associated fibroblasts across many other tumor types.

About ZL-1222

Zai Lab is evaluating ZL-1222 as a potential next-generation bispecific immunocytokine comprising anti-PD-1 and attenuated IL-12 for cancer immunotherapy across multiple indications, with potential to combine potent antitumor activity with improved systemic safety. Previously, interleukin-12 therapies have shown potential benefit across a range of cancer types; however, narrow therapeutic windows and toxicity concerns have limited the utility of this therapeutic class.

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 www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global.

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 zocilurtatug pelitecan (zoci), ZL-6201 and ZL-1222, the potential benefits of zoci, ZL-6201 and ZL-1222, and the potential treatment of small cell lung cancer, neuroendocrine carcinomas, and solid tumors. 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 www.zailaboratory.com and on the SEC’s website at www.SEC.gov.

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Original: Zai Lab Presents New Data Demonstrating Zocilurtatug Pelitecan (Zoci) Induces Rapid and Robust Intracranial Responses in Small Cell Lung Cancer with Brain Metastases and Promising Activity in Other Neuroendocrine Carcinomas

$207B Market Shift: The Race for Fast Track Approval in OncologyFebruary 5, 2026 9:35 AM
PR Newswire (Canada)

Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, Feb. 5, 2026 /CNW/ -- USANewsGroup.com News Commentary – The FDA isn't just approving drugs; they are completely reshaping the landscape. In 2025 alone, the agency issued over 50 oncology approvals[1], but the real story is the aggressive pivot toward targeted therapies for high-unmet-need solid tumors. That momentum has accelerated in 2026 with a sudden flurry of expedited designations[2] for RAS inhibitors and rare malignancies. This regulatory velocity creates a clear validation framework, positioning Oncolytics Biotech Inc. (NASDAQ: ONCY), Relay Therapeutics (NASDAQ: RLAY), MAIA Biotechnology (NYSE-A: MAIA), Zai Lab (NASDAQ: ZLAB), and Arrivent BioPharma (NASDAQ: AVBP) directly at the convergence of urgent unmet medical need and commercial opportunity.

This is projected to be a $326.82 billion market opportunity by 2031[3], fueled by a robust expansion in antibody-drug conjugates and biomarker-driven regimens. But in biotech, time is the ultimate currency. Data confirms that Breakthrough Therapy Designation can slash late-stage development time by 30%[4]. For companies demonstrating clinical efficacy in difficult-to-treat populations, these expedited pathways are no longer just a bonus: they are the primary value drivers for scalable growth.Oncolytics Biotech Inc. (NASDAQ: ONCY) just received Fast Track Designation from the FDA for its cancer treatment pelareorep in second-line microsatellite-stable metastatic colorectal cancer patients with KRAS mutations. This regulatory status can enable more frequent FDA meetings and faster potential approval timelines, and it only gets granted when a treatment shows meaningful advantages over existing options.The designation is based on clinical data showing pelareorep combined with standard chemotherapy achieved a 33% response rate in KRAS-mutant microsatellite-stable (MSS) colorectal cancer patients, compared to roughly 10% with chemotherapy alone. More importantly, patients lived a median 27 months versus 11.2 months with standard treatment, and their cancer stayed stable for 16.6 months compared to 5.7 months. Response rate measures the percentage of patients whose tumors shrink significantly or disappear.This matters because KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat cancer populations, with limited options after first-line treatment fails and minimal benefit from immune therapies. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually."Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate," said Jared Kelly, CEO of Oncolytics Biotech.The company plans to launch a controlled study comparing standard-of-care versus standard-of-care plus pelareorep, with the first clinical site activating in March and interim data expected by year-end 2026. This marks pelareorep's second Fast Track Designation in gastrointestinal cancers, following an earlier designation for pancreatic cancer.Oncolytics is building out its leadership team to handle these expanding programs. The company recently announced two critical hires: John McAdory as Executive Vice President of Strategy and Operations, who ran late-stage clinical trials at CG Oncology, and Yujun Wu as Vice President, Head of Biostatistics, who led statistics at Morphic Therapeutic through its sale to Eli Lilly. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024.Pelareorep is also showing strong results in anal cancer, where third-line patients achieved a 29% response rate with responses lasting around 17 months in a setting with no FDA-approved treatments. In second-line anal cancer patients, the 30% response rate more than doubled the benchmark for available immunotherapy.CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include:Relay Therapeutics (NASDAQ: RLAY) has announced FDA Breakthrough Therapy designation for zovegalisib in combination with fulvestrant for PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancer following progression on CDK4/6 inhibitor treatment. The designation was supported by clinical data from the ReDiscover trial with 600mg BID fasted and 400mg BID fed doses showing comparable exposures across all PIK3CA mutations."This Breakthrough Therapy designation underscores the FDA's recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence we have demonstrated to date," said Don Bergstrom, President of R&D at Relay Therapeutics.Initial Phase 1/2 data of zovegalisib plus fulvestrant at the 400mg BID fed Phase 3 dose in CDK4/6-experienced patients will be presented at the ESMO Targeted Anticancer Therapies Congress on March 16. Relay Therapeutics developed zovegalisib as the first known allosteric, pan-mutant, and isoform-selective PI3Ka inhibitor designed to overcome limitations of traditional orthosteric inhibitors.MAIA Biotechnology (NYSE-A: MAIA) has advanced its ateganosine program as the first and only telomere-targeting anticancer agent in clinical development, securing FDA Fast Track designation for the treatment of non-small cell lung cancer (NSCLC). The company initiated a pivotal Phase 3 trial in third-line NSCLC and expanded its Phase 2 trial with a $2.3 million NIH grant while establishing agreements with Roche and BeOne Medicines for checkpoint inhibitor combinations."MAIA's strong clinical execution in 2025 delivered exceptional efficacy data for ateganosine sequenced with a checkpoint inhibitor, including disease control, response rates, and survival data well above standard of care benchmarks," said Vlad Vitoc, CEO of MAIA Biotechnology. "Our statistical assessments of ateganosine imply a high probability of technical success in our concurrent Phase 3 and Phase 2 trials."The company targets potential commercial approval within 18 to 24 months, with 2026 milestones including interim Phase 3 efficacy data and Phase 2 trial conclusion. MAIA Biotechnology raised approximately $17.6 million in 2025 with board participation in nearly all transactions.Zai Lab (NASDAQ: ZLAB) announced that China's National Medical Products Administration has approved the supplemental New Drug Application for AUGTYRO™ (repotrectinib) for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The approval marks the second indication in China for the next-generation tyrosine kinase inhibitor, which demonstrated robust and durable efficacy and manageable safety in the pivotal Phase 1/2 TRIDENT-1 study."We are pleased with the NMPA's approval of AUGTYRO for patients with NTRK-positive solid tumors," said Rafael Amado, President, Head of Global Research and Development at Zai Lab. "This approval marks its second indication in China, addressing a critical treatment gap, as no prior therapy has been approved across both TKI-naïve and TKI-pretreated patients within this population."The approval represents the first in China to span both TRK TKI-naïve and TRK TKI-pretreated patients across solid tumors. Zai Lab has an exclusive license agreement with Bristol Myers Squibb to develop and commercialize AUGTYRO in Greater China, following their acquisition of Turning Point Therapeutics.Arrivent BioPharma (NASDAQ: AVBP) announced first patient dosing in the global pivotal Phase 3 ALPACCA trial evaluating firmonertinib for first-line treatment of EGFR PACC mutant non-small cell lung cancer. The oral, once-daily, brain-penetrant therapy demonstrated 16-month median progression-free survival and 68% confirmed objective response rate in the FURTHER trial, supporting selection of the 240 mg dose for pivotal development."Initiation of our pivotal Phase 3 ALPACCA trial marks an important milestone in our strategy to expand the global reach of firmonertinib," said Bing Yao, CEO of Arrivent BioPharma. "With a well-characterized safety profile and broad clinical systemic and central nervous system activity in patients, we believe firmonertinib is strongly positioned to bring meaningful innovation to NSCLC patients with PACC mutations."The ALPACCA study is designed to support potential global registration with endpoints for accelerated and full approval pathways. Arrivent BioPharma estimates the global ex-China annual incidence of NSCLC patients with EGFR PACC mutations to be approximately 42,000 patients and the US annual incidence to be approximately 6,200 patients.Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.aacr.org/blog/2026/01/06/fda-approvals-in-oncology-october-december-2025/https://www.targetedonc.com/view/fda-oncology-update-january-2026-new-horizons-in-precision-medicinehttps://www.mordorintelligence.com/industry-reports/solid-tumor-therapeutics-markethttps://pmc.ncbi.nlm.nih.gov/articles/PMC12758617/Logo : https://mma.prnewswire.com/media/2838876/5764584/USA_News_Group_Logo.jpg

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Original: $207B Market Shift: The Race for Fast Track Approval in Oncology