RegulationBreakthrough Therapy (US), Orphan Drug (US), Conditional marketing approval (CN), Orphan Drug (AU), Priority Review (AU), Accelerated Approval (US), Priority Review (CN), Fast Track (US)

Gene Sequence

Sequence Code 122091L

Source: *****

Sequence Code 4720027H

Source: *****

876

Clinical Trials associated with Atezolizumab

NCT06632327 / Not yet recruitingPhase 3IIT

Perioperative Versus Adjuvant Systemic Therapy in Patients With Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG

This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.

Start Date30 May 2025

Sponsor / Collaborator

Alliance for Clinical Trials in Oncology

[+1]

NCT06294548 / Not yet recruitingPhase 1/2IIT

A Phase Ib/II, Dose Escalation and Dose Expansion Study of Valemetostat Tosylate (DS-3201b) with Atezolizumab and Bevacizumab in Advanced Hepatocellular Carcinoma (HCC)

This is a phase Ib/II, dose escalation and dose expansion study of valemetostat (DS-3201) with atezolizumab and bevacizumab in patients advanced Hepatocellular carcinoma (HCC) who did not receive prior systemic therapy for advanced HCC.

Start Date31 Dec 2024

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT05859217 / Not yet recruitingPhase 2IIT

A Multi-center Phase II Study of Combining Cabozantinib and Atezolizumab as the 1st Line Therapy for PD-L1 Negative Advanced/Metastatic NSCLC (Cabatezo-1)

NSCLC patients with low expression level of PD-L1, esp. those with its level less than 1%, do not derive much benefit from anti-PD-1/L1 therapy (e.g. atezoilzumab). In this study, investigators hypothesize that the combination of cabozantinib (a multi-kinase inhibitor) and atezolizumab will result in better therapeutic value.

Start Date01 Dec 2024

Sponsor / Collaborator

University of Kansas

[+2]

100 Clinical Results associated with Atezolizumab

100 Translational Medicine associated with Atezolizumab

100 Patents (Medical) associated with Atezolizumab

3,324

Literatures (Medical) associated with Atezolizumab

31 Dec 2024·Human vaccines & immunotherapeutics

Exploration of genetic characterization in hyperprogressive disease after immunotherapy retreatment in a patient with LCNEC: A case report

Article

Author: Chen, Jialu ; Yang, Jiayao ; Zhang, Yao ; Shou, Liumei ; Shu, Qijin ; Shao, Tianyu

Immune checkpoint inhibitors (ICIs) have emerged as a promising therapeutic option for large cell neuroendocrine carcinoma (LCNEC). However, various studies have suggested a potential risk of hyperprogressive disease (HPD) in patients receiving ICI, which might be associated with gene alterations. Here, this is the first report on an unknown primary LCNEC patient who had achieved a long-term response from ICI treatment (atezolizumab), but developed HPD after tumor progression due to receiving another ICI agent (serplulimab). The mutation region of FAT4, SMARCA4, CYLD, CTNNB1, and KIT was altered prior to serplulimab treatment compared to before atezolizumab treatment. This case suggested a potential association between these mutated genes and HPD. Patients with the aforementioned genes should caution when selecting ICI treatment. These findings required further confirmation in a larger study cohort.

31 Dec 2024·Cancer biology & therapy

Understanding and overcoming resistance to immunotherapy in genitourinary cancers

Review

Author: Yildirim, Ahmet ; Kalemoglu, Ecem ; Evans, Sean T ; Jani, Yash ; Jansen, Caroline S ; Bilen, Mehmet Asim

The introduction of novel immunotherapies has significantly transformed the treatment landscape of genitourinary (GU) cancers, even becoming the standard of care in some settings. One such type of immunotherapy, immune checkpoint inhibitors (ICIs) like nivolumab, ipilimumab, pembrolizumab, and atezolizumab play a pivotal role by disturbing signaling pathways that limit the immune system's ability to fight tumor cells. Despite the profound impact of these treatments, not all tumors are responsive. Recent research efforts have been focused on understanding how cancer cells manage to evade the immune response and identifying the possible mechanisms behind resistance to immunotherapy. In response, ICIs are being combined with other treatments to reduce resistance and attack cancer cells through multiple cellular pathways. Additionally, novel, targeted strategies are currently being investigated to develop innovative methods of overcoming resistance and treatment failure. This article presents a comprehensive overview of the mechanisms of immunotherapy resistance in GU cancers as currently described in the literature. It explores studies that have identified genetic markers, cytokines, and proteins that may predict resistance or response to immunotherapy. Additionally, we review current efforts to overcome this resistance, which include combination ICIs and sequential therapies, novel insights into the host immune profile, and new targeted therapies. Various approaches that combine immunotherapy with chemotherapy, targeted therapy, vaccines, and radiation have been studied in an effort to more effectively overcome resistance to immunotherapy. While each of these combination therapies has shown some efficacy in clinical trials, a deeper understanding of the immune system's role underscores the potential of novel targeted therapies as a particularly promising area of current research. Currently, several targeted agents are in development, along with the identification of key immune mediators involved in immunotherapy resistance. Further research is necessary to identify predictors of response.

31 Dec 2024·OncoImmunology

ADA/CD26 axis increases intra-tumor PD-1 ⁺ CD28 ⁺ CD8 ⁺ T-cell fitness and affects NSCLC prognosis and response to ICB

Article

Author: Panetta, Mariangela ; D'Andrea, Daniel ; Visca, Paolo ; Sperduti, Isabella ; Nisticò, Paola ; Campo, Giulia ; Frisullo, Giuseppe ; Franzese, Ornella ; Palermo, Belinda ; Taje, Riccardo

Improving cancer immunotherapy efficacy hinges on identifying key T-cell populations critical for tumor control and response to Immune Checkpoint Blockade (ICB). We have recently reported that while the co-expression of PD-1 and CD28 is associated with impaired functionality in peripheral blood, it significantly enhances T-cell fitness in the tumor site of non-small cell lung cancer (NSCLC) patients. To uncover the underlying mechanisms, we explored the role of CD26, a key player in T-cell activation through its interaction with adenosine deaminase (ADA), a crucial intra/extracellular enzyme able to neutralize local adenosine (ADO). We found that an autocrine ADA/CD26 axis enhances CD8⁺PD-1⁺CD28⁺ T-cell function, particularly within an immunosuppressive environment marked by CD39 expression. Then, we interrogated the TCGA and OAK datasets to gain insight into the prognostic/predictive potential of our findings. We identified a signature predicting overall survival (OS) in LUAD patients and response to atezolizumab in advanced LUAD cases. These findings suggest promising avenues for therapeutic intervention targeting the ADA/CD26 axis.

931

News (Medical) associated with Atezolizumab

31 Oct 2024

·www.prnewswire.com

HALOZYME REPORTS THIRD QUARTER 2024 FINANCIAL AND OPERATING RESULTS

Total Revenue Increased 34% YOY to $290 million and Royalty Revenue Increased 36% YOY to $155 million Net Income Increased 67% YOY to $137 million and Adjusted EBITDA Increased 60% YOY to $184 million GAAP Diluted EPS Increased 72% YOY to $1.05 and Non-GAAP Diluted EPS Increased 69% YOY to $1.271 Raised 2024 Financial Guidance Ranges for Total Revenue of $970-$1,020 million, Representing YOY Growth of 17%-23%, Adjusted EBITDA of $595-$625 million, Representing YOY Growth of 40%-47%, and Non-GAAP Diluted EPS of $4.00-$4.20, Representing YOY Growth of 44%-52% SAN DIEGO, Oct. 31, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the third quarter ended September 30, 2024, and provided an update on its recent corporate activities and outlook. "Our robust third quarter financial results highlight the strong execution and accelerating momentum we have across our business and exceeded expectations with total revenue growth of 34% and adjusted EBITDA growth of 60%. Based on the strong performance year-to-date, we have raised our 2024 guidance ranges and expect the advancement of our ENHANZE pipeline and new nominations from two global licensing agreements to support our future growth trajectory," said Dr. Helen Torley, president and chief executive officer of Halozyme. "In the quarter, the announcement of two highly anticipated partner approvals in the U.S. for Roche's TECENTRIQ HYBREZA and OCREVUS ZUNOVO reinforces ENHANZE's track record of 100% phase 3 study and subsequent regulatory success. The new nominations for ENHANZE from argenx, for a total of six targets, and ViiV Healthcare, for an additional undisclosed target, further demonstrate the value of our leading technology for rapid, large volume subcutaneous delivery." Recent Partner Highlights: In October 2024, argenx initiated two studies evaluating VYVGART® Hytrulo with ENHANZE®, a Phase 3 study for adult patients with ocular myasthenia gravis ("oMG") and a Phase 2 study for kidney transplant recipients with antibody mediated rejection ("AMR"). In October 2024, Janssen announced the European Commission approved DARZALEX® SC for the treatment of patients newly diagnosed with multiple myeloma ("NDMM") who are eligible for autologous stem cell transplant ("ASCT") in combination with bortezomib, lenalidomide, and dexamethasone ("D-VRd"). In September 2024, argenx expanded its global collaboration and license agreement nominating four additional targets that provides them exclusive access to our ENHANZE® drug delivery technology for a total of six targets. Under the terms of the expanded exclusive agreement, we received upfront payments of $7.5 million per target nomination for a total of $30.0 million. argenx is obligated to make future milestone payments of up to $85.0 million per new nominated target, subject to achievements of specified development, regulatory and sales-based milestones. We are also entitled to receive royalties on net sales of commercialized products with our ENHANZE® technology. In September 2024, ViiV expanded its global collaboration and license agreement providing ViiV the ability to exclusively access our ENHANZE® drug delivery technology for one additional undisclosed target. In September 2024, Roche announced the U.S. Food and Drug Administration ("FDA") approved OCREVUS ZUNOVO™ with ENHANZE® as a twice a year ten-minute subcutaneous ("SC") injection for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis. In September 2024, Roche announced the FDA approved TECENTRIQ HYBREZA™ with ENHANZE® for all approved adult indications of intravenous ("IV") TECENTRIQ® and was made available to patients, resulting in a $12.0 million milestone payment. In September 2024, Janssen announced the submission of a supplemental Biologic License Application to the FDA for approval of a new indication of DARZALEX FASPRO® in combination with D-VRd for the treatment of adult patients with NDMM for whom ASCT is deferred or who are ineligible for ASCT. In August 2024, the FDA designated Janssen's Biologics License Application ("BLA") priority review status for amivantamab SC in combination with LAZCLUZE™ for currently approved or submitted indication of IV in certain patients with non-small cell lung cancer. In August 2024, Takeda submitted a New Drug Application in Japan seeking approval for TAK-771 with ENHANZE® for treatment of chronic inflammatory demyelinating polyneuropathy/Multifocal Motor Neuropathy. In July 2024, Janssen announced the FDA approved DARZALEX FASPRO® for an additional indication in NDMM patients who are eligible for ASCT in combination with D-VRd. In July 2024, argenx announced the National Medical Products Administration approved the BLA of efgartigimod SC for generalized myasthenia gravis in China. In July 2024, Acumen initiated a Phase 1 study of sabirnetug ("ACU193") co-formulated with ENHANZE® for the treatment of early Alzheimer's disease. Third Quarter 2024 Financial Highlights: Revenue was $290.1 million, compared to $216.0 million in the third quarter of 2023. The 34% year-over-year increase was primarily driven by royalty revenue growth and an increase in milestone revenue. Revenue for the quarter included $155.1 million in royalties, an increase of 36% compared to $114.4 million in the third quarter of 2023, primarily attributable to increases in revenue of DARZALEX® SC and Phesgo®, and the prior year launch of VYVGART® Hytrulo. Cost of sales was $49.4 million, compared to $54.8 million in the third quarter of 2023. The decrease was primarily due to lower device and bulk rHuPH20 sales. Amortization of intangibles expense was $17.8 million, compared to $20.3 million in the third quarter of 2023. The decrease was primarily due to an impairment charge of $2.5 million recognized in the prior year to fully impair the TLANDO® product rights intangible asset. Research and development expense was $18.5 million, compared to $17.3 million in the third quarter of 2023. The increase was primarily due to increased compensation expense. Selling, general and administrative expense was $41.2 million, compared to $35.3 million in the third quarter of 2023. The increase was primarily due to increased compensation expense and consulting and professional service fees. Operating income was $163.2 million, compared to $88.3 million in the third quarter of 2023. Net Income was $137.0 million, compared to $81.8 million in the third quarter of 2023. EBITDA was $183.6 million, compared to $124.6 million in the third quarter of 2023. Adjusted EBITDA was $183.6 million, compared to $114.9 million in the third quarter of 2023.1 GAAP diluted earnings per share was $1.05, compared to $0.61 in the third quarter of 2023. Non-GAAP diluted earnings per share was $1.27, compared to $0.75 in the third quarter of 2023.1 Cash, cash equivalents and marketable securities were $666.3 million on September 30, 2024, compared to $336.0 million on December 31, 2023. The increase was primarily a result of cash generated from operations. Financial Outlook for 2024 The Company is raising its financial guidance for 2024. For the full year 2024, the Company expects: Total revenue of $970 million to $1,020 million, representing growth of 17% to 23% over 2023 total revenue primarily driven by increases in royalty revenue, collaboration revenue and growth in product sales from XYOSTED®. Revenue from royalties of $550 million to $565 million, representing growth of 23% to 26% over 2023. Adjusted EBITDA of $595 million to $625 million, representing growth of 40% to 47% over 2023. Non-GAAP diluted earnings per share of $4.00 to $4.20, representing growth of 44% to 52% over 2023. The Company's earnings per share guidance does not consider the impact of potential future share repurchases. Table 1. 2024 Financial Guidance Webcast and Conference Call Halozyme will host its Quarterly Update Conference Call for the third quarter ended September 30, 2024 today, Thursday, October 31, 2024 at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: . The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched more than 800,000 patient lives in post-marketing use in eight commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and Idorsia Pharmaceuticals. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Note Regarding Use of Non-GAAP Financial Measures In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release and the accompanying tables contain certain non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA and Non-GAAP diluted earnings per share, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time changes in contingent liabilities, inventory adjustments, impairment charges, and certain adjustments to income tax expense. The Company calculates non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items such as changes in contingent liabilities and inventory adjustments. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. The Company considers these non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including the Company's financial outlook for 2024) and expectations for future growth, profitability, total revenue, royalty revenue, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and clinical data, regulatory submissions and product launches, the size and growth prospects of our partners' drug franchises, potential new or expanded collaborations and collaborative targets and regulatory review, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-359-3016 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] Footnotes: 1. Reconciliations between GAAP reported and non-GAAP financial information for actual results are provided at the end. SOURCE Halozyme Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inDrug ApprovalPhase 1Phase 3Financial Statement

30 Oct 2024

·www.globenewswire.com

Xilio Therapeutics to Present Initial Phase 1C Dose Escalation Data for XTX101 (Vilastobart) in Combination with Atezolizumab in a Late-Breaker Poster at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting

WALTHAM, Mass., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced that initial data from its Phase 1C dose escalation of XTX101 (vilastobart) in combination with atezolizumab in patients with advanced solid tumors will be presented in a late-breaker poster session at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting taking place in Houston, Texas, from November 6-10, 2024. Poster presentation details: Title: Phase 1/2 Study of Vilastobart (formerly XTX101), a Tumor-Activated, Fc-enhanced Anti-CTLA-4 Monoclonal Antibody, in Combination with Atezolizumab in Patients with Advanced Solid TumorsAbstract Number: 1455Presentation Date: Friday, Nov. 8, 2024Poster Hall Hours: 9 a.m. – 7 p.m. CSTLocation: George R. Brown Convention Center About Vilastobart (XTX101) and the Phase 1/2 Combination Clinical Trial Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq®) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in a Phase 1C dose escalation in patients with advanced solid tumors and the safety and efficacy of the combination in a Phase 2 clinical trial in patients with microsatellite stable colorectal cancer (MSS CRC), including both patients with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details. About Xilio Therapeutics Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including tumor-activated cytokines, antibodies, bispecifics and immune cell engagers. Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc.). Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans to present clinical data from Phase 1C dose escalation for vilastobart (XTX101) in combination with atezolizumab in patients with advanced solid tumors; and Xilio’s strategy, goals, business plans and focus. The words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, general market conditions; risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of Xilio’s current or future product candidates; Xilio’s ability to obtain and maintain sufficient preclinical and clinical supply of current or future product candidates; Xilio’s advancement of multiple early-stage immune cell engager programs; interim or preliminary preclinical or clinical data or results, which may not be replicated in or predictive of future preclinical or clinical data or results; Xilio’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; results from preclinical studies or clinical trials for Xilio’s product candidates, which may not support further development of such product candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of current or future clinical trials; Xilio’s ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio’s ability to obtain and maintain sufficient cash resources to fund its operations; the impact of international trade policies on Xilio’s business, including U.S. and China trade policies; Xilio’s ability to maintain its clinical trial collaboration with Roche to develop vilastobart in combination with atezolizumab; and Xilio’s ability to maintain its license agreement with Gilead to develop and commercialize XTX301. These and other risks and uncertainties are described in greater detail in the sections entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s filings with the U.S. Securities and Exchange Commission (SEC), including Xilio’s most recent Quarterly Report on Form 10-Q and any other filings that Xilio has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Xilio explicitly disclaims any obligation to update any forward-looking statements. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. TECENTRIQ is a registered trademark of Genentech USA, Inc., a member of the Roche Group. Investor and Media Contact Scott YoungVice President, Investor Relations and Corporate Communicationsinvestors@xiliotx.com

ImmunotherapyPhase 1License out/inPhase 2ASCO

25 Oct 2024

·pipelinereview.com

ZL-1310, an Investigational DLL3-Targeted Antibody-Drug Conjugate (ADC), Demonstrates Promising Objective Response Rates and Safety Profile in Extensive-Stage Small Cell Lung Cancer

— Objective response rate (ORR) of 74% across all tested dose levels of ZL-1310 in patients with recurrent extensive-stage small cell lung cancer (SCLC) — Favorable pharmacokinetics (PK) and safety profile support continued evaluation of ZL-1310 as a single agent and in combination for the treatment of extensive-stage SCLC in recurrent and first-line therapy — Zai Lab to host conference call and webcast to discuss data on October 24, 2024, at 8:30 a.m. ET, following presentation of the data at ENA SHANGHAI, China & CAMBRIDGE, MA, USA I October 24, 2024 I Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today presented data from the ongoing global Phase 1a/1b study of ZL-1310, a potential best-in-class next-generation antibody-drug conjugate (ADC), at the EORTC-NCI-AACR (ENA) Symposium 2024 in Barcelona, Spain, as an oral presentation during the plenary session. ZL-1310 is being tested in patients with previously treated extensive-stage Small Cell Lung Cancer (ES-SCLC) after at least one prior platinum-based chemotherapy regimen. Data shared in the ENA presentation from the ongoing Part 1a monotherapy dose-escalation portion of the study included results from 25 patients across four dose cohorts (0.8 mg/kg, 1.6mg/kg, 2.0 mg/kg, and 2.4 mg/kg). Nineteen patients had evaluable tumor assessments. Key efficacy results include (n=19): Key safety findings include (n=25): All patients had progressed following standard platinum-based chemotherapy, and 92% of patients progressed after immune checkpoint inhibitors. Fifty-six percent had failed at least two prior lines of therapy. Twenty-eight percent of patients had brain metastases at baseline. At the time of the data cutoff, Oct. 10, 2024, 19 patients had at least one post-baseline tumor assessment per RECIST v1.1. DLL3 expression H-scores were assessed in 16 out of 19 patients. “The preliminary results from the ongoing Phase 1 trial of ZL-1310 suggest that this next-generation ADC therapy has the potential to deliver anti-tumor responses in the majority of patients with ES-SCLC, with good tolerability,” said Dr. Alex Spira, a medical oncologist at Virginia Cancer Specialists and NEXT Oncology. “This is particularly encouraging given the urgent need for improved treatment options for these patients. These promising data support continued evaluation of ZL-1310 as a monotherapy in the dose-expansion phase of the ongoing Phase 1 clinical trial and in combination.” “The ZL-1310 clinical program demonstrates Zai Lab’s commitment and ability to pursue novel modalities and validated cancer targets, and to advance innovative global oncology programs,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “Based on the encouraging preliminary findings from our Phase 1 trial, we look forward to continuing development of ZL-1310 and advancing this promising asset across lines of therapy as part of our global oncology pipeline.” About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) 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 in China and worldwide. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global . About ZL-1310 ZL-1310 is a novel ADC in Zai Lab’s growing, global oncology pipeline that targets Delta-like ligand 3 (DLL3), an antigen that is overexpressed in many neuroendocrine tumors, is typically associated with poor clinical outcomes, and is a validated therapeutic target for SCLC. ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody linked to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN ® , which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies, including off-target payload toxicity. The ongoing Phase 1a/1b clinical trial is evaluating ZL-1310 as monotherapy and in combination with atezolizumab, an immune checkpoint inhibitor, for the treatment of extensive-stage SCLC. SOURCE: Zai Lab

Phase 1ADCClinical ResultAACR

100 Deals associated with Atezolizumab

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KEGG	Wiki	ATC	Drug Bank
D10773	Atezolizumab	L01XC32	DB11595

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	EU	Roche Registration GmbH	25 Jul 2024
Advanced Lung Non-Small Cell Carcinoma	IS	Roche Registration GmbH	25 Jul 2024
Advanced Lung Non-Small Cell Carcinoma	LI	Roche Registration GmbH	25 Jul 2024
Advanced Lung Non-Small Cell Carcinoma	NO	Roche Registration GmbH	25 Jul 2024
Breast Cancer	CA	F. Hoffmann-La Roche Ltd.	13 Mar 2024
Alveolar Soft Part Sarcoma	US	Genentech, Inc.	09 Dec 2022
PD-L1 positive Non-Small Cell Lung Cancer	JP	Chugai Pharmaceutical Co., Ltd.	26 May 2022
BRAF V600 mutation-positive Melanoma	US	Genentech, Inc.	30 Jul 2020
Advanced Hepatocellular Carcinoma	EU	Roche Registration GmbH	20 Sep 2017
Advanced Hepatocellular Carcinoma	IS	Roche Registration GmbH	20 Sep 2017
Advanced Hepatocellular Carcinoma	LI	Roche Registration GmbH	20 Sep 2017
Advanced Hepatocellular Carcinoma	NO	Roche Registration GmbH	20 Sep 2017
Advanced Triple-Negative Breast Carcinoma	EU	Roche Registration GmbH	20 Sep 2017
Advanced Triple-Negative Breast Carcinoma	IS	Roche Registration GmbH	20 Sep 2017
Advanced Triple-Negative Breast Carcinoma	LI	Roche Registration GmbH	20 Sep 2017
Advanced Triple-Negative Breast Carcinoma	NO	Roche Registration GmbH	20 Sep 2017
Extensive stage Small Cell Lung Cancer	EU	Roche Registration GmbH	20 Sep 2017
Extensive stage Small Cell Lung Cancer	IS	Roche Registration GmbH	20 Sep 2017
Extensive stage Small Cell Lung Cancer	LI	Roche Registration GmbH	20 Sep 2017
Extensive stage Small Cell Lung Cancer	NO	Roche Registration GmbH	20 Sep 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	NDA/BLA	CN	Provention Bio, Inc.	28 Aug 2024
Bladder Cancer	NDA/BLA	CN	Roche Holding AG	25 Feb 2019
Endometrial Carcinoma	Phase 3	GB	Hoffmann-La Roche Ltd.	25 Oct 2023
Lymphoproliferative Disorders	Phase 3	GB	Hoffmann-La Roche Ltd.	25 Oct 2023
Melanoma	Phase 3	GB	Hoffmann-La Roche Ltd.	25 Oct 2023
Microsatellite instability-high cancer	Phase 3	GB	Hoffmann-La Roche Ltd.	25 Oct 2023
Turcot Syndrome	Phase 3	GB	Hoffmann-La Roche Ltd.	25 Oct 2023
Muscle Invasive Bladder Carcinoma	Phase 3	US	Hoffmann-La Roche, Inc.	03 May 2021
Muscle Invasive Bladder Carcinoma	Phase 3	CN	Hoffmann-La Roche, Inc.	03 May 2021
Muscle Invasive Bladder Carcinoma	Phase 3	JP	Hoffmann-La Roche, Inc.	03 May 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04091217 (ML41186, CTgov)	Phase 2	Mucosal Melanoma	43	Atezolizumab+Bevacizumab	peerveaafe(reekkwrzyv) = suogkpykdv bfzottbnta (nnddksplip, yzrvrzjxdk - keuqvpwxlj) View more	-	24 Oct 2024
NCT04661150 (CTgov)	Phase 2	HER2-positive gastric cancer \| Gastroesophageal junction adenocarcinoma	42	Trastuzumab+Atezolizumab+Oxaliplatin+Capecitabine (Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin))	lwcxjpfyqu(rmyuqqrhgy) = dhreveuyvf hygisiysoa (igbcvaimaj, uiitmdwgpi - akcxukhnyd) View more	-	17 Oct 2024
				Trastuzumab+Oxaliplatin+Capecitabine (Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin))	lwcxjpfyqu(rmyuqqrhgy) = dwglrpzhxl hygisiysoa (igbcvaimaj, wzssvagdmc - nhpgnvuxaf) View more
NCT05091567 (IMforte, Company_Website) Manual	Phase 3	Extensive stage Small Cell Lung Cancer Maintenance	-	Zepzelca + atezolizumab	cafmzjzdqb(bgygogpntp) = statistically significant improvement oedjvqbrmw (miaudteydh ) View more	Positive	16 Oct 2024
				atezolizumab
NCT03526900 (ATEZO-BRAIN, CTgov)	Phase 2	metastatic non-small cell lung cancer \| Non-squamous non-small cell lung cancer \| Brain metastases	40	atezolizumab	xzooztnncv(ncnfrdmyky) = hgafsgnfya uiuxkpwlwh (ievfqazmaa, kwznkawsjl - yozxewohcp) View more	-	09 Oct 2024
NCT05315713 (CTgov)	Phase 1/2	Follicular Lymphoma \| B-cell lymphoma refractory	8	Mosunetuzumab SC+tocilizumab+Tiragolumab	ghuehltrap(plobvqfoln) = pjzzszhcdp csquchkngs (vlijftbzlr, kyjnnmqqkn - wzdjbpcbma) View more	-	04 Oct 2024
NCT03148418 (IMbrella A, Pubmed \| Lung Cancer) Manual	Phase 3	Extensive stage Small Cell Lung Cancer First line	26	Atezolizumab (3-year)	wnspsqyiri(yqsfpxjacp) = grade two hypothyroidism was reported mejrirljjk (jkpelpxcix ) View more	Positive	01 Oct 2024
				Atezolizumab (4-year)
EUCTR2018-000257-45-DE \| NCT05052099 (COMBATBIL, ESMO2024) Manual	Phase 1/2	Advanced biliary tract cancer Second line	35	mFOLFOX6, bevacizumab and atezolizumab	dylubttisp(qqxpcgwvew) = jmlkvwypbf vybwpiezfl (dcwrbmxhok ) View more	Positive	16 Sep 2024
ESMO2024 Manual	Not Applicable	Advanced Hepatocellular Carcinoma First line	7,038	Atezolizumab plus bevacizumab (A+B)	juunnzzotu(divdznnbwt) = bnmepyegtj rndntxikcp (manpftyvwc )	Positive	16 Sep 2024
				Lenvatinib (L)	juunnzzotu(divdznnbwt) = xnicqwmkqc rndntxikcp (manpftyvwc )
NCT03237780 (ESMO2024) Manual	Phase 2	Transitional Cell Carcinoma	33	Eribulin 1.4mg/m2 + Atezolizumab 1200mg/m2	whhqivhkzv(rcayweqgos) = otgcraedau arvjrfeess (fbhsuheeze )	Positive	15 Sep 2024
				Atezolizumab 1200mg/m2	whhqivhkzv(rcayweqgos) = xhfobhzeqe arvjrfeess (fbhsuheeze )
NCT02891824 (ATALANTE \| ENGOT-ov29, ESMO2024) Manual	Phase 3	Platinum-Sensitive Ovarian Carcinoma PD-L1 Positive	614	Atezolizumab+bevacizumab+standard chemotherapy	ombccrrzsq(nndzqoumyk) = jbrvauvqat hagquzdrsi (ohgzebkllz, 23 - 32) View more	Positive	15 Sep 2024
				Placebo+bevacizumab+standard chemotherapy	ombccrrzsq(nndzqoumyk) = obajdjbzch hagquzdrsi (ohgzebkllz, 12 - 23) View more

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