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Last update 02 May 2025

Atezolizumab

Last update 02 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-PDL-1-Genentech/Roche, Atezolizumab (Genetical Recombination), Atezolizumab (genetical recombination) (JAN)

+ [11]

Target

PDL1

Action

inhibitors

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [11]

Active Indication

Advanced Lung Non-Small Cell CarcinomaBreast CancerAlveolar Soft Part Sarcoma+ [168]

Inactive Indication

Acute Myeloid LeukemiaAdenocarcinoma of large intestineAdvanced Bile Duct Carcinoma+ [68]

Originator Organization

Genentech, Inc.Universitair Medisch Centrum Groningen

Active Organization

Roche Registration GmbH

Hoffmann-La Roche Ltd.

Roche China Holding Ltd.

+ [24]

Inactive Organization

Kymab Ltd.

Sanofi

Basilea Pharmaceutica AG

+ [7]

Drug Highest PhaseApproved

First Approval Date

United States (18 May 2016),

Transitional Cell Carcinoma

RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Australia), Priority Review (Australia), Breakthrough Therapy (United States)

Structure/Sequence

Sequence Code 122091L

Source: *****

Sequence Code 4720027H

Source: *****

886

Clinical Trials associated with Atezolizumab

NCT06719973

/ Not yet recruitingPhase 1

An Open Label, Multicenter, Phase 1 Study of the PARP1 Inhibitor M9466 in Combination With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 in combinations with carboplatin in advanced or metastatic refractory solid tumor and with the standard of care (carboplatin, etoposide, and atezolizumab) in treatment-naïve ES-SCLC. The results will support any investigation of carboplatin-based combination anticancer treatments with M9466 as well as the selection of a RP2D of M9466 in combination with carboplatin, etoposide, and atezolizumab for a subsequent ES-SCLC study.

Start Date01 Jul 2025

Sponsor / Collaborator

EMD Serono Research & Development Institute, Inc.

[+1]

NCT06762808

/ Not yet recruitingPhase 2

Phase II Trial of Atezolizumab and Tiragolumab for Patients With Detectable Circulating Tumor DNA After Definitive Treatment for HPV-positive Squamous Cell Carcinoma

A single-arm, phase II study for patients with detectable HPV CtDNA at 12 weeks or longer after completion of definitive therapy for non-metastatic, HPV+ squamous cell carcinoma.

Start Date01 Jun 2025

Sponsor / Collaborator

Genentech, Inc.

NCT06492954

/ RecruitingPhase 1IIT

Phase 1b Trial of Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery in Patients With Pulmonary Recurrence of Osteosarcoma

This study aims to determine the safety and tolerability of combined Atezolizumab, stereotactic body radiation therapy (SBRT), and surgical resection of pulmonary metastases in patients with pulmonary recurrence of osteosarcoma

Start Date01 Jun 2025

Sponsor / Collaborator

Emory University

[+1]

100 Clinical Results associated with Atezolizumab

100 Translational Medicine associated with Atezolizumab

100 Patents (Medical) associated with Atezolizumab

4,480

Literatures (Medical) associated with Atezolizumab

01 Aug 2025·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Split T7 switch-based orthogonal logic operation of fluorogenic RNA aptamer for small molecules detection

Article

Author: Ying, Zhan-Ming ; Zha, Cheng-Jun ; Liu, Hao ; Peng, Jia-Min ; Su, Mei

Recent advances in fluorescent biosensors have stimulated the development of molecular detection. We herein developed a new orthogonal logic operation of fluorescent biosensor with cell-free to accomplish the detection of atrazine (ATZ) and tetrachlorobiphenyls (PCB77). The transcriptional process to generate fluorescent RNA aptamers (Mango) was controlled by molecules-probe bindings, which regulate split T7 promoter transcription switches ON or OFF. Leveraging the rapid in vitro T7 transcription process and high signal-to-background ratio of the Mango-TO1-Biotin complex, this biosensor demonstrates remarkable sensitivity in detecting ATZ and PCB77, with detection limit of 1.56 pM and 10.2 pM. Moreover, the orthogonality of four logic gates (AND, NOR, INHIBT, NIMPLY) were utilized the ATZ and PCB77 as input to construct, which could be activated by utilizing the target probe-driven association. The output of the fluorescence signal was controlled by split/intact fluorescent RNA aptamer (Mango) to achieve flexible and sensitive orthogonal operations. Significantly, the development of two-input logic gates has enabled the modular detection of various small molecules, offering a promising approach to intelligent multi-input analysis. Predictably, with the advantages of sensitivity, flexibility and easy-to-operate, this orthogonal logic gate platform holds immense potential in small molecules detection.

01 Jul 2025·Journal of Clinical and Experimental Hepatology

Predictors of Non-response to Atezolizumab Plus Bevacizumab in Patients With Unresectable Hepatocellular Carcinoma: A Multicentre Real World Study (HCC-AB Study)

Article

Author: Kumar, Guresh ; Chaubal, Alisha ; Arora, Vinod ; Shah, Samir ; Taneja, Sunil ; Choudhury, Ashok ; Kumar, Karan ; Kulkarni, Anand ; Saraswat, Vivek ; Sarin, Shiv K ; Singh, Satender P ; Rathi, Sahaj ; Duseja, Ajay ; Kumar, Ashish ; Nagaraja Rao, P

Background:

The approved immunotherapies for patients with advanced HCC are Atezolizumab and Bevacizumab. However, patients in India present late and healthcare is often available through self-financing. To rationalise the therapy, we conducted a large multicentre study to identify the baseline predictors of non-response to atezolizumab and bevacizumab in advanced unresectable HCC.

Methods:

A dose of atezolizumab 1200 mg and bevacizumab 15 mg/kg was used every 3 weeks from 6 centres across India. A total of 278 patients were screened, and 160 were included in the study. The study included patients with locally advanced metastatic or inoperable hepatocellular carcinoma who were at least 18 years of age and those who received <3 injections were excluded. Fifty-four percent of the included patients were BCLC-B and 46% were BCLC-C. The primary objective was to study overall survival and progression-free survival. While identifying radiological response, objective response rate and adverse effects were secondary objectives.

Results:

The mean age was 61.9 ± 11.7 years, 88% were male, 55% had NASH, 16.3% had hepatitis C, 18.8% had hepatitis B and the rest were alcohol. The mean Model for End-Stage Liver Disease (MELD) is 12.05 ± 4.46, Albumin-Bilirubin Score (ALBI) is -2.04 ± 0.57. Fifty-five percent received first-line and 45% as second/other line therapy. The median overall survival was 10 (95% confidence interval [CI]: 6.1-15.6) months. Progression-free survival was found to be 8 (95%CI: 5.1-14.7) months overall. Eleven (6.9%) achieved complete response, 28 (17.5%) partial response, 33 (20.6%) had stable disease and 88 (55%) had progressive disease. On multivariate analysis, CRP>1 mg/dl (P-0.007), PIVKA-II>400 mAU/mL (P-0.019), AFP>100 ng/ml (P-0.009), presence of diabetes (P-0.042) were associated with non-response to atezolizumab and bevacizumab injection. Fifty-three percent of patients developed any grade of adverse effect, and 20% developed grade 3/4 adverse events amounting to the stoppage of therapy.

Conclusion:

Non-response to atezolizumab and bevacizumab immunotherapy was predicted by CRP>1 mg/dl, PIVKA-II>400mAU/ml, AFP>100 ng/ml and the presence of diabetes.

01 Jul 2025·JOURNAL OF HAZARDOUS MATERIALS

Hemolymph responses of the Thai freshwater mussel Hyriopsis bialata exposed to atrazine

Article

Author: Nuchan, Pattanan ; Kovitvadhi, Uthaiwan ; Sangsawang, Akkarasiri ; Srakaew, Nopparat ; Soimalaitong, Sarocha ; Klaimala, Pakasinee ; Kovitvadhi, Satit

An herbicide atrazine (ATZ) is widely applied in agricultural areas of several countries, including Thailand, and has predisposition to contamination in both terrestrial and aquatic environments, leading to deteriorating effects on non-target organisms. Bivalve hemolymph has gained considerable interest as a useful tool and a potential target for assessing and monitoring aquatic toxicity. The primary goal of this study was to determine time-course responses of biochemical, cellular, and functional traits of the hemolymph from Thai freshwater mussel Hyriopsis bialata exposed to ATZ. The mussels were dosed with environmentally-related (0.02 and 0.2 mg/L) and high (2 mg/L) concentrations of ATZ, while ATZ-untreated mussels served as an experimental control. The hemolymph was collected from the anterior adductor muscles over a 28-day exposure. Analysis of pooled hemolymph from the same treatment groups showed that ATZ had limited effects on the hemolymph parameters of the mussels although temporary inhibition was observed in terms of phagocytic activity and lysosomal membrane stability. Overall, the present study generally indicated tolerance of the hemolymph components upon ATZ exposure to the mussels and could lay groundwork on screening of promising hemolymph biomarkers for real-time, repetitive assessment of ATZ toxicity, thus revealing potential risks of ATZ to aquatic ecosystems.

1,343

News (Medical) associated with Atezolizumab

01 May 2025

·www.prnewswire.com

New Cancer Treatments Spark Hope as Traditional Funding Faces Uncertainty

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 1, 2025 /PRNewswire/ -- Equity Insider News Commentary – Optimism in the field of oncology is on the rise, thanks to the National Institutes of Health's latest annual report, which showed a steady decline in cancer death rates. However, incidence rates and diagnoses are on the rise, meaning the need for better treatment and earlier screening remains. With potential NIH budget reductions under discussion and new projections indicating that drug tariffs could raise treatment costs by over $10,000, the future of innovation may increasingly depend on private-sector initiatives rather than government support. Several oncology innovators have already delivered notable updates in 2025, among them Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Sutro Biopharma, Inc. (NASDAQ: STRO), BriaCell Therapeutics Corp. (NASDAQ: BCTX) (NASDAQ: BCTXW) (TSX: BCT), Tempus AI, Inc. (NASDAQ: TEM) and AstraZeneca PLC (NASDAQ: AZN). In general, cancer incidence is projected to rise significantly, with global cases expected to increase by 20% by 2030 and surge 75% by 2050, according to Statista. In parallel, Precedence Research estimates that the global market for immunotherapy drugs could approach US$1.2 trillion by 2033, supported by a robust 18% compound annual growth rate. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just confirmed that it will present new pancreatic cancer data at the upcoming ASCO Annual Meeting in Chicago, highlighting how pelareorep, its intravenously delivered immunotherapy, activates the immune system to attack tumors in one of the most aggressive and least treatable cancers in oncology. Pelareorep's unique mechanism of action has garnered attention from key opinion leaders in immunotherapy. During a recent event hosted by H.C. Wainwright, Profs. Martine Piccart and Alexander Eggermont emphasized pelareorep's ability to turn so-called "cold" tumors "hot," potentially enhancing the effectiveness of checkpoint inhibitors and other cancer therapies in difficult-to-treat cancers like PDAC and HR+/HER2- metastatic breast cancer. "Pelareorep continues to deliver encouraging results in pancreatic cancer, where few effective treatments exist," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "In multiple studies, pelareorep has repeatedly demonstrated its ability to engage the immune system to attack pancreatic cancer tumors, which has the potential to improve outcomes for patients battling this difficult-to-treat cancer." Oncolytics has repeatedly emphasized that pelareorep works by turning "cold" tumors into "hot" ones, meaning it recruits immune cells into the tumor microenvironment where they're typically absent. The poster presentation, scheduled for June 2, will showcase results from Cohort 1 of the GOBLET study. This cohort focuses on first-line metastatic pancreatic ductal adenocarcinoma (PDAC), where pelareorep is being used in combination with atezolizumab, gemcitabine, and nab-paclitaxel. According to Oncolytics, the data will offer new insights into pelareorep's immune-priming effect and its role in enhancing tumor response in a setting with very limited treatment success historically. As of its last reported quarter, the company held $15.9 million in cash and recently secured a $20 million flexible equity facility with Alumni Capital, allowing it to raise capital on its own terms over a 15-month period and potentially increasing available capital by nearly 45% of the company's valuation at the time of the announcement. With multiple trials advancing and the ASCO data potentially drawing renewed attention, Oncolytics appears to be entering a period of high visibility and optionality at a critical stage in its development. This ASCO presentation follows several recent developments in Oncolytics' gastrointestinal cancer program. Earlier this year, the company reported that its GOBLET Cohort 5 had cleared the safety run-in phase and received approval from Germany's Paul-Ehrlich-Institute and the Data Safety Monitoring Board to continue enrolling patients. Notably, Oncolytics is working with the Pancreatic Cancer Action Network (PanCAN) on this cohort, as they provided a US$5 million grant to fund it. In breast cancer, the company recently completed a randomized Phase 2 trial called BRACELET-1. In this study, patients treated with pelareorep and paclitaxel outperformed those receiving paclitaxel alone, showing a near doubling in progression-free survival. The company has stated that the data support moving ahead with a larger registrational study, expected to begin later this year. If new results mirror those seen in BRACELET-1, Oncolytics may have the foundation to submit for accelerated approval in this indication. "With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO in a recent update. "Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy. We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission." In advanced anal cancer, pelareorep is being tested with atezolizumab in another GOBLET cohort. Among the first 12 patients, four showed partial responses and one had a complete response lasting over 15 months. Based on these early outcomes—stronger than what's typically seen from checkpoint inhibitors alone—the company has expanded the cohort to include an additional 18 patients. With late-stage trials being planned, multiple data readouts on the horizon, and a flexible US$20 million equity facility now in place, the company enters Q2 not just with momentum—but with the financial agility to match it. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Sutro Biopharma, Inc. (NASDAQ: STRO) recently presented encouraging results from its REFRαME-O1 study in platinum-resistant ovarian cancer, showing a 32% overall response rate and 96% disease control rate with its antibody-drug conjugate luveltamab tazevibulin (luvelta). The data showed consistent activity across a broader range of FRα expression levels, including patients typically ineligible for other targeted ADCs. "These data demonstrate the potential for improved patient responses compared to standard chemotherapy in PROC, especially patients whose FRα expression falls within the range of at least 25% to less than 75% 2+, which remains an important unmet medical need," said Dr. Jung Yun Lee, Professor, Gynecologic Oncologist, Yonsei Cancer Center and Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. While Sutro has shifted focus away from internal development of luvelta, the company is actively exploring licensing opportunities to advance the program through external partners. BriaCell Therapeutics Corp. (NASDAQ: BCTX) (NASDAQ: BCTXW) (TSX: BCT) recently reported a confirmed 100% resolution of lung metastasis in a metastatic HR+ breast cancer patient treated with its personalized, off-the-shelf immunotherapy Bria-OTS in a Phase 1/2a study. The response was sustained at four months, with stable disease elsewhere and no new safety concerns reported. "This unprecedented anti-cancer response in the first patient dosed with Bria-OTS is an important milestone for us and provides early validation of BriaCell's personalized immunotherapy approach," said Dr. William V. Williams, President and CEO of BriaCell. Bria-OTS is currently under evaluation as monotherapy in a dose-escalation study for patients with limited treatment options. Tempus AI, Inc. (NASDAQ: TEM) has signed expanded strategic agreements with AstraZeneca PLC (NASDAQ: AZN) and Pathos AI to co-develop a multimodal foundation model in oncology, aiming to accelerate drug discovery and enhance clinical outcomes. "Generative AI and the emergence of large multimodal models is the final catalyst needed to usher in precision medicine in oncology at scale," said Eric Lefkofsky, Founder and CEO of Tempus. "We look forward to working with AstraZeneca and Pathos to apply AI-enabled solutions to advance therapies in an effort to help patients live longer and healthier lives." The model will be built using Tempus' vast repository of de-identified data and shared among the three parties to support their respective therapeutic pipelines. "Cancer drug discovery and clinical development are being transformed by the ability to analyze vast amounts of rich data using artificial intelligence," said Jorge Reis-Filho, Chief AI and Data Scientist, Oncology R&D, AstraZeneca. "We are excited to collaborate with Tempus and Pathos to advance our data and AI-driven R&D strategy through the development of a multimodal oncology foundation model that we believe will accelerate and increase the probability of clinical success across our diverse pipeline." The agreement includes $200 million in data and model development fees and marks a major step forward in Tempus' AI-driven approach to precision medicine. This expansion builds on Tempus' 2021 partnership with AstraZeneca and reflects growing industry momentum around foundation models in cancer care. Source: CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: 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. Equity Insider 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. Logo - SOURCE Equity Insider WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyPhase 2ASCO

01 May 2025

·www.sonnetbio.com

Sonnet Chief Medical Officer, Richard Kenney, M.D., to Present at the 6th Annual Cytokine-Based Drug Development Summit

PRINCETON, N.J., May 01, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing immunotherapeutic drugs targeting the tumor microenvironment (TME), today announced it will present at the 6th Annual Cytokine-Based Drug Development Summit being held May 15-16, 2025 in Boston, MA. Details of the presentation are as follows: Title: Managing Toxicity Caused by The Over Expression of Cytokines to Widen the Therapeutic Window Session: Understanding Toxicity Challenges & Improving Safety Profiles to Widen the Therapeutic Window Speaker: Richard Kenney, M.D., Chief Medical Officer of Sonnet Date and Time: Thursday, May 15, 2025 at 11:15 AM ET As part of the session, Dr. Kenney will discuss: Exploring the strategy behind the introduction of receptor bias to reduce toxicity and improve efficacy; Key strategies for optimizing cytokine potency and mitigating their inherent toxicity while considering the role of the therapeutic index in determining the clinical efficacy and safety of cytokine-based therapies; and Examining whether toxicity is the primary limiting factor in achieving therapeutic benefit and considering alternative factors that may influence the ‘therapeutic window’. For more information, please visit the Summit website here. About Sonnet BioTherapeutics Holdings, Inc. Sonnet is an oncology-focused biotechnology company with a proprietary platform for developing targeted biologic drugs with single or bifunctional action. Known as FHAB (Fully Human Albumin-Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. Sonnet's FHAB was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window for optimizing the safety and efficacy of immune modulating biologic drugs. FHAB platform is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies and vaccines. Sonnet’s lead program, SON-1010, or IL-12-FHAB, is in development for the treatment of solid tumors, certain types of sarcoma, and ovarian cancer. SON-1010 is being evaluated in an ongoing Phase 1/2a study through a Master Clinical Trial and Supply Agreement, along with ancillary Quality and Safety Agreements, with Roche in combination with atezolizumab (Tecentriq®) for the treatment of platinum-resistant ovarian cancer (PROC) (NCT05756907). The Company is also evaluating its second program using this platform, SON-1210, an IL12-FHAB-IL15 for solid tumors, in collaboration with the Sarcoma Oncology Center to commence an investigator-initiated and funded Phase 1/2a study for the treatment of pancreatic cancer. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the outcome of the Company’s clinical trials, the Company's cash runway, the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investor Relations Contact: JTC Team, LLC Jenene Thomas 908-824-0775 SONN@jtcir.com Released May 1, 2025

Immunotherapy

30 Apr 2025

·www.globenewswire.com

Affimed Shows Higher Exposure of AFM24 is Associated with Significantly Higher Response Rates and Progression-Free Survival in Refractory NSCLC Patients at AACR Annual Meeting

An exposure-outcome analysis in 72 patients with refractory non-small cell lung cancer (NSCLC) who received AFM24 at 480 mg weekly demonstrates that higher drug exposure (above median) leads to improved objective response rate (33.3% vs 5.6%) and longer progression free survival (PFS) (7.3 mo. vs 2.9 mo.) without a negative impact on safety These findings will be incorporated in future AFM24 trials to further improve efficacy outcomes of patients treated with AFM24 April 29, 2025 -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today presented findings on an exposure-outcome analysis of its innate cell engager (ICE®) AFM24, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) in a poster session at the 2025 Annual Meeting of the American Association for Cancer Research (AACR). The analysis is based on post-hoc exposure-response data from 72 NSCLC patients treated with 480 mg of AFM24 monotherapy or a combination of AFM24 with atezolizumab. For all patients, trough levels over time were used to calculate the patient’s mean exposure to AFM24. Patients were then split into high and low AFM24 exposure groups for the analysis using the respective median as a cut-off. Objective Response Rate (ORR): 33.3% in the high-exposure group vs. 5.6% in the low-exposure group (p=0.0059) Disease Control Rate (DCR): 83.3% vs. 58.3% (p=0.0367) Median Progression-Free Survival (mPFS): 7.33 vs. 2.86 months Overall Survival (OS): Not yet mature in the high-exposure group vs. 13 months in the low-exposure group A quartile analysis further confirmed the exposure-efficacy relationship, showing a stepwise increase in ORR from 0% in the lowest quartile to 50% in the highest. Subgroup analysis of 55 patients treated with AFM24 plus atezolizumab showed consistent results: 37.04% ORR in the high-exposure group vs. 7.14% in the low group. Importantly, higher exposure was not associated with an increased rate of more serious or severe adverse events. “Advanced NSCLC is a devastating disease and remains an area of high unmet need,” said Andreas Harstrick, MD, Chief Medical Officer of Affimed. “These findings strengthen our clinical rationale for dose optimization and highlight the potential of AFM24 – particularly in combination with atezolizumab – as a novel, chemotherapy-free, immunotherapy-based treatment approach. Importantly, the data suggest that achieving higher drug exposure early in treatment may prevent rapid disease progression.” Pharmacokinetic (PK) modeling indicates that a 720 mg weekly dose of AFM24—previously established as safe—achieves target exposure levels by the second week of treatment that correspond to the high exposure group in the post-hoc analysis. Based on these findings, Affimed will include the 720 mg dose moving forward to optimize clinical benefit and reduce early progression risk. “These data provide compelling evidence that higher exposure may translate to better outcomes in patients with advanced NSCLC,” Dr. Harstrick added. “With dose optimization in hand, we are positioned to advance AFM24 in its potential to deliver durable benefit in a difficult-to-treat patient population.” The data show a strong correlation between exposure and clinical outcome with a significantly increased risk for early tumor progression in the low exposure group. PK modeling suggests that a dose of 720 mg AFM24 weekly will result in exposure levels exceeding the cutoff for the high exposure group as early as week two. The 720 mg dose, which has already been established as safe in the phase 1 trial, will be used in future AFM24 studies. AFM24 is a tetravalent, bispecific ICE® that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR), a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the bold vision to stop cancer from ever derailing patients’ lives. The content above comes from the network. if any infringement, please contact us to modify.

$Affimed Shows Higher Exposure of AFM24 is Associated with Significantly Higher Response Rates and Progression-Free Survival in Refractory NSCLC Patients at AACR Annual Meeting$

Clinical ResultAACRImmunotherapy

100 Deals associated with Atezolizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10773	Atezolizumab	L01XC32	DB11595

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	European Union	Roche Registration GmbH	25 Jul 2024
Advanced Lung Non-Small Cell Carcinoma	Iceland	Roche Registration GmbH	25 Jul 2024
Advanced Lung Non-Small Cell Carcinoma	Liechtenstein	Roche Registration GmbH	25 Jul 2024
Advanced Lung Non-Small Cell Carcinoma	Norway	Roche Registration GmbH	25 Jul 2024
Breast Cancer	Canada	F. Hoffmann-La Roche Ltd.	13 Mar 2024
Alveolar Soft Part Sarcoma	United States	Genentech, Inc.	09 Dec 2022
PD-L1 positive Non-Small Cell Lung Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	26 May 2022
BRAF V600 mutation-positive Melanoma	United States	Genentech, Inc.	30 Jul 2020
PD-L1 positive Triple Negative Breast Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	19 Jan 2018
Advanced Hepatocellular Carcinoma	European Union	Roche Registration GmbH	20 Sep 2017
Advanced Hepatocellular Carcinoma	Iceland	Roche Registration GmbH	20 Sep 2017
Advanced Hepatocellular Carcinoma	Liechtenstein	Roche Registration GmbH	20 Sep 2017
Advanced Hepatocellular Carcinoma	Norway	Roche Registration GmbH	20 Sep 2017
Advanced Triple-Negative Breast Carcinoma	European Union	Roche Registration GmbH	20 Sep 2017
Advanced Triple-Negative Breast Carcinoma	Iceland	Roche Registration GmbH	20 Sep 2017
Advanced Triple-Negative Breast Carcinoma	Liechtenstein	Roche Registration GmbH	20 Sep 2017
Advanced Triple-Negative Breast Carcinoma	Norway	Roche Registration GmbH	20 Sep 2017
Extensive stage Small Cell Lung Cancer	European Union	Roche Registration GmbH	20 Sep 2017
Extensive stage Small Cell Lung Cancer	Iceland	Roche Registration GmbH	20 Sep 2017
Extensive stage Small Cell Lung Cancer	Liechtenstein	Roche Registration GmbH	20 Sep 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Extranodal NK-T-Cell Lymphoma	NDA/BLA	Japan	Chugai Pharmaceutical Co., Ltd.	31 Oct 2024
Diabetes Mellitus, Type 1	NDA/BLA	China	Provention Bio, Inc.	28 Aug 2024
Bladder Cancer	NDA/BLA	China	Roche Holding AG	25 Feb 2019
Endometrial Carcinoma	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	25 Oct 2023
Lymphoproliferative Disorders	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	25 Oct 2023
Melanoma	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	25 Oct 2023
Microsatellite instability-high cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	25 Oct 2023
Turcot Syndrome	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	25 Oct 2023
Muscle Invasive Bladder Carcinoma	Phase 3	Belgium	Hoffmann-La Roche, Inc.	03 May 2021
Muscle Invasive Bladder Carcinoma	Phase 3	Hong Kong	Hoffmann-La Roche, Inc.	03 May 2021

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04602078 (AUREA \| SOGUG-AUREA, CTgov)	Phase 2	Urothelial Carcinoma of the Urinary Bladder \| Locally Advanced Urothelial Carcinoma \| Metastatic urothelial carcinoma	82	Cisplatin 70 mg/m2+Gemcitabine 1000 mg/m2+Atezolizumab 1200 mg/m2	bsoelitqhn = ftllzwdrym xjpfpirwya (qcsyollhgq, tmepywwkew - qvkfrbifve) View more	-	24 Apr 2025
NCT04661150 (Pubmed) Manual	Phase 2	Locally Advanced Gastroesophageal Junction Adenocarcinoma \| Stomach Cancer Neoadjuvant \| Adjuvant	42	Atezolizumab + Trastuzumab + XELOX	hbdwvhxfjo(qroygeldfc) = ovxaygihst htszknvyij (atqrokekui ) View more	Positive	17 Apr 2025
NCT04661150 (Pubmed) Manual	Phase 2		42	Trastuzumab + XELOX	hbdwvhxfjo(qroygeldfc) = vvfntrllym htszknvyij (atqrokekui ) View more	Positive	17 Apr 2025
NCT03313804 (CTgov)	Phase 2	Squamous Cell Carcinoma of Head and Neck \| Non-Small Cell Lung Cancer \| metastatic non-small cell lung cancer	76	nivolumab	gdmqirbymu = agtcbmoixk xuadugsaph (umqqbqsaje, fgvckkthkf - otyzaoggnu) View more	-	06 Apr 2025
NCT04512430 (CTgov)	Phase 2	Non-Small Cell Lung Cancer	4	Carboplatin+Pemetrexed+Atezolizumab+Bevacizumab	lryhdljbgx = hpohoiklby ggvzikhmxr (hebxfxvfye, hirzkgytdg - wjohlwykcu) View more	-	02 Apr 2025
NCT03035890 (CTgov)	Not Applicable	metastatic non-small cell lung cancer	35	Radiation+Immuno-Therapeutic Agent	xnhgkpwlel(elymqyuxnj) = hxtxvejbis qtemiprrmq (ixupohhrly, kdzvbgxjgn - aijbrqtqkx) View more	-	01 Apr 2025
JPRN-JapicCTI-184038 (WJOG10718L/@ Be Study, ESMO_ELCC2025) Manual	Phase 2	PD-L1 positive Non-squamous non-small cell lung cancer First line PD-L1 high expression	40	Atezolizumab 1,200 mg + Bevacizumab 15 mg/kg	znhcwwfsfz(gxcbiolfwj) = xwmbkfhcgx lbtvukzuhm (ktdrhvkaxx, 4.17 - 33.28) View more	Positive	26 Mar 2025
NCT04920981 (IFCT-1905 CLINATEZO, ESMO_ELCC2025)	Not Applicable	Extensive stage Small Cell Lung Cancer First line	518	atezolizumab (Former smokers)	exoknkvkts(nlhgqjbwdv) = eioyeekqsu coceaxcnge (gwxkzdqlfh ) View more	Positive	26 Mar 2025
NCT04920981 (IFCT-1905 CLINATEZO, ESMO_ELCC2025)	Not Applicable	Extensive stage Small Cell Lung Cancer First line	518	atezolizumab (Current smokers)	exoknkvkts(nlhgqjbwdv) = qwxtuwrqjj coceaxcnge (gwxkzdqlfh ) View more	Positive	26 Mar 2025
ESMO_ELCC2025	Not Applicable	Extensive stage Small Cell Lung Cancer First line	45	≥6 cycles of induction chemotherapy	botqjqfypf(tzvtbntrix) = jwbvfpbokb ycaltjczqo (owkctwfxka ) View more	Positive	26 Mar 2025
ESMO_ELCC2025	Not Applicable	Extensive stage Small Cell Lung Cancer First line	45	<6 cycles of induction chemotherapy	botqjqfypf(tzvtbntrix) = dkmsgpchjq ycaltjczqo (owkctwfxka ) View more	Positive	26 Mar 2025
NCT03836066 (TELMA, ESMO_ELCC2025)	Phase 2	Cancer with a high tumour mutational burden First line high tumor mutation burden	38	Atezolizumab plus Bevacizumab	kiggunpjwi(vcgocsmszj) = sqjopozews dkxtxpossx (zhfgwtndyx, 38.3 - 69.3) View more	Positive	26 Mar 2025
NCT04322643 (CTgov)	Phase 2	Advanced Urothelial Carcinoma \| Urothelial Carcinoma of the Urinary Bladder	4	nivolumab+Avelumab+Atezolizumab+pembrolizumab+Durvalumab	qotdncnscb = kkeorvwhvk ymmppxjqmm (plbathxlmx, wvndsumdmd - bpkomtblki) View more	-	25 Feb 2025

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