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Last update 20 Mar 2026

Atezolizumab

Last update 20 Mar 2026

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

NeoplasmsImmune System DiseasesDigestive System Disorders+ [10]

Active Indication

Extranodal NK-T-Cell LymphomaAdvanced Lung Non-Small Cell CarcinomaBreast Cancer+ [179]

Inactive Indication

Adenocarcinoma of large intestineAdenocarcinoma of LungAdvanced Bile Duct Carcinoma+ [110]

Originator Organization

Genentech, Inc.

Universitair Medisch Centrum Groningen

Active Organization

Roche Registration GmbHF. Hoffmann-La Roche Ltd.

Genentech, Inc.

+ [26]

Inactive Organization

Sanofi

Pfizer Inc.

Basilea Pharmaceutica AG

+ [10]

License Organization

NeoImmuneTech, Inc.

Harpoon Therapeutics, Inc.Novocure, Inc.

+ [26]

Drug Highest PhaseApproved

First Approval Date

United States (18 May 2016),

Transitional Cell Carcinoma

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Fast Track (United States)

Structure/Sequence

Sequence Code 122091L

Source: *****

Sequence Code 4720027H

Source: *****

883

Clinical Trials associated with Atezolizumab

NCT07322341

/ Not yet recruitingPhase 2IIT

A Phase 2 Trial of SX-682 and Atezolizumab in Patients With Advanced NSCLC Who Progressed on Prior Chemotherapy and Immune Checkpoint Inhibitor (ICI) Therapy

This phase II trial tests how well SX-682 and atezolizumab works for the treatment of non-small cell lung cancer (NSCLC) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic), and has come back after a period of improvement (recurrent). SX-682 blocks proteins that may be able to stimulate the immune system to kill and eliminate tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SX-682 and atezolizumab may be effective for the treatment of advanced or metastatic, recurrent NSCLC.

Start Date01 Jun 2026

Sponsor / Collaborator

University of Washington

[+3]

NCT07472517

/ Not yet recruitingPhase 3

DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer

This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3.
Participants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein.
Participants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Start Date10 Apr 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT07388524

/ Not yet recruitingPhase 3IIT

Evaluating Adjuvant Atezolizumab or Atezolizumab and Hyaluronidase-TQJS to Prevent Recurrence in Stage I Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase III Trial (AASI-NSCLC)

This phase III trial compares the effect of atezolizumab (or atezolizumab and recombinant human hyaluronidase) to standard observation for preventing cancer return after surgery (recurrence) in patients who have undergone a complete surgical removal (resection) of stage I non-small cell lung cancer (NSCLC). Patients who have undergone resection for lung cancer are typically followed by observation or active surveillance, which involves closely watching a patient's condition but not giving treatment unless there are changes in test results. During active surveillance, patients are given certain exams and tests done on a regular schedule. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Atezolizumab and recombinant human hyaluronidase is a formulation of atezolizumab combined with an enzyme called hyaluronidase, which helps increase tissue absorption of the drug. Giving atezolizumab or atezolizumab and recombinant human hyaluronidase after resection may be effective for preventing NSCLC recurrence, and may be a better approach to treating patients with stage I NSCLC than the usual observation approach.

Start Date09 Apr 2026

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Atezolizumab

100 Translational Medicine associated with Atezolizumab

100 Patents (Medical) associated with Atezolizumab

4,425

Literatures (Medical) associated with Atezolizumab

01 May 2026·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Viral hepatitis and immunotherapy outcome in advanced hepatocellular carcinoma: A comprehensive umbrella review of 15 meta-analyses

Review

Author: Dottorini, Lorenzo ; De Giorgi, Annamaria ; Tomasello, Gianluca ; Colombo, Silvia ; Ghidini, Michele ; Petrelli, Fausto ; Ghilardi, Mara ; Carcano, Giulio

BACKGROUND:

First-line systemic therapy for unresectable/advanced hepatocellular carcinoma (HCC) now prioritizes immune checkpoint inhibitor (ICI)-based combinations, but whether viral hepatitis etiology modifies benefit remains clinically uncertain.

OBJECTIVE:

To synthesize meta-analytic evidence for first-line systemic therapy in unresectable/advanced HCC, assessing hepatitis B (HBV), hepatitis C (HCV), and nonviral etiology as effect modifiers. This umbrella review uniquely quantifies overlap across meta-analyses and applies credibility grading to clarify the strength of evidence for etiology-stratified outcomes.

DESIGN:

Umbrella-style systematic review of systematic reviews with pairwise meta-analyses (network meta-analyses excluded). PubMed/MEDLINE, EMBASE, and the Cochrane Library were searched from inception to 1 December 2025. Pooled hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS), etiology-stratified/interaction analyses were extracted, and overlap was quantified using corrected covered area (CCA).

RESULTS:

Fifteen meta-analyses/quantitative syntheses (2021-2025) were included. Across phase III RCT meta-analyses, immune-based combinations improved OS and PFS versus sorafenib/lenvatinib (ICI+targeted therapy: OS HR 0.71, 95% CI 0.62-0.82; PFS HR 0.62, 95% CI 0.54-0.71; PD-(L)1 inhibitor+antiangiogenic therapy: OS HR 0.69, 95% CI 0.53-0.89; PFS HR 0.60, 95% CI 0.53-0.67). In etiology-stratified PD-(L)1 inhibitor+antiangiogenic RCT meta-analyses, OS benefit was larger in HBV (HR 0.64, 0.55-0.74) than in nonviral etiology (HR 0.91, 0.75-1.11); a predictor meta-analysis supported effect modification (interaction P = 0.02 for OS; P < 0.01 for PFS). Real-world head-to-head meta-analyses comparing atezolizumab-bevacizumab versus lenvatinib were inconsistent. Overlap across meta-analyses was very high (CCA 44.4% among RCT meta-analyses; 52.4% among real-world syntheses).

CONCLUSION:

ICI-based combinations are effective first-line therapy for unresectable/advanced HCC. Viral hepatitis status, particularly HBV, may be associated with larger relative benefit than nonviral etiology, but subgroup and real-world findings require cautious interpretation. This synthesis clarifies the strength and limitations of current evidence and identifies priority areas for prospective validation, with direct implications for treatment selection as nonviral HCC becomes more prevalent.

01 Apr 2026·LUNG CANCER

Real-world comparative effectiveness of atezolizumab versus durvalumab for extensive-stage small-cell lung cancer

Article

Author: Yamamoto, Ryo ; Koshio, Jun ; Sakaguchi, Tadashi ; Takigami, Ayako ; Maemondo, Makoto ; Sugawara, Shunichi ; Hara, Shuichiro ; Sakashita, Hiroyuki ; Tominaga, Shinichiro ; Aiba, Tomoiki ; Ando, Yumi

BACKGROUND:

Both atezolizumab and durvalumab combined with platinum-etoposide have become standard first-line treatments for extensive-stage small-cell lung cancer (ES-SCLC), yet head-to-head real-world comparative data remain scarce.

METHODS:

We conducted a multicenter retrospective cohort study of 234 patients with ES-SCLC treated with atezolizumab plus platinum-etoposide (AEP; n = 126) or durvalumab plus platinum-etoposide (DEP; n = 108) across five Japanese institutions between 2016 and 2023. Progression-free survival (PFS) and overall survival (OS) were compared using Kaplan-Meier and overlap-weighted Cox models. Safety, a cost-effectiveness (cost-minimization) analysis based on restricted mean survival time-derived quality-adjusted life years (QALYs), and second-line treatment outcomes were also evaluated.

RESULTS:

Median PFS was 5.0 months for AEP and 5.1 months for DEP (hazard ratio [HR] 0.96; 95% CI, 0.73-1.26), and median OS was 12.0 and 12.1 months for AEP and DEP, respectively (HR 0.94; 95% CI, 0.68-1.31). Safety profiles were broadly equivalent between groups. Economic analysis showed nearly identical QALYs (1.002 vs 1.011) but lower total direct medical cost for AEP (¥4.14 million vs ¥4.88 million). Among 128 patients receiving second-line chemotherapy, those with platinum-sensitive relapse had significantly longer OS than those with platinum-refractory relapse, regardless of regimen.

CONCLUSIONS:

In real-world practice, AEP and DEP demonstrated equivalent efficacy and safety as first-line treatment for ES-SCLC. Given its lower cost with comparable QALYs, AEP may represent the more cost-minimizing option. The prognostic distinction between sensitive and refractory relapse remains clinically relevant after chemoimmunotherapy.

01 Apr 2026·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Clinical Trial: Early Nivolumab Addition to Regorafenib in Patients With Hepatocellular Carcinoma in Second‐Line (The GOING Trial)

Article

Author: José Luis Lledo ; Àngels Kateb ; Marta Fortuny ; Sergio Muñoz-Martínez ; Andrés Castaño-García ; Gemma Iserte ; Neus Llarch ; Maria Reig ; Loreto Boix ; María Varela ; Christie Perelló ; Jordi Bruix ; Ana Matilla ; Antonio Guerrero ; Ferran Torres ; Jordi Rimola ; Esther Samper ; Mercedes Iñarrairaegui ; Ángeles García-Criado ; José Rios-Guillermo ; Gema Domenech ; Marco Sanduzzi-Zamparelli ; Laura Carrión ; Beatriz Mínguez ; Laura Márquez

ABSTRACT:

Background & Aims:

Highly effective second‐line treatments for hepatocellular carcinoma remain an unmet need. The GOING investigator‐initiated Phase I/IIa trial evaluated regorafenib plus nivolumab ( add‐on ) in patients who progressed on sorafenib (Cohort‐A) or discontinued atezolizumab‐bevacizumab (Cohort‐B).

Methods:

Patients received regorafenib for two 28‐day cycles, adding nivolumab in cycle 3, until unacceptable adverse events, symptomatic progression, withdrawal or death. Primary endpoint was safety. Secondary endpoints included overall survival, time to progression, post‐progression survival, objective response rate and incidence of new‐extrahepatic‐spread.

Results:

Of 85 patients screened, 67 were enrolled (75.5% BCLC‐C). All experienced adverse events and 9% led to discontinuation. Severe treatment‐related adverse events occurred in 28.4% overall, 32.1% in Cohort‐A, and 14.3% in Cohort‐B. Median overall survival was 20.0 (95% CI 11–37) months, with 40.6% survival at 36 months. In Cohort‐A, median overall survival was 25 (95% CI 14–39) months with 45% survival at 36 months, while Cohort‐B median overall survival was 8 (95% CI 4–NE) months with 28.6% survival at 24 months. Objective response rate was 16.4%; median time to progression and post‐progression survival were 5 (95% CI 4–9) months and 14 (95% CI 8–33) months. Intrahepatic growth was the most common progression pattern, followed by new‐extrahepatic‐spread.

Conclusions:

The add‐on strategy of regorafenib plus nivolumab in second‐line had manageable safety and significant clinical activity with a noteworthy median overall survival of 20 months. Among those progressing on sorafenib, 45% were alive at 3 years. These findings support further evaluation with mechanism‐guided trials after progression on immunotherapy.

Trial Registration:

EudraCT number: 2019‐003108‐10; https://www.clinicaltrialsregister.eu

1,582

News (Medical) associated with Atezolizumab

19 Mar 2026

·www.biospace.com

Oncolytics Biotech® to Present New Mechanistic and Translational Data Supporting Pelareorep as an Immune-Priming Backbone at AACR 2026

Pelareorep treatment drives coordinated immune activation and tertiary lymphoid structure formation Translational data suggest potential to boost response to immunotherapy and targeted therapy in RAS-driven tumors Pelareorep’s ability to engage the innate and adaptive immune system results in doubling or nearly tripling response rates in breast and gastrointestinal cancers SAN DIEGO, March 19, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech ® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced two abstracts across distinct tumor types were accepted for presentation at the American Association for Cancer Research (“AACR”) Annual Meeting 2026, at the San Diego Convention Center from April 17-22, 2026. Pelareorep is an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways via double‑stranded RNA signaling, driving interferon production, dendritic cell activation, and cytotoxic T‑cell priming. “These new translational findings strengthen our understanding of pelareorep as a systemic immune‑priming agent that reshapes the tumor microenvironment,” said Jared Kelly, Chief Executive Officer of Oncolytics. “The coordinated immune activation and tertiary lymphoid structure formation we are observing support pelareorep as a foundational backbone for combination therapy across multiple tumor types, including RAS-driven cancers. RAS mutations are especially prevalent in deadly cancers, including roughly 95% of pancreatic cancers and 45% of colorectal cancers. As we advance registrational programs in gastrointestinal cancers, we believe pelareorep will enhance immunotherapy activity and potentially help patients who did not respond initially.” Biomarker data from cohort 1 of the Phase 1/2 GOBLET trial in advanced pancreatic cancer suggest pelareorep plus atezolizumab and gemcitabine/nab-paclitaxel can shift tumors toward a more immune-active state. Patients with an immune activation signature after four weeks were more likely to achieve durable clinical benefit, supporting a potential biomarker. Pancreatic cancer continues to pose a significant unmet clinical need, with approximately 510,000 new cases reported globally each year. 1 Additionally, new first-of-its-kind data from AWARE-1 show pelareorep can drive coordinated anti-tumor immune responses, including tertiary lymphoid structure (“TLS”) formation, helping make immunologically cold tumors more susceptible to immunotherapy. This could include patients who have failed checkpoint inhibitors, representing a significant portion of the patient population and a meaningful unmet need in oncology. Pelareorep has also been shown to stimulate RAS-specific T-cell clones in gastrointestinal cancers, which may enhance its ability to target RAS-mutated tumor cells. The Company will present more data on this topic at an upcoming scientific meeting. Together, the data support pelareorep as a novel immune‑priming strategy capable of enhancing the activity of multiple therapeutic classes, including checkpoint inhibitors, targeted therapies, chemotherapy, and emerging immuno‑oncology modalities. Abstract: Pelareorep combined with atezolizumab and chemotherapy shows immune conversion activity in advanced pancreatic cancer: Biomarker results of cohort 1 of the GOBLET trial New biomarker data from cohort 1 of the Phase 1/2 GOBLET study demonstrated that pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel led to meaningful immune activation in patients with metastatic pancreatic ductal adenocarcinoma (“mPDAC”). An exploratory analysis integrating routine serum markers, a 172-protein circulating panel, selected T-cell receptor sequencing, and clinical outcomes found early on-treatment changes showed increases in adaptive immune and cytotoxicity-associated proteins, including interferon signaling and CD8+/NK-related markers, alongside decreases in tumor/stroma-associated proteins. A 14-protein signature linked to oncolytic activity stratified patients at Week 4 into ‘hot’ vs. ‘cold’ immune phenotypes relative to baseline. Patients demonstrating immune activation signatures experienced longer median progression-free survival (7.5 months) compared with patients who did not exhibit similar immune responses (5.6 months). As previously reported, the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel demonstrated a 62% objective response rate in first-line mPDAC patients, more than double the response rates historically observed with chemotherapy alone. Abstract: Imaging mass cytometry of pelareorep treated early breast cancer samples reveals developing tertiary lymphoid structures AWARE-1 is a window-of-opportunity study evaluating the effects of pelareorep in early-stage breast cancer. In biopsies from Cohort 2 (n=8), cellular neighborhood analysis identified immune-cell clusters, including cytotoxic T cells, dendritic cells, T helper cells, activated T helper cells, B cells, differentiated B cells, and M2 macrophages. Interactions between these cells developed into TLS in select patients. TLS function as localized immune hubs that facilitate antigen presentation, T‑cell activation, and sustained anti‑tumor immune responses. Published studies link TLS formation with improved responses to immunotherapy. These findings support pelareorep’s potential to expand cytotoxic T cells, activate dendritic cells, and promote TLS formation, helping to convert immunologically ‘cold’ tumors into immune-responsive ‘hot’ tumors. About GOBLET The GOBLET ( G astrointestinal tum O rs exploring the treatment com B inations with the oncolytic reovirus pe L ar E orep and an T i-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1 st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1 st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3 rd line metastatic colorectal cancer patients Pelareorep in combination with atezolizumab in 2 nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About AWARE-1 AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers. The combination of pelareorep, letrozole, and atezolizumab resulted in 60% of patients experiencing 30% or greater increases in their CelTIL score. Reference Leiphrakpam PD, Chowdhury S, Zhang M, et al. Trends in the Global Incidence of Pancreatic Cancer and a Brief Review of its Histologic and Molecular Subtypes. J Gastrointest Cancer. 2025 Feb 24;56(1):71. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: or follow the Company on social media on LinkedIn and on X @ oncolytics . Tecentriq ® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. Forward-looking statements This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the timing of the AACR Annual Meeting 2026; expectations as to the content and potential opportunities associated with the findings from the various studies expected to be presented via abstracts in the future; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies; anticipated timelines and objectives for future meetings with regulatory bodies, including the FDA; and its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers as well as breast cancer. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law. Company Contact Jon Patton Director of IR & Communication jpatton@oncolytics.ca

Clinical ResultImmunotherapyFast TrackPhase 2AACR

16 Mar 2026

·allsci.com

Immutep’s LAG3 drug eftilagimod alfa halted in Phase III for NSCLC due to futility

Sydney-based Immutep Limited announced that the Independent Data Monitoring Committee for its TACTI-004 Phase III trial recommended discontinuation of the study evaluating eftilagimod alfa in combination with pembrolizumab and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer. The recommendation followed a planned interim futility analysis, indicating the addition of eftilagimod alfa to standard pembrolizumab-chemotherapy was unlikely to demonstrate a treatment benefit over the control arm. TACTI-004 was a randomized, double-blind, controlled Phase III study designed to enroll approximately 756 patients across more than 150 sites in over 25 countries. Eligible patients had advanced or metastatic NSCLC without EGFR, ALK, or ROS1 genomic aberrations and were enrolled regardless of PD-L1 expression status. Patients were randomized 1:1 to receive either eftilagimod alfa plus pembrolizumab plus chemotherapy, or pembrolizumab plus chemotherapy plus placebo. The dual primary endpoints were progression-free survival and overall survival. The IDMC reviewed available safety and efficacy data at the prespecified interim analysis and concluded the trial met criteria for futility. Immutep did not disclose specific efficacy or safety results from the analysis. The company said enrollment has been halted and an orderly wind-down is underway, including patient follow-up and site closure in accordance with regulatory obligations. Immutep stated it is conducting a review of the available data to determine next steps for the eftilagimod alfa program. The company noted that discontinuation of TACTI-004 extends its anticipated cash runway beyond the previously guided Q2 2027 timeframe. Eftilagimod alfa holds US FDA Fast Track designation in both first-line NSCLC and first-line head and neck squamous cell carcinoma, and remains under evaluation in other solid tumor indications. Immutep said it will reassess capital allocation once its operational and data reviews are complete. Eftilagimod alfa is a soluble LAG-3 immunoglobulin fusion protein that functions as an MHC Class II agonist. Rather than blocking an inhibitory checkpoint, it binds MHC Class II molecules on antigen-presenting cells such as dendritic cells and monocytes, activating them to prime cytotoxic T cells and generate co-stimulatory signals intended to amplify anti-tumor immunity. The rationale for combining eftilagimod alfa with pembrolizumab, a PD-1 checkpoint inhibitor, was to simultaneously release T cell inhibition and enhance antigen presentation. The futility finding suggests this dual mechanism did not translate into additional clinical benefit over pembrolizumab and chemotherapy alone in this patient population. First-line treatment for advanced NSCLC without actionable driver mutations is dominated by PD-1 or PD-L1 checkpoint inhibitors combined with platinum-based chemotherapy. Several programs are testing whether additional immune modulation can improve upon this standard. Key competitors include: Roche’s tiragolumab, an anti-TIGIT antibody evaluated in combination with atezolizumab in the Phase III SKYSCRAPER-01 trial for PD-L1-high first-line NSCLC. Arcus Biosciences’ domvanalimab, another anti-TIGIT antibody being studied with the PD-1 inhibitor zimberelimab in the Phase III ARC-10 trial in first-line NSCLC. AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan, a TROP2-directed antibody-drug conjugate in the Phase III TROPION-Lung07 trial testing combination with pembrolizumab against pembrolizumab plus chemotherapy in first-line NSCLC. The TACTI-004 result narrows Immutep’s late-stage pipeline and raises questions about whether MHC Class II agonism via LAG-3 engagement can produce measurable efficacy gains in large randomized trials. Of note, clinicaltrials.gov indicates Immutep is continuing to study eftilagimod alfa in the Phase II/III AIPAC-003 trial focused on metastatic breast cancer. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 3Fast TrackClinical ResultADC

12 Mar 2026

·www.biospace.com

ORYZON Expands Patent Protection for Iadademstat with Grant Decision in Mexico Covering Combinations with PD-1/PD-L1 Inhibitors

Key combination for the treatment of Small Cell Lung Cancer MADRID and CAMBRIDGE, Mass., March 12, 2026 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, today announced that the Mexican Patent Office has issued a decision to grant for its patent application MX/a/2021/011610, entitled “Combinations of iadademstat for cancer therapy”. The allowed claims protect the use of iadademstat in combination with PD-1 or PD-L1 inhibitors for the treatment of cancer, including small cell lung cancer (SCLC). Following formal grant, the patent is expected to provide protection until at least 2040, not including any potential patent term extensions. With this decision, Oryzon has now secured patent protection for these combinations in Australia, Europe, Japan, Mexico and Russia, while corresponding patent applications remain under examination in other jurisdictions. “This decision further strengthens the global intellectual property protection around iadademstat and its use in combination therapies,” said Neus Virgili, Oryzon’s Chief IP Officer. “Securing protection in additional countries supports the development of iadademstat with immune checkpoint inhibitors such as atezolizumab and durvalumab, an approach we are exploring in small cell lung cancer.” Iadademstat is currently being investigated in combination with PD-L1 inhibitors in extensive-stage SCLC (ES-SCLC) in two ongoing clinical trials. One is a Phase I/II study evaluating iadademstat in combination with atezolizumab or durvalumab, conducted and sponsored by the U.S. National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with Oryzon, and carried out at more than 30 clinical sites across the United States. The other is an open-label Phase Ib study sponsored and conducted by Yale University, evaluating iadademstat in combination with atezolizumab and stereotactic body radiation therapy (SBRT), followed by maintenance therapy with atezolizumab and iadademstat in patients with residual, progressive or recurrent ES-SCLC. About Oryzon Founded in 2000 and headquartered in Barcelona, Spain, Oryzon (ISIN: ES0167733015) is a clinical-stage biopharmaceutical company and a European leader in epigenetics, with a strong focus on personalized medicine for central nervous system (CNS) disorders and oncology. Oryzon’s team comprises highly experienced pharmaceutical professionals based in Barcelona, Boston, and New Jersey. The Company has an advanced clinical portfolio built around two LSD1 inhibitors: iadademstat, its oncology/hematology program, with several ongoing Phase I and II studies and outstanding preliminary results in first-line acute myeloid leukemia, including a 100% overall response rate (ORR) presented at ASH 2025; and vafidemstat, its lead CNS program, which is Phase III–ready. In addition, Oryzon is advancing a broader epigenetics pipeline targeting other mechanisms, including HDAC6, for which a clinical candidate, ORY-4001, has been nominated for potential development in Charcot–Marie–Tooth disease (CMT) and amyotrophic lateral sclerosis (ALS). The Company also operates a robust platform for biomarker identification and target validation across a range of malignant and neurological diseases. For more information, visit About Iadademstat Iadademstat (ORY-1001) is a small oral molecule, which acts as a highly selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers (see Maes et al., Cancer Cell 2018 Mar 12; 33 (3): 495-511.e12.doi: 10.1016 / j.ccell.2018.02.002.). A FiM Phase I/IIa clinical trial with iadademstat in R/R AML patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity, including a CRi (see Salamero et al, J Clin Oncol, 2020, 38(36): 4260-4273. doi: 10.1200/JCO.19.03250). Iadademstat has shown encouraging safety and strong clinical activity in combination with azacitidine in a Phase IIa trial in elder 1L AML patients (ALICE trial) (see Salamero et al., ASH 2022 oral presentation & The Lancet Haematology, 2024, 11(7):e487-e498). Iadademstat is currently being evaluated in combination with azacitidine and venetoclax in 1L AML in an investigator-initiated study (IIS) led by OHSU and in combination with gilteritinib in the company-sponsored Phase Ib FRIDA trial in relapsed/refractory FLT3-mutant AML, with highly encouraging preliminary safety and efficacy data recently reported at ASH-2025 for both trials: 100% ORR and 90% strict CR in 1L AML, and 67% CCR (at the dose under expansion) in R/R AML. Additional studies in hemato-oncology include an IIS in MDS, and trials in myeloproliferative neoplasms and 1L AML both sponsored and conducted by the U.S. National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) signed between Oryzon and the NCI. Beyond hematological cancers, the inhibition of LSD1 has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), neuroendocrine tumors (NET), medulloblastoma and others. In a Phase IIa trial in combination with platinum/etoposide in second line ED-SCLC patients (CLEPSIDRA trial), preliminary activity and safety results have been reported (see Navarro et al., ESMO 2018 poster). Iadademstat is in two trials in ED-SCLC: a Phase I/II randomized trial in 1L in combination with ICI sponsored by NCI and led by the Memorial Sloan Kettering Cancer Center, and an IIS trial in 1L/2L in combination with ICI and radiotherapy. In addition, Oryzon has expanded iadademstat’s clinical development into non-oncological hematology indications, with trials in sickle cell disease (approved by EMA, enrolling) and essential thrombocythemia (approved by EMA). Iadademstat has orphan drug designation for SCLC in the US and for AML in the US and EU. FORWARD-LOOKING STATEMENTS This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees, or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward‐looking statements, whether as a result of new information, future events, or otherwise. This document does not constitute an offer or invitation to purchase or subscribe shares in accordance with the provisions of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, and/or the restated text of the Securities Market Law, approved by Law 6/2023 of 17 March, and its implementing regulations. Nothing in this document constitutes investment advice. In addition, this document does not constitute an offer of purchase, sale or exchange, nor a request for an offer of purchase, sale or exchange of securities, nor a request for any vote or approval in any jurisdiction. The shares of Oryzon Genomics, S.A. may not be offered or sold in the United States of America except pursuant to an effective registration statement under the Securities Act of 1933 or pursuant to a valid exemption from registration. Spain Oryzon IR & Media, Europe & US Patricia Cobo/Mario Cordera Emili Torrell Sandya von der Weid Atrevia Chief BD Officer LifeSci Advisors, LLC +34 91 564 07 25 +34 673 33 97 65 +34 93 515 1313 +41 78 680 05 38 pcobo@atrevia.com mcordera@atrevia.com etorrell@oryzon.com svonderweid@lifesciadvisors.com

Clinical ResultPhase 2Phase 1Orphan DrugPhase 3

100 Deals associated with Atezolizumab

External Link

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
Extranodal NK-T-Cell Lymphoma	Japan	Chugai Pharmaceutical Co., Ltd.	19 Sep 2025
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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Muscle Invasive Bladder Carcinoma	NDA/BLA	Japan	Chugai Pharmaceutical Co., Ltd.	28 Jan 2026
Bladder Cancer	NDA/BLA	China	Roche Holding AG	25 Feb 2019
Lymphoproliferative Disorders	Phase 3	United Kingdom	Hoffmann-La Roche Ltd.	25 Oct 2023
Melanoma	Phase 3	United Kingdom	Hoffmann-La Roche Ltd.	25 Oct 2023
Microsatellite instability-high cancer	Phase 3	United Kingdom	Hoffmann-La Roche Ltd.	25 Oct 2023
Turcot Syndrome	Phase 3	United Kingdom	Hoffmann-La Roche Ltd.	25 Oct 2023
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 3	Hungary	NovoCure GmbH	30 Mar 2023
Pancreatic adenocarcinoma metastatic	Phase 3	Hungary	NovoCure GmbH	30 Mar 2023
Liver metastases	Phase 3	Belgium	-	29 Mar 2021
Primary Malignant Liver Neoplasm	Phase 3	Belgium	-	29 Mar 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IMbrave150 (AACR2026)	Not Applicable	Advanced Hepatocellular Carcinoma First line	3,948	Atezolizumab + Bevacizumab	lxlghvlylc(pwpzvwkwdr) = The risk of developing predefined adverse events was similar between regimens with nonsignificant RD ewwegkgqst (wopxagyymn ) View more	Positive	21 Apr 2026
				Nivolumab + Ipilimumab
GOBLET (AACR2026)	Phase 1/2	Pancreatic Cancer First line RAS upregulated	13	Pelareorep + Atezolizumab + Gemcitabine/nab-paclitaxel	avicwudhiq(wnfaxumpwt) = dxciprprda twozkjcrkr (trxvvywijg ) View more	Positive	21 Apr 2026
AACR2026	Not Applicable	metastatic non-small cell lung cancer First line	11,758	Atezolizumab	csafeequeg(wkmuqrkydy) = eklhciabrk bnqrfikhhm (vbtsxisqtg ) View more	Negative	21 Apr 2026
				Pembrolizumab	csafeequeg(wkmuqrkydy) = zbxapzctiw bnqrfikhhm (vbtsxisqtg ) View more
AACR2026	Phase 2	PD-L1 positive Lung Cancer PD-L1 positive	41	SBRT + Atezolizumab + Tiragolumab	okbwklgahe(yylkjjjppo) = diuhtzizhr dpsnaapndp (wktpecgzbi, 6.0 - NR) View more	Positive	20 Apr 2026
				SBRT + Atezolizumab + Tiragolumab (PD-L1 high (> 50%))	okbwklgahe(yylkjjjppo) = aamnknzaqs dpsnaapndp (wktpecgzbi )
IMforte (AACR2026)	Phase 3	Extensive stage Small Cell Lung Cancer Maintenance	452	Lurbinectedin plus atezolizumab	hbbkmbjivt(rncxkedkfq) = hqznpzylks qnqhdcjjie (ccucvpukmz ) View more	Positive	20 Apr 2026
				Durvalumab	hbbkmbjivt(rncxkedkfq) = zijnbiwynd qnqhdcjjie (ccucvpukmz ) View more
NCT03483012 (Pubmed \| Breast Cancer Res Treat)	Phase 2	Triple Negative Breast Cancer \| Brain metastases ER Negative \| PR Negative \| HER2 Negative	6	Atezolizumab (Stereotactic Radiosurgery)	euamqvlwsj(orkvhcboka) = ctjdirlgkf dlcrrcskeb (emqsljkvhp, 0.95 - NA) View more	Negative	01 Apr 2026
NCT04902040 (CTgov)	Phase 1/2	Melanoma, Cutaneous Malignant \| Advanced Malignant Solid Neoplasm \| Advanced Renal Cell Carcinoma ... View more	19	Plinabulin+Pembrolizumab+RTX (Phase 1b: RTX + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W))	yjehnddpip = huqonushio faqudcpsrv (crfxuelosu, sjdppqdarj - rvqenqloji) View more	-	18 Mar 2026
				Nivolumab+Plinabulin+RTX (Phase 1b: RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W))	yjehnddpip = totjqorhhm faqudcpsrv (crfxuelosu, zkhnnxwyun - tbizbtjozj) View more
NCT04832854 (SKYSCRAPER05 \| SKYSCRAPER-05, CTgov)	Phase 2	Non-Small Cell Lung Cancer \| Locally Advanced Lung Non-Small Cell Carcinoma	50	platinum+atezolizumab+tiragolumab (Cohort A: PD-L1 High)	uessofxfof = qmjvsjnovx omvxtpbyrb (whtzedzodq, enlxnxbbgq - zqkvwvtqee) View more	-	11 Mar 2026
				platinum+atezolizumab+tiragolumab (Cohort B: PD-L1 All Comers)	uessofxfof = lhvvonasna omvxtpbyrb (whtzedzodq, npifxhikln - cdutciwymk) View more
NCT03811002 (NRG Oncology/Alliance LU005, Pubmed \| J Clin Oncol)	Phase 3	Small cell lung cancer limited stage	398	Concurrent chemoradiation + concurrent and adjuvant atezolizumab	pupdrttuxe(mytuxncikc) = skkcyrzmef uscmfemcvl (xarhtcbtlu, 28.5 - 44.7) View more	Negative	10 Mar 2026
				Concurrent chemoradiation alone	pupdrttuxe(mytuxncikc) = obofqwtfxo uscmfemcvl (xarhtcbtlu, 28.1 - 42.5) View more
NCT04624399 (ABACUS-2, ASCO_GU2026)	Phase 2	Renal Pelvis and Ureter Urothelial Carcinoma Neoadjuvant ctDNA \| utDNA	27	Atezolizumab	qqkvvnwiig(vkcjunrugi) = mksvfekqlo maqtryptqu (khfmdrvrsq ) View more	Positive	26 Feb 2026

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