RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia)

Structure/Sequence

Sequence Code 10069506H

Source: *****

Sequence Code 13384675L

Source: *****

900

Clinical Trials associated with Durvalumab

NCT07247786

/ Not yet recruitingPhase 2

Phase II Randomized Clinical Trial for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant (FMT) in Stage II-III Non-small Cell Lung Cancer (NSCLC) Patients, Using Immune Checkpoint Inhibitors (ICI) Responders as Donors.

This is a randomized, phase II, multi-centre clinical trial.
Sample size: 68 patients (Experimental Arm (Durvalumab + chemotherapy + FMT capsules): 34 patients, Control Arm (Durvalumab + chemotherapy): 34 patients)
Population: Patients with stage IIA, IIB, IIIA and IIIB (only T3N2) non-small cell lung cancer
In the Experimental arm, patients will receive Fecal Microbiota Transplant. Once done, the patient will start neoadjuvant treatment with Durvalumab + Chemotherapy .
In the Control arm, patients will receive neoadjuvant treatment with Durvalumab + Chemotherapy.
After neoadjuvant/induction treatment every patient will be evaluated to decide if the patient is a candidate for surgery or not. Patients that are R0 after surgery will receive Adjuvant treatment with Durvalumab.
The primary objective is to evaluate the pathological Complete Response (pCR) rate.
The total trial duration will be 6.5 years approximately.

Start Date15 Sep 2026

Sponsor / Collaborator

Fundacion GECP

NCT07507968

/ Not yet recruitingPhase 2IIT

Total Neoadjuvant Treatment With Preoperative FLOT/Durvalumab Plus Postoperative Durvalumab for Resectable Gastroesophageal Adenocarcinoma

This trial is designed to evaluate a total neoadjuvant approach using D-FLOT as the new standard backbone in patients with resectable esophagogastric adenocarcinoma. It addresses major limitations of current treatment paradigms, builds directly on the strong clinical signal from the MATTERHORN trial, and offers a rational, biologically sound framework for future therapy intensification and innovation.
By moving systemic therapy entirely into the preoperative phase, we aim to:
* Improve patient outcomes through better adherence and deeper response
* Minimize postoperative therapy-related dropout
* Create a platform for rational post-surgical drug testing and individualized treatment escalation The trial will provide pivotal evidence to guide the next generation of curative-intent treatment strategies for EGA.

Start Date01 Jul 2026

Sponsor / Collaborator

AstraZeneca PLC

NCT05403723

/ SuspendedPhase 1IIT

A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination With Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer

This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC).

Start Date30 Jun 2026

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

100 Clinical Results associated with Durvalumab

100 Translational Medicine associated with Durvalumab

100 Patents (Medical) associated with Durvalumab

2,455

Literatures (Medical) associated with Durvalumab

01 Jul 2026·LUNG CANCER

Prognostic value of serum CYFRA21-1 in locally advanced non-small cell lung cancer undergoing durvalumab consolidation therapy after chemoradiotherapy

Article

Author: Nibuya, Kyujiro ; Uchibori, Ken ; Nemoto, Teruhisa ; Tsugitomi, Ryosuke ; Ariyasu, Ryo ; Amino, Yoshiaki ; Fujishima, Shunsuke ; Iso, Hirokazu ; Yanagitani, Noriko ; Sugai, Mayu ; Nishio, Makoto ; Ito, Masahiro

INTRODUCTION:

Chemoradiotherapy (CRT) followed by durvalumab consolidation therapy is the standard treatment for locally advanced non-small cell lung cancer (LA-NSCLC), but robust prognostic biomarkers are lacking. This study evaluated the prognostic value of CYFRA 21-1, a serum marker associated with squamous cell carcinoma, in this setting.

METHODS:

Patients with LA-NSCLC were retrospectively reviewed according to treatment (CRT plus durvalumab group vs. CRT-only group). Patients with high and normal CYFRA 21-1 levels were compared within each group, using a threshold of 3.5 ng/mL. Overall survival (OS) and real-world progression-free survival (rw-PFS) were estimated using the Kaplan-Meier method and compared using the log-rank test. Multivariate analyses were conducted using Cox proportional hazards models.

RESULTS:

There were 134 patients in the CRT plus durvalumab group and 100 patients in the CRT-only group. In the CRT plus durvalumab group, patients with high CYFRA 21-1 levels had shorter median OS versus those with normal levels (38.8 vs. 73.4 months; HR, 2.49 [95% CI, 1.31-4.72]; p < 0.05), whereas no significant difference was observed within the CRT-only group (26.2 vs. 46.5 months; HR, 1.37 [95% CI, 0.82-2.27]; p = 0.21). A similar trend in OS was observed among those with non-squamous histology. On multivariate analysis, CYFRA 21-1 emerged as an independent prognostic factor in the CRT plus durvalumab group (HR = 2.21 (95% CI: 1.10-4.44), p < 0.05). Elevated CYFRA 21-1 levels were associated with shorter rw-PFS only in the CRT plus durvalumab group.

CONCLUSION:

CYFRA 21-1 may serve as a prognostic biomarker among patients with LA-NSCLC treated with CRT followed by durvalumab consolidation therapy.

01 Jun 2026·EUROPEAN JOURNAL OF CANCER

Gastric cancer: French intergroup clinical practice guidelines for diagnosis, staging, treatment and follow-up (TNCD, SNFGE, FFCD, UNICANCER, GERCOR, SFCD, SFED, AFEF, SFRO, SFP, SFR, ACHBPT, RENAPE, SNFCP)

Review

Author: Abdelghani, Meher Ben ; Ducreux, Michel ; Dubreuil, Olivier ; Renaud, Florence ; Jary, Marine ; Palle, Juliette ; Zaanan, Aziz ; Gagniere, Johan ; Buecher, Bruno ; Mariani, Antoine ; Barret, Maximilien ; Durand-Labrunie, Jerome ; Chapelle, Nicolas ; Palmieri, Lola-Jade ; Bouché, Olivier ; Fares, Nadim

INTRODUCTION:

The updated edition of the French intergroup guidelines for the management of patients with gastric and gastroesophageal junction adenocarcinoma is a collaborative work of several national medical societies, and available on the website of the French Society of Gastroenterology (SNFGE) (www.tncd.org).

METHODS:

The recommendations are graded into three categories (A, B, and C), based on the level of scientific evidence published until January 2026.

RESULTS:

Initial staging and risk assessment should include physical evaluation, endoscopy and computed tomography-scan of the thorax, abdomen, and pelvis. For resectable disease, endoscopic ultrasonography can be used for T and N staging, while laparoscopic exploration may be performed to exclude occult peritoneal metastases, especially for cT3/cT4 and poorly cohesive tumors. Endoscopic or surgical resection alone is appropriate for very early cT1N0 tumors. For locally advanced disease ≥cT2 and/or cN + , the perioperative FLOT chemotherapy is recommended as the standard of care. Recently, the addition of durvalumab to perioperative FLOT followed by durvalumab for 10 months as maintenance therapy was associated with a significant improvement of survival. For metastatic disease, the first-line chemotherapy is based on platinum-fluoropyrimidine combination. The addition of targeted therapy and/or immunotherapy to doublet chemotherapy depends on the tumor biomarker profile, including HER2 (trastuzumab), claudin18.2 (zolbetuximab), PD-L1 and dMMR/MSI phenotype (anti-PD1 monoclonal antibodies). The addition of docetaxel, based on the triplet TFOX regimen may be considered for selected patients with biomarker-negative tumors. Resection of primary tumor and metastases cannot be recommended but may be considered on an individual basis in highly selected patients with oligometastatic disease who respond to systemic treatment. Various drugs are indicated beyond first-line of treatment, including trastuzumab-deruxtecan for HER2-positive tumors.

CONCLUSION:

These national guidelines on gastric cancer are intended to facilitate decision-making in daily clinical practice. These recommendations are subject to ongoing review. Each individual case should be discussed within a multidisciplinary team.

01 Jun 2026·EUROPEAN JOURNAL OF CANCER

Early and late survival dynamics of immunotherapy combinations in advanced HCC: Anchored indirect comparison of atezolizumab plus bevacizumab versus durvalumab + tremelimumab

Article

Author: Rossari, Federico ; Kumada, Takashi ; Kudo, Masatoshi ; Ferrara, Michele ; Finkelmeier, Fabian ; Rimassa, Lorenza ; Vitale, Alessandro ; Tada, Toshifumi ; Scartozzi, Mario ; Camera, Silvia ; Pia D'Agata, Alessandra ; Passeri, Laura ; Persano, Mara ; Yip, Terry Cheuk-Fung ; Rimini, Margherita ; Presa, José ; Masi, Gianluca ; Cheon, Jaekyung ; Tamburini, Emiliano ; Casadei-Gardini, Andrea ; Suda, Goki ; Shimose, Shigeo ; Lim, Ho Yeong ; Yoo, Changhoon ; Piscaglia, Fabio ; Lonardi, Sara ; Foschi, Francesco Giuseppe

BACKGROUND AND AIMS:

Atezolizumab plus bevacizumab (A+B) and STRIDE (tremelimumab plus durvalumab) represent two of the approved first-line immunotherapy strategies for unresectable hepatocellular carcinoma (HCC). As no head-to-head trial exists, we assessed temporal differences in survival benefit using complementary analytic frameworks.

METHODS:

Three independent analyses were conducted: (1) anchored indirect comparison using reconstructed survival from IMbrave150 and HIMALAYA; (2) a real-world A+B cohort (n = 883) weighted via MAIC to match STRIDE baseline characteristics; and (3) a propensity-matched population-level dataset from TriNetX (n = 309 per arm). Time-interval hazard ratios (HRs), RMST, and conditional landmark survival were calculated. Proportional hazards were assessed by Schoenfeld testing; pooled interval HRs were synthesized through meta-analysis.

RESULTS:

Across all models, A+B showed a consistent early advantage. In the first 6 months, the pooled HR favored A+B (0.75; 95% CI 0.64-0.88), with absolute survival differences of + 5-7%. From 6-12 months, HRs remained numerically favorable but non-significant. Between 12 and 24 months, pooled HRs approached neutrality (0.93-1.06), with confidence intervals crossing unity and no meaningful absolute survival differences. Beyond 24-36 months, the effect reversed in favor of STRIDE (anchored HR 1.41; RWD HR 2.52; TriNetX HR 1.47). Meta-analysis confirmed a progressive late benefit for STRIDE from 36 to 60 months (pooled HR 1.54-1.75). Schoenfeld tests indicated time-dependent effects in all frameworks (p < 0.05), and ΔRMST trajectories were highly concordant (Pearson r > 0.97).

CONCLUSIONS:

A+B is associated with stronger early tumor control, while STRIDE provides more durable long-term survival beyond 2-3 years. These findings support selecting therapy based on temporal treatment objectives and advocate for biomarkers predicting early versus sustained treatment benefit.

1,223

News (Medical) associated with Durvalumab

18 May 2026

·www.biospace.com

Byondis Establishes Scientific Advisory Board of Recognized Leaders in Oncology Research and ADC Development

Global experts in antibody-drug conjugate (ADC) development, oncology clinical development and early-phase trial design, appointed to support advancement of Byondis’ differentiated ADC pipeline and a new generation of cancer therapeutics for patients Nijmegen, The Netherlands, − 18 May 2026 – Byondis B.V., an independent biopharmaceutical company creating targeted medicines for patients with cancer, today announces the formation of its Scientific Advisory Board to support the advancement of its antibody-drug conjugate (ADC) pipeline incorporating novel platform technologies. Comprised of internationally recognized experts in oncology research and drug development, the advisory board will provide strategic and scientific counsel to Byondis and contribute external scientific and clinical perspectives on precision oncology. Its formation comes as the company executes a focused strategy to develop innovative ADC therapies, addressing critical limitations across the current ADC landscape through its proprietary technology platforms and the clinical advancement of its differentiated oncology pipeline. Christoph Korpus, Chief Executive Officer at Byondis, said: “The formation of our Scientific Advisory Board marks a significant milestone for Byondis. I am proud to welcome a group of expert scientists and clinicians who have made exceptional contributions to oncology research, helping to bring some of the most consequential cancer medicines to patients. Their counsel and support will be invaluable as we execute our strategy to deliver breakthrough ADC solutions and develop a new generation of cancer therapeutics for patients.” Scientific Advisory Board Members (in alphabetical order): Dr. Anthony Tolcher, M.D., FRCPC, FACP Dr. Tolcher is one of the most accomplished early-phase clinical investigators in oncology, having served as principal investigator on first-in-human studies of numerous FDA-approved therapies, including trastuzumab emtansine (Kadcyla ® ), pembrolizumab (Keytruda ® ), durvalumab (Imfinzi ® ), and cemiplimab (Libtayo ® ). He is the Founder and Chief Executive Officer of NEXT Oncology, a specialist Phase I clinical company, and previously co-founded START LLC, a leading early-phase oncology organization. Dr. Tolcher has authored over 130 peer-reviewed publications and serves as a reviewer for the Journal of Clinical Oncology, Clinical Cancer Research, and Annals of Oncology. He completed his medical training in Canada before specializing in medical oncology. Dr. John Lambert, Ph.D. Dr. Lambert is one of the foremost pioneers of ADC science, having played a central role in the development of the technologies underpinning Kadcyla ® (trastuzumab emtansine) for HER2-positive breast cancer and Elahere ® (mirvetuximab soravtansine) for platinum-resistant ovarian cancer, two landmark regulatory approvals that helped establish ADCs as a transformative class of oncology medicine. He spent more than three decades at ImmunoGen, serving as Chief Scientific Officer from 2008 to 2015 and subsequently as Distinguished Research Fellow until his retirement in 2018. Dr. Lambert is the author or co-author of over 130 peer-reviewed publications and is a Fellow of the American Institute for Medical and Biological Engineering and an Honorary Professor at Queen’s University Belfast. Dr. Kapil Dhingra, M.D. Dr. Dhingra brings extensive experience in the clinical and strategic development of ADCs and targeted therapeutics, having served as a board member and advisor to numerous oncology companies involved in transformative acquisitions by Amgen, Bayer, and Novartis. As Vice President and Head of Oncology Clinical Development at Hoffmann-La Roche, he contributed to building what became the global leader in oncology. Since founding KAPital Consulting in 2008, Dr. Dhingra has advised companies across the US, Europe, and Australasia, and has served on the boards of publicly listed companies including Micromet, Algeta, Advanced Accelerator Applications, Autolus, Replimune, Five Prime, LAVA Therapeutics, CARGO Therapeutics, and, Black Diamond. He completed his Haematology-Oncology fellowship at Emory University and held faculty positions at M.D. Anderson Cancer Center, Indiana University School of Medicine, and Memorial Sloan Kettering Cancer Center. He is the author or co-author of more than 100 publications and abstracts. Prof. Paul W.H.I. Parren, Ph.D. Professor Parren has contributed to nine FDA- and EMA-approved therapeutic antibodies across eleven registered medicines, including four products derived from the DuoBody ® bispecific antibody platform. He is the inventor or co-inventor of three clinically translated antibody technologies, DuoBody ® , HexaBody ® , and the Gammabody technology and holds over 360 issued patents. His published work has accumulated more than 46,000 citations. Professor Parren led research and preclinical development at Genmab for 16 years before heading R&D at LAVA Therapeutics, which he advanced to a NASDAQ-listed clinical-stage company. He founded several biotech companies in the antibody field, serves as a biotech consultant and he chairs the board of Directors of The Antibody Society. He holds a Ph.D. in molecular immunology from the University of Amsterdam, is tenured Professor of Molecular Immunology at Leiden University Medical Center, and chairs the Board of Directors of The Antibody Society. -END- About Byondis Driven to improve patients’ lives, Byondis is an independent, fully integrated biopharmaceutical research and development company creating innovative targeted medicines for cancer. The company is developing new biological entities (NBEs) with a focus on antibody-drug conjugates. Byondis’ development portfolio leverages expertise in linker-drug (LD) technology, antibody-drug conjugation, and disease biology. Byondis’ fully integrated drug development capabilities cover all stages from pre-clinical and clinical R&D, production of clinical batches of the selected product candidates, and regulatory filings which are all done in-house. The company has a dedicated team of more than 200 staff working in its state-of-the-art R&D and GMP manufacturing facilities in Nijmegen, the Netherlands. Media Contact ICR Healthcare Sarah Elton-Farr / David Daley / Kris Lam byondis@icrhealthcare.com

Drug ApprovalADCPhase 1Executive ChangeAcquisition

17 May 2026

·www.globenewswire.com

Nanobiotix Announces Presentation of Part 1 Data From a Randomized Phase 2 Clinical Trial Evaluating JNJ-1900 (NBTXR3) in Stage 3 Inoperable Lung Cancer

Data presented by Johnson & Johnson at the 2026 European Society for Radiotherapy and Oncology (ESTRO) Annual MeetingPARIS and CAMBRIDGE, Mass., May 17, 2026 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced the presentation of Part 1 data from the CONVERGE study, a Johnson & Johnson-sponsored randomized Phase 2 clinical trial evaluating potential first-in-class Nanoradioenhancer JNJ-1900 (NBTXR3) for patients with stage 3 inoperable non-small cell lung cancer (“NSCLC”), at the 2026 European Society for Radiotherapy and Oncology Annual Meeting (ESTRO 2026). PRESENTATION #116: Radiographic Response in Patients with Stage III Unresectable Non-Small Cell Lung Cancer Treated with an Intratumoral Radioenhancer (JNJ-90301900) Jeffrey Bradley,1 Benjamin T. Cooper,2 Sushma Patel,3 David DiBardino,4 Michael Pritchett,5 Kevin C. Ma,4 Isaac Laniado,6 Melina E. Marmarelis,7 Matthew Scarlotta,8 Joshua K. Sabari,9 Yi -Wen Ma,10 Tori Stromp,10 Yina Kuang,10 Balaji Laxmanan,10 Kiran Devisetty,10 Steven Feigenberg1 Study Conclusions Early results suggest that intratumoral/intranodal injection of JNJ-1900 (NBTXR3) is feasible and can be performed safely in patients with stage III unresectable NSCLCInitial efficacy responses observed in 7 patients following the full treatment regimen of concurrent chemoradiotherapy, JNJ-1900 (NBTXR3), and consolidation with durvalumab are promising: Overall response rate (“ORR”) = 85.7% (6/7 patients)Complete response rate (“CRR”) = 57.1% (4/7 patients) With the current standard of care, concurrent chemoradiation therapy (cCRT) ± durvalumab, depth of response remains limited in Stage 3 Inoperable NSCLC with very low rates of complete response (<5%) * Disease control rate (“DCR”) = 100.0% (7/7 patients) Absence of progressive disease and deepening response over time suggests potential for long-term durability 1Radiation Oncology, University of Pennsylvania, Philadelphia, USA; 2Radiation Oncology, NYU Langone Health, New York, USA; 3Radiation Oncology, FirstHealth of the Carolinas, Pinehurst, USA; 4University of Pennsylvania, Philadelphia, USA; 5Interventional Pulmonology, FirstHealth of the Carolinas, Pinehurst, USA; 6Interventional Pulmonology, NYU Langone Health, New York, USA; 7Medical Oncology, University of Pennsylvania, Philadelphia, USA; 8Medical Oncology, FirstHealth of the Carolinas, Pinehurst, USA; 9Medical Oncology, NYU Langone Health, New York, USA; 10Johnson & Johnson, New Brunswick, NJ, USA * Antonia SJ, et al. N Engl J Med. 2017. About JNJ-1900 (NBTXR3) JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations. Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter. Disclaimer This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on March 31, 2026 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2025 universal registration document filed with the AMF on March 31, 2026 under “chapter 1.5 Risk Factors”, and subsequent filings Nanobiotix makes with the SEC and AMF from time to time, which are available on the SEC’s website at www.sec.gov and on the AMF's website at www.amf.org, The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly. Nanobiotix Communications DepartmentBrandon OwensVP, Communications+1 (617) 852-4835contact@nanobiotix.comInvestor Relations DepartmentJoanne ChoiVP, Investor Relations (US)+1 (713) 609-3150joanne.choi@nanobiotix.comRicky BhajunDirector, Investor Relations (EU)+33 (0) 79 97 29 99investors@nanobiotix.com Media Relations France – HARDYCaroline Hardy+33 06 70 33 49 50carolinehardy@outlook.fr Global – uncappedBecky Lauer +1 (646) 286-0057uncappednanobiotix@uncappedcommunications.com Attachment 2026-05-17 -- NBTX -- Part 1 Ph2 NBTXR3 In Stage 3 Lung Cancer -- FINAL

Phase 2Phase 3License out/inFast TrackClinical Result

15 May 2026

·www.biopharmadive.com

Biotech leaders campaign for Pazdur; Takeda to lay off 4,500 workers

Today, a brief rundown of news involving the Food and Drug Administration and Takeda, as well as updates from BeOne Medicines, AstraZeneca and Alumis that you may have missed.More than 300 biotechnology executives, investors and patient advocates have signed a petition calling for President Donald Trump to nominate Rick Pazdur as the next commissioner of the Food and Drug Administration. A longtime FDA veteran and cancer drug reviewer, Pazdur is a proven leader with a track record of credibility, rigor, and results whose appointment would secure and strengthen the agency at whats now a pivotal moment, the coalition argued. Pazdur left the FDA over reported frustrationswith politically driven decisionmaking under former commissioner Martin Makary. His and other departures have created a crisis of confidence in Americas ability to remain a leader in biomedical progress, the group warned in its petition. Ben FidlerTakeda will lay off 4,500 workers as part of an ongoing restructuring meant to shed $1.3 billion in annual costs by 2028. The Japanese pharmaceutical giant has been working to cut spending for a few years now in response to a broader profit decline catalyzed by patent losses. The latest planned cuts are part of a “transformation program“ the company outlined in March and that, according to an earnings presentation Wednesday, will “reduce management layers“ and streamline corporate functions ahead of multiple crucial drug launches. Takeda is preparing for approvals of medicines for narcolepsy, psoriasis and polycythemia vera over the next 12 to 18 months. All three have “blockbuster potential,“ wrote Jefferies analyst Stephen Barker. Ben FidlerThe Food and Drug Administration on Wednesday granted an accelerated approval to BeOne MedicinesBeqalzi for certain people with the rare, aggressive blood cancer mantle cell lymphoma. The clearance covers patients whose disease has progressed after two treatment lines, including a BTK inhibitor like BeOnes own Brukinsa. Beqalzis clearance was based on study results showing 52% of drug recipients responded to treatment and 16% achieved a complete remission. A so-called BCL-2 inhibitor, Beqalzi is in the same class as Roche and AbbViesVenclexta, which is available in three different leukemia and lymphoma settings but not mantle cell disease. A confirmatory trial of Beqalzi in mantle cell is underway, as well as studies testing the drug directly against Venclexta in other settings.Jonathan GardnerA combination of AstraZenecas immunotherapy Imfinziand Pfizer and Astellas Pharmas antibody-drug conjugate Padcev helped people with bladder cancer live longer than those who didnt when administered before and after surgery in a Phase 3 trial, AstraZeneca said Thursday. The company didnt provide specifics, but said the drug combination resulted in statistically significant and clinically meaningful improvements in both event-free survival and overall survival compared to standard treatment for tumors that have penetrated the bladders muscle walls. AstraZeneca will share the results with regulators. Jonathan GardnerAlumiswill offload a drug it picked up in a merger with Acelyrin in 2025, the company said Thursday in its first-quarter earnings report. The drug,lonigutamab, was being positioned as a competitor to Amgens thyroid eye disease drug Tepezza and was Acelyrins main focus prior to the deal. But Alumis noted last year that it intended to re-evalute the program to confirm its differentiation and revealed Thursday that it now intends to explore strategic alternatives for the program. Alumis stock price has soared in recent months on positive study data for its plaque psoriasis prospect envudeucitinib, which the biotech plans to submit for regulatory approval by the end of the year. Gwendolyn Wu '

Phase 3Clinical ResultExecutive ChangeAccelerated ApprovalDrug Approval

100 Deals associated with Durvalumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10808	Durvalumab	L01XC28	DB11714

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	European Union	AstraZeneca AB	16 Mar 2026
Gastroesophageal junction adenocarcinoma	Iceland	AstraZeneca AB	16 Mar 2026
Gastroesophageal junction adenocarcinoma	Liechtenstein	AstraZeneca AB	16 Mar 2026
Gastroesophageal junction adenocarcinoma	Norway	AstraZeneca AB	16 Mar 2026
Stomach Cancer	European Union	AstraZeneca AB	16 Mar 2026
Stomach Cancer	Iceland	AstraZeneca AB	16 Mar 2026
Stomach Cancer	Liechtenstein	AstraZeneca AB	16 Mar 2026
Stomach Cancer	Norway	AstraZeneca AB	16 Mar 2026
Early gastric cancer	United States	AstraZeneca PLC	25 Nov 2025
Gastrooesophageal junction cancer	United States	AstraZeneca PLC	25 Nov 2025
Locally Advanced Gastric Carcinoma	United States	AstraZeneca PLC	25 Nov 2025
Unresectable Lung Non-Small Cell Carcinoma	China	AstraZeneca UK Ltd.	18 Nov 2025
Muscle Invasive Bladder Carcinoma	United States	AstraZeneca UK Ltd.	28 Mar 2025
Uterine Neoplasms	Japan	AstraZeneca Pharmaceuticals Co. Ltd.	22 Nov 2024
Advanced Endometrial Carcinoma	European Union	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Iceland	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Liechtenstein	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Norway	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	European Union	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	Iceland	AstraZeneca AB	15 Aug 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
ALK positive Non-Small Cell Lung Cancer	NDA/BLA	China	AstraZeneca AB	21 Feb 2025
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	AstraZeneca UK Ltd.	21 Feb 2025
Ovarian Epithelial Carcinoma	NDA/BLA	China	AstraZeneca UK Ltd.	16 Aug 2024
pMMR/MSS/MSI-L Colon Cancer	Phase 3	Spain	AstraZeneca PLC	30 Dec 2024
PD-L1 positive Triple Negative Breast Cancer	Phase 3	United States	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	China	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Japan	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Argentina	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Australia	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Brazil	AstraZeneca PLC	23 Nov 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04786093 (CTgov)	Phase 2	Advanced Lung Non-Small Cell Carcinoma	1	Stereotactic radiation therapy+Durvalumab (Stereotactic Ablative Radiotherapy (SAbR) Arm Plus Durvalumab Arm)	wtihfyetus(izkgstykgz) = jnxrsoucyi szytzwwjyp (nqizibtuii, hytuitekmm - ahpsqrkoaa) View more	-	05 May 2026
				Stereotactic radiation therapy+Durvalumab (Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) Plus Durvalumab Arm)	mvkynzrtuk = goiiqxzmsb imngjolgok (ncqnmpmydy, njfljpfsjq - deoefhomlo) View more
NCT03694236 (AACR2026)	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant	30	Neoadjuvant durvalumab combined with concurrent chemoradiotherapy	tzhlcxzeuf(lwinywxqly) = hlkpyagslx qtygirpkqo (buadyjjrua ) View more	Positive	22 Apr 2026
NCT05640791 (DURGAP, AACR2026)	Phase 2	Biliary Tract Neoplasms Neoadjuvant CD8+ \| CD4+ \| regulatory T cells (Tregs)	8	Neoadjuvant DurGAP therapy (TRG1)	mawjtjkzva(susnllommn) = hptyncftem pcopvzvkrw (catihjrvvj ) View more	Positive	22 Apr 2026
NCT04308174 (DEBATE, AACR2026)	Phase 2	Biliary Tract Neoplasms Neoadjuvant	45	Durvalumab plus Gemcitabine-Cisplatin (D+GP)	ybizwcqmay(zspdrywxen) = qmttgwthyv aoahzvripe (kotgpmcude ) View more	Positive	21 Apr 2026
				Gemcitabine-Cisplatin (GP)	ybizwcqmay(zspdrywxen) = jjebvvhkwe aoahzvripe (kotgpmcude ) View more
NCT06526104 (STRIDE in CP-B, AACR2026)	Phase 2	Hepatocellular Carcinoma First line	30	Tremelimumab 300 mg + Durvalumab 1500 mg (Hepatocellular Carcinoma + Child-Pugh B cirrhosis)	hkvonusxwv(zynbscfnsv) = zycntjxgke euzramglpg (mmqyjtkmxh ) View more	Positive	21 Apr 2026
NCT03820141 (AACR2026)	Phase 2	HER2 Positive Breast Cancer ER-negative \| PR-negative \| HER2-Enriched	37	durvalumab+trastuzumab+pertuzumab	qiysgnxadw(pqcbaavjqc) = pbvaghipfk zlecgghslh (vvpeahlpqo )	Positive	21 Apr 2026
AACR2026	Phase 2/3	Bladder Cancer First line	200	ICI-only regimen(Durvalumab, Durvalumab+Tremelimumab, Pembrolizumab)	bkfcqihixf(flemfcgtpb): HR = 1.92 (95.0% CI, 1.63 - 2.25) View more	Negative	21 Apr 2026
				chemotherapy
NCT05043090 \| NCT02819596 (CALYPSO, Pubmed \| J Clin Oncol)	Phase 2	Neoplasm Metastasis MET \| PD-L1 \| tumor mutational burden (TMB)	41	Savolitinib and Durvalumab	dadhqgoqsu(ddkpceyjka) = ngylizpeps mazxrdxdzs (nerlpoexft, 7.3 - 30.7) View more	Positive	20 Apr 2026
				Savolitinib and Durvalumab (MET-driven patients)	dadhqgoqsu(ddkpceyjka) = vpwqjlmpvf mazxrdxdzs (nerlpoexft, 9.3 - 37.4) View more
IMforte (AACR2026)	Phase 3	Extensive stage Small Cell Lung Cancer Maintenance	452	Lurbinectedin plus atezolizumab	pvsrsrkqhc(amdzpfkgwg) = hdjzykrmdw lklmlcgbpw (panerswsxg ) View more	Positive	20 Apr 2026
				Durvalumab	pvsrsrkqhc(amdzpfkgwg) = edggbqmbxk lklmlcgbpw (panerswsxg ) View more
NCT03820141 (DTP, CTgov)	Phase 2	Breast Cancer \| HER2-negative breast cancer	51	Trastuzumab+Pertuzumab+Durvalumab	caxntckhwr = aryyygrssz shufxlbsqb (tjeuwizfcs, igwpxwmwax - dkpglejbnd) View more	-	20 Apr 2026

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