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Curium™ announces FDA approval of BEXLUTRY lutetium Lu 177 dotatate injection for adults with SSTR-positive GEP-NETs

On September 14, 2026 Curium reported that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for BEXLUTRY lutetium Lu 177 dotatate injection for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

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BEXLUTRY is a radioligand therapy designed to deliver targeted radiation to GEP-NETs by binding to somatostatin receptors commonly expressed on these tumors. NETs originate from neuroendocrine cells, which are specialized cells widely dispersed throughout the body’s organs. The site of origin can vary because of the broad distribution of neuroendocrine cells. GEP-NETs represent 60-70% of NETs.

BEXLUTRY is a radioligand equivalent approved through the FDA’s 505(b)(2) pathway targeting LUTATHERA (lutetium Lu 177 dotatate), supported by published evidence and targeted bridging data that demonstrated a similar biological and chemical profile to a previously approved radiopharmaceutical therapy.

Renaud Dehareng, Curium’s Group Chief Executive Offer, said: "FDA approval of BEXLUTRY is a defining milestone for Curium as we expand our offering into oncology therapeutics. With over 100 years of experience in nuclear medicine and a long-standing commitment to the NET community, we are now bringing the full diagnosis-to-therapy capability needed to scale theranostics responsibly. For decades, Curium has earned trust in nuclear medicine through reliability, quality and day-in, day-out delivery. We are applying that same discipline and commitment to help eligible NET patients access radioligand therapy with confidence."

Mike Patterson, Curium’s North American Chief Executive Officer, said: "As the only vertically integrated, lutetium-based NETs therapy manufacturer, Curium is uniquely positioned to support a reliable supply of BEXLUTRY and help sites of care prepare for radioligand therapy delivery at scale. Today’s FDA approval brings us a step closer to advancing our ambition of aiming to improve the lives of up to 80% of patients with cancer. Our priority now is a high-quality launch supported by our end-to-end nuclear medicine infrastructure, designed to help ensure consistent delivery, predictable scheduling support for sites of care, and a dependable experience for patients receiving radioligand therapy."

BEXLUTRY is now available for prescribing physicians and patient use. Visit www.bexlutry.com.

About BEXLUTRY

INDICATIONS AND USAGE

BexlutryTM (lutetium Lu 177 dotatate injection) is indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk From Radiation Exposure: Bexlutry contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. These risks of radiation associated with the use of Bexlutry are greater in pediatric patients than in adults.
Radiation can be detected in the urine for up to 30 days following Bexlutry administration. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with Bexlutry consistent with institutional good radiation safety practices, patient management procedures, Nuclear Regulatory Commission patient-release guidance, and instructions to the patient for follow-up radiation protection at home.
Myelosuppression: In NETTER-1, myelosuppression occurred more frequently in patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared to patients receiving high-dose long-acting octreotide (all Grades/Grade 3 or 4): anemia (81%/0) versus (54%/1%); thrombocytopenia (53%/1%) versus (17%/0); and neutropenia (26%/3%) versus (11%/0). In NETTER-1, platelet nadir occurred at a median of 5.1 months following the first dose. Of the 59 patients who developed thrombocytopenia, 68% had platelet recovery to baseline or normal levels. The median time to platelet recovery was 2 months. Fifteen of the nineteen patients in whom platelet recovery was not documented had post-nadir platelet counts. Among these 15 patients, 5 improved to Grade 1, 9 to Grade 2, and 1 to Grade 3. Monitor blood cell counts. Withhold dose, reduce dose, or permanently discontinue Bexlutry based on the severity of myelosuppression.
Secondary Myelodysplastic Syndrome (MDS) and Leukemia: In NETTER-1, with a median follow-up time of 76 months in the main study, myelodysplastic syndrome (MDS) was reported in 2.3% of patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared to no patients receiving high-dose long-acting octreotide.
In ERASMUS, 16 patients (2.0%) developed MDS and 4 (0.5%) developed acute leukemia. The median time to onset was 29 months (9 to 45 months) for MDS and 55 months (32 to 125 months) for acute leukemia.
Renal Toxicity: In ERASMUS, 8 patients (< 1%) developed renal failure 3 to 36 months following lutetium Lu 177 dotatate injection. Two of these patients had underlying renal impairment or risk factors for renal failure (e.g., diabetes or hypertension) and required dialysis.
Administer the recommended amino acid solution before, during and after Bexlutry to decrease the reabsorption of lutetium Lu 177 dotatate through the proximal tubules and decrease the radiation dose to the kidneys. Advise patients to hydrate and to urinate frequently before, on the day of, and the day after administration of Bexlutry.

Monitor serum creatinine and calculated creatinine clearance. Withhold dose, reduce dose, or permanently discontinue Bexlutry based on the severity of renal toxicity.

Patients with baseline renal impairment may be at increased risk of toxicity due to increased radiation exposure.

Hepatotoxicity: In ERASMUS, 2 patients (< 1%) were reported to have hepatic tumor hemorrhage, edema, or necrosis, with one patient experiencing intrahepatic congestion and cholestasis. Patients with hepatic metastasis may be at increased risk of hepatotoxicity due to radiation exposure.
Monitor transaminases, bilirubin, serum albumin, and international normalized ratio (INR) during treatment. Withhold dose, reduce dose, or permanently discontinue Bexlutry based on the severity of hepatotoxicity.

Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, occurred in patients treated with lutetium Lu 177 dotatate injection. Monitor patients closely for signs and symptoms of hypersensitivity reactions, including anaphylaxis, during and following Bexlutry administration for a minimum of 2 hours in a setting where cardiopulmonary resuscitation medication and equipment are available. Discontinue the infusion upon the first observation of any signs or symptoms consistent with a severe hypersensitivity reaction and initiate appropriate therapy.
Premedicate patients with a history of Grade 1 or 2 hypersensitivity reactions to Bexlutry before subsequent doses. Permanently discontinue Bexlutry in patients who experience Grade 3 or 4 hypersensitivity reactions.

Neuroendocrine Hormonal Crisis: Neuroendocrine hormonal crises, manifesting with flushing, diarrhea, bronchospasm and hypotension, occurred in < 1% of patients in ERASMUS and typically occurred during or within 24 hours following the initial lutetium Lu 177 dotatate injection dose. Two (< 1%) patients were reported to have hypercalcemia. Monitor patients for flushing, diarrhea, hypotension, bronchoconstriction or other signs and symptoms of tumor-related hormonal release. Administer intravenous somatostatin analogs, fluids, corticosteroids, and electrolytes as indicated.
Embryo-Fetal Toxicity: Based on its mechanism of action, Bexlutry can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating Bexlutry. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Bexlutry and for 7 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Bexlutry and for 4 months after the last dose.
Risk of Infertility: Bexlutry may cause infertility in males and females. The recommended cumulative dose of 29.6 GBq of Bexlutry results in a radiation absorbed dose to the testes and ovaries within the range where temporary or permanent infertility can be expected following external beam radiotherapy.

ADVERSE REACTIONS

The most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in lutetium Lu 177 dotatate injection arm) reported in NETTER-1 were lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia and hypokalemia.

With a median follow-up time of more than 4 years, the following rates of serious adverse reactions were reported in ERASMUS: myelodysplastic syndrome (2%), acute leukemia (1%), renal failure (2%), hypotension (1%), cardiac failure (2%), myocardial infarction (1%), and neuroendocrine hormonal crisis (1%).

DRUG INTERACTIONS

Somatostatin Analogs: Somatostatin and its analogs competitively bind to somatostatin receptors and may interfere with the efficacy of Bexlutry. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each Bexlutry dose. Administer short- and long-acting octreotide during Bexlutry treatment as recommended.

Glucocorticoids: Glucocorticoids can induce down-regulation of subtype 2 somatostatin receptors (SSTR2). Avoid repeated administration of high doses of glucocorticoids during treatment with Bexlutry.

USE IN SPECIFIC POPULATIONS

Lactation

Advise women not to breastfeed during treatment with Bexlutry and for 2.5 months after the last dose.

Pediatric Use

Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors: The risks of radiation exposure associated with Bexlutry are greater in pediatric patients than in adult patients due to longer life expectancy. The safety and effectiveness of Bexlutry have not been established in pediatric patients younger than 12 years old with somatostatin receptor-positive GEP-NETs.

Pediatric use information is approved for Advanced Accelerator Applications USA INC’s LUTATHERA (lutetium Lu 177 dotatate) injection for intravenous use. However, due to Advanced Accelerator Applications USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

*LUTATHERA is a registered trademark of Advanced Accelerator Applications International SA.

(Press release, Curium Pharma, SEP 14, 2026, View Source [SID1234670816])

BioNTech and OncoC4 Present Updated Data Showing Gotistobart Nearly Doubled Median Overall Survival versus Standard-of-Care Chemotherapy in Previously Treated Squamous Non-Small Cell Lung Cancer Patients

On September 14, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech") and OncoC4, Inc. ("OncoC4") reported the first median overall survival ("OS") data from the non-pivotal stage 1 of the global randomized PRESERVE-003 Phase 3 clinical trial (NCT05671510) of gotistobart (also known as BNT316 or ONC-392), in patients with squamous non-small lung cancer ("NSCLC") whose disease progressed on prior immunotherapy and chemotherapy. Gotistobart is an investigational CTLA-4-targeting immunotherapy designed to selectively deplete regulatory T cells ("Tregs") within the tumor microenvironment and restore anti-tumor immune activity.

The data showed that treatment with gotistobart led to a statistically significant and clinically meaningful OS benefit, nearly doubling survival compared with standard-of-care chemotherapy in this patient population. The data were presented at the International Association for the Study of Lung Cancer ("IASLC") 2026 World Conference on Lung Cancer ("WCLC").

"Patients with squamous NSCLC continue to face limited treatment options after progression on immunotherapy. Current survival expectations with established therapies remain less than a year, and despite numerous development efforts, chemotherapy has remained the standard of care in this setting for more than a decade," said Rama Balaraman, M.D., Principal Investigator and medical oncologist at Ocala Oncology Center, Florida, United States. "The magnitude of the survival benefit observed with gotistobart as a chemotherapy-free treatment approach in the PRESERVE-003 clinical trial is highly encouraging. If confirmed in the pivotal portion of the Phase 3 trial, these findings could transform the standard of care in a setting where new therapies are urgently needed."

At the data cut-off on July 17, 2026, with a median follow-up of 25.4 months, 87 patients with metastatic squamous NSCLC had been randomized to receive either gotistobart monotherapy 6 mg/kg with two 10 mg/kg loading doses (N=45) or docetaxel 75 mg/m2 (N=42) in the second-line or later treatment setting. The median OS was 18.5 months for patients treated with gotistobart compared to 10.0 months for patients treated with docetaxel (HR: 0.56; nominal p-value=0.0295). The safety profile of gotistobart was consistent with previously reported data and remained manageable. Grade ≥3 treatment-related adverse events ("AEs") were reported in 20/45 (44.4%) patients receiving gotistobart and 20/42 (48.8%) patients receiving docetaxel.

"These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "In second- and later lines of treatment, the clinical relevance of novel therapeutic options depends on the ability to re-engage a suppressed or exhausted anti-tumor immune response and overcome acquired resistance. This update highlights gotistobart’s unique mode of action and our ambition to translate our deep understanding of the immune system into meaningful survival benefit for patients with lung cancer – particularly in areas where patients still need more. We look forward to continuing our work with our colleagues at OncoC4 to further explore and realize gotistobart’s full potential."

"The data support the differentiated mechanism of action of gotistobart as a tumor microenvironment-selective Treg modulator and reinforce our confidence in the therapeutic potential of this distinct CTLA-4-targeting approach to meaningfully shift the treatment landscape in this indication," said Pan Zheng, M.D., Ph.D., Co-Founder and Chief Medical Officer at OncoC4. "We are encouraged by the clinical activity and safety profile observed to date and remain focused on advancing gotistobart for patients with this difficult-to-treat disease."

The pivotal stage 2 portion of PRESERVE-003 is currently ongoing at more than 160 sites globally. Gotistobart previously demonstrated a clinically meaningful OS benefit and durable anti-tumor activity versus docetaxel in stage 1 of the PRESERVE-003 Phase 3 trial in patients with squamous NSCLC who had progressed on PD-(L)1 inhibitors. This data was published in Nature Medicine and presented at the 2026 European Lung Cancer Congress ("ELCC") and the IASLC ASCO (Free ASCO Whitepaper) 2025 North America Conference on Lung Cancer ("NACLC").

About the PRESERVE-003 clinical trial
PRESERVE-003 (NCT05671510; EUCT:2023-505311-20-01; CTR20232927) is a two-stage, open-label Phase 3 trial evaluating the efficacy and safety of gotistobart as monotherapy compared to the standard-of-care chemotherapy (docetaxel) in squamous NSCLC patients, who have progressed on PD-(L)1 inhibitors and platinum-based chemotherapy. The non-pivotal stage of the trial included all NSCLC patients. The ongoing pivotal stage enrolled patients with squamous NSCLC. The primary endpoint is overall survival. Secondary endpoints include overall response rate, progression-free survival, and safety profile.

About gotistobart (BNT316/ONC-392)
Gotistobart (BNT316/ONC-392) is an investigational immunotherapy that enhances Treg depletion within the tumor microenvironment through targeting CTLA-4 to reignite antitumor immunity and which is being jointly developed by BioNTech and OncoC4.2,3,4,5,6,7,8,9 As a pH-sensitive monoclonal antibody, gotistobart is designed to enable CTLA-4 protein recycling. After binding to the CTLA-4 receptor on the cell surface, the complex is internalized, and the pH change causes the antibody to unbind, allowing CTLA-4 to return to the surface to preserve the immune checkpoint function at peripheral organs and to enhance anti-tumor immunity in the tumor microenvironment.9

Gotistobart is currently in late-stage clinical development as a monotherapy and as a component of combination therapy in various cancer indications. Gotistobart received Fast Track Designation from the U.S. Food and Drug Administration ("FDA") in 2022 for the treatment of patients with metastatic NSCLC whose disease progressed on prior anti-PD-(L)1 therapy and Orphan Drug Designation for the treatment of patients with squamous NSCLC in 2025. The candidate also received Breakthrough Therapy Designation from China’s National Medical Products Administration ("NMPA") in 2025.

About squamous non-small cell lung cancer
With a 5-year relative survival rate of 15% and a median overall survival of 11 months in the United States (2000-2017), squamous NSCLC is a devastating disease with limited treatment options.1 Current standard-of-care includes surgery and radiotherapy in combination with chemotherapy.9 Treatment options for second-line therapy after first-line immunotherapy and chemotherapy are limited to chemotherapy or palliative therapy in advanced/metastatic squamous NSCLC and remain more limited than for non-squamous NSCLC.

(Press release, BioNTech, SEP 14, 2026, View Source [SID1234670815])

Antengene Publishes Preclinical Research Paper on CD73 Small Molecule Inhibitor ATG-037 Combined with Selinexor in Cancer Gene Therapy

On September 14, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) , a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, reported that a preclinical research paper evaluating the combination of ATG-037 (CD73 Small Molecule Inhibitor) and selinexor for the treatment of multiple myeloma (MM), conducted in collaboration with the Department of Hematology at Peking University Third Hospital, has been published in Cancer Gene Therapy, an international SCI journal under Springer Nature.

Details of the Paper
Title: CD73 inhibitor enhances the antitumor activity of selinexor in multiple myeloma by restoring the activation of CD8+ T cells
Journal: Cancer Gene Therapy
DOI: 10.1038/s41417-026-01078-9

Study Design:

The research team first analyzed CD73 expression across multiple tumor cell lines following selinexor treatment, then tested the combination in vivo using a J558-inoculated BALB/c mouse model, with mice divided into a vehicle group, an ATG-037 monotherapy group, a selinexor monotherapy group and a combination-therapy group. Single-cell RNA sequencing was used to characterize immune cell subtypes and tumor-immune crosstalk, immunofluorescence staining was performed on tumor tissue, and a co-culture model of CD8+ T cells and multiple myeloma cell lines was established to confirm the mechanism behind the combination’s antitumor effect.

Key Findings:

Selinexor treatment was found to upregulate CD73 expression in the majority of tumors, a resistance-associated mechanism that the combination approach was designed to counter. In the mouse model, the combination therapy suppressed tumor growth with an inhibition rate of 62%, compared with 31% for ATG-037 monotherapy and 43% for selinexor monotherapy. Single-cell RNA sequencing showed that the combination synergistically potentiated CD8+ T cell activation by enhancing the interaction between CD8+ T cells and Enpp1+ cells via the CD80–CD28 signaling pathway, and the resulting increase in CD8+ T cell infiltration into tumor tissue was confirmed by immunofluorescence staining. In co-culture experiments, CD73 inhibition was shown to strengthen selinexor-mediated tumor cell killing by activating CD8+ T cells, with significantly elevated levels of Granzyme B (P=0.0252) and IFN-γ (P=0.0067) observed in the combination group.

Conclusion:

The study highlights the synergistic potential of combining selinexor with a CD73 inhibitor for enhancing CD8+ T cell-mediated tumor cytotoxicity in MM. Selinexor therapy upregulates CD73 in the TME, driving adenosine accumulation and an immunosuppressive state. Combined use of ATG-037 blocks this immunosuppressive feedback loop via suppression of CD73-dependent adenosine synthesis, restoring CD8+ T cell activation and proliferation while enhancing T cell cytotoxicity through activation of the CD80-CD28 costimulatory axis. These findings establish a novel, clinically feasible therapeutic paradigm for addressing drug resistance and refractory MM.

(Press release, Antengene, SEP 14, 2026, View Source [SID1234670783])

FDA Approves Telix’s Brain Cancer Imaging Drug Pixclara

On September 14, 2026 Telix reported that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Pixclara (floretyrosine F 18 or 18F-FET), an amino acid positron emission tomography (PET) drug for imaging gliomas (brain cancer).

Pixclara is a radioactive diagnostic drug indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older.

PET imaging with floretyrosine F 18 (FET-PET) is recommended in international clinical practice guidelines for the imaging of gliomas, including NCCN Guidelines[1], but until now there has not been an FDA-approved product available in the U.S.

Gliomas are the most common form of central nervous system (CNS) cancer, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors[2]. In the U.S., approximately 24,000 new glioma cases are diagnosed each year[3], representing a significant unmet addressable need.

Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, "FDA approval of Pixclara will enable broad access in the U.S. to FET-PET imaging, which is already recognized in international clinical practice guidelines. As the first FDA-approved PET imaging drug for glioma, Pixclara will provide physicians in the U.S. with more certainty in their diagnoses and greater confidence in their treatment planning for patients."

Kelly Sitkin, President and CEO, American Brain Tumor Association, said, "The approval of Pixclara will advance glioma care by enabling more precise monitoring, complementing the role of MRI. We welcome the FDA’s decision, which provides a pathway to access this technology in the U.S. and helps address a critical unmet need in brain cancer diagnostics."

Patrick Wen, MD, E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, said, "Having an FDA-approved FET-PET product with high diagnostic accuracy will make a significant, positive difference to the management of patients with gliomas. This is a very positive step forward for brain cancer imaging and treatment planning."

About Pixclara (floretyrosine F 18)

Pixclara is an intravenous positron emission tomography (PET) imaging drug for the differentiation of recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older. It comprises a small molecule targeting compound labeled with a diagnostic radioisotope, fluorine-18. After administration into the bloodstream, Pixclara targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). Once bound, energy emissions from the radioisotope can be detected by a PET scanner. Pixclara (TLX101-Px) is also the subject of a Phase 3 registrational study for potential indication expansion for the diagnosis of brain metastases[4].

Pixclara is the only FDA-approved radiopharmaceutical imaging drug for glioma (brain cancer).

INDICATIONS AND USAGE
PIXCLARA is indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Risk for Misinterpretation
Image misinterpretation may occur with PIXCLARA PET. A negative image does not rule out the presence of recurrent or progressive glioma and a positive image does not confirm the presence of recurrent or progressive glioma. Equivocal findings may occur with PIXCLARA PET, including low-level or atypical uptake patterns, which may result in false positive or false negative interpretations.

Interpret PIXCLARA PET findings with caution and correlate results with available clinical evaluations, such as histopathology, cross-sectional imaging, and/or clinical history to support appropriate clinical decision-making.

Radiation Risks
PIXCLARA contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of PIXCLARA was evaluated in 382 patients with gliomas. Among these 382 patients, 371 adult patients received at least one intravenous dose of PIXCLARA at a mean activity of 204 ± 18 MBq (5.5 ± 0.47 mCi). The remaining 11 pediatric patients received at least one intravenous dose of PIXCLARA at a mean activity of 155 ± 53.5 MBq (4.2 ± 1.4 mCi).

The mean age of the patients was 57 years (range: 5 years to 86 years). Sex was 59% male, 37% female, and 3% unreported. Distribution by race was 26% White, 6% Asian, <1% Black or African American, and 67% other or unreported. Distribution by ethnicity was 3% Hispanic/Latino, 96% non-Hispanic/Latino, and <1% unknown or unreported.

Adverse reactions that occurred in ≥0.5% of patients receiving PIXCLARA were headache (0.5%).

Adverse reactions that occurred in <0.5% of patients were nausea, injection site reaction, fatigue, and malaise.

Adverse Reactions in Pediatric Patients
Overall, the safety profile observed in pediatric patients from the clinical study was consistent with the safety profile in adult patients.

(Press release, Telix Pharmaceuticals, SEP 14, 2026, View Source [SID1234670776])

Tagrisso demonstrated unprecedented eight-year landmark survival in early-stage EGFR-mutated lung cancer in ADAURA Phase III trial

On September 14, 2026 Astrazeneca reported updated exploratory results from the ADAURA Phase III trial showed Tagrisso (osimertinib) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at eight years compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.

These results were presented today during the Presidential Symposium at the IASLC 2026 World Conference on Lung Cancer (#WCLC26) hosted by the International Association for the Study of Lung Cancer in Seoul, Republic of Korea (Abstract PL03.01). These data were also simultaneously published in the Journal of Thoracic Oncology.

At eight years of follow-up, results showed that Tagrisso continued to show an OS benefit, reducing the risk of death compared to placebo by 47% in the primary population (Stages II-IIIA) (based on a hazard ratio [HR] of 0.53; 95% confidence interval [CI] 0.38-0.75). In the overall trial population (Stages IB-IIIA), Tagrisso reduced the risk of death compared to placebo by 48% (HR 0.52; 95% CI 0.39-0.71). An estimated 74% of patients treated with Tagrisso were alive at eight years versus 58% of those treated with placebo in the primary population. In the overall trial population, an estimated 79% of patients treated with Tagrisso were alive at eight years versus 64% of those treated with placebo. Consistent with the planned final analysis, OS benefit with Tagrisso versus placebo was observed across all predefined subgroups.

Roy S. Herbst, MD, PhD, Director at Dartmouth Cancer Center, and principal investigator in the ADAURA Phase III trial, said: "These ADAURA findings show patients continue to experience meaningful, long-term benefit following early intervention with adjuvant osimertinib, with a 16 per cent point improvement in overall survival at eight years versus placebo. This is especially impressive given high rates of crossover to osimertinib following disease recurrence. This durable overall survival benefit reinforces the importance of prioritising EGFR testing at diagnosis so as many patients as possible can benefit from this transformative therapy."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "ADAURA continues to set new benchmarks in early-stage EGFR-mutated lung cancer, with nearly 80 per cent of patients treated with adjuvant Tagrisso alive at eight years. These results underscore the importance of treating early and reinforce Tagrisso as the adjuvant standard of care and backbone therapy across stages of the disease."

Summary of updated OS results: ADAURAi,ii

Tagrisso
Placebo
Stages II-IIIA (primary population)
(n=233)
(n=237)
Median duration of follow-up, in months
92
68.5
OS HR (95% CI)
0.53 (0.38, 0.75)
OS rate at 96 months (95% CI), %
74 (67, 80)
58 (50, 65)
Stage IB-IIIA (overall population)
(n=339)
(n=343)
Median duration of follow-up, in months
93.3
79.6
OS HR (95% CI)
0.52 (0.39, 0.71)
OS rate at 96 months (95% CI), %
79 (74, 83)
64 (58, 70)
i The updated analysis data cut-off (DCO) date was May 4, 2026.
ii This exploratory long-term OS analysis was conducted in all randomised patients. 127 patients did not have additional survival data and remained censored, with survival time unchanged from the planned final OS analysis until 4 May 2026.
Final safety data for ADAURA were collected at the planned final OS analysis, at which time the safety and tolerability of Tagrisso were consistent with its established profile with no new safety concerns.

Complementing the ADAURA clinical trial findings, real-world evidence presented at WCLC26 from a retrospective cohort study of US patients with early-stage (I-IIIA) EGFRm NSCLC (Abstract P1.142) showed that early discontinuation of Tagrisso before completion of the three-year treatment course more than doubled the risk of disease recurrence or death. These results reinforce the importance of maintaining the full treatment duration established in ADAURA and underscore the need for clinician-patient communication to support treatment persistence.

In the advanced disease setting, additional data presented at WCLC26 from the FLAURA2 Phase III trial reinforced the benefits of backbone therapy Tagrisso in combination with platinum-pemetrexed chemotherapy in patients with 1st-line advanced EGFRm NSCLC. Results from a novel safety analysis (Abstract PT2.03.03) showed that with long-term follow-up (median 42.6 months), the safety and tolerability of Tagrisso plus platinum–pemetrexed remained consistent with the established safety profiles of these medicines, with clear reductions in new adverse event onset following the initial induction period. Additionally, an exploratory analysis (Abstract P2.237) showed that progression-free survival and OS HRs numerically favoured Tagrisso plus platinum–pemetrexed versus Tagrisso monotherapy regardless of baseline TP53 co-mutation status.

Notes
NSCLC
Lung cancer is the leading cause of cancer death globally, accounting for almost one in five (19%) cancer deaths.1-2 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC.3 Approximately 75% of NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.4-5 Early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition.6

For patients with resectable tumours, the majority eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy.7 Further, 73% of patients with Stage IB and 56-65% of patients with Stage II disease will survive for five years. This decreases to 41% for patients with Stage IIIA.8

Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.9-11 These patients are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor (EGFR-TKI) which block the cell-signalling pathways that drive the growth of tumour cells.12

ADAURA
ADAURA was a randomised, double-blind, placebo-controlled, global Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumour resection and, at physicians’ and patients’ discretion, adjuvant chemotherapy. Patients were treated with Tagrisso 80mg once-daily oral tablets or placebo for three years or until disease recurrence.

The trial was enrolled in more than 200 centres across more than 20 countries, including the US, Europe, South America, Asia and the Middle East. The primary endpoint was disease-free survival (DFS) in Stage II and IIIA patients and key secondary endpoints included DFS in Stage IB, II and IIIA patients, and OS in both the primary and overall populations.

The exploratory analysis presented at WCLC26 was conducted in all randomised patients including complete or partial extended long-term survival data from approximately 77% of those patients who were still alive at the final planned OS analysis DCO. This included trial participants with additional survival data up until the 4 May 2026 DCO or from accessible medical records/information from last contact date. 127 patients did not have additional survival data and remained censored, with survival time unchanged from the planned final OS analysis until 4 May 2026.

Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including the treatment of central nervous system metastases. Tagrisso (40mg and 80mg QD oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.

Tagrisso is approved as monotherapy in more than 120 countries including the US, EU, China and Japan. Approved indications include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, adjuvant treatment of early-stage EGFRm NSCLC and locally advanced, unresectable NSCLC following platinum-based chemoradiation therapy. Tagrisso is also approved in combination with chemotherapy in more than 80 countries, including the US, EU, China and Japan, for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

There is an extensive body of evidence supporting the use of Tagrisso in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.

In late-stage disease, Tagrisso demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. Tagrisso is also being investigated in this setting in combination with Orpathys (savolitinib) in the SAFFRON Phase III trial and in combination with Datroway (datopotamab deruxtecan) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

In addition to ADAURA, Tagrisso also showed improved outcomes in early-stage disease in the NeoADAURA Phase III trial and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

(Press release, AstraZeneca, SEP 14, 2026, View Source [SID1234670775])