On June 2, 2026 Hummingbird Diagnostics GmbH, a molecular diagnostics company focused on blood-based tests for early disease detection and precision medicine, reported that it will present new findings supporting the biological and clinical relevance of its liquid biopsy RNA biomarkers in lung cancer at the upcoming EACR Congress, taking place June 8-11 in Budapest, Hungary.

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The poster provides new insight into how ribosome stress and activation of ribosome quality control (RQC) pathways drive the generation of specific small RNA biomarkers detectable in liquid biopsy samples from lung cancer patients.

The data show that challenging the protein synthesis machinery in cancer cells leads to ribosome stalling and collisions, thereby triggering RQC pathways that generate biomarker precursor molecules. These are subsequently secreted and matured extracellularly, enabling detection in patient-derived samples. The findings further suggest a link between ribosomal RNA methylation dynamics, biomarker biology, and cellular sensitivity to ribotoxic stress.

"These findings strengthen the biological foundation of our liquid biopsy approach and provide compelling evidence linking ribosome stress-sensing pathways directly to measurable small RNA biomarkers’ signal," said Rastislav Horos, CTO of Hummingbird. "Importantly, this work supports the potential of our technology not only for cancer detection but also for identifying patients with specific biological vulnerabilities that may inform treatment decisions."

The study suggests that using an RNA biomarker biogenesis cascade reflecting ribosome stress and quality control activity may help identify patients more likely to respond to therapies that induce RNA damage, such as chemotherapy, supporting improved patient stratification and more precise treatment approaches.

"There remains a significant unmet need for an assay that can guide treatment decisions in lung cancer, especially for patients with unknown tumor-driving mutations, or those where biopsy is not possible," said Dr. Michal Urda, Head of the Department of Pneumology and Phtiseology, University Hospital F.D. Roosevelt, Banská Bystrica, Slovakia. "Such a liquid biopsy assay may help identify patients with increased sensitivity to therapy and thus support more personalized treatment approaches."

Abstract#1530, 09.06.2026, Hall H

(Press release, Hummingbird Diagnostics, JUN 2, 2026, View Source [SID1234666392])

On June 2, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, reported the Society for Advanced Bronchoscopy (SAB) will host a webinar on CyPath Lung’s expanding role in pulmonary, oncology and surgical practices for the detection and management of early-stage lung cancer.

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The live webinar, "Navigating Lower Cancer-Risk Nodules in High-Risk Patients with Noninvasive CyPath Lung Testing," will take place Tuesday, June 16, at 7 p.m. ET. Clinicians, pulmonologists, oncologists, thoracic surgeons, healthcare professionals and the public are invited to register here (https://bit.ly/3PaFPSR) for the complimentary education event.

"We are seeing a significant increase in patients with indeterminate lung nodules as a result of expanded lung cancer screening and imaging for other conditions. When we consider not only prior smoking history but also an aging population, environmental and occupational exposures, and a better understanding of genetic predispositions, we recognize the real clinical challenges of managing this condition, of distinguishing between malignant and benign nodules," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies.

"Advanced navigational bronchoscopy serves as an accurate tool to diagnose lung cancer without major surgery, particularly in nodules greater than a centimeter. For smaller nodules, CyPath Lung complements bronchoscopy by helping to risk stratify and identify patients who should move forward with more invasive follow-up," Dr. Downie said.

Moderated by pulmonologist Robert Sussman, MD, former Medical Director of the Atlantic Health System Pulmonary Clinical Research Center, the webinar will feature:

● Vijay K. Gunuganti, MD – Medical oncologist and hematologist at Texas Oncology
● Reginald Carl Baptiste, MD – Thoracic and cardiovascular surgeon at Christus St. Michael Health System
● Sai Karan Vamsi Guda, DO – Director of Interventional Pulmonary at Texas Pulmonary and Critical Care Consultants, P.A.

The panel will discuss how CyPath Lung, a noninvasive test that uses automated flow cytometry and artificial intelligence to analyze the lung microenvironment, is being incorporated into their practice to help:

● aid in the detection of lung cancer at its earliest and most treatable stages
● support surgical and treatment decision-making
● lower overall healthcare costs by reducing unnecessary invasive procedures
● support surveillance of cancer patients after they complete treatment.

"We are honored to collaborate with the Society for Advanced Bronchoscopy to provide clinicians with an opportunity to discuss innovative tools like CyPath Lung that support earlier intervention leading to better patient outcomes," said Maria Zannes, President and CEO of bioAffinity Technologies.

About the Society for Advanced Bronchoscopy

The Society for Advanced Bronchoscopy (SAB) is a national organization dedicated to advancing the field of bronchoscopy through innovation, collaboration and education. Founded to improve patient outcomes, SAB fosters excellence in interpretive skills, technical knowledge, research, and training for advanced bronchoscopic techniques. The society unites a multidisciplinary community – including physicians, advanced practice providers, respiratory therapists, and technologists – to push the boundaries of minimally invasive lung diagnostics and interventions, ultimately transforming the standard of care and enhancing the diagnosis and treatment of respiratory diseases worldwide.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

(Press release, BioAffinity Technologies, JUN 2, 2026, View Source [SID1234666361])

On June 2, 2026 Astrazeneca reported positive results from the Phase III SERENA-6 trial showed camizestrant plus a cyclin-dependent kinase (CDK) 4/6 inhibitor – palbociclib, ribociclib or abemaciclib – maintained its progression-free survival (PFS) benefit with longer follow-up and delivered a statistically significant and clinically meaningful improvement in second progression-free survival (PFS2), demonstrating sustained benefit beyond initial treatment. Additionally, exploratory analyses showed that the camizestrant combination profoundly reduced total circulating tumour DNA (ctDNA) and enabled substantially more patients to achieve total ctDNA clearance.

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The trial evaluated switching to the camizestrant combination before progression in the 1st-line setting versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor following detection of an ESR1 mutation in patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer.

SERENA-6 met its primary endpoint of PFS at the interim analysis, with results first presented at last year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and simultaneously published in The New England Journal of Medicine.1 The updated results will be presented today during the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (abstract LBA1007).

The updated results showed the camizestrant combination reduced the risk of disease progression or death by 55% versus an AI plus a CDK4/6 inhibitor (based on a hazard ratio [HR] of 0.45; 95% confidence interval [CI] 0.34-0.59; p<0.00001). Median PFS was 16.8 months for the camizestrant combination compared with 9.2 months for the AI combination, representing a median improvement of 7.6 months.

Importantly, the PFS benefit observed with the camizestrant combination was sustained beyond initial progression. For the key secondary endpoint of PFS2, a measure of treatment durability beyond first progression, the final PFS2 analysis showed that the camizestrant combination reduced the risk of second disease progression or death by 37% versus the comparator arm (HR 0.63; 95% CI 0.46-0.86; p=0.00373), indicating that the benefit of switching to camizestrant plus a CDK4/6 inhibitor was maintained even after patients received subsequent therapies.​ Median PFS2 was 25.7 months for the camizestrant combination compared with 19.1 months for the AI combination.

The camizestrant combination also demonstrated substantially greater reductions in total ctDNA in blood than continued treatment with an AI plus a CDK4/6 inhibitor at week 4 and/or week 8 after randomisation. Patients who switched to the camizestrant combination had a median 99% reduction in total ctDNA by week 8, with 51% achieving total ctDNA clearance, compared with a median 64% increase in total ctDNA by week 8, and 1.9% total ctDNA clearance among patients who remained on the AI combination. These results show the early effect of switching to camizestrant on ctDNA which is linked to tumour burden reduction.

Clearance of total ctDNA during treatment has been associated with long-term clinical benefit including improved overall survival (OS) across tumour types, including in patients with HR-positive, HER2-negative advanced breast cancer receiving endocrine-based therapy plus a CDK4/6 inhibitor.2,3 In an exploratory analysis pooled across both arms in SERENA-6, total ctDNA clearance was associated with OS benefit (HR 0.39; 95% CI 0.19-0.73), consistent with other studies.

Data for the key secondary endpoint of OS showed a numerical trend favouring the camizestrant combination (HR 0.87; CI 0.57-1.30) at 30% maturity. ​The trial will continue to final analysis to assess OS.

François-Clément Bidard MD, PhD, Professor of Medical Oncology at Institut Curie & Versailles University (Paris/Saclay) France and co-principal investigator for the trial, said: "Optimising outcomes for patients with HR-positive advanced breast cancer early in their treatment is critical because once the disease progresses, it becomes harder to treat and outcomes worsen. The updated SERENA-6 results support the paradigm of switching to a camizestrant-based combination in the first-line setting upon emergence of an ESR1 mutation and demonstrate durable improvements beyond initial treatment. These results should change how we approach treating patients with HR-positive disease in the first-line setting."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "More than half of patients who switched to the camizestrant combination completely cleared tumour DNA from their bloodstream compared to two per cent with standard of care. This provides robust evidence that an early treatment switch has strong anti-tumour efficacy, and supports the potential for long-term clinical benefit. Switching to the camizestrant combination also extended the time patients lived without disease progression after first- and second-line treatment, delayed the need for more intensive therapies, and helped patients maintain their quality of life. Together, these results add to the growing data supporting the potential of the camizestrant combination to improve outcomes for these patients with advanced breast cancer."

Summary of results: SERENA-6 at ASCO (Free ASCO Whitepaper) 2026

Camizestrant + CDK4/6 inhibitor

AI + CDK4/6 inhibitor

PFSi

Number of patients (n)

157

158

Median PFS (months)

16.8 (14.7-19.4)

9.2 (7.2-9.7)

24-month PFS rate

34.9%

14.2%

Hazard ratio (95% CI)

0.45 (0.34-0.59)

p-value

p<0.00001

PFS2ii

Number of patients (n)

157

158

Median PFS2 (months)

25.7 (20.4-30.3)

19.1 (16.8-21.0)

24-month PFS2 rate

50.8%

36.3%

Hazard ratio (95% CI)

0.63 (0.46-0.86)

p-value

p=0.00373

OSiii

Events, n (%)

46 (29.3)

49 (31.0)

Hazard ratio (95% CI)

0.87 (0.57-1.30)

Change in total ctDNA

Median change from baseline at week 8

-99%

+64%

Total ctDNA clearanceiv

Number of patients with clearance/total analysed

50/98

2/108

Patients with total ctDNA clearance (%)

51.0

1.9

CI, confidence interval; HR, hazard ratio; PFS, progression-free survival; PFS2, progression-free survival 2; OS, overall survival

i PFS was defined per RECIST v1.1. HR was estimated using a Cox proportional hazards model adjusted for stratification factors
ii PFS2 was defined as time from randomisation to the earliest of disease progression following first subsequent therapy or death; results represent final PFS2 analysis
iii Intent-to-treat patient population; maturity was 30%
iv ctDNA clearance defined as the transition from quantifiable total ctDNA at baseline by Guardant360 assay to undetectable ctDNA after treatment at Week 4 and/or Week 8

Additional analyses showed that the camizestrant combination delayed the need for more intensive subsequent treatment, including chemotherapy or antibody-drug conjugates (ADCs). Median chemotherapy/ADC-free survival was 22.6 months for the camizestrant combination versus 18.7 months for the AI combination (HR 0.64; 95% CI 0.47-0.87; p=0.00375). The camizestrant combination was also associated with delayed deterioration in patient-reported cancer symptoms such as pain, global health status and quality of life.

The safety profile of camizestrant in combination with palbociclib, ribociclib or abemaciclib in the SERENA-6 trial was consistent with the known safety profile of each medicine. No new safety concerns were identified, and discontinuations were very low and similar in both arms.

Camizestrant is approved in the United Arab Emirates and Saudi Arabia based on the SERENA-6 trial. The European Medicines Agency’s Committee for Medicinal Products for Human Use recently adopted a positive opinion recommending approval of the camizestrant combination in the European Union based on the results of the SERENA-6 Phase III trial.

Regulatory applications are also currently under review in the US, Japan and several other countries. The US Food and Drug Administration last week extended the Prescription Drug User Free Act date to review the updated results from the SERENA-6 trial.

Notes

HR-positive breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.4 More than two million patients were diagnosed with breast cancer in 2022, with more than 665,000 deaths globally.4 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.5

HR-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative.5 More than 97% of HR-positive breast cancer tumours are estrogen receptor (ER)-positive. ERs often drive the growth of HR-positive breast cancer cells.6

Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target ER-driven disease, which are often paired with CDK4/6 inhibitors.7-9 However, resistance to these therapies develops in many patients.9 Once this occurs, treatment options are limited and survival rates are low with approximately 36% of patients anticipated to live beyond five years after diagnosis.5,9

Mutations in the ESR1 gene are a key driver of endocrine resistance and are associated with poor outcomes, emerging during treatment of the disease and becoming more prevalent as the disease progresses.10,11 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment before disease progression.7

The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research.

SERENA-6
SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation.

The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment.

SERENA-6 is the first global, registrational Phase III trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The innovative trial design used ctDNA monitoring via a blood test at the time of routine tumour scans every two to three months to identify patients for early signs of endocrine resistance via the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to camizestrant from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor.

Camizestrant
Camizestrant is an investigational, potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer.

AstraZeneca’s broad, robust and innovative clinical development programme, including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is evaluating the safety and efficacy of camizestrant when used as a monotherapy or in combination with CDK4/6 inhibitors to address a number of areas of unmet need in HR-positive, HER2-negative breast cancer.

Camizestrant has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated a statistically significant and clinically meaningful improvement in PFS versus Faslodex (fulvestrant) in the overall trial population, including in patients with ESR1 tumour mutations irrespective of prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumour profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors.

(Press release, AstraZeneca, JUN 2, 2026, https://www.astrazeneca.com/media-centre/press-releases/2026/camizestrant-combination-delayed-time-to-first-progression-in-patients-with-advanced-hr-positive-breast-cancer-with-an-ESR1-tumour-mutation.html [SID1234666377])

On June 2, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that updated data from the Company’s novel BCL2 inhibitor mesutoclax in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) has been released at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting as an oral presentation titled "Safety, tolerability, and efficacy of mesutoclax (ICP-248) in combination with azacitidine in patients with myeloid malignancies", demonstrating outstanding efficacy and safety.

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As of April 20, 2026, among evaluable treatment-naïve (TN) MDS patients, the overall response rate (ORR) per IWG 2006 criteria was 100%, including a complete response (CR) rate of 40%, and marrow CR rate of 60%. The composite CR rate was 90% per IWG 2023 criteria, including a CR rate of 60%.

As of April 13, 2026, among the evaluable TN AML patients, 81.8% achieved composite CR (cCR, CR+CRi), and 86.5% were MRD (Minimal Residual Disease) negative. Among cCR responders, 83% achieved cCR in the first treatment cycle, demonstrating that the mesutoclax regimen enables rapid and deep remissions. In the 125mg mesutoclax group, the 6-month duration of response (DOR) rate and overall survival (OS) rate were 93.3% and 90.5% respectively. In TN AML patients with TP53 mutations, the cCR rate was 71.4% and the 6-month DOR rate exceeded 50%.

No dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. Most non-hematologic adverse events were grade 1 or 2. Due to the robust efficacy of the regimen, patients achieved rapid cytopenia recovery. Among TN AML patients, the mortality rate was 0% at both 30 or 60 days.

(Press release, InnoCare Pharma, JUN 2, 2026, View Source [SID1234666393])

On June 2, 2026 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) reported that SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), reported positive results from prespecified interim analyses of two Phase 3 studies evaluating izalontamab brengitecan (iza-bren), an investigational and potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC). The studies demonstrated iza-bren achieved statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) in heavily pretreated, unresectable locally advanced or metastatic triple-negative breast cancer (TNBC; PANKU-Breast02/BL-B01D1-307) and recurrent or metastatic esophageal squamous cell carcinoma (ESCC; PANKU-Esophagus01/BL-B01D1-305). These data, presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, support iza-bren’s potential as a new standard of care in these challenging cancer types.

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Iza-bren has now shown clinical benefit in three Phase 3 trials, underscoring its broad therapeutic potential. PANKU-Breast02 is the first Phase 3 study of a bispecific ADC to report positive results for dual primary endpoints of both PFS and OS in TNBC, while PANKU-Esophagus01 marks the first Phase 3 trial of a bispecific ADC in esophageal cancer to report positive dual primary endpoints of both PFS and OS. Iza-bren previously demonstrated positive phase 3 results in recurrent or metastatic nasopharyngeal carcinoma (NPC), presented at ESMO (Free ESMO Whitepaper) 2025.

"As a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate, iza-bren has now shown significant clinical benefit in three Phase 3 trials in different cancer types, and the strength of these data presented at ASCO (Free ASCO Whitepaper) further reinforce the value iza-bren can deliver over current standards of care," said Dr. Yi Zhu, chief executive officer of Biokin. "We are proud to share these results as we continue to evaluate iza-bren to unlock the full potential of this dual mechanism of action to improve outcomes for patients in need."

"Iza-bren can address a critical gap for patients who develop resistance or experience disease progression after prior therapies and may also hold potential in earlier lines of therapy," said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. "We have a broad development program for iza-bren and believe it has the potential to be a cornerstone treatment in a number of different cancers and easily combined with other therapies."

Results from the Interim Analysis of PANKU-Breast02 (BL-B01D1-307)

The Phase 3 PANKU-Breast02 trial evaluated iza-bren in patients with unresectable locally advanced or metastatic TNBC whose disease progressed following 1-2 prior lines of systemic therapy for advanced disease, including prior taxane therapy. Patients were randomized 1:1 to receive iza-bren (n=207) or physician’s choice of chemotherapy (TPC; n=211), which included eribulin, capecitabine, gemcitabine, or vinorelbine. The study met both dual primary endpoints at a prespecified interim analysis, demonstrating a statistically significant and clinically meaningful improvement in OS and BICR-assessed PFS with iza-bren compared to TPC.

With a median follow-up of 11 months, median OS was 15.9 months with iza-bren vs. 12.5 months with TPC (HR: 0.60; 95% CI: 0.42-0.85; p=0.0019)
Median PFS by Blinded Independent Central Review (BICR) was 8.5 months with iza-bren vs. 3.1 months with TPC (HR: 0.29; 95% CI: 0.22-0.38; p<0.0001)
The confirmed objective response rate (ORR) assessed by BICR was 51.7% with iza-bren compared to 20.5% with TPC (odds ratio, 4.3; 95% CI: 2.8-6.7)
"While there have been significant advancements in breast cancer treatment, advanced triple-negative breast cancer has remained a challenge, with patients facing poor outcomes," said Dr. Jiong Wu, Fudan University Shanghai Cancer Center. "These results highlight the potential for iza-bren to be a new standard of care as the first bispecific ADC to show improved progression-free and overall survival in a Phase 3 study in this patient population."

Iza-bren showed a manageable safety profile in this heavily pre-treated patient population, with no new safety signals observed. Grade >3 treatment-emergent adverse events (TEAEs) were predominantly hematologic toxicities and consistent with the known safety profile of iza-bren. Any grade interstitial lung disease (ILD) was reported in 3 (1.4%; 1 case of grade 1 and 2 cases of grade 2) patients treated with iza-bren and 0 patients treated with TPC. Treatment discontinuation due to TEAEs occurred in 4 (1.9%) patients treated with iza-bren and 1 (0.5%) patients treated with TPC.

Results from the Interim Analysis of PANKU-Esophagus01 (BL-B01D1-305)

The Phase 3 PANKU-Esophagus01 trial evaluated iza-bren in patients with recurrent or metastatic esophageal squamous cell carcinoma who had progressed after first-line treatment with a PD-1/PD-L1 inhibitor plus platinum-based chemotherapy (n=249) compared to chemotherapy of physician’s choice (n=248). Results from the interim analysis show iza-bren demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of OS and BICR-assessed PFS.

Median OS was 9.8 months with iza-bren vs. 7.2 months with chemotherapy (HR: 0.64; 95% CI: 0.49-0.83; p=0.0004).
Median PFS by BICR was 4.2 months with iza-bren vs. 2.0 months with chemotherapy (HR:0.50; 95% CI: 0.40-0.63; p<0.0001).
Iza-bren also demonstrated an improvement in responses with an ORR by BICR of 35.3% compared to 13.1% with chemotherapy.
"Metastatic esophageal squamous cell carcinoma is an aggressive disease with a five-year survival rate of less than 5%, and there remains a critical unmet need for treatment options after first-line immunotherapy and chemotherapy," said Dr. Lin Shen, Peking University Cancer Hospital and Institute. "As the first Phase 3 clinical trial of a novel EGFRxHER3 bispecific antibody-drug conjugate to report positive data in this patient population, these results show the potential for iza-bren to set a new benchmark in significantly extending survival for patients with recurrent or metastatic esophageal squamous cell carcinoma."

Iza-bren also showed a manageable safety profile in this patient population. Grade >3 treatment-related adverse events (TRAEs), which were predominantly hematologic toxicities, occurred in 85.1% of patients treated with iza-bren and 60.2% of patients who received chemotherapy. TRAEs that led to treatment discontinuation occurred in 2% of patients treated with iza-bren and 3.3% treated with chemotherapy. Treatment-related deaths occurred in 1.2% of patients treated with iza-bren and 1.6% of patients treated with chemotherapy. The rates of all grades and grade >3 ILD were low in the iza-bren arm (1.6%/0.8%) and the chemotherapy arm (0.4%/0.4%).

A New Drug Application for iza-bren for the treatment of recurrent or metastatic esophageal squamous cell carcinoma has been accepted by the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) and included in the priority review process.

The PANKU-Breast02 and PANKU-Esophagus01 studies are sponsored by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), in Mainland China. Outside of China, iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement.

About iza-bren

Iza-bren (BL-B01D1) is a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death.

(Press release, Bristol-Myers Squibb, JUN 2, 2026, View Source [SID1234666362])