On August 17, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", Stock Code: 6990.HK) reported its unaudited consolidated results for the period ended 30 June 2026 (the "Reporting Period").

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Key information is as follows:

Revenue amounted to approximately RMB 978 million, with sales of pharmaceutical products reaching RMB 657 million, up by 112% compared to the same period last year, driven by two factors: expert recognition of high quality clinical data and shift in treatment paradigms, and comprehensive enhancement of drug accessibility.
The Company has established a comprehensive operational system in China encompassing R&D, manufacturing, quality management, and commercialization, with integrated drug development capabilities. The Company is also pursuing global expansion through international collaborations, leveraging external partnerships to accumulate global clinical development and commercialization experience, while exploring diversified pathways to progressively achieve independent overseas market entry.
Focusing on ADC and novel DC, the Company not only has two ADC products that have been approved for marketing, but has also built a product pipeline that is differentiated and complimentary to approved ADCs in indications, efficacy performance and safety profile. Through the free combination of conjugation drug components, as well as the pairing with a diverse range of targeting conjugates including antibodies, small molecules, and peptides that leverage TAA/IO/ anti-angiogenetic-based mechanisms, the Company has proactively positioned innovative DC assets, including single-payload DCs such as radioisotope-based/ immuno-agonist-based/degrader-based, and dual-payload DCs such as cytotoxin + cytotoxin or immuno-agonist or degrader combinations, among others.
Doubling down on ADC + IO therapies, including the combination of ADCs with PD-(L)1 or PD-1/VEGF agents, as well as the development of drug candidates with synergetic MoAs within one ADC compound.
Beyond oncology, the Company has also expanded into important therapeutic areas such as autoimmune and metabolic diseases, and is currently conducting multiple clinical studies for asthma, chronic obstructive pulmonary disease (COPD), and atopic dermatitis.
Clinical development progresses efficiently, with a tiered expansion of the pipeline matrix

Focusing on high-incidence tumors such as lung cancer and breast cancer, the Company has built a well-layered clinical pipeline with significant synergistic potential, covering drug modalities including ADCs, immunotherapies, and small-molecule targeted therapies, while further expanding into major therapeutic areas such as autoimmune and metabolic diseases.

Approved ADC Products

Sac-TMT (TROP2 ADC, sacituzumab tirumotecan) (also known as SKB264/MK-2870) (佳泰莱)
The product has currently received marketing approval for four indications, namely 2L+ TNBC, 2L/3L EGFR-mutant NSCLC, and 2L+ HR+/HER2- BC. In addition, two new indication drug applications have been accepted for review, covering the combination with pembrolizumab for 1L PD-L1-positive NSCLC, and as a monotherapy for 1L TNBC.

Clinical progress in the reporting period:

Marketing approval for 2L+ HR+/HER2- BC
New indication drug applications accepted for 1L TNBC and 1L PD-L1-positive NSCLC
The OptiTROP-Lung06 registrational trial in China for 1L PD-L1-negative non-squamous NSCLC met primary endpoint
The global Phase 3 TroFuse-005 trial for 2L+ EC met primary endpoints
Two global Phase 3 trials for OC & UC initiated in H1 2026
Phase 2 study in combination with SKB118 for NSCLC initiated
Granted BTD for 1L PD-L1-positive NSCLC from NMPA
Drawing on all the aforementioned key advances, sac‑TMT has clearly embodied four core development strategies: advancing from monotherapy to combo-therapy, shifting from later-line to earlier-line treatment settings, expanding indications, and conducting clinical research from China to the global.

Trastuzumab botidotin (HER2 ADC, also known as A166) (舒泰莱)
One indication has received marketing approval for the treatment of 2L+ HER2+ BC. Its Phase 2 clinical study in HER2+ BC patients previously treated with topoisomerase inhibitor ADCs is ongoing.

Other ADC and novel DC assets

The Company has also built a pipeline of innovative assets that are differentiated from and complementary to approved ADCs in indications, efficacy and safety profile, including SKB315 (CLDN18.2 ADC), SKB410 (Nectin-4 ADC), SKB571 (novel bsADC), SKB107 (RDC), SKB103 (TAA-IO bsADC), and SKB565 (novel dual-payload ADC), among others.

Non-DC Assets

Clinical progress in the reporting period:
SKB118/CR-001 (PD-1/VEGF bsAb): The IND application for the treatment of solid tumors has been approved by the NMPA, and a Phase 1/2 clinical trial is ongoing.
SKB378/WIN378 (TSLP mAb): A Phase 1 clinical trial in healthy subjects has been completed in China, and its IND application for the treatment of COPD has also been approved by the NMPA.
SKB575 (TSLP/undisclosed target bsAb): Phase 1 clinical trials for atopic dermatitis and asthma are ongoing in China.

Major Key Research Findings Presented at International Academic Conferences & Journals

The Phase 3 trial evaluating sac-TMT plus pembrolizumab versus pembrolizumab monotherapy for first-line treatment of PD-L1-positive advanced NSCLC was delivered as an oral presentation at ASCO (Free ASCO Whitepaper) 2026 and concurrently published in The Lancet. Compared with single-agent immunotherapy, this combination regimen yielded a significant prolongation in PFS (HR = 0.35), with consistent PFS benefits observed across all predefined subgroups; an OS benefit trend was also observed (HR = 0.55).
The final OS analysis results from the pivotal study of sac-TMT for 3L EGFR-mutant NSCLC were selected as a LBA at ELCC 2026 and presented as a mini oral presentation.
Lunbotinib Fumarate Capsules (RET inhibitor, also known as A400/EP0031) (宁泰莱[1]): Key Phase 2 clinical results for advanced RET fusion-positive NSCLC were presented in an oral presentation at ASCO (Free ASCO Whitepaper) 2026.
Multiple products gain market traction, with robust commercial growth momentum

To date, the Company has received marketing authorization for sac-TMT (佳泰莱), tagitanlimab (科泰莱), Cetuximab N01 (达泰莱) and trastuzumab botidotin (舒泰莱), of which 3 products covering 5 indications have been included in the National Reimbursement Drug List (NRDL). The Company has also submitted an NDA for Lunbotinib Fumarate Capsules, and upon regulatory communication and marketing approval, commercialization is expected to commence in the first half of 2027. With this, the Company’s initial commercial product portfolio, comprising 5 products, has taken shape.

In the first half of 2026, the total revenue from sales of pharmaceutical products reaching RMB 657 million, up by 112% compared to the same period last year.

Major growth drivers:

Expert Recognition of High‑Quality Clinical Data and Shift in Treatment Paradigms:

Data from a number of high‑quality clinical studies of international caliber have continued to be released, thereby continuously reinforcing the evidence-based clinical foundation of our products.
Recognized through authoritative endorsement from clinical guideline experts, as reflected in guidelines (CSCO, etc.) and clinical expert consensus.
佳泰莱 is recognized as the "standard of care in 2L and the preferred regimen in 3L" in the LC, and is also the preferred brand among TROP2 ADC in TNBC.
Through ongoing medical education and academic exchange activities, clinicians have gained a deeper understanding of the products. Treatment paradigms have also evolved gradually.
Comprehensive Enhancement of Drug Accessibility

Effective translation of the benefits of NRDL inclusion: 3 indications of 佳泰莱 and 达泰莱 have been included in the 2025 NRDL, which officially took effect on January 1, 2026. This marks 佳泰莱 the only TROP2 ADC and the only domestic ADC in TNBC/NSCLC under the NRDL
Broader hospital access channels: Covers 30 provinces, over 300 prefectures and over 2,000 hospitals; Broaden reimbursement channels, including formal access, temporary procurement and dual-channel reimbursement;
Continuous expansion of the commercialization team: Established a team of 800+; nearly doubling YoY; Achieved extensive grassroots coverage of top-tier hospitals in high-potential districts
Sac-TMT (佳泰莱) achieved positive results in its first global Phase 3 trial, accelerating global collaboration progress

Collaboration with Merck Sharp & Dohme (hereinafter referred to as the "MSD") (默沙东): MSD has initiated 17 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other agents for several types of cancer, with indications covering breast cancer (BC), lung cancer (LC), gynecologic cancers, gastrointestinal (GI) cancers, and genitourinary (GU) cancers.
In May 2026, MSD announced that the pivotal Phase 3 Trofuse-005 trial met its primary endpoints of OS and PFS in certain patients with advanced or recurrent EC. TroFuse-005 is the first global Phase 3 trial to demonstrate statistically significant improvement in both OS and PFS compared to chemotherapy for these patients, and sac-TMT is the first and only ADC to do so for patients with EC in this setting.
Beyond sac‑TMT, the Company has also entered into collaborations with MSD on certain ADC assets, continuously exploring the optimal ADC pipeline portfolio.
Collaboration with Ellipses Pharma: Lunbotinib Fumarate Capsules (A400/EP0031) have received FDA approval to proceed into Phase 2 clinical development. A total of 42 clinical trial sites has been established in the United States, UK, Europe, and the United Arab Emirates for Lunbotinib Fumarate Capsules.
Collaboration with Windward Bio: Windward Bio is evaluating SKB378/WIN378 in the POLARIS Phase 2/3 global trial in patients with asthma and has dosed the first patients in the SIRIUS Phase 2 global study in patients with COPD.
Collaboration with Crescent Biopharma: Entered into a licensing collaboration with Crescent Biopharma for SKB105/CR-003.
ESG capabilities continue to strengthen, delivering outstanding results in capital market performance.

In terms of ESG, in May 2026, the Company was included in the "China ESG Impact List" by Fortune and was awarded bronze medal for "Most Committed to ESG (China)" under "Asia’s Best Company" by FinanceAsia. In March 2026, the Company had received a rating of "AA" in the MSCI ESG Rating Assessment.

In terms of capital markets, the Company was approved by the Hong Kong Stock Exchange to officially remove the "B" marker from its stock code on April 14, 2026. In addition, the Company completed the placing of H Shares in July 2026, with net proceeds from the Placing amounting to approximately HK$2,723.4 million.

Prospect

Kelun-Biotech will continue to drive innovation and strengthen its operational capabilities, steadily advancing towards becoming a world-class biopharmaceutical company. Specifically, the Company will implement the following development strategies: advancing differentiated pipelines targeting indications with significant medical needs; optimizing payload-linker strategies and novel DC designs and structures, while expanding applications in non-oncology diseases; enhancing its end-to-end drug development and commercialization capabilities; expanding its global footprint through strategic partnerships and improve our capabilities for the development, registration and commercialization of our products in ex-China market; and optimizing its operational systems with the aim of becoming a leading global biopharmaceutical company.

(Press release, Kelun, AUG 17, 2026, View Source [SID1234670191])

On August 17, 2026 OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, reported dosing of the first patient following the clearance of the Investigational New Drug (IND) application for a Phase 1 clinical trial (NCT07408258) of ONC-783, the company’s investigational T-cell engager developed based on the proprietary neoCD24 platform.

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"This milestone demonstrates OncoC4’s leading position in developing first-in-class cancer therapeutics," said Dr. Yang Liu, CEO and Chief Scientific Officer, "CD24 is expressed in nearly 70% of human cancers 1, and abnormal glycosylation in malignant cells produces the neoCD24 epitope that is largely absent from the normal tissues. By exploiting this cancer-specific epitope, ONC-783 is designed to maximize selectivity for tumor cells while minimizing the risk of on-target/off-tumor toxicity that has limited other T-cell engagers."

ONC-783 is the world’s first and only clinical stage T-cell engager targeting the cancer-specific glycoform of CD24 (neoCD24). The drug candidate is designed to address the limitations of existing immunotherapies by selectively targeting the tumor-specific epitope while redirecting T cells for potent anti-tumor activity. Preclinical studies have demonstrated broad anti-tumor activity for ONC-783 across multiple solid tumor and hematologic malignancies, including pancreatic cancer, lung cancer, breast cancer, colorectal cancer, ovarian cancer, glioblastoma, and mantle cell lymphoma, which supports the potential of ONC-783 as a treatment across multiple tumor types. In addition, a subcutaneous formulation was developed for ONC-783 to enable gradual systemic exposure and provide a potential safety advantage compared with intravenously administered T-cell engagers.

"We are extremely excited to partner with OncoC4 to explore the potential of targeting neoCD24 to bring clinical benefit for cancer patients with limited treatment options," added Dr. Aiwu Ruth He, Professor of Medicine and medical oncologist at Columbia University Irving Medical Center in New York City. "Advanced solid tumors remain a significant challenge, and this innovative mechanism offers a promising new approach for patients who have progressed or intolerant to standard therapy."

ONC-783 is being tested in ONC-783-001, a Phase 1 trial in the US for patients with advanced solid tumors. The first study patient was successfully dosed at Columbia University Irving Medical Center. The treatment was well tolerated. No severe Adverse Events, Cytokine Release Syndrome, or Immune Effector Cell-Associated Neurotoxicity Syndrome have been observed to date. OncoC4 will continue the innovation in cancer immunotherapy and remain committed to the development of first-in-class therapeutics to address the unmet needs in cancer treatments.

About ONC-783-001

ONC-783-001 is a Phase 1 open-label, dose-escalation study in the United States (U.S.) to evaluate the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer. OncoC4 has engaged several clinical centers across the U.S. to recruit patients for ONC-783-001 including Columbia University Irving Medical Center and The University of Texas MD Anderson Cancer Center. The clinical trial registration number is NCT07408258.

About the NeoCD24 Platform

CD24 is expressed in nearly 70% of human cancers1, along with a significant level of expression also in normal tissues, where it plays a key role in regular cell growth, tissue maintenance, and immune system function. Targeting CD24 as a cancer treatment has been challenging due to the lack of selectivity to tumor cells. OncoC4 has discovered that abnormal glycosylation in malignant cells produces the neoCD24 epitope, a tumor-specific antigen that is largely absent from normal tissues, enabling the development of cancer-specific therapeutics targeting CD24. OncoC4 is developing several first-in-class cancer treatments based on the neoCD24 platform.

(Press release, OncoC4, AUG 17, 2026, View Source [SID1234670190])

On August 17, 2026 Astrazeneca reported that positive high-level results from the SAFFRON Phase III trial showed Tagrisso (osimertinib) plus Orpathys (savolitinib) demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) versus doublet platinum-based chemotherapy in patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Patients in the trial had tumours with high levels of MET overexpression or amplification and had progressed on prior treatment with Tagrisso.

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Third-generation EGFR-tyrosine kinase inhibitors (TKIs) have significantly improved outcomes for patients with EGFRm NSCLC.1 However, one in three patients’ tumours will develop MET overexpression or amplification, one of the most common mechanisms of resistance on third-generation EGFR-TKIs.1-2 MET-driven resistance is associated with poor prognosis, and there is a significant unmet need for effective and well-tolerated treatment options in later-line settings.2

Professor Shun Lu, Director of Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine and principal investigator of the trial, said: "These exciting results from SAFFRON represent a critical advance for patients with EGFR-mutated non-small cell lung cancer experiencing MET-driven resistance after osimertinib, a population with poor outcomes and no biomarker-directed treatment options available that are oral and well-tolerated. MET is one of the most common drivers of progression on targeted therapy in this setting, and these data underscore the potential impact of this novel osimertinib plus savolitinib combination and the urgency of MET testing to inform treatment decisions."​ ​

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "These data demonstrate the clear benefit of adding Orpathys to backbone therapy Tagrisso to address MET overexpression or amplification while maintaining EGFR suppression. By combining Orpathys and Tagrisso, with its established efficacy, safety profile and central nervous system protection, we aim to deliver the first biomarker-directed, all-oral option in this setting to patients across the globe. This further strengthens our leadership in EGFR-mutated lung cancer, reinforcing our strategy to improve patient outcomes across stages and through lines of therapy with novel combinations."

Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: "Overcoming MET-driven resistance after EGFR-TKI therapy has been a long-standing challenge in clinical practice. The SAFFRON global study further reinforces the robust efficacy previously demonstrated in the SACHI Phase III trial that supported approval in China, with the results providing clear evidence to support global registrations of the Tagrisso and Orpathys combination. We are grateful to everyone who supported this trial. Together with AstraZeneca, we look forward to potentially bringing this landmark treatment to patients around the world."

The safety profile for Tagrisso plus Orpathys was consistent with the known profiles of each medicine, and there were no new safety findings. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Tagrisso plus Orpathys is approved in China for patients with locally advanced or metastatic EGFRm NSCLC with MET amplification after disease progression on EGFR-TKI therapy based on the SACHI Phase III trial.

Orpathys is being jointly developed by AstraZeneca and HUTCHMED and commercialised by AstraZeneca.

Notes

NSCLC and MET aberrations
Lung cancer is the leading cause of cancer death globally, accounting for almost one in four (23%) cancer deaths.3 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC.4 Approximately 75% of NSCLC patients are diagnosed with advanced disease.5 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFRm NSCLC.​6-8

MET is a tyrosine kinase receptor that has an essential role in normal cell development.9 MET overexpression or amplification can lead to tumour growth and the metastatic progression of cancer cells.9-10 An estimated 34% of tumours will develop high levels of MET overexpression or amplification after progression on a third-generation EGFR-TKI.1 ​

SAFFRON
SAFFRON is a randomised, open-label, multi-centre, global Phase III trial studying the efficacy of Orpathys (300mg twice daily) added to Tagrisso (80mg once daily) versus doublet platinum-based chemotherapy in 338 patients with EGFRm, locally advanced or metastatic NSCLC with MET overexpression or amplification whose disease progressed following 1st- or 2nd-line treatment with Tagrisso. The trial enrolled patients in 230 centres across 29 countries, including in North America, Europe, South America and Asia. The primary endpoint is PFS and key secondary endpoints include OS and objective response rate.

Patients were prospectively selected for SAFFRON using the high MET level cut-offs identified in the SAVANNAH Phase II trial.​ In SAVANNAH, MET overexpression or amplification levels were determined by two tests: immunohistochemistry (IHC), which detects if cancer cells have a particular protein or marker on their surface, and fluorescence in situ hybridisation (FISH), which detects a specific DNA sequence from cancer cells.

Orpathys
Orpathys (savolitinib) is an oral, potent and highly selective MET-TKI that has demonstrated clinical activity in advanced solid tumours. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

Orpathys is approved in China for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. Orpathys also received a conditional approval in China for the treatment of patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET amplification who have failed at least two prior systemic treatments.

Orpathys in combination with Tagrisso is approved in China for patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR-TKI therapy based on the SACHI Phase III trial. The combination was also granted a temporary authorisation in Switzerland for the treatment of patients with locally advanced or metastatic EGFRm NSCLC and high levels of MET overexpression or amplification who progressed on prior treatment with Tagrisso. This was based on results from the global SAVANNAH Phase II trial.

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 Datroway (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

Tagrisso also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials 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, AUG 17, 2026, View Source [SID1234670189])

On August 17, 2026 AstraZeneca reported it is discontinuing the eVOLVE-Lung02 Phase III trial evaluating volrustomig in combination with chemotherapy as a 1st-line therapy compared to pembrolizumab and chemotherapy in patients with metastatic non-small cell lung cancer (mNSCLC) whose tumours express PD-L1 <50%.

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This decision is based on the recommendation of the Independent Data Monitoring Committee (IDMC) following a planned review of trial data. The IDMC concluded that the volrustomig combination was unlikely to meet either of the dual primary endpoints of progression-free survival (PFS) or overall survival (OS) in the primary analysis population of patients with PD-L1 negative tumours (<1%) versus the comparator arm.

The safety profile of volrustomig plus chemotherapy was consistent with the known profiles of the individual medicines and no new safety signals were identified.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "We initiated the eVOLVE-Lung02 trial aiming to improve the outcomes for patients whose lung cancers have lower PD-L1 expression and a less durable response to current immunotherapy regimens. While we are disappointed, we will learn from this trial and are determined to continue pioneering new medicines from our industry-leading pipeline in our quest to improve outcomes for patients with lung cancer."

The Company will work with investigators to ensure continuity of care and appropriate follow up for patients on the trial. The other Phase III volrustomig trials continue as planned in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.

Notes

NSCLC
Lung cancer is the leading cause of death by cancer globally, accounting for almost one in four (23%) cancer deaths.1 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.1-2 Patients are most commonly diagnosed with metastatic disease, when the tumour has spread outside the lung.3 Approximately 12% of people with metastatic NSCLC will still be alive five years after diagnosis.4

eVOLVE-Lung02
eVOLVE-Lung02 is a randomized, open-label, multi-centre, global Phase III trial of volrustomig plus chemotherapy for 1st-line treatment of patients with mNSCLC whose tumours express PD-L1 <50%. Patients were randomized 1:1 to receive 750mg intravenous volrustomig in combination with chemotherapy every three weeks for four cycles followed by volrustomig every three weeks, or 200mg pembrolizumab plus chemotherapy every three weeks for four cycles followed by pembrolizumab every three weeks until completion of 24 months of treatment or disease progression, or other discontinuation criterion are met.

The trial enrolled 895 patients across 25 countries. The dual primary endpoints were progression-free survival (PFS) and overall survival (OS) in patients whose tumours express PD-L1 <1%. Secondary endpoints included PFS and OS in the intent-to-treat population (PD-L1 <50%).

Volrustomig
Volrustomig is a dual checkpoint inhibitor bispecific antibody designed to deliver coordinated and targeted PD-1 and CTLA-4 blockade on the same T cell. AstraZeneca is evaluating volrustomig as monotherapy and in combinations in several tumour types with high unmet need.

(Press release, AstraZeneca, AUG 17, 2026, View Source [SID1234670188])

On August 17, 2026 Astrazeneca and Daiichi Sankyo reported positive high-level results from the DESTINY-Lung04 Phase III trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as 1st-line treatment of patients with unresectable, locally advanced or metastatic HER2-mutant non-squamous non-small cell lung cancer (NSCLC). The trial will continue as planned to evaluate secondary endpoints including overall survival.

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The global standard of care for patients with HER2-mutant NSCLC in the 1st-line metastatic setting is a combination of immunotherapy and platinum-based chemotherapy.1-3 However, many patients do not respond to 1st-line treatment and experience disease progression, underscoring the need for additional treatment options.3-7 Approximately 2-4% of patients with NSCLC have tumours with a HER2 mutation.8-10

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Our oncology pipeline continues to advance with DESTINY-Lung04 becoming the first Phase III trial to demonstrate a progression-free survival benefit versus the global standard of care in this first-line setting, supporting the potential for Enhertu to move earlier in the treatment of HER2-mutant non-small cell lung cancer. This aggressive lung cancer often affects younger patients and has historically had limited first-line targeted treatment options, making these positive results an important step forward in bringing additional effective therapies to patients at metastatic diagnosis when there is the greatest opportunity to improve outcomes."

John Tsai, Global Head, R&D, Daiichi Sankyo, said: "Enhertu is already established as the first and only antibody drug conjugate for the second-line treatment of HER2-mutant metastatic non-small cell lung cancer. The positive results seen in DESTINY-Lung04 show that treatment with Enhertu in the first-line setting delays disease progression compared to the global standard of care, highlighting its potential to improve outcomes for patients earlier in the treatment of metastatic disease."

The safety profile of Enhertu observed in DESTINY-Lung04 was generally consistent with its known profile, with no new safety concerns identified.

The DESTINY-Lung04 data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Enhertu is currently approved to treat patients with previously treated metastatic NSCLC whose tumours have activating HER2 (ERBB2) mutations, and to treat patients with HER2-positive solid tumours, including HER2-overexpressing metastatic NSCLC, who have received prior treatment and who have no satisfactory treatment options.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

HER2-mutant NSCLC
Lung cancer is the most commonly diagnosed cancer globally and remains the leading cause of cancer-related death in both men and women.11 In 2024, approximately 2.6 million new lung cancer cases were reported worldwide, with an estimated 1.8 million deaths.11 NSCLC is the most common type of lung cancer, accounting for approximately 85% of cases.12 Prognosis is particularly poor for patients with metastatic NSCLC as only approximately 10% will live beyond five years after diagnosis.13-15

HER2 is a tyrosine kinase receptor protein involved in cell growth and differentiation and expressed on the surface of multiple tumour types. HER2 mutations have been identified in NSCLC as distinct molecular targets and have been reported in approximately 2-4% of patients with non-squamous NSCLC.8-10 These HER2 mutations are predominantly seen in younger women and people with no smoking history and have been independently associated with cancer cell growth and poor prognosis, with an increased incidence of brain metastases.8,16-20

The global standard of care in the 1st-line metastatic setting for patients with HER2-mutant NSCLC is a combination of immunotherapy and platinum-based chemotherapy.1-3 While these treatment regimens have been shown to improve survival in NSCLC, many patients do not respond to 1st-line treatment and experience disease progression, underscoring the need for additional treatment options.3-7

DESTINY-Lung04
DESTINY-Lung04 is a global, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) compared to standard of care (platinum-pemetrexed doublet chemotherapy in combination with pembrolizumab) in patients with unresectable, locally advanced or metastatic, non-squamous NSCLC harbouring a HER2 exon 19 or 20 mutation.

Patients were randomised 1:1 to receive either Enhertu or standard of care. Randomisation was stratified by smoking history and presence or history of brain metastasis. The primary endpoint of DESTINY-Lung04 is PFS as assessed by blinded independent central review (BICR). Secondary endpoints include OS, investigator-assessed PFS, overall response rate and duration of response as assessed by BICR and investigator, pharmacokinetics and safety.

DESTINY-Lung04 enrolled 454 patients across multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4mg/kg) followed by THP is approved in the US, China, Singapore and India as a neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4mg/kg) is approved in Brazil and the US as an adjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

Enhertu (5.4mg/kg) in combination with pertuzumab is approved in more than ten countries as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally authorised test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4mg/kg) is approved in more than 100 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 100 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved in more than 80 countries worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 90 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

Enhertu (5.4mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu clinical development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.

(Press release, AstraZeneca, AUG 17, 2026, View Source [SID1234670187])