On May 27, 2026 Gemini Therapeutics, Inc., a privately held biotechnology company focused on advancing aldoxorubicin for patients with cancer, reported two aldoxorubicin abstracts at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The analyses examine complementary elements of aldoxorubicin’s development rationale: tumor-targeted anthracycline delivery and cardiac safety at cumulative doxorubicin-equivalent exposures that are difficult to achieve with conventional doxorubicin.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Aldoxorubicin is an investigational albumin-binding prodrug of doxorubicin designed to bind endogenous albumin after intravenous administration, limit freely circulating doxorubicin, and release native doxorubicin in acidic tumor-associated and intracellular compartments. This exposure profile is intended to exploit albumin transport into tumors while reducing systemic exposure patterns associated with conventional doxorubicin, including exposure to cardiotoxic metabolites such as doxorubicinol.

"Doxorubicin remains one of oncology’s most important cytotoxic therapies, but its use is constrained by tumor-delivery limitations and cumulative cardiotoxicity," said Diego Rey, PhD, Chief Executive Officer of Gemini Therapeutics. "These ASCO (Free ASCO Whitepaper) analyses support a focused re-evaluation of aldoxorubicin from two complementary directions: higher tumor exposure than conventional doxorubicin and better preservation of cardiac function despite substantially higher cumulative doxorubicin-equivalent exposure. The lower systemic doxorubicinol burden provides an important mechanistic bridge between aldoxorubicin’s albumin-bound design and the cardiac-safety findings observed in randomized soft tissue sarcoma studies. Together, these findings support the rationale that a better exposure-toxicity tradeoff could make meaningful anthracycline exposure feasible for more patients and in more tumor settings where conventional doxorubicin has been limited by delivery or cumulative cardiotoxicity."

The first ASCO (Free ASCO Whitepaper) analysis, a poster presentation titled "Cardiac safety of aldoxorubicin compared to doxorubicin: Integrated results from two randomized studies in advanced soft tissue sarcoma," evaluated cardiac safety across two randomized soft tissue sarcoma studies. The pooled analysis included 383 patients in the aldoxorubicin-versus-doxorubicin cardiac safety population: 296 treated with aldoxorubicin and 87 treated with doxorubicin comparator.

In the analysis, patients treated with aldoxorubicin received approximately 3.5-fold higher cumulative doxorubicin-equivalent exposure than patients treated with doxorubicin. Despite this higher exposure, aldoxorubicin was associated with smaller mean declines in left ventricular ejection fraction, fewer patients reaching selected on-treatment LVEF thresholds, and fewer prespecified heart-failure-related treatment-emergent adverse events.

Mechanistically, the cardiac-safety findings are supported by pharmacokinetic data showing that aldoxorubicin plasma exposure is dominated by albumin-bound doxorubicin, with substantially lower free doxorubicin and doxorubicinol concentrations. In Phase 1 aldoxorubicin data, the doxorubicinol-to-free-doxorubicin exposure ratio was approximately 5% to 6%, compared with approximately 40% to 60% reported for conventional doxorubicin, consistent with lower systemic exposure to this cardiotoxic metabolite.

Lowest on-treatment mean LVEF change from baseline was -3.17 percentage points with aldoxorubicin versus -5.77 percentage points with doxorubicin. On-treatment LVEF below 50% occurred in 3.8% of aldoxorubicin-treated patients versus 9.0% of doxorubicin-treated patients; on-treatment LVEF below 45% occurred in 1.1% versus 3.8%, respectively. Prespecified heart-failure-related treatment-emergent adverse events occurred in 3.0% of aldoxorubicin-treated patients versus 6.9% of doxorubicin-treated patients.

The second ASCO (Free ASCO Whitepaper) analysis, titled "Tumor Delivery and Exposure of Aldoxorubicin Compared with Doxorubicin: Integrated Clinical and Preclinical Analysis," evaluated human tumor-biopsy pharmacokinetic data and preclinical biodistribution data comparing aldoxorubicin with doxorubicin. In human Kaposi’s sarcoma tumor biopsies, aldoxorubicin was detected in all sampled lesions and increased with dose. When normalized for dose and adjusted for potency, aldoxorubicin delivered up to approximately 10-fold higher intratumoral doxorubicin-equivalent exposure than conventional doxorubicin.

Aldoxorubicin has previously been evaluated across a broad clinical development and early access program involving more than 750 aldoxorubicin-exposed patients. Gemini acquired the aldoxorubicin program from LadRx Corporation in 2025 and is advancing it under a focused, evidence-guided development strategy informed by the substantial clinical, pharmacokinetic, and safety data generated to date.

ASCO 2026 Abstract Details

Poster Presentation
Abstract #: 11565
Poster Board #: 355
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT
Title: Cardiac safety of aldoxorubicin compared to doxorubicin: Integrated results from two randomized studies in advanced soft tissue sarcoma
First Author: Philip Sager, MD
Presenter: Diego Rey, PhD
Citation: J Clin Oncol 44, 2026 (suppl 16; abstr 11565)
DOI: 10.1200/JCO.2026.44.16_suppl.11565

Publication Only Abstract
Abstract #: e15134
Title: Tumor delivery and exposure of aldoxorubicin compared with doxorubicin: Integrated clinical and preclinical analysis
First Author: Joyce James, PhD
Citation: J Clin Oncol 44, 2026 (suppl 16; abstr e15134)
DOI: 10.1200/JCO.2026.44.16_suppl.e15134

About Aldoxorubicin

Aldoxorubicin, also known historically as INNO-206 or DOXO-EMCH, is an investigational albumin-binding prodrug of doxorubicin. Aldoxorubicin is designed to bind endogenous serum albumin after intravenous administration and release native doxorubicin under acidic conditions found in tumor-associated and intracellular compartments. The intended therapeutic rationale is to alter the exposure pattern of doxorubicin by increasing tumor-directed anthracycline delivery while reducing systemic exposure patterns associated with conventional doxorubicin.

Aldoxorubicin is investigational and has not been approved by the U.S. Food and Drug Administration. Safety and effectiveness have not been established.

(Press release, Gemini Therapeutics, MAY 27, 2026, View Source [SID1234666128])

On May 27, 2026 HCW Biologics Inc. (the "Company") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing first-in-class fusion immunotherapeutics for autoimmune diseases, cancer, and senescence-associated dysplasia, reported that it has exercised its option to regain full ex vivo rights to HCW9206 and HCW9201, two commercial-ready compounds as reagents, from its licensee, Wugen Inc. Wugen held exclusive worldwide rights to these two compounds for ex vivo, cell-based therapy applications. The Company acquired these rights for no cost and retained the nonrefundable upfront license fee, including 2.2 million shares of Wugen common stock.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent data published in the high-impact, peer-reviewed journal, Science Advances, indicate that HCW9206, the Company’s proprietary, commercial-ready multi-cytokine fusion protein reagent, may offer a novel, cost-effective approach to producing CAR-T cells with enhanced function for immunotherapy (see link number 1 for full article below). As a first-in-class cytokine-scaffold platform, HCW9206 has the potential to improve manufacturing efficiency while supporting the development of more potent CAR-T therapies at lower costs.

HCW9206 has the advantage of generating a CAR-T population which is markedly enriched for long-lived T-memory stem ("Tscm") cells, which are rare, highly proliferative, and self-renewing cells. Results from a recent, third-party clinical trial in patients with blood cancer demonstrated that a more defined CAR-T product, enriched with Tscm, persists longer in the body and achieves complete remissions at low doses—without the need for chemotherapy pre-conditioning (see link number 2 to full article below). The Company believes that these results support its perspective that utilizing HCW9206 as part of a manufacturing process may be broadly applicable to increase persistence and functionality of CAR-T therapy.

Dr. Hing C. Wong, the Company’s Founder and CEO, stated, "We are excited to regain the full commercial rights for ex vivo use of HCW9206 and HCW9201. We have a great opportunity to develop Tscm-based CAR-T approaches to benefit patients with blood cancer, solid tumors or autoimmune diseases, through partnerships with larger companies who are focused on CAR-T therapies."

Dr. Wong continued, "HCW9206 is a novel compound that allows a single molecule to deliver synergistic signals from three immune-stimulating cytokines. It is versatile and has demonstrated activity in generating large quantities of memory-like NK cells for cancer cell therapy in a GMP manufacturing scale (see link number 3 to full article below). We have also found that it may enhance CAR-T manufacturing as a promising new reagent with the potential to improve production processes. In addition, experimental models show that HCW9206 may improve the function and persistence of CAR-T cells following adoptive transfer for treatment of infectious disease and cancer, a goal the industry has been pursuing for the past decade."

(Press release, HCW Biologics, MAY 27, 2026, View Source [SID1234666097])

On May 27, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the New England Journal of Medicine has published the Phase 3 HERIZON-GEA-01 trial results, further characterizing the efficacy and safety profile of Ziihera (zanidatamab-hrii) in combination with chemotherapy, with and without the PD-1 inhibitor Tevimbra (tislelizumab), as first-line treatment for adults with HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction, and esophagus.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The manuscript builds on the late-breaking oral presentation of the HERIZON-GEA-01 trial results at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), where zanidatamab-containing combinations demonstrated unprecedented progression-free survival (PFS) and overall survival (OS) outcomes in a global Phase 3 trial.

As previously reported, both zanidatamab-containing combinations significantly improved PFS compared with trastuzumab plus chemotherapy (median PFS 12.4 months versus 8.1 months; Hazard Ratio (HR) 0.63-0.65), and zanidatamab plus tislelizumab and chemotherapy demonstrated a statistically significant OS benefit (median OS 26.4 versus 19.2 months; HR 0.72).
At the first interim analysis, zanidatamab plus chemotherapy also demonstrated a median OS of more than two years. The OS for zanidatamab plus chemotherapy will be assessed at a second interim analysis expected in mid-2026.
The publication includes expanded prespecified subgroup analyses showing that PFS and OS results were generally consistent across clinically relevant patient characteristics, including PD-L1 status, geographic region, and Eastern Cooperative Oncology Group performance status, as well as PFS sensitivity analyses supporting the robustness of the findings.
Expanded safety analyses further characterize the safety profile of zanidatamab-containing regimens.
"The additional analyses from HERIZON-GEA-01 provide further support for using zanidatamab in clinical practice," said Kohei Shitara, M.D., director of the Department of Gastrointestinal Oncology, co-lead author of the New England Journal of Medicine publication, and principal investigator of the HERIZON-GEA-01 trial at the National Cancer Center Hospital East in Kashiwa, Japan. "For patients with HER2+ locally advanced or metastatic GEA, long-term outcomes have historically been limited. The expanded subgroup and sensitivity analyses indicate the durability and consistency of benefit observed with zanidatamab-containing regimens. Importantly, survival benefit with the addition of tislelizumab was suggested across PD-L1-defined subgroups, including in patients with PD-L1-negative tumors, a population that has historically derived limited benefit from PD-1-based approaches."

"We believe the HERIZON-GEA-01 results, together with the additional analyses now published, establish zanidatamab’s differentiated clinical profile in first-line HER2+ locally advanced or metastatic GEA," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "In this global Phase 3 trial, zanidatamab demonstrated superior efficacy compared with trastuzumab-based standard of care, and the addition of tislelizumab enhanced overall survival. Taken together, these findings support the potential for zanidatamab-containing regimens to become a HER2-targeted agent of choice in this setting. Additionally, this marks the first immuno-oncology combination to show efficacy across both PD-L1–positive and PD-L1–negative tumors in this clinical setting, consistent with zanidatamab’s unique mechanism of action that enhances immune activation through complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). These results are reshaping expectations for first-line treatment in this disease, and we continue to work with urgency to deliver this treatment option for patients."

Results of additional safety analyses of zanidatamab plus chemotherapy, with and without tislelizumab, were consistent with the known safety profiles of the individual components. Gastrointestinal events, including diarrhea, most commonly occurred early in treatment, were generally time-limited, and infrequently led to discontinuation of HER2-targeted therapy.

Analyses of subsequent anticancer therapies showed greater use of immune checkpoint inhibitors and HER2-targeted therapies in the trastuzumab plus chemotherapy group than in the zanidatamab-containing groups, reflecting that a higher proportion of patients in that arm experienced disease progression and subsequently received additional therapy. These analyses provide important context for interpreting OS outcomes.

Jazz has submitted the Phase 3 HERIZON-GEA-01 data, including this manuscript, to the National Comprehensive Cancer Network (NCCN) for inclusion in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines).

PD-L1 Subgroup Oral Presentation at ASCO (Free ASCO Whitepaper) 2026

In addition, prespecified PD-L1 subgroup analyses from the Phase 3 HERIZON-GEA-01 trial to be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 29-June 2, 2026, in Chicago) provide further insight into the impact of zanidatamab-containing combinations across PD-L1-defined subgroups.

Zanidatamab in combination with tislelizumab and chemotherapy demonstrated meaningful improvements in PFS and OS in both PD-L1-positive and PD-L1-negative patients as determined by tumor area positivity (TAP) score and combined positive score (CPS).
With 26 months of follow-up, similarly prolonged PFS and OS were observed in both PD-L1-positive and PD-L1-negative patients compared with the control arm.
Notably, in PD-L1-negative patients (TAP <1%), median OS was 29.7 months with zanidatamab in combination with tislelizumab and chemotherapy compared with 15.8 months with trastuzumab plus chemotherapy, with findings consistent across PD-L1 assessment methods.
In PD-L1-positive patients (TAP≥1%), median OS was 26.4 months with zanidatamab in combination with tislelizumab and chemotherapy compared with 21.2 months with trastuzumab plus chemotherapy, with findings consistent across PD-L1 assessment methods.
About the Phase 3 HERIZON-GEA-01 Trial
HERIZON-GEA-01 (NCT05152147) is a global, randomized, open-label Phase 3 trial, conducted jointly with BeOne Medicines, to evaluate and compare the efficacy and safety of zanidatamab plus chemotherapy, with and without tislelizumab, to trastuzumab plus chemotherapy as first-line treatment for adult patients with advanced/metastatic HER2+ GEA. The trial randomized 914 patients from approximately 225 trial sites in more than 30 countries. Appropriate patients for this trial had unresectable locally advanced, recurrent or metastatic HER2+ GEA (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Patients were randomized to the three trial arms: zanidatamab in combination with chemotherapy and tislelizumab; zanidatamab in combination with chemotherapy; and trastuzumab plus chemotherapy. The trial is evaluating dual primary endpoints, PFS per blinded independent central review (BICR) and OS.

About Gastroesophageal Adenocarcinoma
GEA, including cancers of the stomach, gastroesophageal junction, and esophagus, is the fifth most common cancer worldwide, and approximately 20% of patients have HER2+ disease.[1],[2],[3] HER2+ GEA has high morbidity and mortality, and patients are urgently in need of new treatment options. The overall prognosis for patients with GEA remains poor, with a global five-year survival rate of less than 30% for gastric cancer and about 19% for GEA.[4]

About Ziihera (zanidatamab-hrii)
Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab- with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces CDC, ADCC, and ADCP. These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.[5] In the United States, Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.5 The FDA granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).5

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule.  

A supplemental biologics license application for zanidatamab is under FDA Real-Time Oncology Review in first-line HER2+ locally advanced or metastatic GEA. The FDA granted two Breakthrough Therapy designations for zanidatamab’s development: one as a single agent for previously treated HER2 gene-amplified BTC, and one in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab for first-line HER2+ unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal GEA. The FDA also granted two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for first-line GEA. Additionally, zanidatamab has received Orphan Drug designations from the FDA for the treatment of BTC, gastric (including GEJ) cancer, and esophageal cancer, as well as Orphan Drug designations from the European Medicines Agency for the treatment of BTC, gastric/gastroesophageal junction cancer, and esophageal cancer.

Important Safety Information for ZIIHERA

WARNING: EMBRYO-FETAL TOXICITY
Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients
of the risk and need for effective contraception.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity

ZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

Verify the pregnancy status of patients of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA.

Left Ventricular Dysfunction

ZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). LVEF declined by >10% and decreased to <50% in 4.3% of 233 patients. Left ventricular dysfunction (LVD) leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7). LVD resolved in 70% of patients.

Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions.

The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50%.

Infusion-Related Reactions

ZIIHERA can cause infusion-related reactions (IRRs). An IRR was reported in 31% of 233 patients treated with ZIIHERA as a single agent in clinical studies, including Grade 3 (0.4%), and Grade 2 (25%). IRRs leading to permanent discontinuation of ZIIHERA were reported in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients; 97% of IRRs resolved within one day.

Prior to each dose of ZIIHERA, administer premedications to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use.

If an IRR occurs, slow, or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs.

Diarrhea

ZIIHERA can cause severe diarrhea.

Diarrhea was reported in 48% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Withhold or permanently discontinue ZIIHERA based on severity.

ADVERSE REACTIONS

Serious adverse reactions occurred in 53% of 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA. Serious adverse reactions in >2% of patients included biliary obstruction (15%), biliary tract infection (8%), sepsis (8%), pneumonia (5%), diarrhea (3.8%), gastric obstruction (3.8%), and fatigue (2.5%). A fatal adverse reaction of hepatic failure occurred in one patient who received ZIIHERA.

The most common adverse reactions in 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA (≥20%) were diarrhea (50%), infusion-related reaction (35%), abdominal pain (29%), and fatigue (24%).

USE IN SPECIFIC POPULATIONS

Pediatric Use

Safety and efficacy of ZIIHERA have not been established in pediatric patients.

Geriatric Use

Of the 80 patients who received ZIIHERA for unresectable or metastatic HER2-positive BTC, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were aged 65-74 years old and 2 (3%) were aged 75 years or older.

No overall differences in safety or efficacy were observed between these patients and younger adult patients.

The full U.S. Prescribing Information for ZIIHERA, including BOXED Warning, is available at: View Source

TEVIMBRA (tislelizumab) is a registered trademark of BeOne Medicines.

(Press release, Jazz Pharmaceuticals, MAY 27, 2026, View Source [SID1234666113])

On May 27, 2026 Brenus Pharma, a clinical stage biotechnology company developing novel in vivo immunotherapies for solid tumors, reported that the U.S. Food and Drug Administration (FDA) has accept the company’s Investigational New Drug (IND) application for its first drug candidate, STC-1010, in microsatellite stable (MSS) metastatic colorectal cancer (mCRC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

STC-1010 is designed to address a critical unmet need worldwide. Approximately 95% of mCRC patients have MSS tumors, which demonstrate minimal response to standard immunotherapies. The FDA validated Brenus Pharma’s advanced regulatory and manufacturing capabilities. This operational readiness will accelerate patient access and data generation across both European and US sites for a Phase II program planned for 2027.

"FDA’s acceptance of our IND represents a major validation of our program and enables the full execution of our clinical strategy across Europe and the United States. Achieving regulatory alignment across multiple jurisdictions reflects our team’s deep expertise and our commitment to bringing STC-1010 to patients who need it." said Paul BRAVETTI, CEO.

"This is an impressive accomplishment for Brenus, opening the door to planned clinical program expansion in the U.S. By generating de novo, multi-specific lymphocyte responses in immunologically ‘cold’ tumors, the therapy promises to address one of oncology’s biggest challenges. I am very excited to contribute to the company’s strategic growth." said Dr. Diala EZZEDDINE (PhD), US-based Independent Board Director at Brenus Pharma.

(Press release, Brenus Pharma, MAY 27, 2026, View Source [SID1234666129])

On May 26, 2026 AstraZeneca and Daiichi Sankyo reported Datroway (datopotamab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

The approval follows Priority Review by the Food and Drug Administration (FDA) based on results from the TROPION-Breast02 Phase III trial which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology.

Tiffany A. Traina, MD, FASCO, Section Head, Triple-Negative Breast Cancer Clinical Research Programme, Memorial Sloan Kettering Cancer Centre and investigator for TROPION-Breast02, said: "Datopotamab deruxtecan is the first and only medicine to significantly prolong overall survival in the 1st-line setting compared to chemotherapy in patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy. This approval will bring a much-needed treatment option for these patients."

Arlene Brothers, Executive Director, Triple Negative Breast Cancer Foundation, said: "For seven out of 10 patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy, chemotherapy has remained the only treatment option. Today’s approval of Datroway means that for the first time, these patients will have a new standard of care beyond traditional chemotherapy at the outset of their treatment."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Triple-negative breast cancer is notoriously difficult to treat. Patients with metastatic disease, especially those who are unable to receive immunotherapy, urgently need more effective, durable and tolerable treatment options, which extend survival. With today’s approval, we are proud to bring Datroway to a broad population of advanced triple-negative breast cancer patients and we continue to study its promise as a mainstay treatment across tumours, stages and settings."

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., said: "As the first antibody drug conjugate to demonstrate a median overall survival of two years in the 1st-line metastatic setting of triple-negative breast cancer, Datroway has the potential to redefine the treatment landscape for these patients. With this approval, Datroway is now approved for three indications in the US, including two for breast cancer, underscoring its potential to play an important role across tumour types."

In the trial, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0290) and a 43% reduction in patients’ risk of disease progression or death (HR 0.57; 95% CI 0.47-0.69; p<0.0001) compared to chemotherapy as 1st-line treatment in this patient population. Datroway was also associated with more robust treatment responses, including an objective response rate (ORR) of 64% compared to an ORR of 30% with chemotherapy.1

The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical trials of Datroway in breast cancer.

This application was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, reviews are ongoing in Australia, Canada, Singapore and Switzerland. This initiative is designed to bring effective cancer treatments to patients as early as possible. Additional reviews are underway in the EU, China and Japan.

Based on the results of TROPION-Breast02, datopotamab deruxtecan (Datroway) has been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 1 Preferred 1st-line treatment option for patients with metastatic TNBC who are not candidates for immunotherapy. See NCCN Guidelines for detailed recommendations.2

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

Triple-negative breast cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.3,4 In the US, an estimated 32,000 to 48,000 cases of TNBC were diagnosed in 2025, and approximately 11,000 patients with TNBC receive treatment in the 1st-line setting each year.5-7 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.8-10 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.8,11,12

While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.8 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.8 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.13,14 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, prior to the approval of Datroway, chemotherapy was the only approved 1st-line treatment.15

TROP2 is a protein broadly expressed in several solid tumours, including TNBC.16 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.17,18

TROPION-Breast02
TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrolment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are progression-free survival (PFS) as assessed by blinded independent central review and OS. Secondary endpoints include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov.

Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is also approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.

Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Datroway clinical development programme
A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer, and one Phase III trial and one Phase II/III trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Press release, AstraZeneca, MAY 26, 2026, View Source [SID1234666048])