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VolitionRx Limited Announces Third Quarter 2026 Financial Results and Business Update

On November 12, 2026 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, reported financial results and a business update for the third quarter of 2026. Volition management will host a conference call tomorrow, November 13 at 8:30 a.m. U.S. Eastern Time/2:30 p.m. Central European Time to discuss these results. Conference call details can be found below.

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Cameron Reynolds, President and Group Chief Executive Officer, said:

"It has been a very full quarter as we have continued to execute our plan to commercialize our game-changing Nu.Q platform. We have made strong progress across our key product pillars this year, evidencing clinical utility across a broad spectrum of indications whilst driving commercialization and licensing efforts worldwide. At the same time, we have taken decisive action to strengthen our financial profile by cutting costs and significantly reducing convertible note debt.

"In our Nu.Q NETs pillar, in September we participated in the launch of DETECSEPS, a French government-funded €6.3 million program evaluating our automated Nu.Q NETs assay as the sole biomarker for early detection of sepsis in hospital emergency departments. In August, Critical Care Medicine published data showing Nu.Q NETs H3.1 to be an independent predictor of 28-day mortality and need for renal replacement therapy in sepsis. Published clinical data indicate that Nu.Q NETs distinguishes sepsis from non-infectious inflammation and provides strong prognostic value for organ failure and mortality.

"Furthermore, our rapid point-of-care finger-prick lateral flow prototype has demonstrated high correlation with our CE-marked automated assay in ICU sepsis patients. To accelerate commercialization and global market access, particularly in resource-constrained countries and humanitarian emergency settings, we signed in October a Letter of Intent with Missionpharma, a global distributor of healthcare products serving over 100 million patients annually. Initial efforts with Missionpharma are expected to focus on triaging and prognostication for neonatal sepsis. In parallel, our diagnostic collaborations with Sysmex Corporation and Werfen’s Immunoassay Technology Center continue to advance across NETs-related indications.

"In Nu.Q Cancer, we are advancing toward our French reimbursement submission for Nu.Q Lung Cancer with support from our long-term collaborators at Hospices Civils de Lyon in France. We currently expect to submit this quarter. Achieving reimbursement would be an important step on the path to routine clinical use in France before rolling out to additional geographies. For our novel Capture-Seq technology, following peer-reviewed publication of our clinical data in August, we are in active licensing discussions with several major liquid biopsy and diagnostic companies to target Multi-Cancer Early Detection (MCED) and Minimal Residual Disease (MRD) opportunities representing combined annualized addressable markets estimated at over $36 billion¹.

"In our Nu.Q Vet pillar, our clinical manuscript, submitted for peer review in May, demonstrated that our feline prototype assay detected 86% of feline lymphomas at 97% specificity. We currently anticipate publication of this study this quarter. As a reminder, a peer reviewed publication evidencing clinical utility is a necessary condition to unlock a $5 million milestone payment. Commercialization of the assay could open a significant market among senior pet cats.

"I am personally leading our most advanced partner negotiations and, to underline my commitment to closing them, have voluntarily agreed to a further reduction in my base salary, effective November 1, 2026, such that my annual base salary is now 50% of its original level, until execution of a substantial licensing agreement. Furthermore, the chairman and entire board of directors have also agreed to reduce their cash fees by at least 50%".

Financial Highlights for the Third Quarter 2026

Revenue: Third quarter 2026 revenue was approximately $1.6 million, up 157% compared to $0.6 million in the third quarter of 2025, reflecting an increase in recognition of deferred revenue .
Operating Expenses: Operating expenses for the third quarter of 2026 were 14% lower than the same period in 2025, reflecting savings from Volition’s ongoing cost-reduction program, including a 28% reduction in headcount compared to the same point last year.
Operating Loss: Operating loss for the third quarter of 2026 narrowed to $3.3 million, a 35% improvement compared to $5.1 million in the third quarter of 2025.
Net Loss: Net loss for the third quarter of 2026 was $3.8 million, including non-cash charges of $0.4 million related to convertible notes, compared to a net loss of $5.4 million in the prior-year period.
Balance Sheet & Debt Reduction: Cash and cash equivalents totaled approximately $2.4 million as of September 30, 2026, compared to $1.1 million as of December 31, 2025. Receipts in the third quarter included approximately $5.2 million in net proceeds from Volition’s at-the-market facility. During the third quarter, Volition prepaid in cash the outstanding balance of its $7.5 million convertible note.
Event: VolitionRx Limited Third Quarter 2026 Earnings and Business Update Conference Call
Date: Friday, November 13, 2026
Time: 8:30 a.m. U.S. Eastern Time/2:30 p.m. Central European Time

U.S. & Canada Dial-in: 1-877-407-9716 (toll free)
U.K. Dial-in: 0 800 756 3429 (toll free)
Toll/International: 1-201-493-6779
Conference ID: 13763536

Rodney Rootsaert, Corporate Secretary, VolitionRx will host the call along with Cameron Reynolds, President and Group Chief Executive Officer and Terig Hughes, Group Chief Financial Officer. The call will provide an update on important events that have taken place in the third quarter of 2026, subsequent events and upcoming milestones.

A live audio webcast of the conference call will also be available on this link. In addition, a telephone replay of the call will be available until November 27, 2026. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13763536.

(Press release, VolitionRX, NOV 12, 2026, View Source [SID1234674711])

Kazia Therapeutics to Host Virtual Event on December 2, 2026: Advancing a New Frontier in Oncology with a First-in-Class Nuclear PD-L1 Protein Degrader

On November 12, 2026 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, reported that it will host a virtual event on Wednesday, December 2, 2026 at 4:00 PM ET featuring management’s overview of NDL2, the Company’s novel nuclear PD-L1 protein degrader designed to address mechanisms of immunotherapy resistance in advanced solid tumors, with an initial focus on metastatic breast cancer and colorectal cancer. NDL2 represents a potentially first-in-class approach within the emerging field of targeted protein degradation, a therapeutic category with no known nuclear PD-L1 protein degraders currently in clinical development.

The event will explore the scientific discovery of NDL2 from initial concept through molecular optimization and pre-IND development, highlighting its potential to advance a differentiated approach to cancer immunotherapy. NDL2 is an optimized bicyclic peptide designed to selectively degrade disease-associated nuclear PD-L1 protein, with the goal of restoring the body’s natural anti-tumor immune response. While PD-L1 plays an important role in regulating the immune system, cancer cells can exploit this pathway to evade immune detection and resist treatment. Through targeted protein degradation (TPD), Kazia is pursuing an approach designed to harness the body’s natural protein degradation machinery to target disease-associated proteins, with the potential to overcome limitations of conventional immunotherapies.

A live question and answer session will follow the formal presentation. To register, click here. A replay of the event will be available on the Company’s website following the event.

(Press release, Kazia Therapeutics, NOV 12, 2026, View Source [SID1234674710])

Racura Oncology Presents Bisantrene MYC Data at Frontiers in Cancer Science 2026 Conference

On November 12, 2026 Racura Oncology Limited (ASX: RAC), a late clinical-stage biopharmaceutical company developing new small molecule-based approaches to cancer treatment focused on silencing MYC gene expression, reported that new preclinical data on the MYC-directed mechanism of action of (E,E)-bisantrene are being presented as a poster at the Frontiers in Cancer Science (FCS) 2026 Conference, held in Singapore from 11–13 November 2026. The data show that (E,E)-bisantrene is the major active isomer (molecular form) of bisantrene able to stabilize the G-quadruplex in the MYC gene promoter region, leading to reduced MYC gene expression and MYC protein levels.

In these preclinical studies, light exposure converted (E,E)-bisantrene into less active isomers, which resulted in significantly less MYC G-quadruplex stabilization and a lowering of the inhibition of MYC gene expression.

In the study, exposing (E,E)-bisantrene to blue (440 nm) light reduced its content in solution to approximately 60% after 15 minutes, approximately 40% after one hour and an unquantifiable level after four hours. In MDA-MB-231 breast cancer cells, pure (E,E)-bisantrene suppressed MYC gene expression with a half-maximal effective concentration of 277 nM, compared with 514 nM to 1,166 nM for the light-exposed isomer mixtures, and reduced cancer cell viability with a half-maximal inhibitory concentration of 266 nM, compared with 310 nM to 825 nM for the mixtures. An isomer mixture containing 62% (E,E)-bisantrene stabilized the MYC G-quadruplex significantly less than pure (E,E)-bisantrene at the same concentration, and stabilization was restored when the amount of (E,E)-bisantrene was matched.

These findings build on the MYC gene expression inhibition data for (E,E)-bisantrene presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026 and further support the importance of the MYC-directed mechanism of action of RC220. Racura continues to investigate this mechanism through its ongoing research collaboration with Purdue University.

The poster is entitled "Light-Induced Isomerization Attenuates (E,E)-Bisantrene G-Quadruplex Binding and MYC Silencing" and reports work by Racura scientists and collaborators at the University of Wollongong, Australia.

Daniel Tillett, Ph.D., Chief Executive Officer of Racura Oncology, said: "These data show that (E,E)-bisantrene is the form that stabilizes G-quadruplex structures and inhibits MYC gene expression. Bisantrene can exist as several isomers, and confirming that the (E,E)-isomer is the active form supports our development of RC220 as a proprietary formulation of (E,E)-bisantrene. While these are preclinical findings, they add to the growing body of evidence for the MYC-directed mechanism of action of RC220."

Scientific Rationale

RC220 is being clinically developed to target non-canonical G-quadruplex DNA and RNA structures enriched in oncogenic regulatory regions, including promoters, untranslated regions and highly transcribed loci. Stabilization of these structures can disrupt transcriptional and post-transcriptional control networks that sustain malignant proliferation, including the silencing of MYC-driven growth and survival pathways.

(E,E)-bisantrene contains two hydrazone groups that can isomerize, and exposure to light converts it into (E,Z)- and, it is postulated, (Z,Z)-isomers. The FCS 2026 data indicate that the (E,E)-isomer is the form most responsible for MYC G-quadruplex stabilization, MYC suppression and anticancer activity, supporting Racura’s development of RC220 as a proprietary formulation of (E,E)-bisantrene.

About RC220 & (E,E)-bisantrene

RC220 is a proprietary formulation of (E,E)-bisantrene designed to overcome drug solubility issues that prevent safe peripheral intravenous infusion. (E,E)-bisantrene is a clinically validated small molecule anticancer agent that primarily functions via G4-DNA and RNA binding, leading to potent transcriptional silencing of the important cancer growth regulator MYC and downstream pathways.

(Press release, Racura Oncology, NOV 12, 2026, View Source [SID1234674709])

Recordati and Partners to Present New Evidence and Guidance in Rare Hematologic Diseases at American Society of Hematology (ASH) Annual Meeting and Exposition

On November 12, 2026 Recordati Rare Diseases Inc. reported new data presentations across its rare hematology portfolio at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, December 12-15, 2026, in New Orleans, La. Recordati researchers and independent investigators will present findings from five studies spanning clinical research, diagnostic and disease management tools for cold agglutinin disease (CAD) and idiopathic multicentric Castleman disease (iMCD). Two additional iMCD abstracts are published in the November online supplement of Blood, the peer-reviewed journal of ASH (Free ASH Whitepaper).

Highlights include poster presentations on CAD, a rare type of autoimmune hemolytic anemia (AIHA), including international expert consensus treatment guidelines, a post-hoc analysis of the pivotal Phase 3 sutimlimab CARDINAL and CADENZA trials in CAD, and new real-world data from the CADENCE registry. These supplement guidance for patient care, and existing evidence extending beyond the duration of clinical trials of long-term sutimlimab safety and efficacy in CAD.

In iMCD research, there will be an oral presentation on an internationally validated patient-reported outcomes scale to assess disease symptom burden over time. Additional studies explore tools to support diagnostic accuracy and consistency of iMCD, including global use of an expert-curated, disease-specific digital pathology platform. Multicentric Castleman disease commonly presents with enlarged lymph nodes in multiple regions of the body and is often misdiagnosed because it mimics other diseases.

"We are excited about the progress that will be discussed at this meeting around the diagnosis and treatment of CAD and iMCD," said Milan Zdravkovic, Executive Vice President, Research & Development and Chief Medical Officer at Recordati. "This also includes data around the long-term management of these diseases. Through collaborations with researchers worldwide, we aim to continually advance care for patients living with these conditions."

"Recordati is proud to continue our support of the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting as we share research that reflects our commitment to patients with rare hematology and oncology disorders," said Melissa Koomey, President and General Manager of Recordati Rare Diseases North America. "We look forward to continuing our dialogue with the hematology/oncology community when we gather in December."

The ASH (Free ASH Whitepaper) 2026 Annual Meeting will feature the following presentations from Recordati and external investigators:

Cold Agglutinin Disease (CAD)

Title: Multinational Expert Delphi Consensus on Diagnosis and Treatment of Cold Agglutinin Disease*
Poster number: 4633
Presenting author: Ilene C. Weitz, MD, Keck School of Medicine, University of Southern California, Los Angeles

Title: Impact of delayed dosing on hemolytic markers and complement pathway activity in the phase 3 CARDINAL and CADENZA studies of sutimlimab in cold agglutinin disease: a post-hoc analysis
Poster number: 2875
Presenting author: Alexander Röth, MD, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen

Title: Baseline characteristics of cold agglutinin disease/cold agglutinin syndrome patients enrolled in the international CADENCE registry
Poster number: 1113
Presenting author: Catherine M. Broome, MD, Lombardi Cancer Center, MedStar Georgetown University

Title: Updated real-world outcomes of sutimlimab in patients with cold agglutinin disease/cold agglutinin syndrome from CADENCE: a multinational, multi-center, observational, prospective cohort study
Poster number: 4634
Presenting author: Alexander Röth, MD, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen

Castleman Disease

Title: Idiopathic multicentric Castleman disease (iMCD) symptom burden scale (ISBUS): International development and validation of a first-ever tool for assessing symptom burden in iMCD
Oral presentation number: 462
Presenting author: Sudipto Mukherjee, MD, PhD, MPH, Cleveland Clinic Cancer Institute
Presentation date & location: Saturday, December 12, 5:15 PM CT; Room: MCCNO – 260-262

Title: Scaling rare-disease pathology expertise: Real-world adoption of a whole-slide imaging and histologic grading platform for Castleman disease
Abstract book publication: 8612
Primary author: Robert S. Ohgami, MD, PhD, University of Utah, and ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine in Salt Lake City

Title: Divergent outcomes following treatment pauses in idiopathic multicentric Castleman disease: A registry-based case series
Abstract book publication: 6559
Primary author: Joshua Brandstadter, MD, PhD, Hospital of the University of Pennsylvania

*Triducive Partners Ltd. independently provided facilitation of the Delphi process and medical writing support. Funding was provided by Recordati Rare Disease Inc.

About Cold Agglutinin Disease (CAD)
Cold agglutinin disease (CAD) is a rare type of autoimmune hemolytic anemia (AIHA), characterized as a low-grade lymphoproliferative disorder of the bone marrow. In CAD, autoantibodies bind to erythrocytes at temperatures ≤37°C, leading to complement-mediated hemolysis. CAD symptoms include severe, debilitating fatigue and other clinical manifestations (e.g., dyspnea, tachycardia) that can impact patients’ quality of life. While the median age of onset is approximately 60 years, CAD has been diagnosed in patients as young as 30.

About Idiopathic Multicentric Castleman Disease (iMCD)
Idiopathic multicentric Castleman disease is a rare cytokine-driven disorder that may be life-threatening and can affect people of any age. Its symptoms often resemble those of malignant lymphoma, autoimmune, or infectious diseases, making it difficult to diagnose. iMCD is a subtype of Castleman disease (CD), which is a group of rare conditions that affect the immune system, characterized by swollen lymph nodes and a broad range of inflammatory signs and symptoms. The cause of iMCD is unknown, and there are no known risk factors. Some people with iMCD have elevated levels of interleukin 6 (IL-6), a cytokine that is produced in the body during inflammation and which plays a key pathological role in iMCD; IL-6 elevation may explain some of the symptoms patients experience, such as swollen lymph nodes, fever, unexplained weight loss, and night sweats.

INDICATION

ENJAYMO (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS
Serious Infections Including Those Caused by Encapsulated Bacteria

ENJAYMO, a proximal classical complement C1s inhibitor, increases susceptibility to serious infections, including those caused by encapsulated bacteria e.g. Neisseria meningitidis (any serogroup, including non-groupable strains), Streptococcus pneumoniae, and Haemophilus influenzae type B.
Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors.
Serious infections (bacterial and viral) were reported in 15% (10/66) of patients receiving ENJAYMO in the two phase 3 trials. These infections included urinary tract infection with sepsis, respiratory tract infection, pneumonia, otomastoiditis, and skin infections. One patient (1.5%) died due to Klebsiella pneumoniae.
Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of ENJAYMO, according to the most current ACIP recommendations for patients receiving a complement inhibitor.
If urgent ENJAYMO therapy is indicated in a patient who is not up to date on their vaccine(s), administer as soon as possible.
Vaccination does not eliminate the risk of serious encapsulated bacterial infections. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected.
If ENJAYMO treatment is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection. Some infections may become rapidly life-threatening or fatal if not recognized and treated promptly. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care.
Consider interruption of ENJAYMO treatment in patients who are undergoing treatment for serious infection.
Consider patients’ immune status when initiating treatment with ENJAYMO.
Infusion-Related Reactions

Administration of ENJAYMO may result in infusion-related reactions. In the two phase 3 trials, 29% (19/66) of patients treated with ENJAYMO experienced infusion-related reactions. One patient permanently discontinued ENJAYMO due to an infusion-related reaction.
Monitor patients for infusion-related reactions and interrupt if a reaction occurs.
Discontinue ENJAYMO infusion and institute appropriate supportive measures if signs of hypersensitivity reactions, such as cardiovascular instability or respiratory compromise, occur.
Risk of Autoimmune Disease

Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Development of SLE has been associated with inherited classical complement deficiency.
In clinical trials, 4.5% (3/66) of patients developed a relapse or worsening of previously diagnosed autoimmune disease.
Monitor ENJAYMO patients for signs and symptoms and manage medically.
Recurrent Hemolysis After ENJAYMO Discontinuation

If treatment with ENJAYMO is interrupted, closely monitor patients for signs and symptoms of recurrent hemolysis, eg, elevated levels of total bilirubin or lactate dehydrogenase (LDH) accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria. Consider restarting ENJAYMO if signs and symptoms of hemolysis occur after discontinuation.
ADVERSE REACTIONS

The most common adverse reactions in the CADENZA trial (Part A) (incidence ≥18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud’s phenomenon. The most common adverse reactions in the CARDINAL trial (incidence ≥25%) are urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea

(Press release, Recordati, NOV 12, 2026, View Source [SID1234674708])

Enhertu® Supplemental New Drug Application Submitted in Japan for Patients with HER2 Expressing Advanced or Recurrent Uterine Carcinosarcoma

On November 15, 2026 Daiichi Sankyo (TSE: 4568) reported it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Enhertu (trastuzumab deruxtecan) for the treatment of patients with HER2 expressing (immunohistochemistry [IHC] 3+, IHC 2+ or IHC 1+) advanced or recurrent uterine carcinosarcoma.

Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being developed and commercialized by Daiichi Sankyo in Japan.

The sNDA is based on data from the STATICE phase 2 trial, an investigator-initiated trial conducted in Japan, which was published in the Journal of Clinical Oncology. In the trial, Enhertu (5.4 mg/kg) demonstrated durable responses across levels of HER2 expression in patients with advanced or recurrent uterine carcinosarcoma previously treated with chemotherapy (including adjuvant chemotherapy). STATICE is the first prospective trial to show clinical activity with a HER2 directed medicine in this rare form of cancer.

"Patients with HER2 expressing advanced uterine carcinosarcoma in Japan face a poor prognosis, with treatment relying on chemotherapy rather than options directed at a specific molecular target," said Yuki Abe, PhD, Senior Executive Officer, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "The durable activity demonstrated in the STATICE trial underscores the benefit of targeting HER2 with Enhertu in this difficult-to-treat cancer. If approved, Enhertu could provide an important targeted treatment option for patients with uterine carcinosarcoma in Japan."

Enhertu currently is approved in more than 50 countries/regions worldwide to treat patients with HER2 positive (IHC 3+) solid tumors who have received prior treatment and/or who have no satisfactory treatment options. In Japan, Enhertu can be considered as a treatment option for patients with HER2 positive (HER2 [ERBB2] gene amplification or IHC 3+) uterine carcinosarcoma when standard treatment is not appropriate.

Enhertu also is under review in Japan as an adjuvant treatment for patients with HER2 positive (IHC 3+ or in-situ hybridization (ISH)+) breast cancer with residual invasive disease after neoadjuvant therapy based on data from DESTINY-Breast05.

About STATICE

STATICE is a multicenter, open-label, single-arm investigator-initiated phase 2 trial evaluating the efficacy and safety of Enhertu (6.4 or 5.4 mg/kg) in patients in Japan with HER2 expressing (HER2 IHC 3+, IHC 2+ or IHC 1+) advanced or recurrent uterine carcinosarcoma who have received prior chemotherapy (including adjuvant chemotherapy). At trial initiation, Enhertu 6.4 mg/kg was administered; however, based on an assessment of risk/benefit, the dosing was modified mid-trial to 5.4 mg/kg and was determined to be the preferred dose for this patient population.

The primary endpoint of STATICE is objective response rate (ORR) as assessed by central review in patients with HER2 expressing tumors with IHC ≥ 2+. Secondary endpoints include investigator-assessed ORR in patients with HER2 expressing tumors with IHC ≥ 2+, ORR by central review and investigator assessment in patients with HER2 IHC 1+ tumors, progression-free survival (PFS), overall survival (OS) and safety. Results from STATICE were published in the Journal of Clinical Oncology.

STATICE enrolled 34 patients across seven sites in Japan. For more information about the trial, visit Japan’s University Hospital Medical Information Network.

About Uterine Carcinosarcoma

Uterine carcinosarcoma is a rare, highly aggressive form of endometrial cancer that accounts for fewer than 5% of endometrial cancer cases in Japan.1,2,3 Despite its rarity, uterine carcinosarcoma is estimated to account for approximately 15% of endometrial cancer-related deaths.3 Prognosis remains poor, with lower overall survival for uterine carcinosarcoma compared to other types of endometrial cancer and particularly poor outcomes reported following later lines of treatment in recurrent or metastatic uterine carcinosarcoma.

HER2 is a tyrosine kinase receptor protein involved in cell growth and differentiation and expressed on the surface of multiple tumor types.6 HER2 expression (IHC 3+, IHC 2+, or IHC 1+) was observed in 72.3% of patients with uterine carcinosarcoma, supporting HER2 as a potential therapeutic target.7 Pre-clinical trials evaluating HER2 targeted therapies showed promising antitumor effects, supporting the potential of HER2 as a therapeutic target in uterine carcinosarcoma.

In Japan, paclitaxel plus carboplatin chemotherapy is commonly used as systemic treatment for unresectable, advanced uterine carcinosarcoma, including recurrent disease.11,12,13 However, median disease-free survival with this regimen is less than two years and disease recurrence occurs in 57% of patients with uterine carcinosarcoma.

About Enhertu

Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) 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 program 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 (5.4 mg/kg) followed by THP is approved in more than five countries/regions worldwide as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11 trial.

Enhertu (5.4 mg/kg) is approved in more than 35 countries/regions worldwide for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in more than 40 countries/regions worldwide as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior antiHER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have 3 developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial

Enhertu (5.4 mg/kg) is approved in more than 75 countries/regions 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 approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions 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 (5.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors 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 U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4 mg/kg) is approved in more than 90 countries/regions 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 (5.4 mg/kg) is approved in more than 50 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior treatment and/or have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02, DESTINY-PanTumor03 and/or HERALD trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

(Press release, Daiichi Sankyo, NOV 12, 2026, View Source [SID1234674707])