1stOncology™: Cancer Intelligence Service – Page 347 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

AN2 Therapeutics Announces $40 Million Private Placement Financing

On March 9, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company developing novel small molecule therapeutics derived from its boron chemistry platform, reported that it has entered into a securities purchase agreement for a private placement that is expected to result in gross proceeds of approximately $40 million, before deducting placement agent fees and other expenses. The private placement includes participation from Coastlands Capital, Commodore Capital, Vivo Capital and other new and existing institutional investors.

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!

In the private placement, AN2 Therapeutics is selling 8,245,611 shares of common stock at a price of $2.85 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase up to 5,789,493 shares of common stock at a price of $2.84999 per pre-funded warrant. Each pre-funded warrant will have an exercise price of $0.00001 per share of common stock, will be exercisable immediately and will be exercisable until exercised in full, subject to ownership limitations. The private placement is expected to close on March 10, 2026, subject to the satisfaction of customary closing conditions. The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the "Minimum Price" requirement (as defined in the Nasdaq rules).

Leerink Partners is acting as exclusive placement agent for the private placement.

The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. AN2 Therapeutics has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock to be issued in the private placement and the shares of common stock issuable upon exercise of the pre-funded warrants to be issued in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, AN2 Therapeutics, MAR 9, 2026, View Source [SID1234663357])

Alpha Tau Announces Full Year 2025 Financial Results and Provides Corporate Update

On March 9, 2026 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported full year 2025 financial results and provided a corporate update.

"The pace of progress at Alpha Tau today is unlike anything we’ve ever seen before," said Alpha Tau Chief Executive Officer Uzi Sofer. "With a slew of meaningful announcements in the past few months, culminating most recently with our receipt of marketing approval in Japan, our first outside of Israel, and with multiple meaningful milestones targeted for the coming months, we remain laser focused on execution. Clinical trial progress remains our highest priority, with an astounding five clinical trials approved in parallel in the U.S. At the same time, we continue to build out our manufacturing capabilities in New Hampshire as well as our pre-commercial preparations, while entertaining multiple tracks of strategic dialogue with partners who show increasing excitement about the ever-expanding prospects for Alpha DaRT."

Recent Corporate Highlights:

● Commercial-Scale U.S. Manufacturing Milestone: In October, Alpha Tau announced the receipt of a radioactive material license for its New Hampshire manufacturing facility, its first commercial-scale facility. The license paves the way for the introduction of radioactive material and continued positive momentum toward initiating Alpha DaRT treatment manufacturing onsite in 2026. Total expected nameplate capacity from the first phase of construction is approximately 400,000 Alpha DaRT sources for local use, subject to a number of operational and clinical assumptions.

● FDA Approval to Start Prostate Cancer Trial: In December, Alpha Tau announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with locally recurrent prostate cancer using the Company’s Alpha DaRT technology. According to the National Cancer Institute, over 300,000 new cases of prostate cancer were expected to be diagnosed in 2025, and clinical literature indicates that up to 15% of patients treated with external beam radiation therapy can develop local recurrence within 15 years of treatment. The clinical trial is expected to enroll up to 12 U.S. patients with locally recurrent prostate cancer who have demonstrated biochemical recurrence by the Phoenix definition (a rise of PSA levels by 2 ng/mL from the PSA nadir). For more information, please see here: View Source

● First Patient Treated in U.S. Brain Cancer Trial: In December, Alpha Tau treated its first patient in its pilot study for the treatment of patients with recurrent glioblastoma multiforme (GBM) using the Alpha DaRT technology. According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months, and this pilot study is a key part of Alpha Tau’s broader strategy to bring Alpha DaRT to cancer patients with some of the highest unmet needs. For more information, please see here: View Source

● First Module Submitted to FDA as Part of Application for Marketing Authorization in Skin Cancer: In January, the Company announced the submission of the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA), following the FDA’s previous decision to allow the Company to use the more flexible modular approach. The Company submitted the module with respect to non-clinical studies as part of an application for the use of Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer, for patients not indicated for surgery or standard radiation therapy, and for whom no curative systemic treatment is available.

● New Positive Data in Pancreatic Cancer Presented at ASCO (Free ASCO Whitepaper): In January, investigators from the Company’s first-in-human pancreatic cancer study in Montreal, Canada exploring the use of Alpha DaRT in treating pancreatic ductal adenocarcinoma (PDAC) were awarded two separate presentations at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium showcasing results from the trial. The results demonstrated a 22% objective response rate (ORR) and an 81% disease control rate (DCR) across all 32 patients treated in the study, or 23% ORR and 87% DCR when excluding the first two patients, who were deliberately given low dosages in order to examine feasibility and safety only. In addition, investigators presented results showing the immune-preserving profile of Alpha DaRT in PDAC, based on immune markers as well as inflammatory indices known to be negative prognostic indicators, and which typically worsen after other forms of radiation therapy.

● Received Marketing Approval in Japan for Head and Neck Cancer: In February, Alpha Tau announced the receipt of Japanese marketing approval for Alpha DaRT in unresectable locally advanced or locally recurrent head and neck cancer, marking the first regulatory approval of the Alpha DaRT platform outside Israel. As part of the approval, Alpha Tau will need to conduct a post-market surveillance (PMS) study enrolling 66 patients in total at five selected leading clinical centers in Japan, and the Company’s immediate focus is on working closely with Japanese clinicians to complete the PMS study and to generate high-quality clinical data in patients with unresectable locally advanced or locally recurrent disease.

Expected Upcoming Milestone Targets:

● Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma at the end of Q1 2026. For more information, please see here: View Source

● Completion of patient recruitment in pancreatic cancer pilot study in the U.S. in Q2 2026. For more information, please see here: View Source

● Initial safety readout from the first three patients in the recurrent GBM trial in Q2 2026, and completion of patient recruitment in the second half of 2026. For more information, please see here: View Source

Financial results for year ended December 31, 2025

R&D expenses for the year ended December 31, 2025 were $32.1 million, compared to $27.0 million for the same period in 2024, due to increased employee compensation and benefits, increased costs of raw materials, and increased third-party contractor expenses (including clinical trial sites).

Marketing expenses for the year ended December 31, 2025 were $1.9 million, compared to $2.3 million for the same period in 2024, due to decreased compensation expenses and travel abroad.

G&A expenses for the year ended December 31, 2025 were $8.4 million, compared to $6.7 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation, and increased professional fees (including legal and IR expenses).

Financial expense, net, for the year ended December 31, 2025 was $0.2 million, compared to $4.3 million financial income, net, for the same period in 2024, due to a decrease in income from remeasurement of warrants and in interest from bank deposits as well as increased expense from changes in foreign exchange rates.

For the year ended December 31, 2025, the Company had a net loss of $42.6 million, or $0.53 per share, compared to a net loss of $31.8 million, or $0.45 per share, in the year ending December 31, 2024.

Balance Sheet Highlights

As of December 31, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $76.9 million, compared to $62.9 million at December 31, 2024.

Annual Report Availability

Alpha Tau’s Annual Report on Form 20-F for the fiscal year ended December 31, 2025, has been filed today with the Securities and Exchange Commission. The Annual Report on Form 20-F can be accessed on the Investor Relations section of Alpha Tau’s website at View Source and on the SEC’s website at www.sec.gov.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, MAR 9, 2026, View Source [SID1234663356])

AN2 Therapeutics Announces $40 Million Private Placement Financing

Leerink Partners is acting as exclusive placement agent for the private placement.

(Press release, AN2 Therapeutics, MAR 9, 2026, View Source [SID1234663349])

Roche provides update on phase III persevERA study in ER-positive advanced breast cancer

On March 9, 2026 Hoffmann-La Roche reported results from the phase III persevERA Breast Cancer study evaluating investigational giredestrant in combination with palbociclib for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. The study did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed. The adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of each individual treatment.

"While persevERA didn’t meet its primary objective, we are confident in the potential of giredestrant to become a new standard-of-care endocrine therapy in early and advanced ER-positive breast cancer," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "We believe there is a path forward for combining giredestrant with a CDK4/6 inhibitor in the adjuvant setting and we are conducting further studies. The efficacy demonstrated in evERA and lidERA provides clear validation of the clinical activity of giredestrant and reinforces the strength of our expanding clinical development programme."
The giredestrant clinical development programme is made up of distinct studies designed to reflect the specific disease biology of each stage of breast cancer.3-7 Roche will continue to advance the clinical development programme to identify the people with ER-positive breast cancer who can derive the greatest benefit from giredestrant.

Giredestrant phase III clinical development programme

Trial Indication Regimen
lidERA Breast Cancer5 Adjuvant ER+/HER2- breast cancer Giredestrant vs. standard-of-care endocrine therapy (SoC ET)
persevERA Breast Cancer3 1L ER+/HER2- metastatic breast cancer
(endocrine-sensitive) Giredestrant + palbociclib vs. letrozole plus palbociclib
pionERA Breast Cancer4 1L ER+/HER2- metastatic breast cancer
(endocrine-resistant) Giredestrant + physician’s choice of CDK4/6 inhibitor vs. fulvestrant + physician’s choice of CDK4/6 inhibitor
evERA Breast Cancer6 2L+ ER+/HER2- metastatic breast cancer Giredestrant + everolimus vs. SoC ET + everolimus
heredERA Breast Cancer7 1L maintenance ER+/HER2+ metastatic breast cancer Giredestrant + Phesgo (pertuzumab, trastuzumab, and hyaluronidase subcutaneous) vs. Phesgo
evERA was the first positive phase III readout for giredestrant, followed by lidERA in the early-stage setting.8,9 The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the phase II coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division (Ki67 levels).10 This growing body of evidence underscores the potential of giredestrant to become a new standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer.

persevERA is the first of two distinct phase III studies in the first-line setting; the pionERA study of giredestrant in combination with physician’s choice of cyclin-dependent kinase (CDK)4/6 inhibitor in endocrine-resistant ER-positive, HER2-negative breast cancer is expected to readout in 2027.3,4

The United States Food and Drug Administration (FDA) recently accepted the New Drug Application based on the evERA data. In the coming weeks, Roche will submit the giredestrant phase III lidERA data in early-stage breast cancer to the FDA.

The full results from persevERA will be presented at an upcoming medical meeting.

About the persevERA Breast Cancer study
persevERA Breast Cancer [NCT04546009] is a phase III, randomised, double-blind, placebo-controlled, multicentre study evaluating the efficacy and safety of giredestrant plus palbociclib versus letrozole plus palbociclib as first-line treatment for people with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer.3 The study enrolled 992 patients globally.3

The primary endpoint is investigator-assessed progression-free survival.3 Key secondary endpoints include overall survival, objective response rate, duration of response and safety.3

About giredestrant
Giredestrant is an investigational, oral, potent next-generation selective oestrogen receptor degrader and full antagonist.11

Giredestrant is designed to block oestrogen from binding to the oestrogen receptor, triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.12

Giredestrant has an extensive clinical development programme and is being investigated in five company-sponsored phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)5
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)6
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)3
Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK)4/6 inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)4
Giredestrant plus Phesgo (pertuzumab, trastuzumab, and hyaluronidase subcutaneous) versus Phesgo in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)7
About oestrogen receptor (ER)-positive breast cancer
Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year.13 Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.14

ER-positive breast cancer accounts for approximately 70% of breast cancer cases.15 In the US and EU5, an estimated 273,000 people are diagnosed in the early-stage setting, 88,000 people are diagnosed in first-line and 106,000 in the second and third-line setting combined.16

A defining feature of ER-positive breast cancer is that its tumour cells have receptors that attach to oestrogen, which can contribute to tumour growth.17

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity.18 In the early-stage setting, up to a third of people eventually experience disease recurrence on or after adjuvant endocrine therapy treatment.19-21 Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death.22 In advanced settings, resistance to endocrine therapy – particularly following treatment with cyclin-dependent kinase inhibitors – increases the risk of disease progression an is associated with poor outcomes.15,23

There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.18,20,22-24

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years, and it continues to be a major focus of research and development. Our legacy began with the development of the first targeted therapy for human epidermal growth factor receptor 2-positive breast cancer, and we continue to push the boundaries of science to address the complexities of all breast cancer subtypes.

By leveraging our dual expertise in pharmaceuticals and diagnostics, we are dedicated to providing tailored treatment approaches and improving outcomes for every patient, from early to advanced stages of the disease. Together with our partners, we are relentlessly pursuing a cure, as we strive for a future where no one dies from breast cancer.

(Press release, Hoffmann-La Roche, MAR 9, 2026, View Source [SID1234663346])

Enhertu granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer

On March 9, 2026 AstraZeneca and Daiichi Sankyo reported its supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment.

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the third quarter of 2026.

Enhertu was recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.

The sBLA also is being reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners.

Around one in five breast cancers are considered HER2-positive, a subtype that is often associated with aggressive disease and poor prognosis.1-3 Currently, approximately half of patients with HER2-positive early breast cancer have residual disease following neoadjuvant treatment (before surgery), putting them at an increased risk of disease recurrence.4-9 Despite receiving additional treatment in the post-neoadjuvant setting with current standards of care, some patients still experience tumour progression to metastatic disease, where the five-year survival rate drops from nearly 90% to approximately 30%.10,11

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "While there has been significant progress in treating HER2-positive early breast cancer, managing patients at a higher risk of recurrence remains challenging. With this Priority Review, we move closer to bringing Enhertu to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "For patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease. This Priority Review reinforces the potential of Enhertu to become a new standard of care for HER2-positive early breast cancer based on the results of DESTINY-Breast05."

The sBLA is based on data from the DESTINY-Breast05 Phase III trial presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Congress and subsequently published in The New England Journal of Medicine.1

In the trial, Enhertu significantly reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% compared with trastuzumab emtansine (T-DM1; based on a hazard ratio [HR] of 0.47; 95% confidence interval [CI] 0.34-0.66; p<0.0001) as a post-neoadjuvant treatment for patients with HER2-positive breast cancer. Enhertu demonstrated a three-year IDFS rate of 92.4% compared with 83.7% with T-DM1. IDFS findings were consistent across all prespecified subgroups.

Enhertu also significantly reduced the risk of disease recurrence or death (disease-free survival [DFS]), a key secondary endpoint, by 53% versus T-DM1 (HR 0.47; 95% CI 0.34-0.66; p<0.0001). Further, Enhertu lowered the risk of distant disease recurrence (distant recurrence-free interval) by 51% and the risk of brain metastases (brain metastasis-free interval) by 36% compared with T-DM1 (HR 0.64; 95% CI 0.35-1.17).

The safety profile of Enhertu observed in DESTINY-Breast05 was consistent with its known profile with no new safety concerns identified.

Regulatory submissions for Enhertu based upon DESTINY-Breast05 are also under review in the EU and Japan. In addition, an sBLA for Enhertu followed by paclitaxel, trastuzumab and pertuzumab (THP) currently is under review in the US for the neoadjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 trial.

Enhertu is already approved in more than 90 countries as a treatment for patients with HER2-positive metastatic breast cancer.

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

Post-neoadjuvant treatment for HER2-positive early breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.12 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.12 In the US, more than 320,000 cases of breast cancer are diagnosed annually with more than 42,000 deaths.13

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.14 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.14 Approximately one in five cases of breast cancer are considered HER2-positive.2-3

For patients with HER2-positive early breast cancer, achieving pCR with neoadjuvant treatment is the earliest indicator of improved long-term survival.9 However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence.4-9

Despite receiving additional treatment for residual disease in the post-neoadjuvant setting, some patients still experience invasive disease or death, and current treatment options have shown limited impact on central nervous system recurrence.11 In the US, around 16,000 patients with HER2-positive early breast cancer receive treatment in the post-neoadjuvant setting (after surgery) each year.15

DESTINY-Breast05
DESTINY-Breast05 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus T-DM1 in patients with HER2-positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS. IDFS is defined as the time from randomisation until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed disease-free survival. Other secondary endpoints include overall survival, distant recurrence-free interval, brain metastases-free interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, 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) in combination with pertuzumab is approved in the US as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4mg/kg) is approved in more than 90 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 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 90 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 (5.4mg/kg) is approved in more than 60 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 (5.4mg/kg) is approved in more than 70 countries/regions 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 80 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-Gastric06 trials. 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 more than 10 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 and DESTINY-CRC02 trials. Continued approval for this indication in the US 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, MAR 9, 2026, View Source [SID1234663345])