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Genprex Announces Research Collaborators’ Abstract Published in Cancer Research Supplement Proceedings

On April 22, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators’ abstract was published in the online Proceedings supplement of Cancer Research, a scientific journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Genprex, APR 22, 2025, View Source [SID1234652014]).

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Genprex collaborators will present the published abstract in a poster presentation at the 2025 AACR (Free AACR Whitepaper) Annual Meeting being held April 25-30, 2025 in Chicago, Illinois. The collaborators will present positive preclinical data from a study of Genprex’s lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of KRASG12Cmutant non-small cell lung cancer (NSCLC).

"We are pleased to have our collaborators’ abstract selected for both publication and presentation before the world’s top cancer researchers, investigators and healthcare professionals," said Ryan Confer, President and Chief Executive Officer at Genprex. "This publication highlights research-driven advances against cancer, and we are gratified to be featured among those advances. We look forward to this week’s presentation of positive preclinical data on our lead drug candidate, REQORSA, as a potential therapeutic treatment for Ras inhibitor resistant lung cancer."

The featured Genprex-supported poster to be presented at AACR (Free AACR Whitepaper) 2025:

Title: Overcoming sotorasib acquired resistance in KRASG12C mutant NSCLC by TUSC2 gene therapy

Session Category: Experimental and Molecular Therapeutics

Session Title: Drug Resistance in Molecular Targeted Therapies 3

Session Date and Time: Tuesday, April 29 from 2-5 p.m. CT

Location: Poster Section 17

Poster Board Number: 12

Abstract Presentation Number: 5517

The featured Genprex-supported abstract to be presented at AACR (Free AACR Whitepaper) 2025:

Acquired resistance (AR) to Lumakras (sotorasib), the first FDA-approved KRASi, poses a significant challenge in the treatment of KRASG12C mutant NSCLC. Despite initial responses, patients invariably develop resistance, necessitating alternative therapeutic strategies. The mechanisms underlying AR include the emergence of additional mutations in the KRAS gene, reactivation of the KRAS pathway, or activation of alternative signaling pathways. TUSC2, a potent tumor suppressor gene with immunogenic properties, exhibits multifunctional activity by inhibiting downstream signaling pathways, including MAPK and mTOR; arresting the growth and proliferation of cancer cells; inducing tumor cell death; and activating innate and adaptive immune responses. In this study, researchers demonstrated that TUSC2 gene therapy (REQORSA) effectively overcomes sotorasib AR in KRASG12C mutant NSCLC mouse xenografts.

The data indicate that TUSC2 transfection significantly reduced colony formation in two AR cell lines. Transfection of TUSC2 also markedly increased apoptosis in AR cells. Re-expression of TUSC2 into AR PDXOs significantly decreased the viability of organoids compared with the empty vector. The H23AR tumors exhibited significantly lower sensitivity to sotorasib than their parental counterparts. However, treatment with REQORSA was highly effective in controlling tumor growth compared to treatment with sotorasib alone or the control groups. REQORSA alone also exhibited a strong antitumor effect on TC314AR PDXs. Sotorasib alone showed no significant antitumor activity in these models. However, a synergistic antitumor effect was observed when TC314AR PDX tumors were treated with the combination of REQORSA and sotorasib.

In conclusion, researchers demonstrated that REQORSA, alone or in combination with sotorasib,

induced apoptosis, inhibited colony formation, and showed significant antitumor efficacy in KRASG12C mutant sotorasib-acquired resistant xenograft and PDX tumors.

About Reqorsa Gene Therapy

REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company’s Oncoprex Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

Circle Pharma to Present Late-Breaking Data at AACR 2025 Demonstrating Mechanism of Action for Novel Cyclin A/B RxL Inhibitors

On April 22, 2025 Circle Pharma, a clinical-stage biopharmaceutical company focused on developing cell-permeable macrocycle therapeutics, reported a late-breaking poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago, Illinois (Press release, Circle Pharma, APR 22, 2025, View Source;utm_medium=rss&utm_campaign=circle-pharma-to-present-late-breaking-data-at-aacr-2025-demonstrating-mechanism-of-action-for-novel-cyclin-a-b-rxl-inhibitors [SID1234652013]).

The poster will present new mechanistic insights into the anti-cancer activity of cyclin A/B RxL inhibitors, including their impact on DNA repair pathways and mitotic progression in E2F-high cancers. Circle Pharma’s CID-078, an oral macrocycle Cyclin A/B RxL inhibitor, is being evaluated in a Phase 1 clinical study (NCT06577987).

Presentation Details Title: Anti-cancer effect of Cyclin A/B RxL inhibitors is mediated in part by disruption
of the ATR/Chk1 DNA repair pathway 
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3 
Session Start: 4/29/2025 9:00:00 AM CT 
Session End: 4/29/2025 12:00:00 PM CT
Location: Poster Section 52 Poster Board Number: 19 Abstract Number: LB296

The study, led by researchers from Circle Pharma in collaboration with the University of Oxford and Dana-Farber Cancer Institute, highlights the dual mechanism by which Cyclin A/B RxL inhibitors induce tumor regression.

Contributing Authors: Catherine E. Gleason, Ranya Odeh, Frances Hamkins-Indik, Iolanda Vendrell, Roman Fischer, Benedikt Kessler, Shilpa Singh, Matthew Oser, Marie Evangelista, and Pablo D. Garcia, Circle Pharma Inc., South San Francisco, CA, University of Oxford, UK, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA

Enhertu combination improved PFS in 1L HER2+ mBC

On April 22, 2025 Astrazeneca reported positive high-level results from a planned interim analysis of the DESTINY-Breast09 Phase III trial showed Enhertu (trastuzumab deruxtecan) in combination with pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to a taxane, trastuzumab and pertuzumab (THP) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer (Press release, AstraZeneca, APR 22, 2025, View Source [SID1234652012]).

The PFS improvement was seen across all pre-specified patient subgroups with Enhertu in combination with pertuzumab. The key secondary endpoint of overall survival (OS) was not mature at the time of this planned interim analysis; however, interim OS data showed an early trend favouring the Enhertu combination compared with THP.

The second arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

HER2-positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 affecting 15-20% of patients with metastatic breast cancer.1 While HER2-targeted therapies have improved outcomes, prognosis remains poor, with most patients experiencing disease progression within two years of 1st-line treatment with THP, which has been the standard of care for more than a decade.2-4 Further, approximately one in three patients never go on to receive treatment following 1st-line therapy due to disease progression or death.5,6

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "This is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic breast cancer patient population compared to the current 1st-line standard of care. This is a significant milestone for patients and sets the foundation for Enhertu in combination with pertuzumab as an important treatment option in the first-line HER2-positive setting."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "The results from DESTINY-Breast09 reinforce the importance of effectively targeting HER2 to achieve durable disease control early in the treatment of HER2-positive metastatic breast cancer. Building on the positive results seen with Enhertu in the second-line setting, these new findings suggest that starting treatment with Enhertu in combination with pertuzumab at the time of metastatic diagnosis delays disease progression, postponing the time until additional treatment may be needed."

The safety profile of Enhertu in combination with pertuzumab was consistent with the known profiles of each individual therapy.

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.

Data from the combination arm of DESTINY-Breast09 will be presented at an upcoming medical meeting and shared with regulatory authorities.

Enhertu is already approved in more than 75 countries as 2nd-line treatment for patients with HER2-positive breast cancer based on the results from the DESTINY-Breast03 trial.

Notes

HER2-positive metastatic breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.7 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.7 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.8

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast cancer.9 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease in breast cancer.1 Approximately one in five cases of breast cancer are considered HER2-positive.10

While HER2-targeted therapies have improved outcomes, prognosis remains poor, with most patients experiencing disease progression within two years of 1st-line treatment with THP, which has been the standard of care for more than a decade.2-4 Further, approximately one in three patients never go on to receive treatment following 1st-line therapy due to disease progression or death.5,6

DESTINY-Breast09
DESTINY-Breast09 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) either alone or in combination with pertuzumab versus standard of care THP (a taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) as a 1st-line treatment in patients with HER2-positive metastatic breast cancer.

Patients were randomised 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomisation was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is PFS as assessed by blinded independent central review in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, objective response rate, duration of response, investigator-assessed time to second progression or death, patient-reported tolerability, pharmacokinetics and safety.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America 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) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC 3+ or in-situ hybridisation [ISH]+) breast cancer who have received a (or one or more) 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 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved in more than 30 countries 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 50 countries worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 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 will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population.

Enhertu (5.4mg/kg) is approved in the US and other countries 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 the 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 development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials in combination with other anti-cancer treatments, such as immunotherapy, also are underway.

Jechobio Collaborates with Industry Peers to Announce Promising Clinical Data for Innovative GPC3-Targeted Radionuclide Drug

On April 21, 2025 Jecho Biopharmaceuticals Co., Ltd. (hereinafter referred to as "Jechobio"), in collaboration with Wuhan Raydif Biotechnology Co., Ltd. (hereinafter referred to as "Raydif"), and Grand Pharmaceutical Group Limited (stock code: 00512.HK, hereinafter referred to as "Grand Pharma"), have jointly developed GPN02006, an innovative radionuclide-drug conjugate(RDC) targeting Glypican 3 (GPC3) (Press release, Jecho Laboratories, APR 21, 2025, View Source [SID1234653897]). The clinical results of GPN02006 were recently presented at the 2025 Future XDC New Drug Conference (list city location). Clinical strial data demonstrate that GPN02006 exhibits excellent safety and imaging efficacy, providing a novel solution for precision diagnosis of tumors with high GPC3 expression, such as liver cancer. No drug-related adverse reactions were reported in any of the subjects after administration, showcasing outstanding safety and tolerability; high-quality imaging can be achieved as early as 30 minutes post-dosing, fully meeting the rapid diagnostic needs for hepatocellular carcinoma.

‌An Innovative Antibody Technology Platform as the Cornerstone of Precision Targeting‌
The remarkable clinical outcomes of GPN02006 represent a significant breakthrough in the field of radionuclide drugs and highlight the combined core R&D strengths of the three partners. Jechobio, leveraging its proprietary phage antibody library platform, VHH nanobody platform, and single B antibody discovery platform, has established a diverse antibody development system encompassing single-chain antibody fragments (scFv), nanobodies (VHH), Fab, IgG, and other formats. Through these platforms, Jechobio has successfully screened multiple innovative molecules that it is advancing to the clinic.
The GPC3 scFv targeting moiety of GPN02006 developed by Jechobio demonstrates three unique advantages: 1) High specificity and strong affinity -precise recognition of the GPC3 target ensures efficient tumor tissue targeting of the drug; 2) Excellent pharmacokinetic (PK) properties -perfect matching with the imaging agent lays the foundation for radionuclide drug development; 3) Outstanding safety -no adverse reactions were observed in preliminary human trials. These advantages demonstrate Jechobio’s innovative capabilities in the field of antibody drug research and development.
‌

The Powerful Combination of Antibody + Radionuclide Drug"
The success of GPN02006 is a testament to the powerful combination of antibody technology + radionuclide drug development.
To date, this GPC3-targeting RDC clinical trial has enrolled over 80 patients and has demonstrated excellent performance in an investigator-initiated trial (IIT): 1) Exceptional safety: no drug-related adverse events were observed in any subjects; 2) Efficiency and convenience: effective imaging can be achieved 30 minutes post-injection; 3) Superior image quality: low background signal and strong tumor uptake provide a reliable basis for precise diagnosis of liver cancer.
With the rapid development of precision medicine, radionuclide-drug conjugates (RDCs) have emerged as a new frontier in tumor diagnosis and treatment.

ENHERTU® Plus Pertuzumab Demonstrated Highly Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival Versus THP as First-Line Therapy for Patients with HER2 Positive Metastatic Breast Cancer

On April 21, 2025 Astrazeneca reported positive topline results from a planned interim analysis of the DESTINY-Breast09 phase 3 trial showed ENHERTU (trastuzumab deruxtecan) in combination with pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment for patients with HER2 positive metastatic breast cancer (Press release, AstraZeneca, APR 21, 2025, View Source [SID1234652009]).

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The PFS improvement was seen across all pre-specified patient subgroups with ENHERTU in combination with pertuzumab. The key secondary endpoint of overall survival (OS) was not mature at the time of this planned interim analysis; however, interim OS data showed an early trend favoring the ENHERTU combination compared to THP.

The second arm assessing ENHERTU monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.1 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.2,3,4,5 Further, approximately one in three patients never go on to receive treatment following first-line therapy due to disease progression or death.6,7

"The results of DESTINY-Breast09 reinforce the importance of effectively targeting HER2 to achieve durable disease control early in the treatment of HER2 positive metastatic breast cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "Building on the positive results seen with ENHERTU in the second-line setting, these new findings suggest that starting treatment with ENHERTU in combination with pertuzumab at the time of metastatic diagnosis delays disease progression, postponing the time until additional treatment may be needed."

"This is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2 positive metastatic breast cancer patient population compared to the current first-line standard of care," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. "This is a significant milestone for patients and sets the foundation for ENHERTU in combination with pertuzumab as an important treatment option in the first-line HER2 positive setting."

The safety profile of ENHERTU in combination with pertuzumab was consistent with the known profiles of each individual therapy.

Data from the combination arm of DESTINY-Breast09 will be presented at an upcoming medical meeting and shared with regulatory authorities.

About DESTINY-Breast09
DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP (a taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) as a first-line treatment in patients with HER2 positive metastatic breast cancer.

Patients were randomized 1:1:1 to receive either ENHERTU monotherapy with a pertuzumab matching placebo; ENHERTU in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is PFS as assessed by blinded independent central review in both the ENHERTU monotherapy and ENHERTU combination arms. Secondary endpoints include investigator-assessed PFS, OS, objective response rate, duration of response, pharmacokinetics and safety.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America, and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Metastatic Breast Cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.8 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.8 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or progress to metastatic disease are expected to live five years following diagnosis.9

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.10 HER2 protein overexpression may occur as a result of HER2 gene amplification.2 Approximately one in five cases of breast cancer are considered HER2 positive.11

About ENHERTU
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) 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 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) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (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 (5.4 mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 30 countries 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 50 countries 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 65 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in Brazil, Israel, Russia, Taiwan, U.K. and the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors 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 may be contingent upon verification and description of clinical benefit in a confirmatory trial.