On May 22, 2026 AstraZeneca and Daiichi Sankyo reproted that Datroway (datopotamab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

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

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

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

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

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

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

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

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

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

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

Notes

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

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

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

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

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

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

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

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

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

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

(Press release, AstraZeneca, MAY 22, 2026, View Source [SID1234666003])

On May 22, 2026 AstraZeneca reproted that camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) has been recommended for approval in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of ESR1 mutation and without disease progression during 1st-line endocrine therapy in combination with a CDK4/6 inhibitor.

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the pivotal SERENA-6 Phase III trial, which were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.1

In a planned interim analysis, the camizestrant combination reduced the risk of disease progression or death by 56% versus standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (based on a hazard ratio [HR] of 0.44; 95% confidence interval [CI] 0.31-0.60; p<0.00001; median progression-free survival (PFS) 16.0 versus 9.2 months). Data for the key secondary endpoints of time to second disease progression (PFS2) and overall survival (OS) were immature at the time of the interim analysis, however a subsequent pre-planned analysis demonstrated a statistically significant and clinically meaningful PFS2 benefit of 25.7 months versus 19.1 months in favour of the camizestrant combination (HR: 0.63; 95% CI: 0.46-0.86; p = 0.00373) and OS continued to mature in favour of the camizestrant combination (HR: 0.87; 95% CI: 0.57-1.30). The trial will continue to assess OS as a key secondary endpoint.

François-Clément Bidard, MD, PhD, Professor of Medical Oncology at Institut Curie & Versailles University (Paris/Saclay), France, and co-principal investigator for the SERENA-6 trial, said: "This recommendation represents an important step forward for patients with advanced breast cancer in Europe and a milestone in the adoption of new treatment strategies. There is a need for new treatments that delay disease progression in the 1st-line setting, after which the cancer becomes harder to treat, and a patient’s quality of life may decline. Through prompt intervention with the camizestrant combination to treat emergence of resistance before it causes disease progression and deterioration of quality of life, we are able to extend the benefit of 1st-line treatment and optimise outcomes."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "This decision from the EU’s CHMP is a vote of confidence in SERENA-6, the first pivotal trial to demonstrate the clinical value of monitoring circulating tumour DNA to detect emerging endocrine resistance and guide a change of therapeutic strategy in the 1st-line setting. If approved, camizestrant would be the first and only next-generation oral SERD and complete ER antagonist for use in combination with widely approved CDK4/6 inhibitors in this setting, reinforcing the practice-changing potential of this approach to advance patient outcomes and evolve the clinical landscape."

The safety profile of camizestrant in combination with palbociclib, ribociclib or abemaciclib in the SERENA-6 trial was consistent with the known safety profile of each medicine. No new safety concerns were identified and discontinuations were very low and similar in both arms.1

SERENA-6 is the first global, double-blind, registrational Phase III trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The innovative trial design used ctDNA monitoring via a blood test at the time of routine tumour scans every two to three months to identify patients for early signs of endocrine resistance via the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to camizestrant from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor.

The camizestrant combination is approved in the United Arab Emirates and Saudi Arabia in hormone receptor (HR)-positive, HER2-negative advanced breast cancer patients whose tumours have an emergent ESR1 mutation based on the results of the SERENA-6 Phase III trial.

Regulatory applications for camizestrant in this setting are currently under review in the US, Japan and several other countries.

Notes

HR-positive breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.2 More than two million patients were diagnosed with breast cancer in 2022, with more than 665,000 deaths globally.2 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.3

HR-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative.3 More than 97% of HR-positive breast cancer tumours are ER-positive.4,5 ERs often drive the growth of HR-positive breast cancer cells.6

Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target ER-driven disease, which are often paired with CDK4/6 inhibitors.7-9 However, resistance to these therapies develops in many patients.9 Once this occurs, treatment options are limited and survival rates are low with approximately 36% of patients anticipated to live beyond five years after diagnosis.3,9

Mutations in the ESR1 gene are a key driver of endocrine resistance and are associated with poor outcomes, emerging during treatment of the disease and becoming more prevalent as the disease progresses.10,11 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment before disease progression.7

The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research.

SERENA-6
SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation.

The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment.

Camizestrant
Camizestrant is an investigational, potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer.

AstraZeneca’s broad, robust and innovative clinical development programme, including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is evaluating the safety and efficacy of camizestrant when used as a monotherapy or in combination with CDK4/6 inhibitors to address a number of areas of unmet need in HR-positive, HER2-negative breast cancer.

Camizestrant has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated a statistically significant and clinically meaningful improvement in PFS versus Faslodex (fulvestrant) in the overall trial population, including in patients with ESR1 tumour mutations irrespective of prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumour profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors.

(Press release, AstraZeneca, MAY 22, 2026, View Source [SID1234666002])

On May 22, 2026 AstraZeneca and Daiichi Sankyo reported that Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment and who have no satisfactory treatment options.

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from a subgroup of patients with HER2-positive (IHC 3+) tumours across three Phase II trials, DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02, in which Enhertu demonstrated clinically meaningful responses across a broad range of tumours.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "HER2-directed therapies have already transformed care for certain HER2-expressing cancers, including breast and gastric cancers. However, many other cancers overexpress HER2, and targeted treatment options remain unavailable for most of these tumour types. This positive CHMP opinion underscores the importance of precision oncology and marks an important step toward bringing a new targeted option to more patients in the EU living with HER2-positive solid tumours."

John Tsai, Global Head, R&D, Daiichi Sankyo, said: "This positive CHMP opinion acknowledges the clinical value of Enhertu as the potential first HER2-directed medicine and antibody drug conjugate available for patients with HER2-positive metastatic solid tumours in the EU. Enhertu offers meaningful responses for patients with advanced cancers that overexpress HER2 who have limited treatment options. We look forward to continuing to work with the EMA to bring Enhertu to these patients."

In the DESTINY-PanTumor02 Phase II trial, Enhertu demonstrated a confirmed objective response rate (ORR) of 51.4% and median duration of response (DOR) of 14.2 months in previously treated patients with centrally or locally assessed IHC 3+ solid tumours (n=111) including either biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumours. In DESTINY-Lung01, Enhertu demonstrated a confirmed ORR of 52.9% and median DOR of 6.9 months in patients with centrally confirmed IHC 3+ non-small cell lung cancer (NSCLC) (n=17). In DESTINY-CRC02, Enhertu demonstrated a confirmed ORR of 46.9% and median DOR of 5.5 months in patients with centrally confirmed IHC 3+ colorectal cancer (n=64).

The safety profile of Enhertu was consistent with previous clinical trials with no new safety concerns identified.

Enhertu has received a tumour agnostic indication in the US and other countries based on the DESTINY-PanTumor02 trial.

Additional regulatory submissions for Enhertu are under review in the EU, including in combination with pertuzumab for the 1st-line treatment of patients with unresectable or metastatic HER2-positive (IHC 3+ and ISH+) breast cancer based on data from the DESTINY-Breast09 Phase III trial and for patients with HER2-positive (IHC 3+ and ISH+) breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment based on data from the DESTINY-Breast05 Phase III trial.

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

Notes

HER2 expression in solid tumours
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of various tissue cells throughout the body and is involved in normal cell growth.1 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in some cancers.2

HER2-directed therapies have been used to treat HER2 overexpression in breast, gastric and salivary gland cancers in the EU.1,3-5 Although HER2 is overexpressed in additional solid tumour types including biliary tract, lung, bladder, cervical, colorectal, endometrial, ovarian and pancreatic cancers, HER2 testing is not routinely performed for these additional tumour types and there are currently no HER2 directed treatments approved in the EU to treat a broad range of solid tumours.6,7

DESTINY-PanTumor02
DESTINY-PanTumor02 is a global, multicentre, multi-cohort, open-label, Phase II trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) for the treatment of previously treated HER2-expressing tumours, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancer or other tumours.

The primary endpoint of DESTINY-PanTumor02 is confirmed ORR as assessed by investigator. Secondary endpoints include DOR, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, tolerability and pharmacokinetics. Results from DESTINY-PanTumor02 were published in the Journal of Clinical Oncology.8

DESTINY-PanTumor02 enrolled 267 HER2-positive (IHC 3+ [n=111] and IHC 2+ [n=156]) adult patients at multiple sites in Asia, Europe, North America, South America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

DESTINY-Lung01
DESTINY-Lung01 is a global, open-label, two-cohort, Phase II trial evaluating the efficacy and safety of Enhertu (5.4mg/kg or 6.4mg/kg) in patients with HER2-mutant or HER2-overexpressing unresectable or metastatic NSCLC who had progressed after one or more systemic therapies.

The primary endpoint of DESTINY-Lung01 is confirmed ORR by independent central review. Key secondary endpoints include DOR, DCR, PFS, OS and safety. Results from the HER2 mutant cohort were published in The New England Journal of Medicine and results from the HER2 overexpressing cohort were published in The Lancet Oncology.9,10

DESTINY-Lung01 enrolled 181 adult patients (HER2-mutant [n=91] and HER2-overexpressing [n=90; IHC 3+, n=17 and IHC 2+, n=73]) at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

DESTINY-CRC02
DESTINY-CRC02 is a global, randomised, two-arm, parallel, multicentre, Phase II trial evaluating the efficacy and safety of two doses (5.4mg/kg or 6.4mg/kg) of Enhertu in patients with locally advanced, unresectable or metastatic HER2-positive (IHC 3+ or IHC 2+) colorectal cancer of BRAF wild-type, RAS wild-type or RAS mutant tumour types previously treated with standard therapy. The trial was conducted in two stages. In the first stage, patients (n=80) were randomised 1:1 to receive either 5.4mg/kg or 6.4mg/kg of Enhertu. In the second stage, additional patients (n=42) were enrolled in the 5.4mg/kg arm.

The primary endpoint in DESTINY-CRC02 is confirmed ORR as assessed by blinded independent central review. Secondary endpoints include DOR, DCR, investigator-assessed confirmed ORR, clinical benefit ratio, PFS, OS and safety. Results from DESTINY-CRC02 were published in The Lancet Oncology.11

DESTINY-CRC02 enrolled 122 adult patients (including 64 patients with IHC 3+ receiving 5.4mg/kg) at multiple sites in Asia, Europe, North America and Oceania. 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 the US as an adjuvant treatment for adult patients with HER2-positive breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

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

Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US, Switzerland, United Arab Emirates and Saudi Arabia as a first-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 95 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 95 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 70 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 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic 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 85 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 (5.4mg/kg) is approved in more than 15 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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

(Press release, AstraZeneca, MAY 22, 2026, View Source [SID1234666001])

On May 22, 2026 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported data from its azer-cel Phase 1b abstract, now published on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website following the lifting of the conference embargo.

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The abstract, titled "Safety and efficacy of Azer-cel, an allogeneic CD19 CAR T for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia not previously exposed to autologous CAR T therapy" reports data from the CAR T-naïve cohort of the ongoing Phase 1b basket study across multiple malignancies.

At the time of the abstract data cut, nineteen patients with relapsed or refractory blood cancers received azer-cel in combination with low-dose IL-2; 16 patients were evaluable for response following their first disease assessment at Day 28. Patients had a median age of 59 years (range 56–73) and included diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), primary central nervous system lymphoma (PCNSL), follicular lymphoma (FL) and Waldenström macroglobulinemia (WM). Several patients had received multiple prior therapies, including bispecific antibodies and autologous stem cell transplant.

Among the 16 evaluable patients, the overall response rate (ORR) was 81% (13/16). Responses were observed across multiple lymphoma and leukemia subtypes, including:
• DLBCL: 60% response rate (1 CR [CR], 2 partial responses [PRs])
• MZL: 100% response rate (3 CRs, 1 PR)
• CLL: 100% response rate (3 PRs)
• PCNSL: 50% response rate (1 PR)
• FL: 100% response rate (1 CR)
• WM: 100% response rate (1 PR)

Imugene will present updated data during their oral presentation at ASCO (Free ASCO Whitepaper) on 29May 2026 at 1:00pm. These promising response rates and the broader maturing data package from the basket study informs future clinical development, ensuring we target the specific indications where azer-cel can deliver the strongest clinical impact.

Dr John Byon MD PhD, Chief Medical Officer, commented "Our ASCO (Free ASCO Whitepaper) 2026 abstract supports our clinical strategy and highlights the potential of our off-the-shelf allogeneic CAR-T platform. The response rates seen in this CAR-T naïve patient group, particularly in these heavily pre-treated patients across multiple blood cancer types, are very encouraging. We look forward to presenting the updated dataset during our oral presentation at ASCO (Free ASCO Whitepaper) next week."

Leslie Chong, Managing Director and CEO of Imugene, said "We are excited to showcase these highly encouraging results during our oral presentation at ASCO (Free ASCO Whitepaper) next week. This represents an important milestone for Imugene and further increases the Company’s visibility to an international audience, including leading cancer experts, potential pharmaceutical partners and global investors."

The full abstract is available at asco.org/abstracts (Abstract #7012; DOI:
10.1200/JCO.2026.44.16_suppl.7012).

Dr Supriya Gupta, University of Minnesota will present the data in person at the Rapid Oral Abstract Session — Hematologic Malignancies: Lymphoma and Chronic Lymphocytic Leukemia, on 29 May 2026 at 1:00 PM CDT at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago. The final presentation will be made available at imugene.com/investors/conferencepresentations following the session.

BTKi Combination Cohort

Imugene has recently opened cohort 3 in the Phase 1b protocol to evaluate azer-cel in combination with a Bruton Tyrosine Kinase inhibitor (BTKi) and added Mantle Cell Lymphoma (MCL) as an indication. The combination arm will enrol patients who previously failed BTKi therapy. BTKis are an established standard of care therapy across multiple B-cell malignancies including CLL, MCL, MZL and WM. The global BTKi market reached approximately US$12.0 billion in 2025.

About Dr John Byon MD PhD, Chief Medical Officer

Dr Byon is an accomplished physician-scientist with extensive experience in clinical development and cancer immunotherapy, particularly in CAR-T cell therapy. Prior to Imugene, Dr Byon served as Vice President, Clinical Development, Hematology at Fate Therapeutics, overseeing a portfolio of CAR-NK and CAR-T therapies for hematologic malignancies including acute myeloid leukemia and multiple myeloma. His career also spans leadership roles at Lyell Immunopharma, Juno Therapeutics, and Genentech. Dr Byon holds a Doctor of Medicine and Doctor of Philosophy from Tulane University and a Bachelor of Science from the Massachusetts Institute of Technology.

(Press release, Imugene, MAY 22, 2026, View Source [SID1234665952])

On May 22, 2026 Formosa Pharmaceuticals, Inc. reported that its abstract highlighting the differentiated binding profile and preclinical efficacy of TSY-310, a novel bispecific antibody-drug conjugate (ADC), has been selected for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 29 – June 2, 2026, in Chicago, Illinois. TSY-310 simultaneously targets EGFR and ROR1, two receptors frequently co-expressed in prevalent solid tumors. By leveraging a unique bispecific modality, TSY-310 optimizes target engagement and intracellular delivery, facilitating a potent bystander effect to address the challenges of tumor heterogeneity.

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Details

Title: TSY-310, A Novel Bispecific EGFR x ROR1 ADC, Exhibits Potent Antitumor Activity in Heterogeneous Breast Tumors Through Enhanced Internalization and Bystander Cytotoxicity
Session: Developmental Therapeutics: Molecularly Targeted Agents and Tumor Biology
Date & Time: May 30, 2026, 1:30 pm – 4:30 pm CT
Abstract Number: 3086
Poster Number: 223
Presenter: Dr. Kuo-Ming Yu, Ph.D., Director, CMC and Production

Highlights

Superior Selectivity: Bispecific binding, enhancing internalization specifically in tumor cells co-expressing EGFR and ROR1.
Enhanced Payload Delivery: Evidence of efficient lysosomal trafficking and the subsequent release of the cytotoxic payload.
Bystander Efficacy: Eradication of neighboring antigen-negative tumor cells, a critical factor in treating complex, heterogeneous tumor environments.

"Our participation at ASCO (Free ASCO Whitepaper) is an acknowledgement of the program’s potential as a worthy contributor to the future oncology treatment landscape," said Erick Co, President & CEO of Formosa Pharmaceuticals. "We are eager to place TSY-310 in the toolbox of oncologists and patients who face the evolving challenges with traditional single-target therapies."

Full abstract and presentation details will be available through ASCO (Free ASCO Whitepaper) and corporate websites in accordance with the meeting’s policies.

About TSY-310: TSY-310 is a next-generation bispecific ADC targeting EGFR and ROR1. By achieving high-affinity target recognition through an efficient, simplified protein architecture, TSY-310 aims to provide a durable, "best-in-class" therapeutic option for patients with advanced solid tumors, including Non-Small Cell Lung Cancer (NSCLC).

(Press release, Formosa Pharmaceuticals, MAY 22, 2026, View Source [SID1234665926])