On May 28, 2026 Daiichi Sankyo (TSE: 4568) reported it will present new clinical research across its oncology portfolio with more than 25 abstracts in multiple cancers at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (#ASCO26).

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Data at ASCO (Free ASCO Whitepaper) will highlight the company’s progress toward advancing new standards of care for patients with cancer, including new analyses from five landmark trials in breast and gastric cancer, including the DESTINY-Breast05 (#516), DESTINY-Breast06 (#1063), DESTINY-Breast09 (#1021) and DESTINY-Gastric04 (#4111) phase 3 trials of Enhertu (trastuzumab deruxtecan), and the TROPION-Breast02 (#1002) phase 3 trial of Datroway (datopotamab deruxtecan). Additional results from earlier phase trials as well as trials-in-progress across new medicines being developed through the company’s breakthrough generating technology (BGT), a platform-based drug discovery model designed to deliver innovative medicines to patients faster, will be highlighted.

Data from DESTINY-Breast05 formed the basis of one of two new Enhertu indications recently approved in the U.S. for certain patients with early-stage HER2 positive breast cancer and data from DESTINY-Gastric04 was included as part of a label update to expand the use of Enhertu in Japan and China to include the second-line treatment of patients with HER2 positive metastatic gastric cancer. Additionally, results from TROPION-Breast02 formed the basis of the recent U.S. approval of Datroway in patients with metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy, the first antibody drug conjugate (ADC) to be approved in this setting of TNBC.

"The approvals received just prior to ASCO (Free ASCO Whitepaper) for Enhertu and Datroway, two of our leading DXd antibody drug conjugates, together with the strong science being showcased across our pipeline, highlight the momentum of our oncology portfolio," said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. "Daiichi Sankyo is committed to creating new standards of care for patients with cancer and continues to leverage its scientific and technological expertise to advance innovation."

Additional Enhertu Data Spans Broad Range of HER2 Expressing Cancers
Additional research updates across several additional HER2 expressing cancers include oral and poster sessions highlighting the preliminary safety run-in results from the DESTINY-Ovarian01 (#5554) phase 3 trial evaluating Enhertu in combination with bevacizumab compared to bevacizumab monotherapy as a first-line maintenance therapy in patients with HER2 expressing ovarian cancer; the primary analysis from part 1 of the DESTINY-PanTumor03 (#3026) phase 2 trial evaluating Enhertu in pretreated patients in China with HER2 positive (IHC 3+) solid tumors (excluding breast and gastric cancer); and, findings from the MYTHOS (#6011) phase 2 trial evaluating Enhertu in patients with HER2-low recurrent or metastatic salivary gland cancer.

Additional breast and gastric cancer data for Enhertu include an oral presentation from one arm of the DESTINY-Breast07 (#1012) phase 1b/2 trial evaluating Enhertu in combination with durvalumab as a first-line treatment in patients with HER2 positive metastatic breast cancer and a poster presentation highlighting a safety analysis from the DESTINY-Gastric03 (#4022) phase 1b/2 trial evaluating Enhertu in combination with chemotherapy and immunotherapy as a first-line treatment in patients with HER2 expressing metastatic gastric cancer, gastroesophageal junction (GEJ) adenocarcinoma or esophageal adenocarcinoma.

Results from cohort two of the EPOC2203 (#4024) phase 1b/2 trial evaluating Enhertu in combination with nivolumab and capecitabine and oxaliplatin in patients with HER2 low gastroesophageal adenocarcinoma and an exploratory analysis of translational data from the EPOC2003 (#3129) phase 2 trial evaluating neoadjuvant chemotherapy in combination with Enhertu in patients with HER2 positive gastric cancer will be highlighted as poster presentations.

New Data and Trials-in-Progress Presentations Across Oncology Portfolio
Poster presentations will include a trial-in-progress update of REJOICE-Ovarian01 (TPS5637) for the phase 3 part of a phase 2/3 trial evaluating raludotatug deruxtecan (R-DXd) compared to treatment of physician’s choice in patients with platinum-resistant ovarian cancer. Two additional poster presentations will highlight an exposure-response analysis (#5570) and a population pharmacokinetic analysis (#5571) of data from both the REJOICE-Ovarian01 phase 2/3 trial and the phase 1 trial evaluating raludotatug deruxtecan in patients with advanced ovarian cancer or renal cell carcinoma.

An oral presentation will highlight results from a phase 1/2 trial (#6504) of Vanflyta (quizartinib) plus decitabine and venetoclax in patients with newly diagnosed or relapsed/refractory FLT3-ITD acute myeloid leukemia.

Trials-in-progress poster presentations across the DXd ADC portfolio include the TROPION-Urothelial03 (TPS4642) phase 2/3 trial evaluating Datroway and platinum chemotherapy compared to gemcitabine plus platinum chemotherapy in patients with locally advanced or metastatic urothelial carcinoma; the HERTHENA-Breast04 (TPS1149) phase 3 trial evaluating patritumab deruxtecan (HER3-DXd) compared to treatment of physician’s choice in patients with HR positive, HER2 negative unresectable locally advanced or metastatic breast cancer; and the DESTINY-PanTumor04 (TPS11202) hybrid observational trial evaluating Enhertu in patients with HER2 positive (IHC 3+) solid tumors.

Trials-in-Progress Presentations Highlight Breakthrough Generating Technology Focus
Daiichi Sankyo is leveraging its strength in science and technology to create new medicines for patients with cancer through its BGT approach which is designed to deliver innovative medicines to patients faster and with a higher probability of success. Trials-in-progress poster presentations featuring three potential new medicines include DS3610 (TPS3159), a STING (stimulator of interferon genes) ADC, in patients with advanced or metastatic solid tumors; DS5361 (TPS2680), a small-molecule, nonsense-mediated mRNA decay inhibitor, in patients with advanced or metastatic solid tumors; and, DS9051 (TPS3179), a novel targeted protein degradation molecule, in patients with advanced or metastatic adrenocortical carcinoma or metastatic castration-resistant prostate cancer.

Overview of clinical data and trials-in-progress from oncology pipeline of Daiichi Sankyo include:

Presentation Title

Author

Abstract

Presentation (CDT)

Breast

A DESTINY-Breast09 analysis of treatment duration and clinical outcomes by best response to trastuzumab deruxtecan (T-DXd) + pertuzumab

Y. Park

1021

Rapid Oral Presentation
Sunday, May 31
11:30 am – 1:00 pm

Secondary safety analysis of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in DESTINY-Breast05: clinical and demographic risk factors of interstitial lung disease and radiation pneumonitis

M. Untch

516

Rapid Oral Presentation
Monday, June 1
9:45 – 11:15 am

Neoadjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial

C. O’Sullivan

LBA514

Rapid Oral Presentation
Monday, June 1
9:45 – 11:15 am

Trastuzumab deruxtecan (T-DXd) + durvalumab in patients with previously untreated HER2 positive unresectable/metastatic breast cancer (mBC): final analysis from DESTINY-Breast07

S. Loi

1012

Oral Presentation
Sunday, May 31
8:30 – 10:00 am

First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: additional efficacy endpoints from the TROPION-Breast02 study

D. Cescon

1002

Oral Presentation
Tuesday, June 2
9:45 am – 12:45 pm

Impact of adherence to interstitial lung disease (ILD)/pneumonitis toxicity management guidelines on ILD/pneumonitis outcomes: a retrospective analysis of patients treated with trastuzumab deruxtecan (T-DXd) in DESTINY-Breast06

C. Mateo

1063

Poster Session
Monday, June 1
1:30 – 4:30 pm

HERTHENA-Breast04: a phase 3, randomized, open-label study evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus treatment of physician’s choice in hormone receptor positive (HR +)/HER2-) unresectable locally advanced or metastatic breast cancer

B. Pistilli

TPS1149

Poster Session
Monday, June 1
1:30 – 4:30 pm

Identifying patients with human epidermal growth factor receptor 2 (HER2) low and ultralow breast cancer: use of digital, artificial intelligence-based computational algorithms to assist HER2 scoring by pathologists

S. Krishnamurthy

1022

Poster Session
Monday, June 1
1:30 – 4:30 pm

Gastric

Additional health-related quality of life analysis from DESTINY-Gastric04, a randomized phase 3 study of trastuzumab deruxtecan (T-DXd) vs ramucirumab + paclitaxel in patients with HER2 positive unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma

K. Shitara

4111

Poster Session
Saturday, May 30
9:00 am – 12:00 pm

First-line trastuzumab deruxtecan (T-DXd)-based regimens in advanced HER2 expressing gastric cancer, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma: safety results from DESTINY-Gastric03 Part 2 arms D and F, and Part 4

Y. Janjigian

4022

Poster Session
Saturday, May 30
9:00 am – 12:00 pm

An open-label phase 1b/2 study of trastuzumab deruxtecan combined with nivolumab and CAPOX in patients with HER2 low gastroesophageal adenocarcinoma (EPOC2203)

Y. Aoki

4024

Poster Session
Saturday, May 30
9:00 am – 12:00 pm

Tumor and immune microenvironment remodeling with neoadjuvant trastuzumab deruxtecan in HER2 positive gastric cancer: exploratory analyses from the phase 2 EPOC2003 study

A. Kawazoe

3129

Poster Session
Saturday, May 30
1:30 – 4:30 pm

Ovarian

Trastuzumab deruxtecan (T-DXd) + bevacizumab (BEV) as first-line (1L) maintenance therapy in patients with HER2 expressing ovarian cancer: results from the DESTINY-Ovarian01 safety run-in

A. Gonzalez Martin

5554

Poster Session
Monday, June 1
9:00 am – 12:00 pm

REJOICE-Ovarian01: phase 3 part of a phase 2/3 study evaluating raludotatug deruxtecan (R-DXd) versus treatment of physician’s choice in patients with platinum-resistant ovarian cancer

D. Richardson

TPS5637

Poster Session
Monday, June 1
9:00 am – 12:00 pm

Exposure-response analyses of efficacy and safety with raludotatug deruxtecan (R-DXd), a CDH6-directed ADC, to inform dose selection for phase 3 development in platinum-resistant ovarian cancer

F. Hurtado

5570

Poster Session
Monday, June 1
9:00 am – 12:00 pm

Population pharmacokinetic analysis of raludotatug deruxtecan (R-DXd), a CDH6-directed ADC, in patients with advanced ovarian cancer or renal cell carcinoma

F. Hurtado

5571

Poster Session
Monday, June 1
9:00 am – 12:00 pm

Urothelial

TROPION-Urothelial03: a phase 2/3 study of datopotamab deruxtecan (Dato-DXd) + platinum chemotherapy vs gemcitabine + platinum chemotherapy in participants with locally advanced or metastatic urothelial carcinoma with progression on or after enfortumab vedotin + pembrolizumab

M. Galsky

TPS4642

Poster Session
Sunday, May 31
9:00 am – 12:00 pm

Salivary

Trastuzumab deruxtecan in patients with HER2 low recurrent/metastatic salivary gland carcinoma: results from the phase 2 MYTHOS trial

I. Kinoshita

6011

Oral Presentation
Monday, June 1
8:00 – 9:30 am

AML

Quizartinib in combination with decitabine and venetoclax for newly diagnosed and relapsed/refractory FLT3 mutated acute myeloid leukemia

M. Yilmaz

6504

Oral Presentation
Tuesday, June 2
9:45 am – 12:45 pm

Pan Tumor

Trastuzumab deruxtecan (T-DXd) for pretreated patients in China with HER2 IHC 3+ solid tumors: DESTINY-PanTumor03 Part 1 primary analysis

Y. Zhang

3026

Poster Session
Saturday, May 30
1:30 – 4:30 pm

A pragmatic, hybrid observational study evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with HER2 IHC3+ solid tumors: DESTINY-PanTumor04

B. Monk

TPS11202

Poster Session
Monday, June 1
9:00 am – 12:00 pm

HER2 independent antitumor and pharmacodynamic responses to trastuzumab deruxtecan in patients with advanced solid tumors

S. Shin

3031

Poster Session
Saturday, May 30
1:30 – 4:30 pm

Topoisomerase 1 and DNA damage: pharmacodynamic responses and mechanism of trastuzumab deruxtecan in HER2-expressing advanced solid tumors

D. Wilsker

3092

Poster Session
Saturday, May 30
1:30 – 4:30 pm

BGT

A phase 1, first-in-human study of DS3610, a stimulator of interferon genes (STING) agonist ADC, in patients with advanced/metastatic solid tumors

S. Koganemaru

TPS3159

Poster Session
Saturday, May 30
1:30 – 4:30 pm

A phase 1, first-in-human study of DS5361, a small-molecule, nonsense-mediated mRNA decay inhibitor, in patients with advanced/metastatic solid tumors (Parts 1 and 2)

S. Sen

TPS2680

Poster Session
Saturday, May 30
1:30 – 4:30 pm

A phase 1, first-in-human study of DS9051, a novel targeted protein degradation molecule, in patients with advanced/metastatic adrenocortical carcinoma or metastatic castration-resistant prostate cancer

M. Patel

TPS3179

Poster Session
Saturday, May 30
1:30 – 4:30 pm

(Press release, Daiichi Sankyo, MAY 28, 2026, https://www.businesswire.com/news/home/20260528097415/en/Daiichi-Sankyo-Showcases-Progress-Across-Industry-Leading-Oncology-Portfolio-with-Latest-Research-Updates-at-ASCO [SID1234666173])

On May 28, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026. In addition, the FDA communicated that at this time, there is no plan to hold an advisory committee, nor have they identified any potential review issues.

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"We are excited to announce that our bezuclastinib NDA for patients with GIST has been accepted for review by the FDA," said Andrew Robbins, President and Chief Executive Officer of Cogent Biosciences. "We look forward to presenting the full, groundbreaking results from the PEAK trial at ASCO (Free ASCO Whitepaper) this weekend, and our preparations for expected bezuclastinib launches in both GIST and systemic mastocytosis later this year are well underway."

PEAK Phase 3 Trial Results

As reported in November 2025, PEAK is a global, randomized Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib monotherapy in patients with imatinib-resistant or intolerant GIST. As of the cutoff date, September 30, 2025, the bezuclastinib combination demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of PFS, reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented ORR in imatinib-resistant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. Data for overall survival remains immature.

Safety Data

As of the data cutoff, the bezuclastinib combination was generally well tolerated, and no unique risks were observed with the novel combination when compared to the known safety profile of sunitinib. ​The most commonly reported Grade 3+ treatment emergent adverse events in either arm (bezuclastinib combination vs. sunitinib) included: Hypertension (29.4% vs. 27.4%), Neutropenia (15.2% vs. 15.4%), ALT/AST increased (10.8% vs. 1.4%), Anemia (9.3% vs. 4.8%) and Diarrhea (7.8% vs. 7.2%). 7.4% of patients on the bezuclastinib combination and 3.8% of patients on sunitinib monotherapy discontinued study treatment(s) due to treatment related adverse events. Hepatic adverse events were predominantly transient and manageable lab abnormalities; the majority of which were low grade, non-serious, reversible and asymptomatic. In the combination arm, ALT/AST elevations led to bezuclastinib dose reductions in 12.7% of patients with only 3 subjects (1.5%) discontinuing bezuclastinib for ALT/AST elevations. All Grade 3 ALT/AST elevations resolved, and no Grade 4 elevations were reported.

PEAK Phase 3 – ASCO (Free ASCO Whitepaper) Oral Presentation Details

Abstract Title: Primary Results of the Phase 3 Peak Study of bezuclastinib + sunitinib vs sunitinib Monotherapy in Advanced Gastrointestinal Stromal Tumors (GIST)
Abstract Number for Publication: 11500
Presenter: Andrew J. Wagner, M.D., Ph.D., Senior Physician, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School
Session Date and Time: May 30, 2026, 3:00 PM-6:00 PM CT (4:00 PM-7:00 PM ET)
Session Title: Oral Abstract Session – Sarcoma
Location: South Building, Floor 1, Grand Ballroom, S100bc – McCormick Place Convention Center, Chicago, IL

Bezuclastinib – Expanded Access Program

Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. For more information please visit: View Source

(Press release, Cogent Biosciences, MAY 28, 2026, View Source [SID1234666142])

On May 28, 2026 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported that Erik Ostrowski, Chief Financial and Business Officer, and Nicholas Grund, Chief Commercial Officer, will present at the 2026 Jefferies Global Healthcare Conference on Thursday, June 4, 2026 at 7:35 AM ET in New York, NY.

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A live webcast of the presentation can be accessed through the "Investors" section of Akebia’s website at View Source A replay of the webcast will also be available for 90 days following the presentation.

The 2026 Jefferies Global Healthcare Conference will take place June 2-4, 2026, in New York, NY.

(Press release, Akebia, MAY 28, 2026, View Source [SID1234666158])

On May 28, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported enrollment of the first patients in SIgnatera-Guided iNterventionAL (SIGNAL)-ER 101, a prospective, single-arm, multi-center study evaluating Signatera MRD-guided de-escalation in early-stage breast cancer.

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The current standard of care recommends two or three years of an adjuvant CDK4/6 inhibitor in combination with endocrine therapy for patients with intermediate-risk, hormone receptor (HR) positive, HER2 negative, early stage breast cancer. This is despite the fact that only ~3% of eligible patients derive benefit, over 60% of patients experience serious adverse events,1-2 and the U.S. retail costs can be over $400,000 for a full course of treatment. Meanwhile, data presented at SABCS 2025 from the PALLAS trial show that HR+ breast cancer patients who tested MRD-negative with Signatera had excellent long-term outcomes, with >95% distant recurrence-free interval at 5 years. This suggests that MRD-negative patients can safely defer CDK4/6 inhibition with no impact to clinical outcomes, with the provision that it be added if and when MRD is detected on serial testing using a TOMR (Treatment on MRD) approach.

SIGNAL-ER 101 plans to enroll approximately 725 patients across 50 sites in the United States. Patients who test MRD-positive will receive endocrine therapy plus CDK4/6 inhibitors, while those who test MRD-negative (the vast majority of patients) will receive endocrine therapy alone with quarterly Signatera monitoring. Patients who become MRD-positive during surveillance will be eligible to initiate CDK4/6 inhibition at that time, consistent with the TOMR approach.

"Many women with this type and stage of breast cancer are overtreated, which can have a profound impact on their quality of life," said Minetta Liu, M.D., chief medical officer, oncology and early cancer detection at Natera. "SIGNAL-ER 101 is a key part of our evidence generation roadmap, to support Signatera-guided treatment optimization without compromising the survival benefit from CDK4/6 inhibitors. This approach also allows patients to get the most effective treatment when Signatera shows it is necessary."

SIGNAL-ER 101 is the first in a series of innovative Natera-sponsored SIGNAL trials across multiple cancer types, designed to demonstrate that MRD-negative patients may be able to delay or defer treatment. There are many instances of overtreatment in cancer. This concept has already been studied in the IMvigor011 trial where MRD-negative patients with muscle-invasive bladder cancer achieved 97% overall survival at 2 years without any adjuvant therapy, and in the GALAXY and CALGB/SWOG 80702 trials, where MRD-negative patients with colorectal cancer saw no clinical benefit from adjuvant chemotherapy and celecoxib, respectively.

(Press release, Natera, MAY 28, 2026, View Source [SID1234666174])

On May 28, 2026 Imugene Limited (ASX: IMU) a clinical-stage immunooncology company, reported the enrolment of first patient into the BTK inhibitor combination cohort of its ongoing Phase 1b basket study of azer-cel. Azer-cel is an offthe-shelf, allogeneic CAR T cell therapy being evaluated across multiple advanced blood cancers with significant unmet medical need.

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Patients in this third cohort will be treated with azer-cel in combination with a BTKi with the objective of evaluating safety and preliminary efficacy. These patients have previously failed BTKi therapy, an established standard of care therapy across multiple B-cell malignancies. including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Enrolment is ongoing across ten US and five Australian sites.

Despite their efficacy as front-line and subsequent treatments, many patients ultimately develop resistance or intolerance to BTKi therapy, representing a significant area of unmet medical need. The combination of azer-cel with a BTKi aims to explore whether concurrent dosing may enhance the activity of azer-cel and BTKi in this setting.

The addition of the BTKi combination cohort expands the clinical scope of the azer-cel program and may support further partnering and collaboration opportunities. By broadening the range of eligible B-cell malignancies in the Phase 1b study, the Company is better positioned to prioritise indications where azer-cel demonstrates the strongest clinical potential, supporting a disciplined and capital-efficient development strategy. The global BTKi market was valued at approximately US$12.0 billion in 2025.

Chief Executive Officer Leslie Chong said "The enrolment of first patients into the BTKi combination cohort is a meaningful step in expanding the clinical scope of the azer-cel program. BTKi-relapsed patients represent a significant population with limited options, and we believe the concurrent combination approach has the potential to address this unmet need.

We look forward to reporting safety and preliminary efficacy data as patients become evaluable, and to continuing to build the evidence base for azer-cel across B-cell malignancies."

Further updates will be provided as patients become evaluable and data matures.

About the Phase 1b azer-cel trial

The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients and CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), and mantle cell lymphoma (MCL). The trial has recently expanded into a BTKi combination cohort, for patients with a range of B-cell malignancies who have previously failed BTKi therapy. Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.

(Press release, Imugene, MAY 28, 2026, View Source [SID1234666111])