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BioNTech Clinical Data at ELCC 2026 Highlight Potential of Differentiated Late-Stage Portfolio in Lung Cancer

On March 24, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will present data from its diversified portfolio in the field of lung cancer at the European Lung Cancer Congress ("ELCC") held in Copenhagen, Denmark, from March 25-28, 2026. The data updates covered in both oral and poster presentations highlight progress across late-stage immunomodulator candidates pumitamig and gotistobart, as well as antibody-drug conjugate ("ADC") programs, across various lung cancer subtypes and lines of treatment. BioNTech’s clinical portfolio encompasses both monotherapies and combinations with standard of care treatments, as well as novel-novel combination regimens aimed at delivering differentiated therapeutic profiles for the treatment of patients with lung cancer across all stages of the disease.

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"The data we will present at this year’s ELCC further define the potential of our late-stage portfolio in lung cancer. With updates on pumitamig and gotistobart, as well as first clinical data for our HER3-targeted ADC, we continue to advance differentiated treatment approaches across lung cancer settings while building the clinical evidence to guide their further development," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Our aim is to offer patients with lung cancer transformative treatment options that help provide meaningful long-term benefit across all stages of the disease."

Highlights of BioNTech’s lung cancer programs to be presented at ELCC 2026:

Pumitamig (BNT327/BMS986545) – a bispecific immunomodulator candidate combining PD-L1 checkpoint inhibition and VEGF-A neutralization, developed in collaboration with Bristol Myers Squibb Company ("BMS"):

1L ES-SCLC: Updated follow-up data from a single-arm Phase 2 clinical trial (NCT05844150) conducted in China continued to show encouraging preliminary antitumor activity and survival outcomes, together with a manageable tolerability profile for pumitamig plus chemotherapy as first-line therapy in patients with extensive-stage small cell lung cancer ("ES-SCLC"), an aggressive subtype of lung cancer. The data support the ongoing pivotal global Phase 3 ROSETTA Lung-01 clinical trial (NCT06712355) in first-line ES-SCLC.

1L NSCLC: New findings from a Phase 1b/2a clinical trial (NCT05918445) conducted in China showed preliminary antitumor activity irrespective of PD-L1 expression levels and a manageable safety profile for pumitamig as first-line monotherapy in both squamous and non-squamous advanced non-small cell lung cancer ("NSCLC"). The results complement the ongoing global Phase 2/3 ROSETTA Lung-02 clinical trial (NCT06712316) evaluating the combination of pumitamig with chemotherapy in first-line NSCLC.

EGFR-mutant NSCLC: Data from a Phase 2 clinical trial (NCT05756972) conducted in China showed clinically meaningful survival outcomes and a manageable safety and tolerability profile for pumitamig combined with chemotherapy in patients with EGFR-mutant advanced or metastatic NSCLC, regardless of PD-L1 expression level. These data highlight its potential in patients progressing on EGFR tyrosine kinase inhibitors.

Gotistobart (BNT316/ONC-392) – a tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4 and developed in collaboration with OncoC4, Inc. ("OncoC4"):

2L+ squamous NSCLC: Data from the non-pivotal, dose-confirmation stage 1 portion of the global Phase 3 PRESERVE-003 clinical trial (NCT05671510) showed clinically meaningful antitumor activity, an overall survival benefit with a 54% reduction in the risk of death compared with standard of care chemotherapy, and a manageable safety profile for gotistobart in patients with squamous NSCLC who have progressed on prior immunotherapy plus chemotherapy. The pivotal stage of the Phase 3 clinical trial is ongoing.

BNT326/YL202 – a HER3-targeted ADC candidate developed in collaboration with MediLink Therapeutics (Suzhou) Co., Ltd. ("MediLink"):

NSCLC: First clinical data from the NSCLC cohort of a Phase 2 clinical trial with BNT326/YL202 (NCT06107686) conducted in China showed antitumor activity and a favorable safety profile in patients with advanced or metastatic NSCLC who progressed after standard of care therapy. The findings support the ongoing Phase 1b/2 clinical trial (NCT07070232) evaluating the novel combination of pumitamig and BNT326/YL202.

Lung cancer is among BioNTech’s tumor focus areas, as the Company aims to address the significant unmet medical needs in the treatment of patients with lung cancer. BioNTech is advancing a diversified and robust clinical development approach in lung cancer spanning investigational next-generation immunomodulators, antibody-drug conjugates, mRNA cancer immunotherapies, and their combinations. With 16 ongoing clinical trials across various lung cancer subtypes and lines of treatment, including four ongoing pivotal Phase 3 clinical trials and five ongoing novel-novel combination trials, BioNTech is focused on developing innovative approaches to address the challenges of lung cancer treatment from early to late-stage conditions.

The abstracts are available on the ELCC Congress website. Click here for further information on BioNTech’s lung cancer portfolio.

Full presentation details:

Medicine Abstract Title Abstract Number/Presentation Details
Pumitamig First-Line Pumitamig (PD-L1 × VEGF-A bsAb) Monotherapy in PD-L1+ Non-Squamous and Squamous Non-Small Cell Lung Cancer: Data from a Phase 1b/2a Trial in China Abstract #69P
Poster
March 27, 2026; 1:00 – 2:00pm CET
Progression-Free Survival and Overall Survival with Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer Following Progression with EGFR TKI in China: Phase 2 Study Results Abstract #21P
Poster
March 27, 2026; 1:00 – 2:00pm CET
Phase 2 Study of First-Line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy for Extensive-Stage Small-Cell Lung Cancer (ES-SCLC): Updated Efficacy and Safety Results Abstract #426P
Poster
March 26, 2026; 1:00 – 2:00pm CET
ROSETTA Lung-01: A Phase 3, Two-Stage Trial of Pumitamig, a PD-L1 × VEGF-A Bispecific Antibody, Plus Chemotherapy Versus Atezolizumab + Chemotherapy as First-Line Treatment in Patients with Extensive-Stage Small Cell Lung Cancer Abstract #439TiP
Poster
March 26, 2026; 1:00 – 2:00pm CET
ROSETTA Lung-02: A Global Phase 2/3, Randomized, Open-Label Trial of Pumitamig, a PD-L1 × VEGF-A Bispecific Antibody, in Combination with Chemotherapy in Patients (pts) With First-Line Non-Small Cell Lung Cancer Abstract #149TiP
Poster
March 27, 2026; 1:00 – 2:00pm CET
Gotistobart Anti-Tumor Activity of Gotistobart Compared to Docetaxel in Patients with Metastatic Squamous Non-Small Cell Lung Cancer (sqNSCLC) Progressing on PD-(L)1 Inhibitors: Stage 1 PRESERVE-003 Phase 3 Trial Abstract #3O
Proffered paper session
March 27, 2026; 3:35 – 3:45pm CET
BNT326/YL202 First Disclosure of Efficacy and Safety Data for YL202/BNT326 (HER3 ADC) From a Phase 2 Trial in Patients (pts) with Non-Small Cell Lung Cancer (NSCLC) Abstract #11MO
Mini oral session
March 27, 2026; 09:15 – 09:20am CET
BNT326-02: A Phase 1b/2 Trial of BNT326/YL202 (HER3 ADC) with Pumitamig (PD-L1 × VEGF-A bsAb) in Non-Small Cell Lung Cancer (NSCLC) Abstract #6147TiP
Poster
March 27, 2026; 1:00 – 2:00pm CET

(Press release, BioNTech, MAR 24, 2026, View Source [SID1234663860])

Haihe Pharmaceutical’s Resorliside has been approved for marketing in Japan

On March 23, 2026, Haihe Pharmaceuticals reported that its independently developed selective PI3Kα inhibitor. Resorliside mesylate tablets have been approved for marketing in Japan for the treatment of ovarian clear cell carcinoma (OCCC) that has progressed after chemotherapy and carries the PIK3CA gene mutation.

Resorlisel is the world’s first monotherapy targeted therapy for OCCC that has progressed after chemotherapy, and it is also the world’s first selective PI3Kα inhibitor approved in Japan.Resorlisel possesses a novel chemical structure. This approval is based on a single-arm, open-label, international multicenter pivotal phase II clinical trial (NCT05043922), conducted at 39 centers in China and Japan. The study population included patients with ovarian clear cell carcinoma who had progressed after chemotherapy and carried the PIK3CA gene mutation. The primary endpoint was objective response rate (ORR) assessed by a blinded independent review committee (BIRC). The medication was administered orally at a dose of 40 mg once daily on an empty stomach. Among 84 patients (45.2% in China, 54.8% in Japan) with evaluable efficacy…Resorlisel has demonstrated clinically significant antitumor activity. Its overall safety profile is manageable and well-tolerated. Common adverse reactions include hyperglycemia and rash, which are generally consistent with the safety profile of other approved PI3Kα inhibitors and can be effectively managed and reversed with symptomatic treatment or dose adjustment.

(Press release, Shanghai HaiHe Pharmaceutical, MAR 23, 2026, View Source;utm_source=official [SID1234669250])

CDR-Life Announces First Milestone Achievement in Boehringer Ingelheim Autoimmune Partnership

On March 23, 2026 CDR-Life, Inc., a clinical-stage biotechnology company developing highly selective T cell engagers (TCEs) to treat cancer and autoimmune diseases, reported achievement of the first preclinical milestone under its 2025 license agreement with Boehringer Ingelheim. This milestone marks continued progress in the companies’ efforts to develop next-generation antibody-based therapies for autoimmune diseases.

The candidate is a trispecific M-gager, an antibody-based T cell engager designed to selectively target and deplete B cells with the goal of achieving an immune system reset. Dysregulated B cells are key drivers in many autoimmune and inflammatory diseases, including lupus, multiple sclerosis and certain forms of arthritis, making deep and selective B-cell depletion a promising therapeutic strategy across multiple indications.

The milestone was achieved following in vitro and in vivo preclinical proof of concept studies. Based on these results, Boehringer Ingelheim has elected to proceed with further development of the candidate.

"This milestone reflects the strength of our antibody-derived platform and its ability to rapidly generate highly potent, selective molecules," said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. "We are excited to see continued momentum in our partnership with Boehringer Ingelheim and look forward to further advancements of this program."

The partnership combines CDR-Life’s proprietary antibody fragment technology and M-gager platform with Boehringer Ingelheim’s global expertise in drug development to advance novel therapeutic approaches aimed at selectively targeting disease-driving immune cells. The Licensing deal was first announced in November 2025.

(Press release, CDR-Life, MAR 23, 2026, View Source [SID1234666502])

ENHERTU® Approved in Japan as First Tumor Agnostic HER2 Directed Medicine for Previously Treated Patients with HER2 Positive Metastatic Solid Tumors

On March 23, 2026 Daiichi Sankyo reported ENHERTU (trastuzumab deruxtecan) has been approved in Japan for the treatment of adult patients with HER2 positive (HER2 [ERBB2] gene amplification or immunohistochemistry [IHC] 3+) advanced or recurrent solid cancers refractory or intolerant to standard treatments.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being developed and commercialized by Daiichi Sankyo in Japan.

The approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on results from four phase 2 trials, including HERALD, an investigator-initiated trial conducted in Japan, DESTINYPanTumor02, DESTINY-CRC02 and DESTINY-Lung01 where ENHERTU demonstrated clinically meaningful responses across a broad range of tumors. A companion diagnostic (CDx) to test liquid biopsy for HER2 amplification is approved for this new tumor agnostic indication of ENHERTU in Japan. A separate CDx submission to test tumor tissue for HER2 expression (IHC 3+) is planned.

In HERALD, ENHERTU demonstrated a confirmed objective response rate (ORR) of 56.5% (95% confidence interval [CI]: 43.3-69.0) as assessed by investigator in patients (n=62) with unresectable, advanced or recurrent HER2 positive solid cancers refractory or intolerant to standard treatments, including biliary tract, cervical, colorectal, endometrial, esophageal, gastric, melanoma, non-small cell lung (NSCLC), ovarian, pancreatic, prostate, salivary gland, small intestine, urothelial cancer or other tumors.

In DESTINY-PanTumor02, ENHERTU demonstrated a confirmed ORR of 61.3% (95% CI: 49.4-72.4) as assessed by investigator in a subgroup of previously treated patients (n=75) with HER2 positive unresectable advanced or recurrent solid tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors. In DESTINY-Lung01, ENHERTU demonstrated a confirmed ORR of 52.9% (95% CI: 27.8- 77.0) in a subgroup of patients (n=17) with HER2 positive unresectable or metastatic NSCLC. In DESTINY-CRC02, ENHERTU demonstrated a confirmed ORR of 46.9% (95% CI: 34.3-59.8) in a subgroup of patients (n=64) with HER2 positive locally advanced, unresectable or metastatic colorectal cancer.

"This is the first tumor agnostic approval for a HER2 directed medicine and antibody drug conjugate in Japan and marks the sixth approved indication for ENHERTU," said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "Based on the clinically meaningful efficacy seen with ENHERTU across numerous types of metastatic cancer, this milestone validates the importance of testing for HER2 across a broad range of tumors

In HERALD, adverse reactions occurred in 59 patients (95.2%) treated with ENHERTU. The most common adverse reactions were nausea (58.1%), decreased appetite (53.2%), fatigue (46.8%), anemia (38.7%), decreased neutrophil count (32.3%), decreased white blood cell count (32.3%), decreased platelet count (24.2%) and stomatitis (22.6%). In DESTINY-PanTumor02, adverse reactions occurred in 65 patients (86.7%) treated with ENHERTU. The most common adverse reactions were fatigue (50.7%), nausea (46.7%), decreased neutrophil count (45.3%), diarrhea (33.3%), anemia (28.0%) and decreased appetite (21.3%). In DESTINY-Lung01, adverse reactions occurred in 17 patients (100%), including two Japanese patients, treated with ENHERTU. The most common adverse reactions were nausea (82.4%), fatigue (52.9%), decreased appetite (35.3%), vomiting (23.5%), diarrhea (23.5%) and anemia (23.5%). In DESTINY-CRC02, adverse reactions occurred in 61 patients (93.8%) treated with ENHERTU. The most common adverse reactions were nausea (56.9%), fatigue (43.1%), decreased neutrophil count (30.8%), diarrhea (23.1%), decreased appetite (23.1%), alopecia (23.1%) and vomiting (20.0%).

ENHERTU is approved in Japan with a Warning in its prescribing information for interstitial lung disease (ILD). ILD occurred in 262 patients (11.6%) treated with ENHERTU across multiple clinical trials. As cases of ILD, including fatal cases, have occurred in ENHERTU-treated patients, ENHERTU is to be used in close collaboration with a respiratory disease expert. Patients should be closely observed during therapy by monitoring for early signs or symptoms of ILD (such as dyspnea, cough or fever) and performing regular peripheral artery oxygen saturation (SpO2) tests, chest X-ray scans and chest CT scans. If abnormalities are observed, discontinue administration of ENHERTU and take appropriate measures, such as corticosteroid administration. Prior to initiation of ENHERTU therapy, a chest CT scan should be performed and medical history taken to confirm the absence of any comorbidity or history of ILD with the patient and carefully consider the eligibility of the patient for ENHERTU therapy.

About HERALD
HERALD is a multicenter, open-label, single-arm, investigator-initiated, phase 2 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) in patients with unresectable, advanced or recurrent solid tumors refractory or intolerant to standard treatments and have HER2 gene amplification in circulating tumor DNA, including biliary tract, cervical, colorectal, endometrial, esophageal, gastric, melanoma, NSCLC, ovarian, pancreatic, prostate, salivary gland, small intestine, urothelial cancer or other tumors.

The primary endpoint of HERALD is confirmed ORR as assessed by investigator. Secondary endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), time to treatment failure, overall survival (OS), ORR by independent central review and safety. Results from HERALD were published in the Journal of Clinical Oncology.

HERALD enrolled 62 patients at seven sites in Japan. For more information about the trial, visit Japan’s Registry of Clinical Trials.

About DESTINY-PanTumor02
DESTINY-PanTumor02 is a global, multicenter, multi-cohort, open-label, phase 2 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) for the treatment of previously treated HER2 expressing tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancer or other tumors.

The primary endpoint of DESTINY-PanTumor02 is confirmed ORR as assessed by investigator. Secondary endpoints include DOR, DCR, PFS, OS, safety, tolerability and pharmacokinetics. Results from DESTINYPanTumor02 were published in the Journal of Clinical Oncology.

ENHERTU® Now Available in Japan as First Antibody Drug Conjugate for the Second-Line Treatment of Patients with HER2 Positive Metastatic Gastric Cancer

On March 23, 2026 Daiichi Sankyo reported the Japan Pharmaceuticals and Medical Devices Agency (PMDA) has accepted the update of the ENHERTU (trastuzumab deruxtecan) prescribing information following review of data from the DESTINY-Gastric04 phase 3 trial, which now expands the use of ENHERTU in Japan to include the second-line treatment of patients with HER2 positive (immunohistochemistry [IHC] 3+ or IHC 2+/in-situ hybridization [ISH]+) unresectable advanced or recurrent gastric cancer. ENHERTU previously was approved as a third-line treatment based on the results from the DESTINY-Gastric01 phase 2 trial.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being developed and commercialized by Daiichi Sankyo in Japan.

Gastric cancer is the third most common cancer in Japan.1 More than 125,000 cases of gastric cancer were diagnosed in Japan in 2022, with more than 43,000 deaths.1 Approximately one in five gastric cancers are considered HER2 positive. 2,3 Prior to the results of DESTINY-Gastric04, no other HER2 directed medicine has demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial.4

In DESTINY-Gastric04, ENHERTU demonstrated a 30% reduction in risk of death compared to ramucirumab plus paclitaxel in patients with second-line HER2 positive unresectable and/or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma (hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.550-0.896; p=0.0044). Median overall survival (OS) was 14.7 months with ENHERTU (n=246; 95% CI: 12.1-16.6) compared to 11.4 months with ramucirumab plus paclitaxel (n=248; 95% CI: 9.9-15.5). DESTINY-Gastric04 was presented as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO25) Annual Meeting and simultaneously published in The New England Journal of Medicine.

"Gastric cancer can be particularly challenging to treat and is associated with a poor prognosis, especially in the metastatic setting where outcomes are notably worse for patients with disease progression after first-line treatment," said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "The impressive survival results seen in DESTINY-Gastric04 support the expanded use of ENHERTU in Japan, making it available as a new second-line option for patients with HER2 positive metastatic gastric cancer."

In DESTINY-Gastric04, the safety profile of ENHERTU was consistent with previous clinical trials with no new safety concerns identified. Adverse reactions occurred in 227 patients (93.0%) treated with ENHERTU (6.4 mg/kg), including 26 Japanese patients. The most common adverse reactions were fatigue (48.0%), decreased neutrophil count (48.0%), nausea (44.3%), anemia (31.1%), decreased appetite (29.1%), decreased leukocyte count (26.6%), decreased platelet count (26.6%), diarrhea (25.8%), alopecia (24.2%), increased transaminase (21.7%) and vomiting (20.1%).

About DESTINY-Gastric04
DESTINY-Gastric04 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (6.4 mg/kg) versus ramucirumab and paclitaxel in patients with HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen.

The primary endpoint is OS. Secondary endpoints include investigator-assessed progression-free survival, objective response rate, duration of response, disease control rate and safety.

At disclosure of the topline results, an Independent Data Monitoring Committee recommended unblinding DESTINY-Gastric04 based on the superior efficacy of ENHERTU seen at a planned interim analysis.

DESTINY-Gastric04 enrolled 494 patients in Asia, Europe and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Gastric Cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth leading cause of cancerrelated death, with a five-year global survival rate of 5% to 10%. 5,6 Approximately one million cases of gastric cancer were diagnosed in 2022. 5 Gastric cancer is the third most common cancer in Japan.1 More than 125,000 cases of gastric cancer were diagnosed in Japan in 2022, with more than 43,000 deaths.1

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including gastric cancer.3,7 Approximately one in five gastric cancers are considered HER2 positive. 2,3

Prior to the results of the DESTINY-Gastric04 trial of ENHERTU, no other HER2 directed medicine has demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial

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) in combination with pertuzumab is approved in the U.S. 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 (5.4 mg/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 (5.4 mg/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 (5.4 mg/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 (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 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 GEJ adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

ENHERTU (5.4 mg/kg) is approved in more than 15 countries/regions worldwide 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, DESTINY-CRC02 and/or HERALD trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program
A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY.

About the ADC Portfolio of Daiichi Sankyo
The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.

The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU and DATROWAY, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo.

An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING.

Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

(Press release, Daiichi Sankyo, MAR 23, 2026, View Source [SID1234665016])