On June 29, 2026 Daiichi Sankyo and Astrazeneca reported that Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options.

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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/NYSE: AZN).

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from subgroups of patients with HER2 positive (IHC 3+) tumors across three phase 2 trials, including DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02.

In DESTINY-PanTumor02, Enhertu demonstrated a confirmed objective response rate (ORR) of 52.3% (95% confidence interval [CI]: 42.6-61.8) and median duration of response (DOR) of 21.1 months (95% CI: 10.6-25.0) in a subgroup of previously treated patients (n=111) with centrally or locally assessed HER2 positive 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) and median DOR of 6.9 months (95% CI: 4.0-9.8) in a subgroup of previously treated patients (n=17) with centrally confirmed HER2 positive non-small cell lung cancer (NSCLC). In DESTINY-CRC02, Enhertu demonstrated a confirmed ORR of 46.9% (95% CI: 34.3-59.8) and median DOR of 5.5 months (95% CI: 4.2-8.1) in a subgroup of previously treated patients (n=64) with centrally confirmed HER2 positive colorectal cancer.

"HER2 overexpression occurs across multiple tumor types and is associated with aggressive disease and a poor prognosis. Until now, HER2 directed therapies were only available for specific tumor types," said Benedikt Westphalen, MD, Head of the Precision Oncology Program, Comprehensive Cancer Center of the University of Munich, Germany. "The approval of trastuzumab deruxtecan as a tumor agnostic therapy opens a new treatment option for patients with HER2 positive cancers regardless of where the tumor originated."

In DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02, the safety profile of Enhertu was consistent with previous clinical trials with no new safety concerns identified. Grade 3 or grade 4 adverse reactions from a pooled safety analysis of patients treated with Enhertu (5.4 mg/kg) across multiple tumor types in clinical studies included neutropenia (18.5%), anemia (9.9%), fatigue (8.2%), leukopenia (5.8%), thrombocytopenia (5.2%), nausea (4.8%), lymphopenia (4.2%), hypokalemia (3.6%), increased transaminases (3.6%), diarrhea (2.5%), vomiting (2.4%), decreased appetite (1.6%), pneumonia (1.4%) and decreased ejection fraction (1.0%). Grade 5 adverse reactions occurred in 1.1% of patients, including interstitial lung disease/pneumonitis (1.0%).

"This approval of Enhertu marks a significant milestone in the EU for patients with HER2 positive metastatic solid tumors and establishes the first tumor agnostic indication for a HER2 directed therapy and antibody drug conjugate in the region," said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. "Enhertu is now approved for six indications in the EU, which demonstrates our commitment to advancing innovative medicines in areas of high unmet need to patients with cancer."

"Precision medicine is reshaping cancer care by helping inform treatment decisions based on the molecular and biological characteristics of a patient’s disease," said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. "Enhertu is already approved in breast, gastric and lung cancers, and with this approval, clinicians may now consider Enhertu for patients with HER2 positive status across multiple additional tumor types. This highlights the importance of biomarker testing to identify eligible patients and ensure that those with HER2 positive disease are considered for targeted treatment."

Enhertu (5.4 mg/kg) is approved in more than 40 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/or have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials.

Additional regulatory submissions for Enhertu also are underway in the EU, including in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer based on data from the DESTINY-Breast09 trial and for patients with HER2 positive breast cancer with residual invasive disease after neoadjuvant HER2 targeted treatment based on data from the DESTINY-Breast05 trial.

Financial Considerations

Following this approval in the EU, an amount of $25 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the HER2 positive metastatic solid tumor indication. Sales of Enhertu in most EU territories are recognized by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019.

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, 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.

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

About DESTINY-Lung01

DESTINY-Lung01 is a global, open-label, two-cohort, phase 2 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg or 6.4 mg/kg) in patients with HER2 mutant (Cohort 2, n=91) or HER2 overexpressing (defined as IHC 3+ or IHC 2+) (Cohort 1 and 1a, n=90) 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.

DESTINY-Lung01 enrolled 181 patients, including 17 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About DESTINY-CRC02

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

DESTINY-CRC02 enrolled 122 patients, including 64 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Expression in Solid Tumors

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 overexpression occurs in a range of solid tumors with the prevalence varying by tumor type.3

HER2 directed therapies have been used to treat HER2 overexpression in breast, gastric and biliary tract cancers in the EU.1,4,5,6 Although HER2 is overexpressed in additional solid tumor types including biliary tract, lung, bladder, cervical, colorectal, endometrial, ovarian, salivary gland and pancreatic cancers, HER2 testing is not routinely performed in these additional tumor types and prior to this approval there were no HER2 directed treatments approved in the EU to treat a broad range of solid tumors.2,7,8

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 the U.S. for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

Enhertu (5.4 mg/kg) followed by THP is approved in China and the U.S. as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 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 (5.4 mg/kg) in combination with pertuzumab is approved in Brazil, India, Israel, Saudi Arabia, Switzerland, the United Arab Emirates and 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 a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4 mg/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 (5.4 mg/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 (5.4 mg/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 (5.4 mg/kg) is approved in more than 75 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 90 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 (5.4 mg/kg) is approved in more than 40 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/or 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.

(Press release, Daiichi Sankyo, JUN 29, 2026, View Source [SID1234668982])

On June 29, 2026 Excalipoint Therapeutics, a clinical-stage biotechnology company advancing novel T-cell engager (TCE) therapies for solid tumors and autoimmune disorders, reported a clinical collaboration with Roche to explore the combination of Excalipoint’s lead product candidate EXP011 (CTM012), a tri-specific T-cell engager targeting DLL3, CD3, and 4-1BB and Roche’s atezolizumab in patients with DLL3-expressing solid tumors.

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Roche will supply atezolizumab for use in the planned clinical studies. The clinical studies under the collaboration are designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of EXP011 combined with atezolizumab in small cell lung cancer (SCLC), with potential extension into other tumor types such as neuroendocrine tumors (NET).

"We are pleased to partner with Roche to explore the combination potential of EXP011 and atezolizumab for patients with SCLC and other hard-to-treat solid tumors." said Lei Fang, Ph.D., Co-Founder, Chairman and Chief Executive Officer, Excalipoint Therapeutics. "This collaboration enables us to evaluate a differentiated immuno-oncology combination strategy to address the limitations of current treatment regimens and deliver better clinical benefits for patients."

"This clinical collaboration with Roche will further crystallize the clinical value of EXP011 in solid tumors and accelerate the global development of this highly differentiated asset," said Jielun Zhu, Co-Founder, CFO & CBO, Excalipoint Therapeutics. "This partnership is also a strong endorsement of the potential of EXP011 in overcoming treatment barriers of existing therapies to drive more durable response and improve patient outcomes."

EXP011 is Excalipoint’s lead tri-specific T-cell engager from its proprietary co-stimulatory EXCOPIA Platform (formerly known as TOPABody) designed to selectively target DLL3, a tumor-specific antigen highly expressed in SCLC and neuroendocrine tumors, while engaging CD3 and 4-1BB to achieve potent, controlled and synergistic T-cell activation and anti-tumor activity.

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

(Press release, Excalipoint Therapeutics, JUN 29, 2026, View Source [SID1234669000])

On June 29, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and Aveta Biomics, Inc., a clinical-stage immuno-oncology company advancing first-in-class oral immunotherapies for solid tumors, reported a strategic partnership supporting AVTA 30-01, Aveta’s global Phase 3 registrational clinical trial evaluating APG-157 in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) (NCT07667296).

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APG-157 is Aveta’s first-in-class oral immunotherapy intended to expand the benefits of immunotherapy to both immune-cold and immune-hot tumors in patients with LA-HNSCC. APG-157 has received FDA Fast Track and Orphan Drug Designations for this indication.

AVTA 30-01 builds upon previously reported Phase 2 clinical data of APG-157 monotherapy in demonstrating favorable safety, evidence of tumor-control, deep molecular responses, and encouraging event-free survival outcomes. The trial will incorporate serial Signatera testing to assess molecular residual disease (MRD) and treatment response throughout therapy and follow-up. Circulating tumor DNA (ctDNA) has emerged as one of the most promising approaches for detecting MRD and identifying recurrence earlier than conventional imaging alone.

Approximately 826 patients are expected to be enrolled across North America, Europe, Asia-Pacific, and Australia. The study includes separate randomized cohorts for resectable and unresectable locally advanced disease, each with treatment and control arms, and Signatera will be a secondary endpoint. The trial is expected to begin enrollment in 2H’26.

Global annual incidence of head and neck cancer is approximately 950,000,1 and disease recurrence remains a major cause of mortality despite advances in surgery, radiation therapy, and immunotherapy.

"Patients with locally advanced head and neck cancer continue to face substantial risks of recurrence despite aggressive treatment," said Parag Mehta, Ph.D., founder and chief executive officer of Aveta Biomics. "We believe APG-157 has the potential to transform treatment by activating anti-tumor immunity in both immune-cold and immune-hot tumors. Incorporating serial Signatera testing into AVTA 30-01 will allow us to further validate the ctDNA findings observed in Phase 2 while generating molecular response data that will advance the understanding of treatment benefits for patients and strengthen the regulatory submission."

This study adds to the evidence Natera continues to generate in head and neck cancer. The company recently announced a successful readout of the prospective Phase 2 SINERGY trial, supporting Signatera MRD-guided treatment in this histology.

"Growing evidence continues to demonstrate the value of Signatera MRD detection in head and neck cancer," said Eric Matthews, general manager, biopharma, Natera. "We’re pleased to partner with Aveta on AVTA 30-01 to demonstrate how Signatera has the potential to advance the field and improve care for patients."

(Press release, Aveta Biomics, JUN 29, 2026, View Source [SID1234669001])

On June 27, 2026 PDX Pharma reported it has secured intellectual property protection in Japan for the AIRISE (Augmenting Immune Response and Inhibiting Immune Suppressive Environment) family, marking an important milestone in our continued innovation and global IP strategy. This achievement strengthens the AIRISE platform and supports the advancement of in situ cancer vaccination approaches based on our Pdx-NP platform, designed for the co-delivery of anticancer agents and nucleic acid adjuvants.

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This news follows our recent success in securing an additional US patent for the ARAC (Antigen Release Agent and Checkpoint inhibitor) family last month (US12,582,658). This patent includes broad claims covering Pdx-NP-based co-delivery of a wide range of anticancer agents and immune checkpoint inhibitors. Both AIRISE and ARAC developments have been funded by the National Cancer Institute.

(Press release, PDX Pharmaceuticals, JUN 27, 2026, View Source [SID1234668967])

On June 26, 2026 Lantheus Holdings, Inc. ("Lantheus" or "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs).

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The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of June 29, 2026, due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the LNTH-2501 NDA may be approved.

The CRL did not identify any concerns regarding the data submitted by Lantheus in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501.

"We remain confident in LNTH-2501 and are committed to bringing this imaging agent to NETs patients and healthcare providers as soon as possible," said Mary Anne Heino, Executive Chairperson and Chief Executive Officer, Lantheus. "The feedback received from the FDA relates solely to our third-party manufacturer, and not to the clinical performance of the product. We are working closely with our partner and the Agency to address these facility manufacturing-related conditions and advance the program."

About LNTH-2501 (Ga 68 edotreotide)
LNTH-2501 (Kit for Preparation of Ga 68 edotreotide Injection), is an investigational radioactive diagnostic kit indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. LNTH-2501 is supplied as a 2-vial kit to radiopharmacies which allows for direct preparation of Ga 68 edotreotide injection with the eluate of Gallium from an on-site generator at the radiopharmacy. LNTH-2501 is not currently approved by the FDA and is not yet available for sale in the United States.

(Press release, Lantheus, JUN 26, 2026, View Source [SID1234668965])