On December 22, 2025 Daiichi Sankyo and Astrazeneca reported the first patient has been dosed in the DESTINY-Endometrial02 phase 3 trial evaluating ENHERTU (trastuzumab deruxtecan) with or without radiotherapy compared to standard of care chemotherapy with or without radiotherapy as an adjuvant treatment (after surgery) in patients with HER2 expressing (IHC 3+/2+) endometrial cancer.

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DESTINY-Endometrial02 is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F) and the European Network of Gynecological Oncological Trial Groups (ENGOT), with the French cooperative group (GINECO) as the lead ENGOT group.

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

While surgery is the recommended initial treatment for endometrial cancer, further treatment in the adjuvant setting is determined by the stage of disease and risk of recurrence.1,2 Following current standard of care adjuvant treatment, approximately 39% to 56% of patients with high-risk characteristics will experience disease recurrence or death within 18 months of diagnosis.3 HER2 expression (IHC 3+/2+) is present in approximately 18% to 56% of endometrial cancers and is associated with aggressive disease.4,5,6,7,8 There currently are no HER2 directed medicines approved in the adjuvant setting for HER2 expressing endometrial cancer.9,10

"Following the positive results of DESTINY-PanTumor02, which included a cohort of patients with metastatic endometrial cancer, we are now evaluating the use of ENHERTU in earlier lines of treatment for this disease," said Abderrahmane Laadem, MD, Head, Late-Stage Oncology Clinical Development, Daiichi Sankyo. "We recently initiated DESTINY-Endometrial01 to evaluate ENHERTU as a first-line treatment in patients with HER2 expressing primary advanced or recurrent endometrial cancer and are now initiating DESTINY-Endometrial02, the first trial to investigate a HER2 directed therapy in the adjuvant setting for patients with HER2 expressing endometrial cancer, to explore if ENHERTU can replace current standard of care chemotherapy and improve the long term outcome in this setting."

About DESTINY-Endometrial02

DESTINY-Endometrial02 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) with or without radiotherapy versus standard of care chemotherapy with or without radiotherapy as an adjuvant therapy in patients with treatment naïve HER2 expressing (IHC 3+/2+) endometrial cancer. Patients will be randomized 1:1 to receive either ENHERTU monotherapy or standard of care chemotherapy (carboplatin and paclitaxel). Both treatment arms may also receive radiotherapy.

The primary endpoint is disease-free survival (DFS) as assessed by blinded independent central review (BICR) or locally assessed histopathologic confirmation of disease recurrence. The key secondary endpoint is overall survival. Additional secondary endpoints include DFS as assessed by investigator; distant metastatic, local and regional recurrence as assessed by BICR or locally assessed histopathologic confirmation of disease recurrence; pharmacokinetics and safety.

DESTINY-Endometrial02 will enroll approximately 710 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

About Endometrial Cancer

Endometrial cancer is the second most common gynecologic cancer and the sixth most common cancer among women worldwide.11 Approximately 420,000 endometrial cancer cases were diagnosed in 2022, with more than 97,000 deaths globally.12 Incidence and mortality rates of endometrial cancer are expected to increase by approximately 61% and 87% respectively by 2050.13

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors.14 HER2 expression (IHC 3+/ 2+) is present in approximately 18% to 56% of endometrial cancers and is associated with markers of aggressive disease.4,5,6,7,8

Surgery is the recommended initial treatment for all stages of endometrial cancer, while adjuvant therapy recommendations are determined by the stage of disease and risk of recurrence.1,2 Endometrial cancer has a five-year overall survival rate of 81.1%; however, following current standard of care adjuvant treatment, approximately 39% to 56% of patients with high-risk characteristics will experience disease recurrence or death within 18 months of diagnosis.3,15,16,17,18 Current adjuvant treatment options for patients with high-risk endometrial cancer are external beam radiation therapy (EBRT) with concurrent chemotherapy, sequential chemotherapy and radiotherapy or chemotherapy alone.1 There currently are no HER2 directed medicines approved in the adjuvant setting for HER2 expressing endometrial cancer.9,10

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 85 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 55 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 60 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 70 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-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in more than 10 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 and DESTINY-CRC02 trials. Continued approval 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, DEC 22, 2025, View Source [SID1234661602])

On December 22, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion [generic name: atezolizumab (genetical recombination)] for an additional indication of unresectable thymic carcinoma. Tecentriq received orphan drug designation for this indication from the MHLW on March 31, 2025. Chugai subsequently filed an application on May 14, 2025, which underwent Priority Review.

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"We are very pleased to be able to deliver Tecentriq as a new treatment option for unresectable thymic carcinoma. Effective treatment options for this disease are limited, and new therapies have been highly anticipated. We will continue our efforts to provide information on the proper use of Tecentriq to contribute to the patients with thymic carcinoma." said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval is based on the results from the investigator-initiated phase II MARBLE study conducted in Japan, which evaluated the efficacy and safety of Tecentriq in combination with carboplatin and paclitaxel as first-line treatment for patients with unresectable thymic carcinoma.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines, supporting patients and healthcare professionals.

Approval Information *Excerpt from related parts

Indication: Unresectable thymic carcinoma
Dosage and administration:
All indications: The initial dose of Tecentriq must be administered over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be administered over 30 minutes.
Unresectable thymic carcinoma: The usual adult dosage is 1200 mg atezolizumab (genetical recombination) in combination with carboplatin and paclitaxel by intravenous infusion once every 3 weeks.

[Reference]
Chugai Files for Additional Indication of Tecentriq for the Treatment of Thymic Carcinoma
(Press release by Chugai issued on May 14, 2025)
View Source

About MARBLE study1
MARBLE study (jRCT2031220144) is a Japanese Phase II, multicenter, open-label, single-arm study led by investigators to evaluate the efficacy and safety of Tecentriq in combination with carboplatin and paclitaxel in patients aged 20 years or older with unresectable or advanced recurrent thymic carcinoma. The study evaluated safety and efficacy in 48 patients. The primary endpoint was overall response rate, and secondary endpoints included progression-free survival, overall survival, and safety.

About thymic carcinoma
Thymic carcinoma is a type of thymic epithelial tumor that originates from the thymic epithelium, which plays an important role in T-lymphocyte maturation, and is characterized by cellular atypia. The annual incidence in Japan is estimated to be 0.29 per 100,000 people2. The prognosis for unresectable cases is poor, highlighting the need for new therapeutic options.

About Tecentriq
Tecentriq is a cancer immune checkpoint inhibitor targeting PD-L1, which is a protein expressed on tumor and tumor-infiltrating immune cells. PD-L1 blocks T cell activity by binding with PD-1 and B7.1 receptors on the T cell surface. By inhibiting PD-L1, Tecentriq may enable the activation of T cells and boost immune response against cancer cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 6 tumour types (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma, alveolar soft part sarcoma, and extranodal NK/T-cell lymphoma, nasal type).

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, DEC 22, 2025, View Source;category= [SID1234661587])

On December 22, 2025 AngioDynamics, Inc. (NASDAQ: ANGO), a medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, reported, that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, Jan. 14, 2026. The Company’s presentation will begin at 3:00 p.m. (PT).

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A live webcast of the event will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

(Press release, AngioDynamics, DEC 22, 2025, View Source [SID1234661603])

On December 22, 2025 Daiichi Sankyo reported that ENHERTU (trastuzumab deruxtecan) has been approved in China 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 that has progressed on one or more endocrine therapies in the metastatic setting.

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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/Nasdaq: AZN).

Breast cancer is the second most common cancer in women in China.1 Approximately 357,000 cases of breast cancer were diagnosed in China in 2022, with nearly 75,000 deaths.1 HR positive, HER2 negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers.2 Despite being classified as HER2 negative, many of these tumors still carry some level of HER2 expression.

The approval of ENHERTU by China’s National Medical Products Administration (NMPA) is based on results from the DESTINY-Breast06 phase 3 trial presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO24) Annual Meeting and published in The New England Journal of Medicine.

In DESTINY-Breast06, ENHERTU demonstrated a 38% reduction in the risk of disease progression or death versus chemotherapy in patients with chemotherapy-naïve HR positive, HER2 low metastatic breast cancer (n=713; hazard ratio [HR] 0.62; 95% confidence interval [CI]: 0.52-0.75; p<0.0001) as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 13.2 months (95% CI: 11.4- 15.2) in the ENHERTU arm compared to 8.1 months (95% CI: 7.0-9.0) in the chemotherapy arm. Confirmed objective response rate (ORR) in the HER2 low population was 56.5% (95% CI: 51.2-61.7) with ENHERTU compared to 32.2% (95% CI: 27.4, 37.3) with chemotherapy. Median duration of response (DOR) was 14.1 months (95% CI: 11.8-15.9) with ENHERTU compared to 8.6 months (95% CI: 6.7-11.3) with chemotherapy.

In the HER2 ultralow population (n=153; HR 0.78; 95% CI: 0.50-1.21), median PFS was 13.2 months (95% CI: 9.8-17.3) in patients treated with ENHERTU compared to 8.3 months (95% CI: 5.8-15.2) in those treated with chemotherapy. Confirmed ORR was 61.8% (95% CI: 50.0, 72.8) with ENHERTU compared to 26.3% (95% CI: 16.9, 37.7) with chemotherapy. Median DOR was 14.3 months (95% CI: 9.2, 20.7) with ENHERTU compared to 14.1 months (95% CI: 5.9-not estimable) with chemotherapy.

"For many years, tumors with low levels of HER2 expression were grouped under the broader category of HER2 negative, leaving patients with HER2 low and HER2 ultralow breast cancer without targeted treatment options after progressing on endocrine therapy," said Xichun Hu, MD, PhD, Chair Professor of the Department of Medical Oncology, Fudan University Shanghai Cancer Center and lead investigator of the DESTINY-Breast06 trial in China. "The DESTINY-Breast06 results demonstrate for the first time that a precision-targeted therapy can benefit this underserved population, marking an important scientific advance. With this approval, more patients can benefit from antibody drug conjugate therapy, including those with HER2 expressing, HR positive metastatic breast cancer."

"As the first HER2 directed medicine approved in China for patients with HER2 low or ultralow disease, ENHERTU continues to redefine the diagnosis and treatment of metastatic breast cancer with this new use," said Michio Hayashi, China President, Daiichi Sankyo. "This fifth approval for ENHERTU in China in less than three years underscores our commitment to bringing this innovative therapy to more patients that may benefit from treatment."

"DESTINY-Breast06 marks a meaningful shift in the treatment of patients with HR positive breast cancer, enabling more patients to benefit from a HER2 directed treatment option," said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. "This new approval in China underscores the critical need to test metastatic breast cancer tumors for any level of HER2 staining to identify those with HER2 low or ultralow disease that could potentially be treated with ENHERTU following disease progression on endocrine therapy."

The safety profile of ENHERTU in DESTINY-Breast06 was consistent with previous clinical trials with no new safety concerns identified. The most common grade 3 or grade 4 adverse reactions from a pooled safety population receiving at least one dose of ENHERTU (n=2,225) were neutropenia (18.0%), anemia (10.5%), fatigue (7.8%), leukopenia (6.0%), thrombocytopenia (5.4%), nausea (4.9%), lymphopenia (3.9%), hypokalemia (3.8%), increased transaminases (3.5%), diarrhea (2.5%), vomiting (2.4%), decreased appetite (1.8%), pneumonia (1.3%) and decreased ejection fraction (1.0%). Grade 5 adverse reactions occurred in 1.4% of patients, including interstitial lung disease (ILD; 1.0%). Discontinuation of treatment due to an adverse reaction occurred in 11.2% of patients. The most frequent adverse reaction associated with permanent discontinuation was ILD (8.1%).

About DESTINY-Breast06

DESTINY-Breast06 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus investigator’s choice of chemotherapy (capecitabine, paclitaxel or nab paclitaxel) in patients with HR positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (defined as IHC 0 with membrane staining) advanced or metastatic breast cancer. Patients in the trial had no prior chemotherapy for advanced or metastatic disease and received at least two lines of prior endocrine therapy in the metastatic setting. Patients also were eligible if they had received one prior line of endocrine therapy combined with a CDK4/6 inhibitor in the metastatic setting and experienced disease progression within six months of starting first-line treatment or received endocrine therapy as an adjuvant treatment and experienced disease recurrence within 24 months.

HER2 IHC status was confirmed by a central laboratory and determined based on the most recent evaluable metastatic sample prior to randomization. In tumor samples from patients screened for trial eligibility, nearly two-thirds of tumors previously assessed as IHC 0 at a local laboratory were re-classified as HER2 low or HER2 ultralow upon central analysis of the archival tumor sample. It was also observed that approximately 85% to 90% of patients with HR positive, HER2 negative metastatic breast cancer may have actionable levels of HER2 expression.

The primary endpoint of DESTINY-Breast06 is PFS in the HR positive, HER2 low patient population as measured by BICR. Key secondary endpoints include PFS by BICR in the overall trial population (HER2 low and HER2 ultralow), overall survival (OS) in patients in the HER2 low patient population and OS in the overall trial population. Other secondary endpoints include ORR, DOR, time to first subsequent treatment or death, time to second subsequent treatment or death and safety. Analysis of the HER2 ultralow subgroup was not powered to demonstrate statistical significance.

DESTINY-Breast06 enrolled 866 patients (n=713 for HER2 low and n=153 for HER2 ultralow) in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

About Breast Cancer and HER2 Expression

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.4 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.4 In China, breast cancer is the second most common cancer in women.5 Approximately 357,000 cases of breast cancer were diagnosed in China in 2022, with nearly 75,000 deaths.5 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.

HR positive, HER2 negative breast cancer is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers.2 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including breast cancer.6 Patients with high levels of HER2 expression (IHC 3+ or IHC 2+/ISH+) are classified as HER2 positive and treated with HER2 targeted therapies, representing approximately 15% to 20% of all breast cancers.7,8 Historically, tumors that were not classified as HER2 positive were classified as HER2 negative, despite the fact that many of these tumors still have some level of HER2 expression.

Endocrine therapy is widely given consecutively in the early lines of treatment for HR positive metastatic breast cancer. However, after initial therapy, further efficacy with additional endocrine treatment is often limited.9 Prior to the approval of ENHERTU in HER2 low and HER2 ultralow metastatic breast cancer based on the DESTINY-Breast04 and DESTINY-Breast06 trials, there were no HER2 targeted therapies approved specifically for these patient populations.

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 (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 85 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 55 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 60 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 70 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-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in more than 10 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 and DESTINY-CRC02 trials. Continued approval 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, DEC 22, 2025, View Source [SID1234665024])

On December 22, 2025 Merck, a leading science and technology company, reported that following Priority Review, the China National Medical Products Administration (NMPA) has approved pimicotinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause functional limitation or relatively severe morbidity. Pimicotinib, a colony stimulating factor-1 receptor (CSF-1R) inhibitor developed by Abbisko Therapeutics Co., Ltd., Shanghai, China, is the first Chemical Drug Class 1 approved in China for the treatment of TGCT.

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"We are continuing to deliver on our commitment to improving the lives of patients with rare tumors with this first-in-the-world regulatory approval of pimicotinib," said Danny Bar-Zohar, CEO Healthcare and Member of the Executive Board of Merck. "This approval is a significant step forward in further strengthening our leadership in rare tumors, while offering patients the opportunity to change the course of their disease and help alleviate symptoms that impact their daily lives. We are now working to make pimicotinib available to patients in China as quickly as possible, as we continue to progress applications with regulatory authorities in additional markets."

TGCT is a rare, locally aggressive tumor of the joint leading to progressive swelling, stiffness and reduced mobility of the affected joint, significantly impacting daily activities and quality of life in the otherwise healthy population that it affects. If left untreated or in recurrent cases, TGCT can result in irreversible damage to the bone, joint and surrounding tissues. Historically TGCT may have been known by several different names, including pigmented villonodular synovitis (PVNS).

The approval of pimicotinib by the China NMPA is based on results from the global Phase 3 MANEUVER study, in which pimicotinib demonstrated the highest objective response rate (ORR) based on RECIST v1.1 seen in a Phase 3 trial of a systemic TGCT treatment, as well as meaningful improvements in clinical outcomes. At week 25, pimicotinib demonstrated a statistically significant improvement in the primary endpoint of ORR assessed by blinded independent review committee (BIRC) based on RECIST v1.1 compared with placebo at week 25 (54.0% vs. 3.2% for placebo; p<0.0001). Pimicotinib also demonstrated clinically meaningful and statistically significant improvements across secondary endpoints relevant to patients’ daily lives, improving relative range of motion (p=0.0003) and physical function measured by PROMIS-PF scale (p=0.0074) and reducing worst stiffness (p<0.0001) and worst pain (p<0.0001). These findings were presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. Longer-term results presented at the ESMO (Free ESMO Whitepaper) Congress 2025 showed that with a median follow-up of 14.3 months, ORR per RECIST v1.1 increased considerably among patients treated with pimicotinib from the beginning of the study, to 76.2% (95% CI: 63.8, 86.0).

"Many people living with TGCT in China have faced a long and difficult journey due to the lack of approved options beyond surgery, which may not address the needs of patients whose tumors recur or are not amenable to resection," said Prof. Niu Xiaohui, Director of the Bone and Soft Tissue Tumour Diagnosis and Research Centre at Beijing Jishuitan Hospital. "With the approval of pimicotinib based on the results of the global MANEUVER study, healthcare professionals in China will soon have the opportunity to prescribe their patients an effective and well-tolerated systemic treatment option, offering a much-needed advance in how they manage this challenging condition."

In MANEUVER, pimicotinib was well-tolerated, with no evidence of cholestatic hepatotoxicity or hair/skin hypopigmentation. During the randomized, double-blind treatment phase of the trial, treatment-emergent adverse events (TEAEs) leading to treatment discontinuation occurred in one patient (1.6%) treated with pimicotinib; TEAEs leading to dose reduction occurred in 7.9% (n=5) of pimicotinib-treated patients.

"Pain and restricted mobility induced by TGCT impair patients’ daily functioning and impose huge psychological burden on them," commented Kevin Huang, Founder and President of Chinese Organization for Rare Disorders (CORD), and Founder and Secretary-General of the Hope For Rare Foundation. "Following the approval of pimicotinib in China, this systemic therapeutic regimen enables effective control of tumor progression and alleviation of clinical symptoms, bringing hope for patients who may regain the ability to join in activities deemed common by the most, such as climbing stairs, commuting to work, or playing with their children."

About MANEUVER

The pivotal global Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT who require systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The study is being conducted by Abbisko Therapeutics in China (n=45), Europe (n=28), and the US and Canada (n=21).

In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. The primary endpoint was objective response rate (ORR) at week 25, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in the intent-to-treat (ITT) population. Secondary endpoints include ORR per tumor volume score (TVS), relative range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS-PF).

After the double-blind Part 1, eligible patients could continue to the open-label Part 2 for up to 24 weeks of further treatment. Patients who completed Part 2 could then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up.

About pimicotinib (ABSK021)

Pimicotinib, developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. It has been granted breakthrough therapy designation (BTD) for the treatment of inoperable TGCT by the U.S. Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck holds worldwide commercialization rights for pimicotinib.

(Press release, Merck KGaA, DEC 22, 2025, View Source [SID1234661588])