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 Alphamab Oncology (stock code: 9966.HK) reported that that the clinical trial application for the independently developed TROP2/HER3 bispecific antibody-drug conjugate (ADC) JSKN016, in combination with InventisBio’s oral selective estrogen receptor degrader (SERD) D-0502, has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The trial (Study Number: JSKN016-204) is for the treatment of locally advanced or metastatic HR-positive, HER2-negative (HR+/HER2-) breast cancer.

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Breast cancer is the most prevalent malignancy among Chinese women, with the HR+/HER2- subtype accounting for approximately 70% of all breast cancer cases. The current first-line standard of care involves endocrine therapy combined with CDK4/6 inhibitors. However, primary or acquired resistance often leads to disease progression, resulting in a significant unmet clinical need in later-line treatment. Therefore, it is crucial to explore novel-mechanism drugs and combination therapies.

JSKN016 is a novel bispecific ADC that simultaneously targets TROP2 and HER3 on the surface of tumor cells. It blocks the corresponding signaling pathways while enhancing cellular endocytosis and release of topoisomerase I inhibitors, enabling precise tumor killing. Early phase clinical studies have shown promising antitumor activity and a favorable safety profile in various solid tumors, including breast cancer. D-0502 is a novel, oral SERD independently developed by InventisBio. Early phase clinical studies have demonstrated its antitumor activity and good tolerability as monotherapy. The combination of both drugs is expected to achieve multiple synergistic effects, which may lead to prolonged disease control and improved survival outcomes for patients.

JSKN016-204 is a multicenter, open-label, randomized controlled phase Ib/II clinical study. It aims to evaluate the safety, tolerability, dose-limiting toxicity (DLT), preliminary antitumor activity, and pharmacokinetics (PK)/pharmacodynamics (PD) of JSKN016 in combination with D-0502 in patients with locally advanced or metastatic HR+/HER2- breast cancer who have been previously treated with CDK4/6 inhibitor in combination with endocrine therapy.

Ms. Yang Liu, Chief Operating Officer of Alphamab Oncology, stated: "Oral SERDs, including InventisBio’s D-0502, have recently demonstrated superior efficacy in HR+ breast cancer. Currently, there are no global precedents for combining an ADC with an oral SERD. Our JSKN016 has shown excellent efficacy and safety in later-line HR+ breast cancer. By combining with D-0502, we hope to further extend the progression-free survival for HR+ breast cancer patients after front-line therapy resistance and translate it into high-quality, long-term survival benefits. We greatly look forward to this collaboration."

Dr. Ling Zhang, Chief Medical Officer of InventisBio, stated: "We are very pleased that the clinical trial application for the combination therapy of D-0502 and JSKN016 has been approved. Drug resistance in HR+/HER2- breast cancer remains a major clinical challenge, with limited treatment options in later lines. D-0502, an oral SERD with a favorable safety profile and high bioavailability, in combination with the ADC JSKN016, is expected to synergistically inhibit tumor growth through a dual mechanism of action, offering new hope for patients with refractory disease."

About JSKN016

JSKN016 is a TROP2/HER3 targeting bispecific ADC developed using the proprietary single-domain antibody and bispecific antibody platforms. It is conjugated via site-specific glycosylation to generate a homogeneous and stable ADC with a drug-to-antibody ratio (DAR) of 4. Upon binding to TROP2 and/or HER3 on the tumor cell surface, JSKN016 blocks the corresponding signaling pathways and enhances cellular endocytosis to release topoisomerase I inhibitors, thereby exerting anti-tumor effects.

JSKN016 has demonstrated promising antitumor activity and a favorable safety profile across multiple solid tumors. Dose optimization and dose confirmation have been completed, and it is poised to advance into Phase III clinical studies.

About D-0502 (Taragarestrant)

D-0502 is a novel, oral selective estrogen receptor degrader (SERD) independently developed by InventisBio, intended for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Compared to existing injectable SERDs, its oral administration offers greater convenience for patients. D-0502 has demonstrated favorable antitumor activity and a promising safety profile in both preclinical studies and clinical trials. In October 2021, the Center for Drug Evaluation (CDE) granted approval to initiate a registrational Phase III clinical trial in China for D-0502. This trial is designed as a head-to-head comparison against standard of care in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. The first patient was successfully enrolled in this registrational Phase III trial in September 2022, and the trial is currently proceeding as planned.

(Press release, Alphamab, DEC 22, 2025, View Source [SID1234662085]).

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 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 Incyte Biosciences Japan G.K. reported the Japan Ministry of Health, Labour and Welfare (MHLW) approval of Zynyz (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC).

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"Today’s approval marks a significant milestone for patients with advanced anal cancer in Japan – the MHLW’s approval of Zynyz as the first and only first-line treatment for SCAC," said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan G.K. "By offering combination therapy with chemotherapy, Zynyz provides a vital new path forward for patients facing this challenging disease, addressing a significant unmet need in cancer care for patients with SCAC and their families."

The approval was based on data from the Phase 3 POD1UM-303/InterAACT2 trial evaluating Zynyz in combination with platinum-based chemotherapy (carboplatin-paclitaxel) in adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy.

Results from POD1UM-303/InterAACT2 (NCT04472429) published in The Lancet showed a statistically significant 37% reduction in the risk of progression or death (P=0.0006). 1 Patients in the Zynyz and chemotherapy combination group achieved a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for patients in the placebo combination group.1 No new safety concerns were identified. Serious adverse reactions occurred in 47% of patients receiving Zynyz in combination with chemotherapy.1 The most frequent serious adverse reactions (≥ 2% of patients) were sepsis, pulmonary embolism, diarrhea and vomiting.1

SCAC accounts for approximately 16% to 24% of anal canal cancer cases in Japan, with adenocarcinomas comprising about 70%.2 The overall incidence rate for anal canal in Japan is approximately 0.26 to 0.41 per 100,000 persons.2

This is the first regulatory approval for Zynyz in Japan, and the second regulatory approval for Zynyz in advanced SCAC. In May 2025, the U.S. Food and Drug Administration (FDA) approved Zynyz in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic SCAC.

Incyte has also submitted a Type II variation Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for retifanlimab in advanced SCAC.

About Squamous Cell Carcinoma of the Anal Canal (SCAC)

Worldwide, SCAC is the most common type of anal cancer, making up 85% of cases.3 It is a rare disease for which the incidence increases approximately 3% per year.4,5,6,7 About 90% of cases are associated with human papillomavirus (HPV) infection—the number one risk factor for anal cancer.7 HIV is an important amplifier of anal cancer, as people with HIV are 25 to 35 times more likely to develop it.8,9 Anal cancer shares many of the same symptoms as non-cancerous conditions, such as hemorrhoids—including pain, itching, a lump or mass and changes in bowel movements—and as a result can go undetected leading to the majority of patients presenting with locally advanced disease.10

About POD1UM

The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-303, POD1UM-202 and several other Phase 1, 2 and 3 studies for patients with solid tumors, including a registration-directed trial evaluating retifanlimab in combination with platinum-based chemotherapy for patients with non-small cell lung cancer.

About Zynyz (retifanlimab)

Zynyz (retifanlimab) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).

Zynyz is also indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Zynyz is marketed by Incyte in the United States. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a registered trademark of Incyte.

Important Safety

Please refer to the Zynyz package insert for precautions concerning indications, dosage and administration, and safety information in Japan, Japan Pharmaceuticals and Medical Devices Agency.

(Press release, Incyte, DEC 22, 2025, View Source [SID1234661601])