utidelone IV (UTD1) / Beijing Biostar Technologies, Luye Group - LARVOL DELTA

Effcacy and safety results of a multi-center phase I/II study of utidelone capsule, a novel oral microtubule inhibitor. (ASCO 2025) - P1 | "Phase II is for UTD2 at 60mg/m2/d-5day in combination with capecitabine at 1000mg/m2 bid-14day in a 21-day cycle for metastatic BC, with ORR as the primary objective. This study demonstrated UTD2's good bioavailability as a microtubule inhibitor, manageable safety, and promising combination therapy efficacy consistent with the injectable formulation for the treatment of advanced BC. The final data will be provided at the time of presentation."

Clinical • P1/2 data • Breast Cancer • Neutropenia • Oncology • Solid Tumor

Efficacy and safety results of a multi-center phase I study of utidelone capsule, a novel oral microtubule inhibitor, in advanced solid tumor patients. (ASCO 2025) - P1 | "This completed study demonstrates encouraging anti-tumor activity with manageable safety of UTD2 in patients with heavily pre-treated advanced solid tumors. The results support continuing development of UTD2 for the upcoming phase II/III studies for gastric and ovarian cancers."

Clinical • Metastases • P1 data • Appendix Cancer • Breast Cancer • Fatigue • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Testicular Cancer

Utidelone in combination with etoposide and bevacizumab in HER2-negative breast cancer patients with brain metastasis: A prospective, single-arm, phase II trial. (ASCO 2025) - P=N/A | "The median CNS-PFS was 15 months (95% CI, 6.760-23.240), with supportive treatment for some of the patients after extracranial progression which included etoposide re-administration, or abraxane, endocrine therapy, radiotherapy and immunotherapy. Utidelone in combination with etoposide and bevacizumab has shown promising anti-tumor activity and manageable toxicity in HER2 negative breast cancer patients with brain metastasis, and a randomized control trial is warrantied."

Clinical • Combination therapy • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Solid Tumor • Triple Negative Breast Cancer • HER-2

Efficacy and safety results of a multi-center phase II study of utidelone injection in combination with PD-1 inhibitor and chemotherapy for the first-line treatment of advanced gastric and esophagus cancers. (ASCO 2025) - P2 | " Eligible patients were recruited into the two cohorts of metastatic and/or unresectable HER2 negative GC or ESCC, receiving utidelone (30mg/m2/day iv on days 1–5 every 21-day) plus sintilimab (200 mg iv Q3W) and oxaliplatin (130 mg/m2/day Q3W for up to 6 cycles), or utidelone (30mg/m2/day iv on days 1–5 every 21-day) plus tislelizumab (200 mg iv Q3W) and capecitabine (2000mg/m2/day po on days 1–14 every 21-day), respectively, until disease progression or unacceptable toxicity. Utidelone plus PD-1 inhibitor and chemotherapy demonstrated promising efficacy and acceptable safety as first-line treatment for advanced GC and ESCC. There are 11 patients still on the study receiving continuous treatment. The final data will be provided at the time of presentation."

Clinical • Combination therapy • Metastases • P2 data • Anemia • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hypotension • Leukopenia • Neutropenia • Oncology • Pain • Squamous Cell Carcinoma • HER-2

The efficacy and safety of utidelone plus tislelizumab and bevacizumab for advanced or metastatic triple-negative breast cancer (UTILIZABLE) (ESMO-BC 2025) - P2 | "This study shows preliminary efficacy and manageable toxicity of utidelone plus tislelizumab and bevacizumab for pretreated mTNBC, particularly demonstrating intracranial activity, representing a potential therapeutic option for this high-risk population. Limited sample size warrants validation in larger cohorts."

Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-1 • PD-L1

A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients with Brain Metastases (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

Utidelone combined with anti‑angiogenic therapy for the treatment of anthracycline/taxane‑treated and endocrine‑resistant HR+/HER2‑ refractory breast cancer with brain metastases: A case report. (PubMed, Oncol Lett) - "This result was superior to the second-line treatment with nab-paclitaxel, which resulted in a PFS of 8 months and best overall response of stable disease with slight shrinkage. The present case indicates that a combination of utidelone with apatinib/anlotinib exhibited antitumor activity in a patient with HR+/HER2- mBC with BMs. Therefore, this combination offers a promising therapeutic option for the clinical treatment of patients with breast cancer and BMs."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real world analysis of the efficacy and safety of eribulin compared to utidelone in combination with capecitabine for the treatment of metastatic breast cancer. (PubMed, Cancer Cell Int) - "In conclusion, either utidelone/capecitabine or eribulin chemotherapy may result in a survival benefit with a tolerable adverse effect profile and favorable safety profile in patients with metastatic breast cancer. The first-line use of eribulin resulted in better PFS and ORR than posterior-line use, and the combination of utidelone/capecitabine represents a more efficacious approach in the advanced first-line therapy of breast cancer."

Journal • Metastases • Real-world • Real-world evidence • Breast Cancer • Dermatology • Gastrointestinal Disorder • Hematological Disorders • Oncology • Solid Tumor

Efficacy and safety of utidelone plus bevacizumab in the treatment of patients with Her2- metastatic breast cancer study (SABCS 2024) - "This study showed promising efficacy and a manageable safety profile of utidelone plus bevacizumab in the treatment of Her2- MBC patients relapsed after taxanes therapy. This combination regimen could become a new choice for these patients, especially for asymptomatic brain metastasis patients. Further study is warranted with expanded number of patients."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases (clinicaltrials.gov) - P2 | N=118 | Not yet recruiting | Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.

New P2 trial • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Utidelone plus pembrolizumab as the fourth-line combination treatment in non-small cell lung cancer with EGFR mutation: a case report. (PubMed, Anticancer Drugs) - "The patient had progressed after targeted therapy with oxitinib, ametinib, and vometinib. Although peripheral neurotoxicity occurred during treatment, it improved after symptomatic treatment. The treatment of EGFR mutant stage IV NSCLC with utidelone combined with pabolizumab has good effect and mild adverse reactions."

Journal • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PGR

Utidelone-based therapy in advanced or metastatic solid tumors after failure of standard therapies: a prospective, multicenter, single-arm trial. (PubMed, Am J Cancer Res) - "This study demonstrated a promising anti-tumor activity of UTD1 in patients with advanced or metastatic solid tumors after failure of the standard therapies. Moreover, 120 h continuous intravenous infusion was a more tolerable administration mode than 5 days intermittent infusion, and worthy of further study."

Journal • Metastases • Breast Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Gynecologic Cancers • Lung Cancer • Oncology • Pain • Solid Tumor

ORIENTA: Organoid-based Functional Precision Therapy for Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=252 | Recruiting | Sponsor: Guangdong Provincial People's Hospital | Initiation date: Jan 2024 ➔ Sep 2024

Metastases • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Efficacy and safety of utidelone in heavily pretreated patients with metastatic breast cancer in China: a multicenter real-world study (CSCO 2024) - "Study group: [CSCO Breast Cancer Expert Committee]"

Clinical • Metastases • Real-world • Real-world evidence • Breast Cancer • Oncology • Solid Tumor

A single-arm, prospective phase Ⅱ clinical study of Utidelone combined with capecitabine in the treatment of active brain metastasis of triple-negative advanced breast cancer. (ChiCTR) - P2 | N=48 | Not yet recruiting | Sponsor: Henan Cancer Hospital; Henan Cancer Hospital

Metastases • New P2 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined with Capecitabine in the Treatment of Active Brain Metastasis of TNBC (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Henan Cancer Hospital

Metastases • New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Cost-effectiveness of utidelone and capecitabine versus monotherapy in anthracycline- and taxane-refractory metastatic breast cancer. (PubMed, Front Pharmacol) - P3 | "Subgroup analysis revealed that the combination was more cost-effective than capecitabine alone in specific patient groups, including those <60 years, patients with more than two chemotherapy rounds, patients lacking certain metastases, patients having limited metastatic sites, patients with an Eastern Cooperative Oncology Group status of 0, and patients with particular hormone receptor profiles. Although the combination of utidelone and capecitabine may not be an economically viable universal choice for anthracycline- and taxane-refractory metastatic breast cancer, it could be more cost-effective in specific patient subgroups than capecitabine monotherapy."

Cost effectiveness • HEOR • Journal • Metastases • Monotherapy • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA) (clinicaltrials.gov) - P2 | N=143 | Not yet recruiting | Sponsor: RenJi Hospital

New P2 trial • Breast Cancer • Oncology • Solid Tumor

Biostar Pharma Announces FDA Clearance of the IND Application for a Phase 2 Study of Utidelone Injection (UTD1) in HER2- Breast Cancer Brain Metastasis (PRNewswire) - "Biostar Pharma...announced today that their core pipeline product Utidelone Injection (UTD1) had been granted to conduct a phase 2 study (BG01-2402) for HER2- breast cancer brain metastasis (BCBM) by the US FDA....The purpose of the study is to evaluate the intracranial and systemic efficacy of Utidelone Injection in combination with capecitabine in HER2- BCBM patients. This study follows a Simon's 2-stage design, and is planned to be conducted at 10-15 sites in the US with enrollment target of 120 patients."

IND • New P2 trial • HER2 Negative Breast Cancer

Cost-Effectiveness of Utidelone and Capecitabine versus Monotherapy in Anthracycline-and Taxane-Refractory Metastatic Breast Cancer (Front Pharmacol) - "Over a five-year span, the combination therapy manifested substantially higher costs than capecitabine monotherapy, with a differential of US$ 26,370.63. This combined approach conferred an additional 0.49 QALYs, resulting in an ICER of US$ 53,874.17/QALY. Utilizing the established willingness-to-pay threshold, the combination might not consistently be deemed cost-effective when juxtaposed against monotherapy. However, at an ICER of US$ 53,874.4/QALY, the probability of the combination being cost-effective increased to 48.97%."

HEOR • Breast Cancer

A single-arm, multicenter, phase II study of utidelone in advanced solid tumors: Efficacy data from screening and the expansion cohort assessing utidelone plus sintilimab and oxaliplatin for advanced gastric cancer. (ASCO 2024) - P2 | "Utidelone monotherapy showed antitumor activity and manageable toxicity in pts with advanced solid tumors. Utidelone plus sintilimab and oxaliplatin demonstrated promising efficacy and an acceptable safety profile as first-line treatment for pts with GC. Stage II of the USO-G study is still actively enrolling; further data will be provided at the time of presentation."

Clinical • Metastases • P2 data • Anemia • Biliary Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Esophageal Cancer • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Ovarian Cancer • Pain • Pancreatic Cancer • Solid Tumor • HER-2

Utidelone plus bevacizumab for the treatment of HER2-negative breast cancer brain metastases (U-BOMB): A multicenter, single-arm phase II study. (ASCO 2024) - P2 | "This study preliminarily shows promising efficacy and manageable safety of the combination of utidelone and bevacizumab in the treatment of HER2-negative metastatic breast cancer patients with brain metastases."

Clinical • P2 data • Anemia • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Solid Tumor • HER-2

Utidelone for heavily pretreated metastatic castration-resistant prostate cancer after failing docetaxel treatment: An open-label, single-arm, phase II trial. (ASCO 2024) - " In this perspective, phase II clinical trial, men with progressive mCRPC after docetaxel and abiraterone, and/or enzalutamide, and/or apalutamide received UTD1 monotherapy treatment at a total dose of 150 mg/m2 for five days intravenous, every three weeks until disease progression, or intolerable toxicity, or death. UTD1 has demonstrated promising efficacy and favorable tolerance in heavily pretreated mCRPC patients after progression on docetaxel in the preliminary analyses. Additional randomized trials are warranted for this new regimen. Clinical trial information: ChiCTR2200061635."

Clinical • Metastases • P2 data • Anemia • Breast Cancer • Constipation • Dyspepsia • Fatigue • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hematological Disorders • Leukopenia • Metastatic Castration-Resistant Prostate Cancer • Musculoskeletal Pain • Oncology • Pain • Prostate Cancer • Solid Tumor

Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Min Yan, MD

Metastases • New P2 trial • Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

A genetically engineered epothilone analog as a novel oral microtubule inhibitor: A clinical study of utidelone capsule for advanced breast cancer. (ASCO 2024) - P1 | " This is an ongoing open-label, multi-center study (NCT05700084) consisting of three parts: dose escalation, bioavailability and food effect, and in combination with capecitabine for treatment of metastatic breast cancer. These preliminary results suggested promising efficacy with a manageable safety profile of UTD2 in pretreated metastatic breast cancer patients. This study is still actively enrolling; further data will be provided at the time of presentation. Clinical trial information: NCT05700084."

Clinical • Metastases • Anorexia • Breast Cancer • CNS Disorders • Insomnia • Oncology • Oral Cancer • Pain • Sleep Disorder • Solid Tumor