Phase II Clinical Trial on the Efficacy and Safety of Utidelone Combined with Bevacizumab in Patients with Non-small Cell Lung Cancer with Brain Metastases.

This study is a prospective, multicenter, two-stage phase II clinical trial evaluating the efficacy and safety of Utidelone combined with Bevacizumab in patients with non-small cell lung cancer with brain metastases.
The main objective of the first stage was to determine the combined dose of the first stage and the second stage, and to compare the intracranial efficacy of the two treatment groups. Secondary objectives were to compare other intracranial efficacy, systemic efficacy, safety and tolerability between the two treatment groups.In the second stage, the main purpose was to evaluate the intracranial efficacy of Utidelone combined with Bevacizumab in patients, and the secondary purpose was to evaluate the other intracranial efficacy, systemic efficacy, safety and tolerability of Utidelone combined with Bevacizumab in patients, and to explore the improvement of patients' quality of life.

Start Date01 Dec 2024

Sponsor / Collaborator

Beijing Biostar Pharmaceuticals Co. Ltd.

NCT06730581 / Not yet recruitingPhase 2

Phase II Clinical Trial of Utidelone Capsule in the Treatment of Advanced Solid Tumor Patients

This trial is an open, multicenter, phase II clinical trial to evaluate the efficacy and safety of Utidelone capsules in patients with advanced solid tumors. The target population of the study is patients with advanced solid tumors (gastric cancer, ovarian cancer, cholangiocarcinoma and other tumors (esophageal cancer, hepatocellular carcinoma, colorectal cancer, cervical cancer). The number of evaluable cases for tumor enrollment in gastric, ovarian, and bile duct cancers will be 20 cases each, and the total number of other tumors (including esophageal, liver, colorectal, and cervical cancers) will be no more than 40 cases. Patients who met the enrollment criteria received Utidelone capsule (UTD2) monotherapy.

Start Date01 Dec 2024

Sponsor / Collaborator

Beijing Biostar Pharmaceuticals Co. Ltd.

NCT06510465 / Not yet recruitingPhase 2IIT

Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA): A Multi-center, Prospective Study

This study is a prospective, multi-center, single-arm, two-cohort, exploratory study, aiming to explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in breast cancer patients.

Start Date01 Aug 2024

Sponsor / Collaborator

Shanghai Renji Hospital

100 Clinical Results associated with Utidelone

100 Translational Medicine associated with Utidelone

100 Patents (Medical) associated with Utidelone

112

Literatures (Medical) associated with Utidelone

01 Jan 2025·ANTI-CANCER DRUGS

Utidelone plus pembrolizumab as the fourth-line combination treatment in non-small cell lung cancer with EGFR mutation: a case report

Article

Author: Fang, Henghu ; Zhu, Qi ; Han, Qing ; Wu, Shanshan ; Guan, Gaowa ; Yang, Wei ; Li, Jingjiao ; Wen, Juyi ; Zhao, Rugang ; Zheng, Wei ; Lu, Zejun

Utidelone is an ebomycin derivative chemotherapeutic drug, which can promote tubulin polymerization and stabilize microtubule structure, so as to induce apoptosis. The drug is an innovative drug independently developed by China with independent intellectual property rights. Phase II clinical trials for advanced breast cancer are being approved by National Medical Products Administration for the treatment of advanced breast cancer. However, there is no report on the application in non-small cell lung cancer (NSCLC) patients with the epidermal growth factor receptor (EGFR) mutation. This case is a patient with EGFR mutant stage IV NSCLC who has progressed after third-line targeted therapy. The fourth line was treated with utidelone combined with pabolizumab. The patient had progressed after targeted therapy with oxitinib, ametinib, and vometinib. Due to the patient’s physical reasons, the traditional platinum drugs were not suitable, so the patient was treated with utidelone combined with pabolizumab. The curative effect was evaluated as SD after two cycles and progesterone receptor after four cycles. At present, it is still in the maintenance of reduction of utidelone combined with pabolizumab, and the tumor continues to shrink. 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.

01 Apr 2024·Cancer pathogenesis and therapy

Efficacy and safety of utidelone for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who have failed standard second-line treatment: A phase 2 clinical trial (BG01-1801)

Article

Author: Chen, Gongyan ; Zhao, Jing ; Shi, Yuankai ; Zhao, Yanqiu ; Lin, Lin

Background:

Chemotherapy remains the standard-of-care for many patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC), but acquired resistance presents challenges. The aim of this open-label, multicenter phase 2 clinical trial was to determine the efficacy and safety of utidelone, a novel genetically engineered epothilone analog and microtubule-stabilizing agent, as a third- or later-line treatment for locally advanced or metastatic NSCLC.

Methods:

Patients who had failed standard second-line treatment (including platinum-containing chemotherapy or targeted therapy) received utidelone (40 mg/m² via intravenous injection daily, day 1-5) every 21 days. The primary endpoint was the objective response rate (ORR). Secondary endpoints were the duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety.

Results:

From March 12, 2019 to January 18, 2021, 26 pretreated patients with locally advanced or metastatic NSCLC (100% of patients had received prior platinum and 65.4% patients had received prior taxane treatment) were enrolled (80.8% of patients had adenocarcinoma). At baseline, nine (34.6%) patients had received second-line treatment, 10 (38.5%) patients had received third-line treatment, and seven (26.9%) patients had received fourth- or later-line treatment. By the data cut-off date of August 10, 2021, the median follow-up was 7.49 months (range, 1.4-26.7 months). The ORR was 15.4% (95% confidence interval [CI], 4.4%-34.9%) in the intention-to-treat (ITT) cohort (N = 26) and 19.0% (95% CI, 5.4%-41.9%) in the per-protocol (PP) cohort (N = 21). The disease control rate was 69.2% (95% CI, 48.2%-85.7%) and 81.0% (95% CI, 58.1%-94.6%) in the ITT and PP cohorts, respectively. The median DoR was 4.1 months (95% CI, 3.1-5.1 months) in the ITT cohort. The median PFS was 4.37 months (95% CI, 2.50-5.29 months) in the ITT cohort and 4.37 months (95% CI, 2.50-9.76 months) in the PP cohort. The median OS was not reached, and the 12-month OS rate was 69% (95% CI, 45.1%-84.1%). Grade 3/4 treatment-emergent adverse events occurred in 38.5% of patients, and the most common was peripheral neuropathy (23.1%, all Grade 3), which was manageable with dose modifications.

Conclusions:

In this clinical trial, utidelone showed promising efficacy and had a manageable safety profile. Further clinical studies are warranted to confirm its role in NSCLC treatment.

Trial registration:

No.NCT03693547; https://classic.clinicaltrials.gov.

01 Dec 2023·Surgery open science

Efficacy and safety of utidelone plus capecitabine in advanced first-line therapy for metastatic breast cancer: A multicenter real-world study

Article

Author: Zheng, Kai ; Xun, Xueqiong ; Mao, Qing ; Zhang, Fan ; Zhou, Shaoqiang ; Zhao, Jiawen ; Tang, Shicong ; Wang, Xi ; Tang, Baoyan ; Wei, Shanrong ; Guo, Rong ; Li, Xiuqin ; Zhang, Ying ; Bi, Pingping ; Tan, Xin ; Liu, Rui

Background:

The purpose of this study was to compare the efficacy and safety of utidelone plus capecitabine for advanced first-line versus second-line or above therapy in metastatic breast cancer patients who had previously received anthracycline and taxane. At the same time, we compared the efficacy of utidelone plus capecitabine and vinorelbine plus cisplatin in advanced first-line treatment of metastatic breast cancer.

Patients and methods:

A retrospective cohort of 11 patients with metastatic breast cancer previously treated with anthracycline and taxane (including neoadjuvant and adjuvant therapies) for advanced first-line with utidelone plus capecitabine, 32 patients treated with second-line or above, and 60 patients with vinorelbine plus cisplatin between October 2011 and August 2022 was collected. The first and second groups were treated with utidelone plus capecitabine, and the third group was treated with vinorelbine plus cisplatin. The primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS), objective response rate (ORR), and treatment safety.

Results:

By 03/31/2023, median PFS reached 11.70 months (95 % CI 0.093-0.141) in utidelone plus capecitabine group in the advanced first-line therapy, compared to 5.60 months (95 % CI 0.025-0.079) in the second-line or above therapy [HR 0.42, (95 % CI 0.226-0.787), P = 0.0077]. In utidelone plus capecitabine, the median OS was not reached in the advanced first-line therapy, with a mean overall survival of 23.16 months (95 % CI 0.198-0.265); whereas the median OS in the second-line or above therapy was 19.50 months (95 % CI 0.083-0.307), with a mean overall survival of 16.89 months (95 % CI 0.136-0.202) [HR 0.26, (95 % CI 0.098-0.678), P = 0.0495]. The ORR for advanced first-line therapy was 27.27 % (95%CI 0.060, 0.610) compared with 15.63 % (95%CI 0.053, 0.328) for second-line or above. In advanced first-line therapy, utidelone plus capecitabine was superior to vinorelbine plus cisplatin with a median PFS of 6.12 months (95 % CI 0.051-0.072) [HR 0.49, (95 % CI 0.286-0.839), P = 0.0291]. Compared with utidelone plus capecitabine, the median OS in vinorelbine plus cisplatin advanced first-line therapy group was 35.37 months (95 % CI 0.258-0.449), and the mean overall survival was 40.79 months (95 % CI 0.315-0.501) [HR 0.54, (95 % CI 0.188-1.568), P = 0.2587]. The ORR for vinorelbine plus cisplatin was 18.33 % (95 % CI 0.095, 0.304). The most common adverse events in our study were neurological toxicity, hand-foot syndrome, hematological toxicity, gastrointestinal toxicity, and hepatic and renal function abnormalities. There were no deaths due to adverse effects during the utidelone plus capecitabine treatment period.

Conclusions:

In MBC, advanced first-line therapy with utidelone plus capecitabine resulted in more favorable PFS, OS, and ORR than second-line or above therapy. In advanced first-line therapy, utidelone plus capecitabine had superior PFS, and ORR compared with vinorelbine plus cisplatin. This study concludes that utidelone plus capecitabine is a more valuable chemotherapy option in advanced first-line MBC.

News (Medical) associated with Utidelone

03 Sep 2024

·www.prnewswire.com

Biostar Announces Completion of Patient Recruitment for US Phase 1 Clinical Study of Utidelone Capsule

SAN FRANCISCO, Sept. 3, 2024 /PRNewswire/ -- Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that subject recruitment of a US Phase 1 clinical study of Utidelone Capsule (UTD2), a company's key pipeline product, for advanced solid tumors (NCT05681000) has been completed. This study is an open-label, dose-escalation Phase 1 clinical study, and conducted in several institutions across the US including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, and the Washington University in St. Louis. The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT); the secondary objective is to evaluate the efficacy and pharmacokinetic profile of UTD2 monotherapy in patients with advanced solid tumors. Five dose cohorts were explored in this study. After confirming the DLT (diarrhea) in the highest dose cohort, 75mg/m2/day x 5 days was determined as MTD. A total of 18 patients with more than 10 different types of advanced solid tumors were enrolled. The median age was 63 years old, and 2/3 of the patients had received ≥ 3 lines of prior treatments. As of now, efficacy evaluations were completed in 12 patients, and 1 complete response (CR, ovarian cancer), 1 partial response (PR, ovarian cancer), and 8 stable disease (SD, prostate cancer, testicular cancer, non-small cell lung cancer, pancreatic cancer, appendix adenocarcinoma, soft tissue sarcoma, etc.) were obtained with a clinical benefit rate of 83%. The results further demonstrated the broad-spectrum anti-tumor property of Utidelone. As for treatment duration, more than half of these patients received ≥3 cycles of treatments, and the maximum duration of response reached 36 weeks. In terms of safety, most treatment-related adverse events (TRAEs) were grade 1-2, and the most frequently seen TRAEs (incidence ≥ 20%, including all grades) were diarrhea (55.6%), fatigue (33.3%), and neutropenia (22.2%), all of which were manageable. The preliminary results of this study were also presented at the 2024 ASCO meeting. Dr. Li Tang, Chairman of Biostar Pharma commented: "This is the first study of UTD2 that has completed enrollment globally. We successfully achieved the primary objectives and observed encouraging efficacy and safety profiles. We are very grateful for the joint engagement and dedication of our US clinical institutions and investigators. We are confident that this blockbuster product will substantially change the administration regimen of microtubule inhibitors. We will advance the following pipelines for UTD2 at full speed and hopefully bring it to the market to benefit global cancer patients as soon as possible". Biostar is actively carrying out clinical studies of UTD2 in China and abroad. A pivotal study in China for advanced breast cancer led by Professor Xu Binghe, Cancer Hospital of Chinese Academy of Medical Sciences, is in recruitment. The preliminary findings of this study were also presented at the ASCO meeting in 2024; the China Phase 2 study for advanced solid tumors including ovarian cancer and cholangiocarcinoma, etc. is in initiation. In addition, US FDA has granted an Orphan Drug Designation (ODD) to UTD2 for the treatment of advanced gastric cancer, and Biostar is preparing for IND filing of a Phase 2/3 multi-reginal clinical study (MRCT) led by Professor Ruihua Xu of Sun Yat-sen University Cancer Center in both China and US simultaneously. Utidelone is a new-generation genetically engineered microtubule inhibitor. Utidelone Injection (UTD1) has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC) progressed after at least one anthracycline- or taxane-containing chemotherapy regimen. The phase 3 study data showed that UTD1 is the only one to achieve both PFS and OS benefits for heavily pretreated MBC patients, and the results were twice orally presented at ASCO annual meetings. Utidelone has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, better safety profile with very low hematologic toxicity, effective against multidrug-resistant tumors with less prone to develop drug resistance, capability of crossing the blood-brain barrier so as to prevent and treat brain tumor, and high oral bioavailability. Multiple indication expansion clinical studies for UTD1 are also in progress in China and US, including but not limited to MRCT Phase 3 study for non-small-cell lung cancer (NSCLC), Phase 2 pivotal study for breast cancer brain metastasis in US and NSCLC brain metastasis in China, and Phase 3 study for breast cancer neoadjuvant in China. Compared to taxanes, which are difficult for oral formulation development, Utidelone is not susceptible to P-glycoprotein thus cannot be pumped out of the cancer cell by P-glycoprotein and has the advantage for higher oral bioavailability. By utilizing its synthetic biology technology platform, Biostar developed Utidelone Capsule, and its efficacy and safety have been confirmed in both US and China's studies. Utidelone Capsule will significantly improve the convenience of administration, compliance of patients, decrease in treatment cost and ease of combination therapy with other oral anti-cancer drugs, meaning more suitable for adjuvant and maintenance therapy. About Beijing Biostar Pharmaceuticals Co., Ltd. Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the development of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at [email protected] on partnering with us. SOURCE Beijing Biostar Pharmaceuticals Co., Ltd.

Phase 1Clinical ResultPhase 3Orphan DrugPhase 2

05 Jul 2024

·www.biospace.com

Biostar Pharma Announces FDA Clearance of the IND Application for a Phase 2 Study of Utidelone Injection (UTD1) in HER2- Breast Cancer Brain Metastasis

SAN FRANCISCO, July 5, 2024 /PRNewswire/ -- Biostar Pharma, Inc., the U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. (Biostar), which is a synthetic biology-driven biopharma company focusing on the development and commercialization of innovative oncology drugs, 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. Depending on the molecular classification of breast cancer, approximately 20~50% of metastatic breast cancer patients develop brain metastases.[1] The current standard of care for BCBM is primarily local treatment with surgery and radiation therapy, supplemented by drug therapy. Due to blood-brain barrier (BBB) and blood-tumor barrier (BTB), many drugs that are effective for extracranial metastasis of breast cancer have very limited intracranial permeability, leading to poor prognosis for BCBM patients, especially with HER2- BCBM.[2-3] The mPFS for HR+/HER2- BCBM is about 4-6 months,[4-8] while the mFPS for TNBC brain metastasis is only 2.8 months.[9] In recent years, multiple small-molecule TKIs and ADC drugs have brought survival benefits to HER2+ BCBM patients. However, there is still a lack of drug treatment regimens with proven efficacy for HER2- BCBM, and no drug has been approved for HER2- BCBM worldwide, suggesting a significant unmet medical need. Utidelone can penetrate BBB due to its unique physicochemical characteristics and insusceptibility to P-glycoprotein-mediated efflux, which has been confirmed by preclinical drug tissue distribution studies and several clinical trials. A phase 2 study of utidelone in combination with bevacizumab for the treatment of HER2- BCBM presented at the ASCO 2024 demonstrated efficacy outcomes of 42.6% of CNS-ORR, 7.7 months of mPFS, and 74.4% of 12-month OS rate with total 47 eligible patients being enrolled. The efficacy was even better in HR-/HER2- subgroup, showing 55% of CNS-ORR and 8.4 months of mPFS. The safety was manageable with majority of the AEs being Grade 1~2, suggesting a promising efficacy and manageable safety pro utidelone for HER2- BCBM, and the potential of utidelone to become a new treatment option in the space. Utidelone has been granted an "orphan drug designation" by the US FDA for the treatment of BCBM in Mar 2024. Biostar then filed an IND application for this phase 2 study for HER2- BCBM. The US FDA clearance of the application marks an important milestone of Biostar's globalization development strategy. About BG01-2402 Study BG01-2402 study refers to "A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with Brain Metastases". 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. The primary endpoint is CNS-ORR; the secondary endpoints include PFS, DOR and OS, etc. About Beijing Biostar Pharmaceuticals Co., Ltd. Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the development of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at bd@biostar-pharma.com on partnering with us. View original content: SOURCE Biostar Pharma, Inc.

Phase 2Clinical ResultOrphan DrugIND

29 May 2024

·www.prnewswire.com

Sixteen Researchers from Florida Cancer Specialists & Research Institute Share Cancer Care Discoveries at 2024 ASCO® Annual Meeting

37 Cutting-Edge Study Results Presented at Global Gathering, Six Oral Presentations.2024 ASCO Annual Meeting abstracts featuring FCS research: 1015, 1051, 1056, 1105, 1594, 1631, 2521, 2582, 2588, 2599, 2618, 3074, 3597, 4046, 4136, 5554, 5607, 6014, 8521, 8556, 8585, 9010, 9051, 449374, e14587, e15014, e23059, LBA8500, TPS1128, TPS3160, TPS3165, TPS3166, TPS3173, TPS3178, TPS4607, TPS5637 FORT MYERS, Fla., May 29, 2024 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) physicians will present findings from multiple clinical studies that are contributing to global advancements in cancer care at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting in Chicago. Clinical research originating from trials conducted at the three FCS Phase 1 Drug Development Units and late-phase studies at FCS clinics throughout Florida are among those being published or presented during the five-day international gathering of oncology physicians and professionals. Continue Reading Florida Cancer Specialists & Research Institute research featured in 37 presentations/publications at 2024 ASCO. Post this 16 researchers from Florida Cancer Specialists & Research Institute will be featured in 37 abstracts and presentations during the 2024 ASCO Annual Meeting in Chicago. "It is gratifying to see how FCS continues to expand the understanding of cancer worldwide," said FCS President & Managing Physician Lucio N. Gordan, MD. "Our clinical research efforts are patient centric. Each discovery enables us to target treatments with greater precision and impact for patients." Manish Patel, MD, FCS director of drug development, notes that much of the clinical research being presented is focused on targeted treatments and biological combinations. Dr. Patel said, "The phase 1/2 trials offered at FCS provide patients early access to the most promising therapies and consistently lead to expedited FDA approvals that expand availability on a global scale." Several FCS principal investigators are first authors of four abstracts that will be presented throughout the meeting: Manish Patel, MD Preliminary results from a phase 1 study of AC699, an orally bioavailable chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer Safety and preliminary efficacy of EIK1001 in combination with atezolizumab in participants with advanced solid tumors. Dr. Patel is a co-author of eight additional presentations Judy Wang, MD, FCS associate director of drug development Phase 1/2 study of NGM707, an ILT2/ILT4 dual antagonist antibody, in advanced solid tumors: Interim results from dose-escalation. She also is first author of the published abstract, A novel oral microtubule inhibitor utidelone capsule (UTD2): A phase 1 clinical study to assess the tolerability, safety, and efficacy in advanced solid tumors, of which Dr. Manish Patel is a co-author. Dr. Wang is also a co-author of six additional presentations Maen Hussein, MD – NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Updated overall survival analysis with 29-month follow-up of NAPOLI 3. FCS hematologist and medical oncologist Cesar Augusto Perez, MD will present an oral education session titled, "Emerging Data for Antibody Drug Conjugates in Head and Neck Squamous Cell Carcinoma." The following FCS principal investigators will have their abstracts presented during oral presentations of research results and other clinical findings which they have co-authored: Kapisthalam Kumar, MD, FACP – Are we bridging the gap? A ten-year probe into NIH grants for early-career and independent investigators in oncology. Manish Patel, MD – Safety and preliminary efficacy of EIK1001 in combination with pembrolizumab in participants with advanced solid tumors Vipul Patel, MD – Primary results from the phase 3 EVOKE-01 study of sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO). Cesar Augusto Perez, MD, Amir Harandi, MD, MS – Phase 2 study of petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC) Cesar Augusto Perez, MD – Updated phase 1 results of efficacy and safety of sigvotatug vedotin, an investigational ADC, in non-small cell lung cancer FCS Associate Director of Drug Development Judy Wang, MD, Gail Lynn Shaw Wright, MD, FACP, FCCP, Fadi Kayali, MD -- H3B-6545 in women with locally advanced/metastatic estrogen receptor-positive (ER+), HER2 negative (–) breast cancer (BC). "We're winning. We're beating cancer," said Bradley Monk, MD, gynecologic oncologist and FCS medical director of late-phase clinical research. "Our discoveries through clinical trials are helping patients live longer and better lives." Dr. Monk is co-author of four presentations at ASCO, including the results of the international phase 3 OUTBACK trial of racial disparities and survival outcome of patients with locally advanced cervix cancer. Results from additional FCS co-authors will also be presented in various sessions, 26 in total, highlighting a variety of cancer types and treatment modalities: Faithlore Gardner, MD Todd Gersten, MD Lucio N. Gordan, MD with FCS Senior Director of Partnerships, Managed Care Kiana Mehring Joel Grossman, MD Elizabeth Guancial, MD "Our commitment to oncology research is stronger than ever and clearly demonstrated by sheer volume of abstracts presented by FCS researchers at this global symposium," stated FCS Chief Executive Officer Nathan H. Walcker. "The insights and breakthroughs revealed here fortify our resolve to tirelessly innovate and improve outcomes for patients worldwide." FCS will be featured in 37 presentations and publications over the course of the conference. All abstracts and presentations are available to view at ASCO® 2024 Annual Meeting. The American Society of Clinical Oncology (ASCO®) represents nearly 50,000 physicians and oncology professionals representing 150 countries who care for people living with all forms of cancer. ASCO® works to conquer cancer through research, education, policy and promotion of high quality and equitable patient care. View a full list of the FCS abstracts presented here: FLCancer.com/FCS-2024-ASCO-Presentations-052924.pdf About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report. Celebrating its 40th year in 2024, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff. *Prior to approval SOURCE Florida Cancer Specialists & Research Institute

ASCOPhase 1Clinical ResultPhase 2Phase 3

100 Deals associated with Utidelone

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01	DB01873

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Breast cancer recurrent	CN	Chengdu Biostar Pharmaceuticals Ltd.	11 Mar 2021
Metastatic breast cancer	CN	Chengdu Biostar Pharmaceuticals Ltd.	11 Mar 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	CN	Beijing Biostar Pharmaceuticals Co. Ltd.	12 May 2023
HER2-negative breast cancer	Phase 3	CN	Sun Yat-Sen University	01 Mar 2022
Locally advanced breast cancer	Phase 3	CN	Chengdu Biostar Pharmaceuticals Ltd.	01 Mar 2022
Locally advanced breast cancer	Phase 3	CN	Sun Yat-Sen University	01 Mar 2022
Metastatic gastric adenocarcinoma	Phase 2	-	Beijing Biostar Pharmaceuticals Co. Ltd.	01 Dec 2024
Non-Small Cell Lung Cancer	Phase 2	-	Beijing Biostar Pharmaceuticals Co. Ltd.	01 Dec 2024
Advanced gastric carcinoma	Phase 2	CN	Beijing Biostar Pharmaceuticals Co. Ltd.	14 Nov 2024
Bile Duct Neoplasms	Phase 2	CN	Beijing Biostar Pharmaceuticals Co. Ltd.	14 Nov 2024
Esophageal Carcinoma	Phase 2	CN	Beijing Biostar Pharmaceuticals Co. Ltd.	14 Nov 2024
Liver Cancer	Phase 2	CN	Beijing Biostar Pharmaceuticals Co. Ltd.	14 Nov 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05700084 (ASCO2024)	Phase 1	Advanced breast cancer	5	Utidelone Capsule 50 mg/m2/d-5day	nrqqvkkkgh(nsslmltveo) = jfjcjgwpqt hzrtxfidds (vrfmttxafo )	Positive	24 May 2024
NCT05700084 (ASCO2024)	Phase 1	Advanced breast cancer	5	Utidelone Capsule 75 mg/m2/d-5day	nrqqvkkkgh(nsslmltveo) = fnthhsfzgi hzrtxfidds (vrfmttxafo ) View more	Positive	24 May 2024
NCT05357417 (U-BOMB, ASCO2024)	Phase 2	Brain metastases HER2-negative	46	Utidelone plus bevacizumab	qvwgpngzir(udbmwygxsk) = jhzcvyxdck piyqafgwcx (misbnqpsmn, 28.9% - 58.9) View more	Positive	24 May 2024
NCT04911907 (ASCO2024)	Phase 2	Advanced Malignant Solid Neoplasm \| Advanced gastric carcinoma First line HER2 negative	79	Utidelone plus sintilimab and oxaliplatin	ssgmjjhhvp(fxyemgttvv) = Grade 3/4 TRAEs occurred in 27.8% of pts in stage I, and included anemia (13.9%), peripheral neuropathy (11.4%) and neutropenia (7.6%). No treatment-related deaths occurred. Gastric cancer was chosen as the expansion cohort indication. As of February 1st2024, 14 eligible pts with GC with a median age of 57 years (range, 41-69) were enrolled. The median follow-up was 5.5 months (range, 1.0-9.7) and the longest duration of response was 8.0 months. A total of 8 PRs and 3 SDs were achieved in the 11 pts evaluable for efficacy, and 6 pts including the 3 with SD were still receiving treatment. Grade 3/4 TRAEs occurred in 28.6% of pts including diarrhea (14.3%), fatigue (14.3%), neutropenia (14.3%), and vomiting (7.1%). Other AEs were all Grade 1 or 2, with no treatment-related deaths. mygcpkgvcd (tjtpvcixtm ) View more	Positive	24 May 2024
NCT03693547 (BG01-1801, Pubmed) Manual	Phase 2	metastatic non-small cell lung cancer \| Locally Advanced Lung Non-Small Cell Carcinoma	26	Utideloneutidelone	essbowzivm(ipgqnnemxg) = teitfojvoj nrdacxlfrm (uqpkmvrkqs, 4.4 - 34.9) View more	Positive	01 Apr 2024
NCT03693547 (BG01-1801, Pubmed) Manual	Phase 2		26	at least two cycles of utidelone (PP cohort)utidelone (PP cohort)	essbowzivm(ipgqnnemxg) = wepjsgymkk nrdacxlfrm (uqpkmvrkqs, 5.4 - 41.9) View more	Positive	01 Apr 2024
ESMO_ASIA2023	Not Applicable	Metastatic Solid Tumor	50	Utidelone	nzcvydgqou(gmotenvmhd) = axcwayqfcx cetfklkoub (voketvfdid ) View more	Positive	02 Dec 2023
ChiCTR2200062161 (HX-SARC02, ESMO 12023 \| ESMO 22023) Manual	Phase 2	Soft Tissue Sarcoma	10	Utidelone	clvfvimony(wmxpjvkgff) = byjucoswtj jswottwpql (xsovcvltax ) View more	Positive	23 Oct 2023
IPU (ESMO 12023 \| ESMO 22023) Manual	Phase 2	HER2 Positive Breast Cancer First line \| Second line HER2 positive	29	Inetetamab+ pyrotinib+utidelone	krkilnfcdp(whiiuqmfqg) = adcztyieee onptnfctmj (qboaxgljni ) View more	Positive	21 Oct 2023
NCT04681287 (ASCO2022) Manual	Phase 2	Advanced HER2-Positive Breast Carcinoma HER2 Positive	20	utidelone+camrelizumab+inetetamab	pqhimajiqw(wirohnyyou) = chlosyaecy cvntvunmuf (oheidtwfdt ) View more	Positive	02 Jun 2022
NCT03693547 (ESMO_ELCC2022)	Phase 2	Advanced Lung Non-Small Cell Carcinoma Second line	26	Utidelone	uscvspnrhd(hiuvonbmrp) = mmtpdtadur clktyzegug (lamqsevepj, 4.4 - 34.9) View more	-	03 Apr 2022
ASCO2006	Phase 1	Neoplasms	13	KOS-862 (Epothilone D)	ibtpqkhfle(fqmtngsnor) = kalevvjdaz mvoyecodji (keednqequf )	-	20 Jun 2006

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