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Last update 07 Jun 2025

Bevacizumab

Last update 07 Jun 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Bevacizumab(Genetical Recombination), rhuMAb-VEGF, 贝伐单抗

+ [17]

Target

VEGF-A

Action

inhibitors

Mechanism

VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors), Angiogenesis inhibitors

Therapeutic Areas

NeoplasmsNervous System DiseasesDigestive System Disorders+ [11]

Active Indication

Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaRecurrent Glioblastoma+ [223]

Inactive Indication

Acidemia, IsovalericAcute Basophilic LeukemiaAcute Eosinophilic Leukemia+ [279]

Originator Organization

Genentech, Inc.

Active Organization

Roche Pharma AGHoffmann-La Roche, Inc.Replimune, Inc.

+ [29]

Inactive Organization

Eli Lilly & Co.

Eastern Cooperative Oncology Group

Alliance Foundation Trials LLC

+ [50]

License Organization

Roche Korea Co., Ltd.

Immune-Onc Therapeutics, Inc.

Roche Holding AG

+ [5]

Drug Highest PhaseApproved

First Approval Date

United States (26 Feb 2004),

Colonic CancerRectal Cancer

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States)

Structure/Sequence

Sequence Code 41632H

Source: *****

Sequence Code 41637L

Source: *****

3,179

Clinical Trials associated with Bevacizumab

NCT06543576

/ Not yet recruitingPhase 1/2IIT

A Prospective Cohort Study of Integrating Radiotherapy Into Chemotherapy With Pembrolizumab and Bevacizumab in Newly Diagnosed Stage IVB Cervical Cancer

This phase I/II trial tests the safety and effectiveness of receiving external beam radiation therapy (EBRT) and brachytherapy along with chemotherapy, consisting of cisplatin and paclitaxel, and immunotherapy, consisting of bevacizumab and pembrolizumab, for the treatment of patients with stage IVB cervical cancer. EBRT is type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving EBRT and brachytherapy along with chemotherapy and immunotherapy may be a safe and effective way to treat patients with stage IVB cervical cancer.

Start Date31 Jan 2026

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

[+1]

NCT06696768

/ RecruitingPhase 1IIT

Phase I Clinical Trial of CA-4948 (Emavusertib) in Combination With FOLFOX Plus Bevacizumab as Frontline Treatment in Patients With Metastatic Colorectal Cancer

This phase I trial studies the side effects and best dose of CA-4948 when given together with fluorouracil, leucovorin, oxaliplatin (FOLFOX) plus bevacizumab in treating patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). CA-4948 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The chemotherapy drugs used in FOLOX, fluorouracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin is used with fluorouracil to treat colorectal cancer. Bevacizumab is in a class of medications called anti-angiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of the tumor. Giving CA-4948 with FOLFOX plus bevacizumab may be safe, tolerable and/or effective in treating patients with metastatic colorectal cancer.

Start Date23 Jan 2026

Sponsor / Collaborator

National Cancer Institute

NCT05375708

/ SuspendedPhase 2IIT

A Multicenter Phase II Randomized Trial to Evaluate Systemic Therapy Versus Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer

A small number of colorectal cancer patients with limited oligometastases may be candidates for local treatment of metastases (e.g., resection, ablation). However, it is unclear if patients with more extensive metastatic disease benefit from local therapies to control visible metastasis.
The purpose of this study is to assess the impact of stereotactic body radiation therapy (SBRT) in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with metastatic colorectal cancer (mCRC) and ≤10 metastases.

Start Date01 Dec 2025

Sponsor / Collaborator

University Medical Center of Utrecht

100 Clinical Results associated with Bevacizumab

100 Translational Medicine associated with Bevacizumab

100 Patents (Medical) associated with Bevacizumab

23,219

Literatures (Medical) associated with Bevacizumab

01 Apr 2026·DEN open

Long‐term results of palliative placement of very low‐axial force self‐expandable metallic stents for malignant colorectal obstruction

Article

Author: Moroi, Rintaro ; Kuwai, Toshio ; Yoshida, Shuntaro ; Enomoto, Toshiyuki ; Tomita, Masafumi ; Kyo, Rika ; Shiratori, Toshiyasu ; Saida, Yoshihisa ; Matsuzawa, Takeaki ; Isayama, Hiroyuki ; Sumida, Yorinobu ; Yamada, Tomonori ; Sasaki, Takashi

Abstract:

Objectives:

Stent placement is a standard option for palliative decompression in patients with malignant colorectal obstruction. Long‐term stent placement is associated with perforation, migration, and stent occlusion. Perforation is associated with life expectancy. Several studies have shown that stents with a high axial force (AF), which is defined as the force required to maintain the stent straight after it has bent, are associated with a higher perforation rate. Therefore, we evaluated the long‐term outcomes of using a very low AF stent (Niti‐S Enteral Colonic Uncovered stent D‐type) for palliative purposes.

Methods:

Eighty‐one consecutive patients with malignant colorectal obstruction in 33 medical institutions were evaluated. A stent with very low AF was placed using an endoscope system. We evaluated the adverse events (including perforation, migration, and stent occlusion), 1‐year survival rate, and cumulative patency rate. Univariate analysis was conducted using Fisher's exact test. The overall survival and cumulative patency rates were assessed using the Kaplan–Meier method.

Results:

The 1‐year cumulative survival rate was 37.8% after stent placement. The 3‐month, 6‐month, and 1‐year cumulative patency rates after stenting were 93.6%, 84.2%, and 75.8%, respectively. The major adverse events included stent migration (6.2%), stent occlusion (9.9%), and perforation (2.5%). Chemotherapy was administered in 26 cases (32.1%) after stenting, and bevacizumab was administered in five cases. However, no cases of perforation occurred following bevacizumab administration.

Conclusions:

Our results suggest that very low AF stents are safe and effective. Therefore, they may be a suitable option for applications, such as palliation. (UMIN 000011304)

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of regorafenib dose optimization for refractory metastatic colorectal cancer

Article

Author: Appukkuttan, Sreevalsa ; Cho, Sang Kyu ; Barzi, Afsaneh ; Grossman, Jamie ; Lee, Woojung ; Babajanyan, Svetlana ; Hocum, Brian ; Marian, Marisca ; Yang, Min ; Bekaii-Saab, Tanios

BACKGROUND:

New regimens have emerged as third-line or later therapies for metastatic colorectal cancer (mCRC), including regorafenib dose optimization (ReDO), trifluridine/tipiracil and bevacizumab (TAS-BEV) combination therapy, and fruquintinib. We evaluated relative cost-effectiveness of these therapies in patients with mCRC from a US payer's perspective.

MATERIALS AND METHODS:

A partitioned survival model (PSM) was constructed to estimate total costs and quality-adjusted life years (QALYs). Clinical parameters were obtained from pivotal trials of the respective therapies and incremental cost-effectiveness ratios (ICERs) were estimated to assess relative cost-effectiveness of these treatments. Model robustness was assessed using deterministic (DSA) and probabilistic sensitivity analysis (PSA). Three scenario analyses were conducted: (1) assuming equal efficacy across treatments, (2) with prior exposure to anti-vascular endothelial growth factor (VEGF) therapy, and (3) alternative clinical inputs for fruquintinib from a different clinical trial.

RESULTS:

Under the conventional willingness-to-pay (WTP) threshold in US ($150,000 per QALY gained), ReDO was cost-effective when compared with TAS-BEV and was dominant over fruquintinib. TAS-BEV was associated with an incremental QALY of 0.197 over ReDO, resulting in an ICER at $554,567 per QALY gained. The base case results were robust in DSA and PSA. Most influential parameters were treatment cost and effectiveness. In patients with prior anti-VEGF therapy, ReDO remained cost-effective compared to TAS-BEV and fruquintinib under the conventional WTP threshold.

LIMITATION:

Differences in trial populations may affect the comparability of the outcomes. Sensitivity and scenario analyses were conducted to address these limitations.

CONCLUSION:

ReDO was cost-effective compared with TAS-BEV from the US payer's perspective despite a higher QALY gain associated with TAS-BEV. ReDO was dominant over fruquintinib, consistently having a higher QALY gain and lower cost.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare

Article

Author: Bernauer, Mark ; Roth, Joshua A. ; Dorman, Stephanie ; Kratochvil, David

BACKGROUND:

Biosimilars to originator bevacizumab (Avastin), such as bevacizumab-bvzr (Zirabev), can deliver substantial savings and/or expanded access to biologic therapy for patients with metastatic colorectal (mCRC) and non-squamous non-small cell lung cancer (mNSCLC). The objective of this study is to explore the cost-efficiency and budget-neutral expanded access of bevacizumab-bvzr in mCRC and mNSCLC in Medicare.

METHODS:

We developed a Medicare payer perspective simulation model of patients treated for mCRC and mNSCLC to estimate cost-savings from converting bevacizumab (originator) to bevacizumab-bvzr or alternative biosimilars such as bevacizumab-awwb, -maly, and -abcd. The target patient population receiving annual first-line systemic therapy was calculated using Medicare enrollment data, SEER cancer incidence rates in patients age ≥65, and an assumption that 39.3% and 77.2% of new diagnoses receive systemic therapy for mCRC and mNSCLC respectively based on recent evidence. 76.0% of systemically treated mCRC patients and 11.4% of incident mNSCLC patients were expected to be treated with bevacizumab-based regimens based on recent evidence. Costs were derived from the 2024 Average Sales Price (ASP). Results include per-patient per-month (PPPM) cost savings (vs. originator), total monthly savings in the cohort, and number needed to convert (NNC) to biosimilar to fund the treatment of an additional 100 patients.

RESULTS:

PPPM savings from conversion to bevacizumab-bvzr were $4,205 in mCRC and $8,410 in mNSCLC. In 100% conversion scenarios, full cohort monthly savings were $27,664,432 in mCRC (n = 6,579) and $32,319,323 in mNSCLC (n = 3,843), respectively. At 100% conversion, monthly savings from biosimilar conversion could fund up to 13,887 additional mCRC patient-months of treatment with bevacizumab-bvzr + FOLFOX, and up to 8,959 additional mNSCLC patient-months of treatment with bevacizumab-bvzr + paclitaxel + carboplatin. In mCRC and mNSCLC the biosimilar NNC from the originator was 47 and 43, respectively. The biosimilar NNC from other biosimilars ranged from 60-4,564 and 55-4,422 for mCRC and NSCLC, respectively.

CONCLUSION:

In the first cost-efficiency and expanded access study of biosimilar bevacizumab in mCRC and mNSCLC, we find that bevacizumab-bvzr-based regimens can result in substantial cost savings relative to originator-based first line treatment in Medicare. These cost savings could be reinvested to treat a substantial number of additional patients with mCRC or mNSCLC, or fund other costs of care in Medicare, on a budget-neutral basis.

1,239

News (Medical) associated with Bevacizumab

05 Jun 2025

·www.globenewswire.com

Tempest Receives Orphan Drug Designation from the European Medicines Agency for Amezalpat for the Treatment of Patients with HCC

EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, underscoring the urgent need for new treatment optionsThe multiple regulatory designations were granted following strong positive results from a global randomized Phase 1b/2 study in first-line HCC demonstrating superior outcomes for amezalpat combination therapy across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to standard of care alone BRISBANE, Calif., June 05, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with hepatocellular carcinoma (HCC). “We’re incredibly pleased to receive Orphan Drug Designation from the EMA, building on the momentum of regulatory support we've already received from the FDA,” said Stephen Brady, president and chief executive officer of Tempest. “These designations reflect the significant unmet need in liver cancer and reinforce our belief in the potential of amezalpat to make a meaningful difference for patients and families affected by this devastating disease.” The company announced earlier this year that the FDA had granted both ODD and Fast Track Designation (FTD) to amezalpat to treat patients with HCC. These three designations follow positive data across multiple key study efficacy and safety endpoints from a global, randomized Phase 1b/2 clinical study evaluating amezalpat plus standard-of-care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic HCC. Notable positive outcomes of the randomized comparison include a six-month improvement in median overall survival (OS) with a hazard ratio (HR) of 0.65 for patients receiving the amezalpat combination therapy. In addition, a survival benefit from patients receiving amezalpat was preserved in key sub-populations including PD-L1 negative disease, which is consistent with amezalpat’s proposed mechanism of action to target both the tumor cells directly and the patient’s immune system. About Hepatocellular Carcinoma HCC is an aggressive cancer with rising mortality and is projected to become the third leading cause of cancer death by 2030.2 Every year, more than 900,000 people worldwide are diagnosed with HCC.3 Incidence and mortality are highest in East Asia and are increasing in parts of Europe and the US.4 In the US, HCC represents the fastest-rising cause of cancer-related death.3 Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD) and cirrhosis resulting from these conditions.5 Even if diagnosed in the early stage, an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery.6 Early recurrence is associated with poorer prognosis and shorter survival.5,7 Tumor size, number of tumors, and portal vein invasion are associated with an increased risk of recurrence.6 About Amezalpat Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Data suggest that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In a global randomized Phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, the amezalpat arm showed clinical superiority across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to atezolizumab and bevacizumab alone, the standard of care. These randomized data were supported by additional positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors, including renal cell carcinoma and cholangiocarcinoma. About Orphan Drug Designation Orphan Designation is granted to therapies intended for the treatment, prevention, or diagnosis of life-threatening or chronically debilitating diseases that affect no more than two in 10,000 people in the European Union (EU) and for which no satisfactory therapy is available. The treatment must also provide significant benefit to those affected by the condition. EMA orphan drug designation provides certain benefits, including the potential for 10 years of market exclusivity following regulatory approval in the EU, reduction in regulatory fees and a centralized EU approval process.8 About Tempest Therapeutics Tempest Therapeutics is a clinical-stage biotechnology company advancing a diverse portfolio of small molecule product candidates containing tumor-targeted and/or immune-mediated mechanisms with the potential to treat a wide range of tumors. The company’s novel programs range from early research to later-stage investigation in a randomized global study in first-line cancer patients. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at www.tempesttx.com. Investor & Media Contacts: Sylvia WheelerWheelhouse Life Science Advisorsswheeler@wheelhouselsa.com Aljanae Reynolds Wheelhouse Life Science Advisorsareynolds@wheelhouselsa.com ___________________1 If approved by the FDA2 Rahib, L. et al. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 74, 2913-2921 (2014).3 World Health Organization. Liver Cancer Factsheet. Globocan. 2020. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf. Last accessed: April 2023.4 Llovet, J. M., Kelley, R. K., Villanueva, A., et al. Hepatocellular carcinoma. Nature Reviews Disease Primers. 2021, 7(1), 6.5 Office for Health Improvement & Disparities. Liver disease profiles: November 2021 update. Available at: https://www.gov.uk/government/statistics/liver-disease-profiles-november-2021-update/liver-disease-profiles-november-2021-update. Last accessed: April 2023.6 Hack SP, Spahn J, Chen M et al. IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation. Future Oncology. 2020 May;16(15):975-989.7 Saito A, Toyoda H, Kobayashi M et al. Prediction of early recurrence of hepatocellular carcinoma after resection using digital pathology images assessed by machine learning. Modern Pathology. 2021. 34, 417-425.8 European Medicines Agency, "Orphan Designation." https://www.ema.europa.eu/en/human-regulatory-overview/orphan-designation-overview

Orphan DrugClinical ResultFast TrackPhase 3Phase 1

05 Jun 2025

·www.prnewswire.com

Akeso's PD-1/CTLA-4 Bispecific Antibody Cadonilimab Approved for First-Line Treatment of Cervical Cancer in All-Comer Populations--Third Approved Indication for Cadonilimab

HONG KONG, June 4, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has approved the company's first- in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer, in combination with platinum-based chemotherapy, with or without bevacizumab. The NMPA approval marks the third approved indication for cadonilimab. With the approval for first-line cervical cancer, cadonilimab has achieved comprehensive coverage for the treatment of advanced cervical cancer, offering an innovative treatment option for patients across all stages of advanced cervical cancer. This approval addresses the critical unmet need for immune-based therapies for first-line cervical cancer patients in China and represents a significant step forward in the treatment of this disease. In addition to the treatment for first-line cervical cancer, cadonilimab is also approved for first-line treatment of advanced gastric cancer, and for the treatment of relapsed or metastatic cervical cancer who progressed on or after platinum-based chemotherapy. The approval for cadonilimab's use in combination with chemotherapy (with or without bevacizumab) in first-line cervical cancer is based on the clinical data from the Phase III COMPASSION-16 (AK104-303) study. In COMPASSION-16, the cadonilimab combination regimen showed a notable efficacy benefit in patients with tumors that have a negative PD-L1 expression (CPS <1), comprising 27.9% of the population in the treatment group, compared to 24.2% in the control group. The study met both progression-free survival (PFS) and overall survival (OS) endpoints, demonstrating significant improvements in both endpoints for patients treated with the cadonilimab regimen compared to standard therapies in the first-line setting for cervical cancer. Subgroup analyses from COMPASSION-16 study indicated that both PD-L1-positive and PD-L1-negative populations, regardless of bevacizumab inclusion, benefited from the treatment. The results of the COMPASSION-16 trial were presented as a Late-Breaking Abstract (LBA) at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting, and were subsequently published in The Lancet and later reported again in Nature Reviews Clinical Oncology. Cervical cancer remains one of the most prevalent and deadly cancers among women, with a 5-year survival rate of approximately 17.0% for patients in the advanced stages. In 2022, China reported 150,700 new cervical cancer cases, resulting in the second-largest burden of cervical cancer worldwide. Professor Wu Xiaohua, the principal investigator of COMPASSION-16 and a professor at the Fudan University Shanghai Cancer Center, stated, "COMPASSION-16 is the first Phase III study focused on first-line cervical cancer patients in China, with internationally recognized data. We've seen cadonilimab's breakthrough efficacy in both recurrent and metastatic cervical cancer, showing high effectiveness, low toxicity, and strong anti-tumor activity regardless of PD-L1 expression. This first-line combination therapy sets a new standard in cancer treatment and is expected to accelerate the clinical adoption of cadonilimab, benefiting more patients." Dr. Xia Yu, founder, chairwoman, president, and CEO of Akeso, commented, "Cadonilimab has demonstrated significant survival benefit for cervical cancer patients across all-comer populations in both clinical trials and real-world settings. For patients who respond to PD-1/L1 monotherapy, cadonilimab offers superior therapeutic outcomes over PD-1/PD-L1 therapies. For patients with low PD-L1 expression or those who are resistant to PD-1 monotherapy, cadonilimab provides significant clinical benefits over current treatment options. Cadonilimab takes advantage of the synergistic anti-tumor effect of two immune checkpoint targets, PD-1 and CTLA-4, while producing a meaningfully lower immune side effects than the combination of PD-1 and CTLA-4 antibody therapies. This approval represents another advancement of immunotherapy 2.0 in cervical cancer therapy, offering clinically meaningful improvements in disease treatment and in patient quality of life. This achievement reflects Akeso's robust innovation capabilities and commitment to cancer patient outcomes, and it also aligns with our corporate vision to become a global leader in developing next-generation therapeutic antibodies for patients worldwide. " Currently, cadonilimab is included in 16 authoritative clinical treatment guidelines and consensus documents across multiple oncology indications, including gastric cancer, gynecological cancers, liver cancer, esophageal cancer, and nasopharyngeal cancer. Beyond the three approved indications, cadonilimab is also currently in over 30 Phase II and III clinical trials for other cancer types, which includes different stages of disease progression as well as different cancer sub-types. These include clinical studies on gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. ( 9926.HK, "Akeso") contains "forward-looking statements" . These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalClinical ResultImmunotherapyPhase 2

04 Jun 2025

·firstwordpharma.com

Ascletis' Sagimet-sourced oral FASN inhibitor hits all goals in pivotal acne study

Ascletis Pharma on Tuesday said its oral FASN inhibitor denifanstat — in-licensed from Sagiment Biosciences for Greater China rights — met all primary and secondary endpoints in a Phase III study for the treatment of moderate-to-severe acne vulgaris, paving the way for a marketing application in the country. The trial randomised 480 patients in China to receive either denifanstat once daily or placebo for 12 weeks. For the primary endpoint of treatment success — defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from baseline at week 12 — the denifanstat group demonstrated a statistically significant 33.2% success rate over the placebo group’s 14.6%.Additional primary goals further corroborated denifanstat's efficacy versus placebo: reduction in total lesion count (57.4% vs 35.4%) and reduction in inflammatory lesion count (63.5% vs 43.2%). Moreover, a key secondary endpoint showed a significant 51.9% reduction in non-inflammatory lesion count for denifanstat versus 28.9% for placebo.“Denifanstat…demonstrated impressive efficacy beyond treatment success," said Jinzi Jason Wu, chief executive of Ascletis, adding that the drug will "soon" be submitted to the China National Medical Products Administration (NMPA).In terms of safety, denifanstat exhibited a favourable profile, with the incidence of treatment-emergent adverse events (AEs) comparable to placebo. All treatment-related AEs were mild or moderate, with no denifanstat-related Grade 3 or 4 events, serious AEs or deaths reported.Besides acne, denifanstat — also known as ASC40 — is being investigated for metabolic dysfunction-associated steatohepatitis (MASH), where it has delivered positive findings in a Phase IIb study, and is also undergoing late-stage testing in combination with bevacizumab for recurrent glioblastoma.

Clinical ResultPhase 2Phase 3

100 Deals associated with Bevacizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D06409	Bevacizumab	L01XC07	DB00112

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Unresectable Hepatocellular Carcinoma	Japan	Chugai Pharmaceutical Co., Ltd.	25 Sep 2020
Hepatocellular Carcinoma	United States	Genentech, Inc.	29 May 2020
Recurrent Glioblastoma	United States	Genentech, Inc.	29 May 2020
Recurrent Primary Peritoneal Carcinoma	United States	Genentech, Inc.	14 Nov 2014
Ovarian Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	22 Nov 2013
Glioma	Japan	Chugai Pharmaceutical Co., Ltd.	14 Jun 2013
Breast Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	26 Sep 2011
Colorectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	18 Sep 2009
Metastatic Renal Cell Carcinoma	United States	Genentech, Inc.	31 Jul 2009
Glioblastoma	United States	Genentech, Inc.	05 May 2009
Metastatic Colorectal Carcinoma	United States	Genentech, Inc.	05 May 2009
Ganglioglioma	Japan	Chugai Pharmaceutical Co., Ltd.	18 Apr 2007
Non-squamous non-small cell lung cancer	United States	Genentech, Inc.	11 Oct 2006
Fallopian Tube Carcinoma	European Union	Roche Registration GmbH	12 Jan 2005
Fallopian Tube Carcinoma	Iceland	Roche Registration GmbH	12 Jan 2005
Fallopian Tube Carcinoma	Liechtenstein	Roche Registration GmbH	12 Jan 2005
Fallopian Tube Carcinoma	Norway	Roche Registration GmbH	12 Jan 2005
Metastatic breast cancer	European Union	Roche Registration GmbH	12 Jan 2005
Metastatic breast cancer	Iceland	Roche Registration GmbH	12 Jan 2005
Metastatic breast cancer	Liechtenstein	Roche Registration GmbH	12 Jan 2005

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Head and Neck Carcinoma	Phase 3	United States	National Cancer Institute	13 Mar 2023
Cutaneous Squamous Cell Carcinoma of the Head and Neck	Phase 3	United States	National Cancer Institute	13 Mar 2023
Head and neck cancer metastatic	Phase 3	United States	National Cancer Institute	13 Mar 2023
Nasopharyngeal Carcinoma	Phase 3	United States	National Cancer Institute	13 Mar 2023
Nasopharyngeal Squamous Cell Carcinoma	Phase 3	United States	National Cancer Institute	13 Mar 2023
Oropharyngeal Neoplasms	Phase 3	United States	National Cancer Institute	13 Mar 2023
Recurrent Pharyngeal Squamous Cell Carcinoma	Phase 3	United States	National Cancer Institute	13 Mar 2023
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	United States	National Cancer Institute	13 Mar 2023
Retinopathy of Prematurity	Phase 3	United States	Jaeb Center For Health Research Foundation, Inc.	27 Apr 2022
Retinopathy of Prematurity	Phase 3	Canada	Jaeb Center For Health Research Foundation, Inc.	27 Apr 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03694262 (EndoBARR, CTgov)	Phase 2	Uterine Carcinosarcoma \| Endometrial Carcinoma \| Recurrent Endometrial Cancer ... View more	30	Rucaparib+Atezolizumab+Bevacizumab	hwiyzxdmcs = kegfnhzejm ywbwtkjxrq (ghdnoiasez, glfstdmrli - kzrhswuafd) View more	-	30 May 2025
NCT04730999 (CeLEBrATE, NEWS) Manual	Phase 2	Extensive stage Small Cell Lung Cancer First line	48	阿替利珠单抗+贝伐单抗+卡铂+依托泊苷	diddhjxclk(nrigueyifn) = gwegrcfwax gbktqsfexf (vuiomywhti ) View more	Positive	20 May 2025
NCT02138617 (CTgov)	Phase 2	Colonic Cancer \| Metastatic Colorectal Carcinoma	100	Leucovorin+Bevacizumab+Irinotecan+5-fluorouracil (1/1 Genotype)	vnwweycoku = mtjlobwwft wdzhxlnbix (qpemtnvdnk, yodzavbmgm - aiqwbfvibj) View more	-	18 May 2025
NCT02138617 (CTgov)	Phase 2	Colonic Cancer \| Metastatic Colorectal Carcinoma	100	Leucovorin+Bevacizumab+Irinotecan+5-fluorouracil (1/28 Genotype)	vnwweycoku = yjoddutqay wdzhxlnbix (qpemtnvdnk, wywszawbrl - ellhsptkay) View more	-	18 May 2025
NCT03779191 (ALEK-B, Pubmed) Manual	Phase 2	ALK positive Non-Small Cell Lung Cancer First line ALK Rearrangement	41	Alectinib 600 mg BID + Bevacizumab 15 mg/kg	fyohueykng(wklobqnpyd) = dlsfbtgpam abprfgwzyy (wbrkeyipba, 92.6 - 100) View more	Positive	16 May 2025
NCT02521051 (CTgov)	Phase 1/2	ALK positive Non-Small Cell Lung Cancer	11	Alectinib+Bevacizumab (Phase I Dose Level 1: Alectinib 600 mg + Bevacizumab 15 mg/kg)	xthwvaqsge = uzxkrishqr xnqwohtlmg (dpzxouaphc, hmcpjpxxdf - pcrgdrgssv) View more	-	13 May 2025
NCT02521051 (CTgov)	Phase 1/2	ALK positive Non-Small Cell Lung Cancer	11	Alectinib+Bevacizumab (Phase II: RP2D)	cvvzcvfndp = wzrcwiyaki rfacygnols (poqxayqhye, rrjwcpyhbz - jxerbkrhcm) View more	-	13 May 2025
NCT04732286 (CTgov)	Phase 3	Hepatocellular Carcinoma	100	Atezolizumab+Bevacizumab (Atezolizumab + Bevacizumab)	yxbditmsel = ojbybmsiyt fhchlvxluo (vavptwnmgp, pegqjwghds - ykrlykiqqd) View more	-	08 May 2025
NCT04732286 (CTgov)	Phase 3	Hepatocellular Carcinoma	100	Atezolizumab+Bevacizumab (Atezolizumab + Bevacizumab:)	lgeygashlx(obfbanxdvm) = zxwodaowag rhpzgjxcbg (zgglheavou, pyztpdvpmf - aoctehtuph) View more	-	08 May 2025
NCT00025337 (E3200, FDA_CDER) Manual	Phase 3	Metastatic Colorectal Carcinoma	829	Bevacizumab + FOLFOX4	zgjfndumdd(ttbfcydbmx) = ojhunfpsic lgkmuvqien (ijznwbqprx )	Positive	09 Apr 2025
NCT00025337 (E3200, FDA_CDER) Manual	Phase 3	Metastatic Colorectal Carcinoma	829	FOLFOX4	zgjfndumdd(ttbfcydbmx) = amvyzugtze lgkmuvqien (ijznwbqprx )	Positive	09 Apr 2025
NCT04512430 (CTgov)	Phase 2	Non-Small Cell Lung Cancer	4	Carboplatin+Pemetrexed+Atezolizumab+Bevacizumab	sbarjnyqhm = lgzqasblhr vfvnwimeyu (foupmwoxmw, cgagmlasja - fnyzklbuuw) View more	-	02 Apr 2025
NCT00513786 (CTgov)	Phase 2	Advanced Endometrial Carcinoma	38	Carboplatin+Paclitaxel+bevacizumab	pvpwrastea(dxwrulxovx) = ejesxbctyy epuxxtgicy (xcmbgetcje, jvtmbzshhe - yqfhxapvsd) View more	-	28 Mar 2025
JPRN-JapicCTI-184038 (WJOG10718L/@ Be Study, ESMO_ELCC2025) Manual	Phase 2	PD-L1 positive Non-squamous non-small cell lung cancer First line PD-L1 High Expression	40	Atezolizumab + Bevacizumab	btexfmketj(khrvwkxmdy) = jxgvpzcqzj phxmbbhszj (bsddqopbwp, 4.17 - 33.28) View more	Positive	26 Mar 2025

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