Delving into the Latest Updates on Paclitaxel with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

EmPAC, LDE-paclitaxel, NanoPac

+ [75]

Target

Tubulin

Action

inhibitors

Mechanism

Tubulin inhibitors

Therapeutic Areas

NeoplasmsInfectious DiseasesDigestive System Disorders+ [12]

Active Indication

Advanced gastric carcinomaPancreatic adenocarcinoma metastaticMetastatic breast cancer+ [217]

Inactive Indication

Acidemia, IsovalericAcute Lymphoblastic LeukemiaAdenocarcinoma of Esophagus+ [202]

Originator Organization

National Institutes of Health

Active Organization

National Cancer Institute

NRG Oncology

Celcuity, Inc.

+ [54]

Inactive Organization

Hoffmann-La Roche, Inc.

Alliance for Clinical Trials in Oncology

The Gynecologic Oncology Group

+ [48]

License Organization

Shenzhen Kangzhe Pharmaceutical Co., Ltd.

Shenyang Sunshine Pharmaceuticals Co., Ltd.

Hanmi Pharmaceutical Co., Ltd.

+ [26]

Drug Highest PhaseApproved

First Approval Date

United States (29 Dec 1992),

RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China)

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Structure/Sequence

Molecular FormulaC47H51NO14

InChIKeyRCINICONZNJXQF-MZXODVADSA-N

CAS Registry33069-62-4

This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.

Start Date09 Oct 2026

Sponsor / Collaborator

National Cancer Institute

NCT05411237

/ Not yet recruitingPhase 3IIT

A Phase III, Randomized, Open-Label, Non-Inferiority Study of Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma in Resource-Limited Settings

This study is being done to determine if two different anti-cancer drugs, paclitaxel (PTX) and pegylated liposomal doxorubicin (PLD) have similar effects on treating Kaposi Sarcoma (KS) in people living with HIV (human immunodeficiency virus) in sub-Saharan Africa. Patients with HIV-related KS will receive either PTX or PLD once every 3 weeks for a total of six cycles.

Start Date01 Sep 2026

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Paclitaxel

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100 Translational Medicine associated with Paclitaxel

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100 Patents (Medical) associated with Paclitaxel

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50,579

Literatures (Medical) associated with Paclitaxel

31 Dec 2026·Future Science OA

Clinical efficacy of 2-week and 3-week albumin-bound paclitaxel therapy for advanced pancreatic cancer

Article

Author: Su, Zhimin ; Li, Zhiyong ; Shen, Feng ; Jiang, Jiana

OBJECTIVE:

We aim to compare the clinical efficacy and safety of albumin-bound paclitaxel (nab-PTX) (125 mg/m2, q2w) for two weeks and (125 mg/m2, d1, d8, q3w) for three weeks in the first-line treatment of advanced pancreatic cancer.

METHODS:

The medical records of patients with advanced pancreatic cancer who received nab-PTX for 2 weeks and 3 weeks, combined with gemcitabine, from July 2018 to January 2023, were retrospectively analyzed. The efficacy and adverse reactions of the two groups of patients were compared.

RESULT:

A total of 64 patients were included. The median progression-free survival (mPFS) of the 2-week group was 5.6 months, while the 3-week group was 7.8 months. The median overall survival (mOS) of the 2-week group was 14.0 months, while the 3-week group was 14.7 months. The multivariate analysis showed that a physical fitness status score of 0-1 was an independent factor with better OS, while metastatic sites ≥ 3 were related to poor OS. The incidence of leukopenia or neutropenia, neurotoxicity, fatigue, and poor appetite in the 2-week group was lower than that in the 3-week group.

CONCLUSION:

The clinical efficacy of nab-PTX in the 2-week and dose intensive 3 week did not show significant difference, but the 2-week treatment group had better tolerance and safety.

31 Dec 2026·ANNALS OF MEDICINE

Comparative effectiveness of percutaneous coronary intervention strategies for coronary small-vessel disease: a network meta-analysis of randomized trials

Review

Author: Du, Zhiyan ; Xu, Yixin ; Fan, Chao ; Wang, ZhiLong ; Jiang, Zhihui ; Wu, Tingting ; Zheng, Yingying ; Lv, Mingming ; Pan, Ying ; Adilijiang, Adilai. ; Bai, Bingxin ; Xie, Xiang ; Deng, Changjiang

BACKGROUND:

Coronary small-vessel disease (SVD) remains challenging for percutaneous coronary intervention (PCI) because small lumens magnify restenosis and ischemic risk. Multiple devices are available, yet their comparative performance is uncertain. This study evaluated and ranked PCI strategies for SVD.

METHODS:

A systematic review and network meta-analysis was conducted in accordance with PRISMA. PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, and Google Scholar were searched from inception to 15 August 2025. Eligible studies were English-language randomized controlled trials enrolling adults with angiographic SVD defined as reference vessel diameter ≤3.0 mm, comparing PCI strategies, and reporting target lesion revascularization (TLR), binary restenosis (BR), or myocardial infarction (MI). A frequentist random-effects network meta-analysis generated odds ratios (ORs) with 95% confidence intervals (CIs) and treatment rankings using the surface under the cumulative ranking curve (SUCRA).

RESULTS:

Thirty-nine trials including 14,503 patients met the criteria. For TLR (37 studies; 11,980 patients), the highest SUCRA values were observed with sirolimus-eluting stents (SES 90.1%), zotarolimus-eluting stents (ZES 83.9%), and everolimus-eluting stents (EES 82.2%). For BR (32; 6,468), SES, ZES, and paclitaxel-coated balloons (DCB-PTX) ranked highest (95.0%, 80.0%, and 78.3%). For MI (37; 11,602), SES, DCB-PTX, and ZES ranked highest (79.0%, 78.7%, and 68.5%). Representative effects showed SES reduced TLR versus bare-metal stents (BMS) (OR, 0.25; 95% CI, 0.15-0.43) and MI versus BMS (OR, 0.41; 95% CI, 0.21-0.79). Conventional approaches such as BMS, plain old balloon angioplasty (POBA), and gold-plated balloon angioplasty (GPBA) ranked lowest across outcomes.

CONCLUSION:

SES provides the most consistent clinical benefit for coronary SVD. ZES, EES, and DCB-PTX are effective alternatives in selected settings, whereas BMS, POBA, and GPBA are less effective. These findings offer comparative evidence to guide device selection in SVD.

31 Dec 2026·DRUG DELIVERY

The colloidal stability of albumin-based drug delivery systems has a profound effect on tumoricidal activity

Article

Author: Jiang, Chengwei ; Schätzlein, Andreas G. ; Uchegbu, Ijeoma F. ; Xiong, Guojun

Human serum albumin (HSA) has attracted significant attention in drug delivery since the approval of Abraxane in 2005. Abraxane is a nanoparticle albumin-bound paclitaxel (nab-PTX) formulation. Although HSA offers advantages such as prolonged circulation time (half-life ~19 days) and intrinsic hydrophobic pockets, the translation of other HSA-based nanomedicines remains limited. In fact, the significant differences between native and pharmaceutical HSA in protein structure and biological interactions could hinder their translational use in drug delivery. In this study, we demonstrate that pharmaceutical HSA (α-helix = 17%) is structurally denatured compared with native HSA (α-helix = 68%), leading to rapid clearance (<1 h) from the circulation and that drug loading is driven by pharmaceutical HSA's amphiphilicity rather than by its hydrophobic pockets. Here, we revealed that Nab-PTX is composed of protein-coated PTX solid cores. These nanosystems have insufficient surface charge (ζ = -13.7 mV), leading to aggregation, and low colloidal stability, resulting in premature drug release upon dilution (<0.1 mg/mL). To address these shortcomings, we developed HSA-polylactic acid (HSA-PLA) nanoparticles with enhanced negative surface charge (ζ = -27.4 mV) and improved colloidal stability to reduce the premature release of encapsulated PTX upon dilution (<0.01 mg/mL). In tumor models, comparative pharmacokinetics, biodistribution, and efficacy studies demonstrated that HSA-PLA (PTX) nanoparticles reduce premature drug release, resulting in greater tumor exposure (129 ± 3 vs. 90 ± 12 µg·h/g, p < 0.01) and superior antitumor efficacy compared with Abraxane. These improvements further suggest that optimization may require only a simple modification when guided by proper theoretical principles.

1,433

News (Medical) associated with Paclitaxel

13 Feb 2026

·www.prnewswire.com

HanchorBio Receives FDA Orphan Drug Designation for HCB101 in Gastric Cancer

First SIRPα-IgG4 Fc Fusion Protein Granted Orphan Status in Gastric Cancer TAIPEI, SHANGHAI and SAN FRANCISCO, Feb. 13, 2026 /PRNewswire/ -- HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to HCB101 for the treatment of gastric cancer. The designation covers gastric cancer broadly, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative subtypes. This milestone underscores the significant unmet medical need in gastric cancer and provides important regulatory support for the continued clinical development of HCB101 in this patient population. This designation marks the first FDA Orphan Drug Designation for HanchorBio, representing a significant regulatory milestone for the company and further validating its strategy of advancing differentiated immunotherapies in areas of high unmet medical need. HCB101 is a next-generation CD47–SIRPα pathway inhibitor, engineered as an affinity-optimized and toxicity-mitigated SIRPα-IgG4 Fc fusion protein. The molecule is designed to restore macrophage-mediated phagocytosis and enhance antigen presentation while minimizing the hematologic toxicities that have historically limited earlier CD47-targeting approaches, enabling rational combination with established standards of care. "Receiving our first FDA Orphan Drug Designation is a major milestone for HanchorBio and important validation of our scientific, regulatory, and development strategy," said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. "Gastric cancer remains an area of profound unmet medical need, and this designation reinforces our commitment to developing differentiated immunotherapies that can meaningfully improve outcomes for patients. This designation strengthens HCB101's profile as a globally relevant asset and represents a strategically important step as we advance the program toward U.S. and international development. It further supports our ongoing engagement with multinational partners as we explore collaboration and licensing opportunities for HCB101 and our broader immunotherapy pipeline." Gastric cancer is a rare disease in the United States, with prevalence well below the FDA's statutory threshold for orphan designation. Despite advances in targeted therapy and immune checkpoint inhibition, outcomes, particularly in the second-line setting, remain poor, with limited durability of response and substantial treatment-related toxicity. HCB101 is currently being evaluated in multiple ongoing clinical studies, including a Phase 1b/2a trial (NCT06771622) assessing HCB101 in combination with ramucirumab and paclitaxel in second-line advanced gastric cancer. Early clinical findings have demonstrated promising antitumor activity with a safety profile consistent with the molecule's differentiated design. Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio, added, "The FDA's decision reflects the seriousness of gastric cancer and the clinical rationale underlying HCB101's development. HCB101's IgG4-based SIRPα-Fc design was intentionally selected to support repeated dosing and combination strategies as an innate immune checkpoint backbone in solid tumors. In a second-line gastric cancer setting, where standard regimens offer limited durability, the depth of tumor shrinkage and consistency of response observed to date, while remaining compatible with standard ramucirumab-paclitaxel administration, support the continued global advancement of HCB101 for patients with significant unmet need." Orphan Drug Designation provides certain development incentives, including eligibility for tax credits on qualified clinical trial expenses, exemption from FDA user fees, and the potential for seven years of market exclusivity upon approval in the United States. HanchorBio plans to continue advancing HCB101 through global clinical development while exploring its potential as a backbone immunotherapy across multiple solid tumor indications. About HCB101 HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed on HanchorBio's FBDB™ platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing binding to red blood cells, a limitation that historically constrained the clinical utility of CD47-directed therapies. HCB101 was engineered using AI-assisted structural modeling to achieve differentiated binding to CD47 on cancer cells while maintaining low affinity for CD47 on red blood cells. Its safety profile, receptor occupancy characteristics, and pharmacologic properties are designed to support integration with established oncology regimens without disrupting standard dosing, safety expectations, or clinical workflows. Across ongoing clinical and translational evaluation, HCB101 has demonstrated consistent target engagement and early antitumor activity as both monotherapy and in combination settings, including tumor types historically considered challenging for CD47-directed therapies. Together, these attributes position HCB101 as a differentiated innate immune checkpoint backbone with broad potential for a wide variety of combination strategies across solid tumors and hematologic malignancies. About HanchorBio Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TPEx: 7827) is a global biotechnology company specializing in immuno-oncology. It is led by an experienced team of pharmaceutical industry veterans with a proven track record in biologics discovery and international development, aiming to reshape the landscape of cancer therapies. Committed to reactivating the immune system to fight disease, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By advancing breakthroughs in multi-functional, innovative molecular configurations in R&D and improving CMC manufacturing processes, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: SOURCE HanchorBio Inc. 21% more press release views with Request a Demo

ImmunotherapyOrphan DrugClinical Study

13 Feb 2026

·www.prnewswire.com

Innovent Dosed First Participant in Phase 3 Clinical Study of IBI354 (Novel HER2 ADC) for First Line Treatment of HER2-positive Breast Cancer

SAN FRANCISCO and SUZHOU, China, Feb. 12, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent",HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed in the pivotal Phase 3 clinical study (HeriCare-Breast01). The trial is evaluating the company's developed IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate, HER2 ADC) as a first-line treatment for patients with unresectable locally advanced or metastatic HER2-positive breast cancer. IBI354 has two pivotal Phase 3 trials ongoing (HeriCare-Ovarian01, HeriCare-Breast01), which holds potential to deliver a new generation of ADC therapies characterized by "high potency and low-toxicity". HeriCare-Breast01 (NCT07377643) is a multicenter, randomized, open-label, active-controlled study designed to evaluate the safety and efficacy of IBI354, with or without pertuzumab, compared with the current standard-of-care, paclitaxel plus trastuzumab and pertuzumab (THP). The primary endpoint is progression-free survival (PFS). Previously, in a multicenter Phase 1/2 study in participants with advanced solid tumors, a total of 88 participants with HER2-positive breast cancer were enrolled（the median prior treatment lines was 4) and were treated with 6-15 mg/kg doses of IBI354. As of March 24, 2025, the overall confirmed objective response rate (cORR) was 59.1% and the disease control rate (DCR) was 90.9%. Among them, ORR reached 72.4% and DCR reached 89.7% in 29 breast cancer participants treated with 9mg/kg Q3W. The median follow-up time of 9mg/kg Q3W dose group was 13.6 months as of the cut-off date, and progression-free survival (PFS) was 14.1 month (95%CI: 8.3, NC). The data were presented at the ASCO 2025[Link]. IBI354 also demonstrated an excellent safety profile in this Phase 1/2 clinical study (n=368). No DLT was occurred up to 18mg/kg dose group. The overall incidence of grade 3 or higher treatment-related adverse events (TRAEs) in 9mg/kg Q3W dose group was 21.0%, the incidence of TRAEs leading to dose interruption was 9.9%, the incidence of TRAEs leading to dose reduction was 1.2%, the overall incidence of TRAEs leading to discontinuation was 1.2%, and no TRAE leading to death reported. The most common TRAEs are white blood cell count decreased, nausea and anemia. The incidence of interstitial lung disease was only 1.2%, all were grade 1. The Principal Investigator of the HeriCare-Breast01 study, Binghe Xu, academician of the Chinese Academy of Engineering from Cancer Hospital Chinese Academy of Medical Sciences, stated, "We are pleased to complete the first patient enrollment for the HeriCare-Breast01 study at our center. Although first-line treatment for HER2-positive advanced breast cancer has improved substantially—with the THP regimen delivering durable responses for many patients—important clinical challenges remain. These include treatment discontinuation driven by toxicity and limited tolerability of currently available ADCs, particularly among older patients and those with comorbid conditions. As a next-generation HER2-targeted ADC, IBI354 has shown compelling antitumor activity in Phase 1/1b studies, achieving class-leading ORR and DCR, alongside a notably favorable safety profile. In particular, IBI354 has demonstrated reduced incidence of key adverse events such as interstitial lung disease (ILD), peripheral neuropathy, and neutropenia. This "high-efficacy, low-toxicity" therapeutic window may allow a broader range of patients to achieve sustained, high-quality treatment outcomes. We look forward to the Phase 3 HeriCare-Breast01 study to further validate this potential and advancing IBI354 toward becoming a new standard of care in the first-line treatment for HER2-positive advanced breast cancer. " Dr. Zhou Hui, Chief R&D Officer (Oncology) of Innovent, stated, "The initiation of the pivotal Phase 3 HeriCare-Breast01 trial in China marks a significant milestone in the clinical translation of Innovent's ADC pipeline. Leveraging the world's leading antibody engineering and differentiated linker-payload technologies, Innovent has established a highly competitive and innovative TOPO1i ADC technology platform SoloTx®. IBI354 has demonstrated a compelling safety and efficacy profile in early-stage studies, strongly validating the strengths of our SoloTx® ADC platform. IBI354 holds strong potential to offer a new first-line treatment option for patients with HER2-positive advanced breast cancer—one that combines durable antitumor activity with favorable long-term tolerability. Looking ahead, Innovent will continue to advance innovation of next-generation IO+ADC, with a steadfast commitment to delivering improved therapeutic outcomes for cancer patients." About Breast Cancer Breast cancer is one of the most common cancers among women worldwide. Approximately 1.3 million women are diagnosed with breast cancer each year, and about 30% of them develop locally advanced or metastatic breast cancer. The clinical proportion of HER2-positive breast cancer is approximately 20%[1]. Previous studies have demonstrated that overexpression of this HER2 gene plays a significant role in the occurrence and development of invasive breast cancer and is associated with an increased recurrence rate and poor prognosis [2]. At present, no ADC targeting HER2 has been fully approved for first-line treatment of advanced breast cancer in China. There is an urgent need for new drugs to improve the prognosis of patients. About IBI354 IBI354 is an innovative HER2-targeted antibody–drug conjugate developed using Innovent's proprietary SoloTx® ADC platform. Based on this platform, Innovent is promoting clinical trial studies multiple self-developed ADC molecules, which have shown promising safety and efficacy signals. With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors. Starting from the urgent clinical needs, in addition to the Phase 3 studies (HeriCare-Breast01 and HeriCare-Ovarian01) already initiated in BC and PROC, Innovent will explore IBI354 in multiple solid tumor indications. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: 1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). 2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Disclaimer: Innovent does not recommend any off-label usage. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. SOURCE Innovent Biologics 21% more press release views with Request a Demo

Phase 3Clinical ResultADCPhase 1IND

12 Feb 2026

·www.pharmaceutical-technology.com

MSD receives FDA approval for Keytruda combo to treat ovarian cancer

The approval of Keytruda Qlex for its indications is supported by data from well-controlled studies of Keytruda. Credit: 89stocker / Shutterstock.com. MSD has received the US Food and Drug Administration (FDA) approval for Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), along with paclitaxel, with or without bevacizumab, for ovarian cancer. The therapies are approved as second or third line treatment for adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express programmed death-ligand 1 (PD-L1) (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorised test. The approvals stem from the Phase III KEYNOTE-B96 trial (ENGOT-ov65) data, which was presented at the 2025 European Society for Medical Oncology (ESMO) Congress. Results demonstrated statistically significant improvements in progression-free survival and overall survival compared to placebo plus paclitaxel with or without bevacizumab for patients whose tumours express PD-L1 (CPS ≥1). The approval of Keytruda Qlex for its indications is supported by data from well-controlled studies of Keytruda and additional results from MK-3475A-D77, which compared the efficacy, safety, and pharmacokinetic profiles of Keytruda Qlex and Keytruda. MSD research laboratories global clinical development vice-president Dr Gursel Aktan said: “Historically, the prognosis has been poor for patients living with platinum-resistant recurrent ovarian cancer who have limited treatment options that may reduce the risk of disease progression or death. These approvals mark an important moment for the ovarian cancer community, reflecting years of focused investment in Keytruda. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “Introducing the first PD-1 inhibitors for platinum-resistant ovarian cancer means we’re expanding what’s possible for patients facing this disease. It also reinforces our commitment to advancing innovative therapies and improved outcomes across women’s cancers, where the need is greatest.” In June 2025, MSD received FDA approval for its anti-PD-1 therapy, Keytruda, for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).

Phase 3Clinical ResultDrug Approval

100 Deals associated with Paclitaxel

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KEGG	Wiki	ATC	Drug Bank
D00491	Paclitaxel	L01CD01	DB01229

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced gastric carcinoma	China	DAE HWA PHARM Co., Ltd.	19 Sep 2024
Advanced gastric carcinoma	China	Haihe Biopharma Co., Ltd.	19 Sep 2024
Pancreatic adenocarcinoma metastatic	European Union	Accord Healthcare SLU	05 Jan 2024
Pancreatic adenocarcinoma metastatic	Iceland	Accord Healthcare SLU	05 Jan 2024
Pancreatic adenocarcinoma metastatic	Liechtenstein	Accord Healthcare SLU	05 Jan 2024
Pancreatic adenocarcinoma metastatic	Norway	Accord Healthcare SLU	05 Jan 2024
Platinum-Resistant Primary Peritoneal Carcinoma	European Union	Inceptua SA	20 Nov 2018
Platinum-Resistant Primary Peritoneal Carcinoma	Iceland	Inceptua SA	20 Nov 2018
Platinum-Resistant Primary Peritoneal Carcinoma	Liechtenstein	Inceptua SA	20 Nov 2018
Platinum-Resistant Primary Peritoneal Carcinoma	Norway	Inceptua SA	20 Nov 2018
Platinum-sensitive epithelial ovarian cancer	European Union	Inceptua SA	20 Nov 2018
Platinum-sensitive epithelial ovarian cancer	Iceland	Inceptua SA	20 Nov 2018
Platinum-sensitive epithelial ovarian cancer	Liechtenstein	Inceptua SA	20 Nov 2018
Platinum-sensitive epithelial ovarian cancer	Norway	Inceptua SA	20 Nov 2018
Platinum-Sensitive Fallopian Tube Carcinoma	European Union	Inceptua SA	20 Nov 2018
Platinum-Sensitive Fallopian Tube Carcinoma	Iceland	Inceptua SA	20 Nov 2018
Platinum-Sensitive Fallopian Tube Carcinoma	Liechtenstein	Inceptua SA	20 Nov 2018
Platinum-Sensitive Fallopian Tube Carcinoma	Norway	Inceptua SA	20 Nov 2018
Germinoma	Japan	Clinigen KK	21 Feb 2013
Germinoma	Japan	CHEPLAPHARM Arzneimittel GmbH	21 Feb 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Cancer	NDA/BLA	European Union	Accord Healthcare SLU	09 Nov 2023
Metastatic Pancreatic Cancer	Phase 3	China	Shanghai Yizhong Pharmaceutical Co., Ltd.	21 Jan 2025
High grade glioma	Phase 3	China	Zhejiang University	01 Apr 2024
Human epidermal growth factor 2 negative carcinoma of breast	Phase 3	China	Shanghai Yizhong Pharmaceutical Co., Ltd.	25 Sep 2023
Cutaneous Squamous Cell Carcinoma	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	08 Jun 2023
Hypopharyngeal Carcinoma	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	08 Jun 2023
Squamous cell carcinoma of head and neck metastatic	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	08 Jun 2023
Squamous cell carcinoma of the hypopharynx	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	08 Jun 2023
Squamous Cell Carcinoma of the Larynx	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	08 Jun 2023
Squamous cell carcinoma of the oral cavity	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	08 Jun 2023

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03101748 (CTgov)	Phase 1/2	Inflammatory Breast Neoplasms \| Breast Cancer \| Locally advanced breast cancer ... View more	34	trastuzumab+neratinib+paclitaxel+pertuzumab (Cohort 1 Phase Ib Dose Level 0)	jovlgvtbkf = gzazacenfj ojzgwyyffv (fiatffetji, fceqcsrter - wkvrxiztfl) View more	-	12 Feb 2026
				trastuzumab+neratinib+paclitaxel+pertuzumab (Cohort 1 Phase Ib Dose Level 1)	jovlgvtbkf = tvpuecfxtp ojzgwyyffv (fiatffetji, hytcybqpct - nmhxgazvsl) View more
NCT03829722 (CTgov)	Phase 2	Squamous Cell Carcinoma of the Oropharynx \| Human Papillomavirus-Related Head and Neck Neoplasms	26	Radiation Therapy+Nivolumab+Carboplatin+Paclitaxel	djeaifqytz = rmcjdlrblz fxsykbeglf (gqrdvgwzxq, vzsqtkuyxz - gsvqbntjor) View more	-	22 Jan 2026
NCT04770272 (neoMono, CTgov)	Phase 2	Triple Negative Breast Cancer	442	Biopsy Arm A+Cyclophosphamide+Carboplatin+Paclitaxel+Atezolizumab 840 MG in 14 ML Injection+epirubicin (Arm A)	gytivcilmj = ntiwmqhugr edhoijkpka (bnbsofilcw, bpzfhxbnbn - fjgjvrdtfr) View more	-	12 Jan 2026
				Biopsy Arm B+Cyclophosphamide+Carboplatin+Paclitaxel+Atezolizumab 1200 MG in 20 ML Injection+epirubicin (Arm B)	gytivcilmj = jdaymyrlws edhoijkpka (bnbsofilcw, azhzjmbjxd - aorvyfpkei) View more
NCT02931890 (CRITICS-II, ASCO_GI2026 \| NEWS) Manual	Phase 2	Stomach Cancer Neoadjuvant	201	docetaxel+oxaliplatin+capecitabine	afyfsocuqw(wmlcstcfvc) = lvhbugwxac rapkuynvqw (okxktpmvpi, 58 - 80) View more	Positive	08 Jan 2026
				docetaxel+oxaliplatin+capecitabine+45Gy/25 fractions + paclitaxel or carboplatin	afyfsocuqw(wmlcstcfvc) = ueiwhcvoos rapkuynvqw (okxktpmvpi, 75 - 94) View more
NCT04762953 (STOPGAP, ASCO_GI2026)	Phase 2	Peritoneal Neoplasms Consolidation	31	IP PTX + systemic therapy	qavxcfhdpf(kycnegibpy) = cyrkgtfgen saiuqtabcq (ywwwksehgq ) View more	Positive	08 Jan 2026
NCT04660760 (ACCRU-GI-1810, ASCO_GI2026)	Phase 2	Advanced Gastroesophageal Junction Adenocarcinoma Second line	29	FTD-TPI+RAM	zbsdzezlhp(inpjszaqxr) = qhqukxhekk nlfnxnhixl (jjifnnpexx ) View more	Negative	08 Jan 2026
				PAC+RAM	zbsdzezlhp(inpjszaqxr) = vqgacwtoqi nlfnxnhixl (jjifnnpexx ) View more
NCT03199885 (NRG-BR004, CTgov)	Phase 3	Breast cancer recurrent \| Metastatic human epidermal growth factor 2 positive carcinoma of breast \| Unresectable Breast Carcinoma	190	Computed Tomography+Trastuzumab+Paclitaxel+Pertuzumab+Docetaxel (Arm I (Pertuzumab, Trastuzumab, Taxane Therapy, Placebo))	ebtpnoigoy = dnblvjsudi fdkzwkmzsn (jaufzvipil, blvohwuaie - kwtlghfrns) View more	-	30 Dec 2025
				Computed Tomography+Trastuzumab+Paclitaxel+Pertuzumab+Docetaxel+Atezolizumab (Arm II (Pertuzumab, Trastuzumab, Taxane Therapy, Atezolizumab))	ebtpnoigoy = qiskjyedyp fdkzwkmzsn (jaufzvipil, nbsacakqca - lfjvkrqave) View more
NCT05276973 (CTgov)	Phase 1	Primary peritoneal carcinoma \| Primary Peritoneal High-Grade Serous Adenocarcinoma \| Primary Peritoneal Endometrioid Adenocarcinoma ... View more	25	carboplatin+Paclitaxel+ipatasertib (DL1 Dose Escalation Cohort)	brgkaabgoi = wmpjaopnyy txdxedonju (jdulmlbord, xxwlmohwlh - rzqlrchjiv) View more	-	19 Dec 2025
				carboplatin+Paclitaxel+ipatasertib (DL2 Dose Escalation Cohort)	brgkaabgoi = bxnspdjowf txdxedonju (jdulmlbord, zokrerithf - dasyqwfvhp) View more
NCT03132532 (CTgov)	Phase 2	Recurrent Non-Small Cell Lung Cancer \| Unresectable Lung Non-Small Cell Carcinoma	20	Quality-of-Life Assessment+Etoposide+Carboplatin+Pemetrexed+Paclitaxel+cisplatin (Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT))	qjsayzosbz = znerdlaryg bxpvxrpsvi (tlrvqrjzlr, bpbcrzihiv - uuynroskjp) View more	-	25 Nov 2025
				Quality-of-Life Assessment+Carboplatin+Paclitaxel (Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT))	qjsayzosbz = vorxeuhhvh bxpvxrpsvi (tlrvqrjzlr, whrszkekwx - uuiwxtahpa) View more
NCT03694002 (S1701, CTgov)	Phase 2	Metastatic thymic carcinoma \| thymic carcinoma \| Recurrent Thymic Carcinoma	21	Carboplatin+Paclitaxel+Ramucirumab (Experimental: Arm A (Ramucirumab, Carboplatin, Paclitaxel))	vtjbizswwt(mnseyxazpw) = bphlnyxihj oqxempbhyj (juonidhprj, pddfahzlcg - hrupyexote) View more	-	30 Oct 2025
				Carboplatin+Paclitaxel (Active Comparator: Arm B (Carboplatin, Paclitaxel))	vtjbizswwt(mnseyxazpw) = bqmpeaxbgo oqxempbhyj (juonidhprj, uygzetzhho - aaodhkkxfr) View more