Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases

This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.

Start Date17 Oct 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06904378

/ Not yet recruitingPhase 1/2IIT

Phase I/II Clinical Trial of Ontegimod and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma: Reprogramming Tumor-associated Myeloid Cells

The investigators hypothesize that CD11b agonism reprograms the tumor microenvironment (TME) to overcome resistance to checkpoint immunotherapy in pancreatic ductal adenocarcinoma (PDAC). Therefore, the investigators propose an open label phase I/II clinical trial of Ontegimod with gemcitabine and nab-paclitaxel in unresectable pancreatic ductal adenocarcinoma prior to future studies incorporating anti-PD1 checkpoint immunotherapy.

Start Date31 Jul 2025

Sponsor / Collaborator

Washington University School of Medicine

[+1]

NCT06897046

/ Not yet recruitingPhase 2IIT

Perioperative Study of Iparomlimab and Tuvonralimab in Resectable NSCLC

This project intends to study the efficacy and safety of Iparomlimab and Tuvonralimab with or without chemotherapyin the perioperative treatment of NSCLC

Start Date10 Jul 2025

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

100 Clinical Results associated with Albumin-Bound Paclitaxel

100 Translational Medicine associated with Albumin-Bound Paclitaxel

100 Patents (Medical) associated with Albumin-Bound Paclitaxel

42,366

Literatures (Medical) associated with Albumin-Bound Paclitaxel

31 Dec 2025·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Selisistat, a SIRT1 inhibitor, enhances paclitaxel activity in luminal and triple-negative breast cancer: in silico, in vitro, and in vivo studies

Article

Author: Bartuzi, Damian ; Stepulak, Andrzej ; Okon, Estera ; Kalafut, Joanna ; Wawruszak, Anna ; Czerwonka, Arkadiusz ; Luszczki, Jarogniew

Sirtuins (SIRTs) are NAD+-dependent histone deacetylases, which play a key role in cancer progression; however, their prognostic values in breast cancer (BC) remain a subject of debate and controversy. Accumulative evidence suggests that each sirtuin possesses individual character, implicating its role in the regulation of multifaceted biological functions leading to BC initiation, progression and metastasis. Selisistat (EX527) is a potent, cell permeable, highly selective SIRT1 inhibitor. In the study, the tumour-suppressive effects of the SIRT1 inhibitor EX527 (selisistat) alone and in combination with paclitaxel (PAX) in different breast cancer cell lines and zebrafish xenograft models were investigated. The type of pharmacological drug-drug interaction between EX527 and PAX was determined using the isobolographic method. EX527 and PAX used individually inhibited proliferation, induced apoptosis and caused cell cycle arrest in G1 and subG1/G2 phases. Interestingly, the combination of these compounds used in the 1:1 dose-ratio augmented all these effects (IC_50add 29.52 ± 3.29 - 38.45 ± 5.26). The co-treatment of EX527 with PAX generated desirable additive drug-drug interaction. The simultaneous application of EX527 and PAX induced a stronger inhibition of tumour growth compared to individual treatments in zebrafish xenografts. In silico analysis revealed a protein-protein interaction pathway (SIRT1-AKT-S1PR1-GNAI1/GNAO1-Tubulin) connecting molecular targets of both ligands. To summarise, the combination of EX527 and PAX more effectively impairs breast cancer cell growth compared to individual treatments. However, further investigations are required to clarify the specific targets and molecular mechanisms underlying the activity of EX527:PAX in other preclinical models.

01 Jun 2025·Nanomedicine-Nanotechnology Biology and Medicine

Nanoparticles may influence mast cells gene expression profiles without affecting their degranulation function

Article

Author: Xie, Shaojun ; Xu, Weining ; Liptrott, Neill J ; Grunberger, Jason ; Dobrovolskaia, Marina A ; Cedrone, Edward ; Zhao, Yongmei ; Tran, Bao ; Plant-Hately, Alexander ; Toms, Bradley ; Newton, Hannah S

An in vitro method for monitoring nanoparticle effects on IgE-dependent mast cell degranulation was developed and validated. The assayed nanoparticles included four clinical-grade nanomedicines (Abraxane, Doxil, AmBisome, and Feraheme) and three commercial research-grade nanomaterials (generation 5 PAMAM dendrimers with carboxy-, hydroxy-, or amine- surface functionalities). Most of the tested materials did not alter IgE-dependent mast cell degranulation, suggesting that nanoparticles and nanomedicines are unlikely to worsen pre-existing allergies to other antigens. Two clinical-grade formulations containing cytotoxic oncology drugs-Abraxane and Doxil-decreased degranulation. Abraxane but not Doxil decreased FcεR expression on the cell surface. Single-cell sequencing revealed the most differentially expressed genes (DEG) in Abraxane and Doxil-treated cultures. Interestingly, Feraheme induced DEG without affecting degranulation. These data demonstrate that some nanomaterials have more effects on immune cells than can be detected by a functional immunoassay.

01 May 2025·BIOMATERIALS

Macrophage-hitchhiked, effervescence-induced nanoemulsions for enhanced oral chemotherapy and immunotherapy: Impact on absorption route

Article

Author: Chen, Chun-Chieh ; Lin, Kun-Ju ; Chang, Hsiao-Huan ; Huang, Tun-Yu ; Nguyen, Nhien ; Chang, Yen ; Sung, Hsing-Wen ; Hoang, Tuyet-Mai ; Thi Nguyen, Mai Thanh ; Nguyen, Lam-Duc-Huy

Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal cancer. Paclitaxel (PTX), typically administered intravenously (IV) as chemotherapy, shows promise for triggering immunogenic cell death (ICD) and may serve as a potential immunotherapy. This study introduces an oral PTX delivery method using an enteric-coated gelatin capsule containing capric acid oil and an effervescent agent, optionally with decylamine-conjugated β-glucans (DA-βGlus). Upon dissolving in the small intestine, the capsule undergoes an effervescence reaction that produces emulsified oil droplets (ODs) by bile salts, forming either Bared/ODs/PTX or DA-βGlus/ODs/PTX, with the latter featuring surface-attached DA-βGlus. The study evaluates the oral absorption, pharmacokinetics, and therapeutic efficacy of these formulations, comparing them to IV administration. IV PTX causes rapid spikes in plasma concentration, quick metabolism, and elimination, which can be unsafe. In contrast, the oral delivery system maintains consistent drug levels in the bloodstream for longer periods, improving overall effectiveness. Bared/ODs/PTX follows conventional fat absorption pathways, limiting tumor targeting. On the other hand, DA-βGlus/ODs/PTX uses DA-βGlus to enhance specificity for tumors through endogenous macrophage-mediated transport, effectively acting as "cellular tumor-seeking vehicles". This method reduces tumor stroma fibrosis, delivers PTX precisely, induces apoptosis, triggers PTX-induced ICD, and enhances cytotoxic T cell responses, augmenting targeted anti-PDAC strategies.

702

News (Medical) associated with Albumin-Bound Paclitaxel

04 Apr 2025

·pipelinereview.com

ENHERTU® Approved in the EU as First HER2 Directed Therapy for Patients with HR Positive, HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following at Least One Endocrine Therapy

TOKYO, Japan & MUNICH, Germany I April 04, 2025 I Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU ® (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from the DESTINY-Breast06 phase 3 trial presented at the 2024 American Society of Clinical Oncology (#ASCO24) Annual Meeting and published in The New England Journal of Medicine . HR positive, HER2 negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers. 1 Despite being classified as HER2 negative, many of these tumors still have some level of HER2 expression. Currently, regardless of HER2 expression, endocrine-based therapies are widely used in the early lines of treatment for HR positive metastatic breast cancer. Following endocrine-based therapy, some patients discontinue treatment, and others are treated with conventional chemotherapy which is associated with poor response rates and outcomes. 2,3,4,5 “This approval introduces a new treatment option for HR positive metastatic breast cancers that express HER2,” said Giuseppe Curigliano, MD, PhD, Professor of Medical Oncology at the University of Milan and the Head of the Division of Early Drug Development at the European Institute of Oncology, IRCCS, Italy and Principal Investigator of DESTINY-Breast06. “In DESTINY-Breast06, ENHERTU outperformed chemotherapy, providing progression-free survival of more than one year for patients with HR positive, HER2 low or HER2 ultralow metastatic breast cancer, demonstrating the benefit of treating these patients with ENHERTU instead of chemotherapy.” In the DESTINY-Breast06 trial, ENHERTU demonstrated a 38% reduction in the risk of disease progression or death versus chemotherapy in patients with chemotherapy-naïve HR positive, HER2 low metastatic breast cancer (n=713; hazard ratio [HR] 0.62; 95% confidence interval [CI]: 0.52-0.75; p<0.0001) as assessed by blinded independent review (BICR). Median progression-free survival (PFS) was 13.2 months (95% CI: 11.4-15.2) in the ENHERTU arm compared to 8.1 months (95% CI: 7.0-9.0) in the chemotherapy arm. The confirmed objective response rate (ORR) in the HER2 low population was 56.5% (95% CI: 51.2-61.7) in the ENHERTU arm versus 32.2% (95% CI: 27.4-37.3) in the chemotherapy arm. Median duration of response (DOR) was 14.1 months (95% CI: 11.8-15.9) in the ENHERTU arm versus 8.6 months (95% CI: 6.7-11.3) in the chemotherapy arm. In the overall trial population of patients with chemotherapy-naïve HR positive, HER2 low or HER2 ultralow metastatic breast cancer (n=866), ENHERTU achieved a similar 36% reduction in the risk of disease progression or death versus chemotherapy (HR 0.64; 95% CI: 0.54-0.76; p<0.0001). A median PFS of 13.2 months (95% CI: 12.0-15.2) was seen in patients treated with ENHERTU compared to 8.1 months (95% CI: 7.0-9.0) in patients treated with chemotherapy. Confirmed ORR in the overall trial population was 57.3% (95% CI: 52.5-62.0) in the ENHERTU arm versus 31.2% (95% CI: 26.8-35.8) in the chemotherapy arm. Median DOR was 14.3 months (95% CI: 12.5-15.9) in the ENHERTU arm versus 8.6 months (95% CI: 6.9-11.5) in the chemotherapy arm. An exploratory analysis of the HER2 ultralow population (n=152; HR 0.78; 95% CI: 0.50-1.21) showed the clinically meaningful improvement in PFS was consistent between patients with HER2 low and HER2 ultralow expression, with 13.2 months (95% CI: 9.8-17.3) in patients treated with ENHERTU compared to 8.3 months (95% CI: 5.8-15.2) in those treated with chemotherapy. Confirmed ORR was 61.8% (95% CI: 50.0-72.8) in the ENHERTU arm versus 26.3% (95% CI: 16.9-37.7) in the chemotherapy arm. Median DOR was 14.3 months (95% CI: 9.2-20.7) in the ENHERTU arm versus 14.1 months (95% CI: 5.9, not estimable) in the chemotherapy arm. “ENHERTU continues to evolve what is possible with breast cancer treatment, becoming the first HER2 directed medicine approved in the EU for patients with HR positive metastatic breast cancer with HER2 low or HER2 ultralow expression following endocrine therapy,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “Today’s approval expands the use of ENHERTU to now include an earlier treatment setting of HER2 low metastatic breast cancer and broadens the patient population eligible for treatment to those with HER2 ultralow disease.” “ENHERTU continues to open up new approaches to the diagnosis and treatment of patients with metastatic breast cancer,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “This approval underscores the importance of testing metastatic breast cancer tumors for any IHC staining to identify patients with HR positive, HER2 low or HER2 ultralow disease who may be eligible for ENHERTU once sustained responses are no longer achieved with endocrine-based therapy.” In DESTINY-Breast06, the safety profile of ENHERTU was consistent with previous clinical trials with no new safety concerns identified. Grade 3 or grade 4 treatment-related adverse events from a pooled safety analysis of patients treated with ENHERTU (5.4 mg/kg) across multiple tumor types in clinical studies included neutropenia (18.0%), anemia (10.5%), fatigue (7.8%), leukopenia (6.0%), thrombocytopenia (5.4%), nausea (4.9%), lymphopenia (3.9%), hypokalemia (3.8%), transaminases increased (3.5%), diarrhea (2.5%), vomiting (2.4%), decreased appetite (1.8%), pneumonia (1.3%), and ejection fraction decreased (1.0%). Grade 5 adverse reactions occurred in 1.4% of patients, including interstitial lung disease (1.1%). ENHERTU is already approved in more than 75 countries, including the EU, for patients with HER2 low metastatic breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Financial Considerations Following this approval in the EU, an amount of $125 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the HER2 low and HER2 ultralow chemotherapy-naive breast cancer indication. Sales of ENHERTU in most EU territories are recognized by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019 . About DESTINY-Breast06 DESTINY-Breast06 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus investigator’s choice of chemotherapy (capecitabine, paclitaxel or nab paclitaxel) in patients with HR positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (defined as IHC 0 with membrane staining) advanced or metastatic breast cancer. Patients in the trial had no prior chemotherapy for advanced or metastatic disease and received at least two lines of prior endocrine therapy in the metastatic setting. Patients also were eligible if they had received one prior line of endocrine therapy combined with a CDK4/6 inhibitor in the metastatic setting and experienced disease progression within six months of starting first-line treatment or received endocrine therapy as an adjuvant treatment and experienced disease recurrence within 24 months. HER2 IHC status was confirmed by a central laboratory and determined based on the most recent evaluable HER2 IHC sample prior to randomization. In tumor samples from patients screened for trial eligibility, nearly two-thirds of tumors previously assessed as IHC 0 at a local laboratory were re-classified as HER2 low or HER2 ultralow upon central analysis of the archival tumor sample. It was also observed that approximately 85% to 90% of patients with HR positive, HER2 negative metastatic breast cancer may have actionable levels of HER2 expression. The primary endpoint of DESTINY-Breast06 is PFS in the HR positive, HER2 low patient population as measured by BICR. Key secondary endpoints include PFS by BICR in the overall trial population (HER2 low and HER2 ultralow), OS in patients in the HER2 low patient population and OS in the overall trial population. Other secondary endpoints include ORR, DOR, time to first subsequent treatment or death, time to second subsequent treatment or death and safety. Analysis of the HER2 ultralow subgroup was not powered to demonstrate statistical significance. DESTINY-Breast06 enrolled 866 patients (n=713 for HER2 low and n=152 for HER2 ultralow) in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov . About Breast Cancer and HER2 Expression Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 6 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally. 6 In Europe, approximately 557,000 cases of breast cancer are diagnosed annually. 7 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis. 1 HR positive, HER2 negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers. 1 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including breast cancer. 8 Patients with high levels of HER2 expression (IHC 3+ or IHC 2+/ISH+) are classified as HER2 positive and treated with HER2 targeted therapies, representing approximately 15% to 20% of all breast cancers. 9 Historically, tumors that were not classified as HER2 positive were classified as HER2 negative, despite the fact that many of these tumors still carry some level of HER2 expression. 10 Endocrine therapy is widely given consecutively in the early lines of treatment for HR positive metastatic breast cancer. However, after initial therapy, further efficacy with additional endocrine treatment is often limited. 2 Prior to the approval of ENHERTU in HER2 low and HER2 ultralow metastatic breast cancer based on the DESTINY-Breast04 and DESTINY-Breast06 trials, there were no HER2 targeted therapies approved specifically for these patient populations. 11,12 About ENHERTU ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. ENHERTU (5.4 mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. ENHERTU (5.4 mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. ENHERTU (5.4 mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that has progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. ENHERTU (5.4 mg/kg) is approved in more than 50 countries worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 ( ERBB2 ) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (6.4 mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 , DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (5.4 mg/kg) is approved in Brazil, Israel, Russia and the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02 , DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About the ENHERTU Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY ® in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com . References 1 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes . Accessed April 2025. 2 Manohar P, et al. Cancer Biol Med . 2022 Feb 15; 19(2):202–212. 3 Cortes J, et al. Lancet . 2011;377:914-923. 4 Yuan P, et al. Eur J Cancer . 2019;112:57-65. 5 Jerusalem G, et al. JAMA Oncol . 2018;4(10):1367–1374. 6 Bray F, et al. CA Cancer J. Clin . 2024; 10.3322/caac.21834. 7 Globocan 2022. Breast Cancer. Accessed April 2025. 8 Iqbal N, et al. Mol Biol Int . 2014;852748. 9 Ahn S, et al. J Pathol Transl Med. 2020;54(1):34-44. 10 Sajjadi E, et al. Cancer Drug Resist . 2022;5(4):882-888. 11 Modi S, et al. N Engl J Med . 2022;387:9-20. 12 Eiger D, et al. Cancers . 2021 Mar; 13(5): 1015. SOURCE: Daiichi Sankyo

Drug ApprovalClinical ResultPhase 3ASCOLicense out/in

31 Mar 2025

·pipelinereview.com

Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer

REDWOOD CITY, CA, USA I March 31, 2025 I Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that ROSELLA, the company’s pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR). In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.70; p-value: 0.008). Their median PFS-BICR was 6.5 months, compared to 5.5 months in patients who received nab-paclitaxel alone. At an interim evaluation of overall survival (OS), patients treated with relacorilant plus nab-paclitaxel had a significant improvement in OS, with a median OS of 16.0 months, compared to 11.5 months for patients receiving nab-paclitaxel alone (hazard ratio: 0.69; p-value: 0.012). Relacorilant was well-tolerated and no new safety signals were observed. As was the case in the company’s Phase 2 trial, safety and tolerability were comparable in the two groups. Complete results from ROSELLA will be presented at a medical conference this year. Results from Corcept’s Phase 2 trial of relacorilant in patients with platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology in June 2023. The ROSELLA trial enrolled 381 patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia; biomarker selection was not required. Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. ROSELLA has dual primary endpoints — PFS-BICR and OS. A positive outcome is achieved if either endpoint is met. “Patients with advanced ovarian cancer have few good treatment options and, unfortunately, patients with recurrent disease eventually develop resistance to available therapies. The ROSELLA results represent an important advancement in the development of a treatment for patients with platinum-resistant ovarian cancer,” said Alexander B. Olawaiye, M.D., Director of gynecological cancer research at Magee-Women’s Hospital of the University of Pittsburgh and Principal Investigator in the ROSELLA trial. “Platinum-resistant ovarian cancer poses a significant treatment challenge. The ROSELLA results demonstrate that relacorilant in combination with nab-paclitaxel has the potential to become a key strategy to help improve patient outcomes,” said Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and Full Professor of Obstetrics and Gynaecology, Humanitas University, Rozzano and investigator in the ROSELLA trial. “The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look forward to presenting the trial’s full results in the coming months. We expect to submit our NDA in the third quarter and our MAA shortly thereafter.” The ROSELLA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG). About Relacorilant Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing’s syndrome) and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. About Platinum-Resistant Ovarian Cancer Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have “platinum-resistant” disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe. About Corcept’s Oncology Programs Cortisol helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response, which weakens its ability to fight disease. About Corcept Therapeutics For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators and GR antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com . SOURCE: Corcept Therapeutics

Clinical ResultOrphan DrugPhase 3Drug Approval

31 Mar 2025

·www.fiercebiotech.com

Corcept\'s investigational oral therapy cuts ovarian cancer progression by 30%, teeing up FDA filing

Corcept Therapeutics plans to use the full data set to request market approval from U.S. regulators in the third quarter.\n Corcept Therapeutics’ oral antiglucocorticoid plus chemotherapy slashed risk of ovarian cancer progression by 30% compared to chemotherapy alone. The biopharma intends to take the phase 3 data to regulators in hopes of delivering a new standard of care for patients with platinum-resistant cancer.The California-based company’s stock has skyrocketed 85% since Friday’s market close, climbing from $54.60 per share to $101 as of 10:30 a.m. ET today.The top-line results come from Corcept’s pivotal late-stage trial, dubbed Rosella, which recruited 381 patients with platinum-resistant ovarian cancer. Participants were randomized to receive either Corcept’s antiglucocorticoid relacorilant alongside nab-paclitaxel (sold as Abraxane), or nab-paclitaxel alone.The trial measured two primary endpoints—progression-free survival, as evaluated by a blinded independent central review (PFS-BICR), and overall survival (OS)—with a win achieved if either were met, according to Corcept. It was on progression-free survival where Corcept claimed a win, with patients treated with relacorilant and chemotherapy experiencing a median PFS-BICR of 6.5 months compared to 5.5 months for patients who received nab-paclitaxel alone, representing a statistically significant 30% reduction.An interim evaluation found a significant improvement for OS in patients receiving the investigational combo, with a median OS of 16 months compared to 11.5 months for patients receiving only nab-paclitaxel. The full data set was not shared, with complete findings expected to be presented at a medical conference later this year, according to the biopharma. No new safety signals related to relacorilant were reported, and the therapy was well tolerated, according to Corcept. The company plans to use the full data set to request market approval from U.S. regulators in the third quarter of this year, with a European ask to follow, Corcept Chief Development Officer Bill Guyer said in a March 31 release. Relacorilant, an oral therapy, is a selective glucocorticoid receptor antagonist designed to modulate cortisol activity by binding to the receptor while avoiding other hormone receptors.“Patients with advanced ovarian cancer have few good treatment options and, unfortunately, patients with recurrent disease eventually develop resistance to available therapies,” Alexander Olawaiye, M.D., director of gynecological cancer research at Magee-Womens Hospital of the University of Pittsburgh and principal investigator for Rosella, said in the release. “The Rosella results represent an important advancement in the development of a treatment for patients with platinum-resistant ovarian cancer.”Corcept is studying relacorilant in multiple indications, including endogenous hypercortisolism, a hormonal disorder also known as Cushing’s syndrome in which the drug has snagged FDA orphan drug designation.In May 2024, the biopharma reported a phase 3 win for the antiglucocorticoid in Cushing’s, with a new drug application submitted to the FDA in the indication earlier this month. A decision is expected by or before Dec. 30 of this year.

$Corcept\'s investigational oral therapy cuts ovarian cancer progression by 30%, teeing up FDA filing$

Phase 3Clinical ResultOrphan Drug

100 Deals associated with Albumin-Bound Paclitaxel

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Approved

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Indication	Country/Location	Organization	Date
Pancreatic adenocarcinoma metastatic	United States	Teva Pharmaceuticals, Inc.	11 May 2023
Pancreatic adenocarcinoma	United States	Bristol Myers Squibb Co.	06 Sep 2013
Non-Small Cell Lung Cancer	Japan	Taiho Pharmaceutical Co., Ltd.	23 Jul 2010
Pancreatic Cancer	Japan	Taiho Pharmaceutical Co., Ltd.	23 Jul 2010
Stomach Cancer	Japan	Taiho Pharmaceutical Co., Ltd.	23 Jul 2010
Breast Cancer	China	Abraxis BioScience, Inc.	30 Jun 2008
Metastatic breast cancer	United States	Bristol Myers Squibb Co.	07 Jan 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 3	China	CSPC Ouyi Pharmaceutical Co., Ltd.	27 Apr 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Argentina	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Chile	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Czechia	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	France	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Hungary	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Italy	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Mexico	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Peru	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Poland	Hoffmann-La Roche, Inc.	17 Dec 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04581343 (PanCAN-SR1, CTgov)	Phase 1	Metastatic Pancreatic Cancer \| Metastatic Pancreatic Ductal Adenocarcinoma	10	Canakinumab	rqwlzxpxsl = vvqlmpqatk uxasgijqrt (ybqwqbcfzu, rkethrgsim - dgrhxxhlcs) View more	-	08 Apr 2025
Pubmed \| Int J Cancer Manual	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant	46	tislelizumab + nab-paclitaxel + cisplatin	gkcjqtgiqt(nykcjlgrqr) = laxbplwtdm buojkyprmg (hskxkyvfku ) View more	Positive	01 Apr 2025
				tislelizumab + paclitaxel + cisplatin	gkcjqtgiqt(nykcjlgrqr) = ofqfsrbtgp buojkyprmg (hskxkyvfku ) View more
NCT03240016 (ABLE, CTgov)	Phase 2	Advanced Urothelial Carcinoma \| Urothelial Carcinoma of the Urinary Bladder	36	Abraxane+pembrolizumab	fqozxydest = lwcjtpejpf xgpepzzzmb (jtguqnjihu, jkzuhgohij - vgijmdqdql) View more	-	16 Jan 2025
NCT05244993 (NEWS) Manual	Phase 2	Advanced Triple-Negative Breast Carcinoma First line	43	安罗替尼 +派安普利单抗 +白蛋白紫杉醇	cibfeagydd(yxrdipbxzf) = lcjkqayzlm lgtpwgyzek (oeqcrkgvqo ) View more	Positive	14 Dec 2024
NEWS Manual	Phase 3	Breast Cancer	-	SYHX2011	rsbvfnxptk(kwixfblnzt): HR = 1.38 (95% CI, 1.040 - 1.842) View more	Positive	10 Dec 2024
				紫杉醇（白蛋白结合型）
NCT05659056 (SABCS2024) Manual	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	52	pyrotinib + trastuzumab + nab-paclitaxel	qmlmpbauja(ssamnkygks) = ushzqducqp dgfxwybopu (ntbnbpgbwq, 29.0 - 56.7) View more	Positive	10 Dec 2024
				pyrotinib + trastuzumab + nab-paclitaxel (HER2-enriched subtype)	qmlmpbauja(ssamnkygks) = nhmkwhsdyy dgfxwybopu (ntbnbpgbwq, 37.9 - 73.2)
NCT02754726 (CTgov)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma	35	nivolumab+albumin-bound paclitaxel+Gemcitabine+Paricalcitol+cisplatin	ghumngbmpr = vejcmalwle ukfljhtnok (cwrjtbsfdj, hmvrnntjus - dorxqehgxt) View more	-	10 Dec 2024
ESMO_ASIA2024	Not Applicable	Breast Cancer Neoadjuvant neutrophil-to-lymphocyte ratio (NLR)	142	nab-paclitaxel (Low NLR (<2.1))	mqmzxkcxwv(hvalegwysz) = DFS in the low NLR group was longer than in the high NLR group nuizuosrhd (zzihpneahp )	-	07 Dec 2024
				nab-paclitaxel (High NLR (≥2.1))
NCT03768414 (SWOG S1815 \| SWOG 1815, CTgov)	Phase 3	Unresectable Intrahepatic Cholangiocarcinoma \| Advanced biliary tract cancer \| Gallbladder Neoplasms ... View more	452	Nab-paclitaxel+Gem+Cisplatin (Gem+Cisplatin+Nab-paclitaxel)	ajqrgcpklq(uuunvtskjg) = eacpnnwdww eoyfugasgj (gkqbxfxqul, ctdqrppmxr - zerauvulzo) View more	-	22 Oct 2024
				Gemcitabine+Cisplatin (Gemcitabine + Cisplatin)	ajqrgcpklq(uuunvtskjg) = ttdpdtglpv eoyfugasgj (gkqbxfxqul, oiumqypacg - vaytoahsvp) View more
NCT04964960 (CTgov)	Phase 2	Metabolic Syndrome \| Non-Small Cell Lung Cancer \| Brain metastases	3	nab paclitaxel+Carboplatin+Paclitaxel+Pembrolizumab+Pemetrexed	tserhkfnca = zjhkrzoaqt nsjvkvqbur (tkfhtwmbgj, matvkpuawz - klehvpvaua) View more	-	21 Oct 2024

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