Last update 01 Jul 2024

Bortezomib

Last update 01 Jul 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

[(1R)-3-methyl-1-({(2S)-3-phenyl-2-[(pyrazin-2-ylcarbonyl)amino]propanoyl}amino)butyl]boronic acid, Bortezomib (JAN/USAN/INN), N-[(1R)-1-(DIHYDROXYBORYL)-3-methylbutyl]-N-(pyrazin-2-ylcarbonyl)-L-phenylalaninamide

+ [14]

Target

Proteasome

Mechanism

Proteasome inhibitors

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [6]

Active Indication

Immunoglobulin Light-Chain AmyloidosisWaldenstrom MacroglobulinemiaMantle-Cell Lymphoma+ [25]

Inactive Indication

Acinar Cell CarcinomaAcute Basophilic LeukemiaAcute cellular graft rejection+ [191]

Originator Organization

Millennium Pharmaceuticals, Inc.

Active Organization

Janssen Pharmaceutical KKJanssen Research & Development LLC

National Cancer Institute

+ [18]

Inactive Organization

Janssen Scientific Affairs LLCJohnson & Johnson Pharmaceutical Research & Development LLC

Singapore General Hospital Pte Ltd.

+ [33]

Drug Highest PhaseApproved

First Approval Date

US (13 May 2003),

Multiple Myeloma

RegulationAccelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Orphan Drug (JP)

Structure

Molecular FormulaC19H25BN4O4

InChIKeyGXJABQQUPOEUTA-RDJZCZTQSA-N

CAS Registry179324-69-7

1,076

Clinical Trials associated with Bortezomib

NCT06169215 / RecruitingPhase 2IIT

A Randomized Phase 2 Study of Daratumumab-Selinexor-Velcade-Dexamethasone (Dara-SVD) for High-Risk Newly Diagnosed Multiple Myeloma

This phase II trial compares the combination of selinexor, daratumumab, Velcade (bortezomib), and dexamethasone (Dara-SVD) to the usual treatment of daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVD) in treating patients with high-risk newly diagnosed multiple myeloma. Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by blocking a protein called CRM1, which may keep cancer cells from growing and may kill them. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Bortezomib blocks several molecular pathways in a cell and may cause cancer cells to die. It is a type of proteasome inhibitor and a type of dipeptidyl boronic acid. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. The drugs daratumumab, lenalidomide, bortezomib, dexamethasone and selinexor are already approved by the FDA for use in myeloma. But selinexor is not used until myeloma comes back (relapses) after initial treatment. Giving selinexor in the initial treatment may be a superior type of treatment for patients with high-risk newly diagnosed multiple myeloma.

Start Date16 Nov 2024

Sponsor / Collaborator

National Cancer Institute

NCT05272826 / Not yet recruitingPhase 2IIT

A Single Arm, Response-adapted, Open Label Study of Iberdomide, Weekly Bortezomib and Dexamethasone (IberBd) With Isatuximab Added on Demand for Transplant-ineligible, Newly Diagnosed Multiple Myeloma Patients: the BOREALIS Trial

This study will evaluate efficacy and tolerability of iberdomide, bortezomib, dexamethasone and isatuximab on demand administered in combination.

Start Date01 Oct 2024

Sponsor / Collaborator-

NCT06348147 / Not yet recruitingPhase 2IIT

An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation

This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.
This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing.

Start Date01 Aug 2024

Sponsor / Collaborator

UNC Lineberger Comprehensive Cancer Center

100 Clinical Results associated with Bortezomib

100 Translational Medicine associated with Bortezomib

100 Patents (Medical) associated with Bortezomib

9,964

Literatures (Medical) associated with Bortezomib

05 Jul 2106·Oncotarget

Phospholipid scramblase 1 as a critical node at the crossroad between autophagy and apoptosis in mantle cell lymphoma

Article

Author: Dolcetti, Riccardo ; Col, Jessica Dal ; Inghirami, Giorgio ; Faè, Damiana A. ; Ponzoni, Maurilio ; Montico, Barbara ; Mastorci, Katy ; Sigalotti, Luca

Mantle cell lymphoma (MCL) is an aggressive haematological malignancy in which the response to therapy can be limited by aberrantly activated molecular and cellular pathways, among which autophagy was recently listed. Our study shows that the 9-cis-retinoic acid (RA)/Interferon(IFN)-α combination induces protective autophagy in MCL cell lines and primary cultures reducing the extent of drug-induced apoptosis. The treatment significantly up-regulates phospholipid scramblase 1 (PLSCR1), a protein which bi-directionally flips lipids across membranes. In particular, RA/IFN-α combination concomitantly increases PLSCR1 transcription and controls PLSCR1 protein levels via lysosomal degradation. Herein we describe a new function for PLSCR1 as negative regulator of autophagy. Indeed, PLSCR1 overexpression reduced MCL cell susceptibility to autophagy induced by RA/IFN-α, serum deprivation or mTOR pharmacological inhibition. Moreover, PLSCR1 can bind the ATG12/ATG5 complex preventing ATG16L1 recruitment and its full activation, as indicated by co-immunoprecipitation experiments. The combination of doxorubicin or bortezomib with RA/IFN-α strengthened PLSCR1 up-regulation and enhanced apoptosis, as a likely consequence of the blockade of RA/IFN-α-induced autophagy. Immunohistochemical analysis of 32 MCL biopsies revealed heterogeneous expression of PLSCR1 and suggests its possible implication in the response to anticancer therapies, especially to drugs promoting protective autophagy.

01 Dec 2024·Molecular biology reports

MiR-383 sensitizes osteosarcoma cells to bortezomib treatment via down-regulating PSMB5

Article

Author: Dang, Xiaoqian ; Wang, Haoyu ; Wang, Haifan ; Bai, Chuanyi

BACKGROUND:

Proteasome inhibition is a promising strategy for cancer therapy. Bortezomib, which primarily targets the chymotrypsin-like activity of PSMB5, has demonstrated efficacy in various tumors. However, there is variable sensitivity to bortezomib, which could be attributed, in part, to variations in the expression of proteasome subunits.

METHODS AND RESULTS:

In this study, we investigated whether miR-383 affects the expression of proteasome subunits in osteosarcoma (OS) cells, and if so, whether OS cells display differential sensitivity to bortezomib concerning miR-383 expression. We detected a decreased miR-383 expression in OS cells and tissues. Then we found a negative correlation between the cytotoxicity of bortezomib and the expression level of the proteasome 20S core particle subunit β5 (PSMB5). Intriguingly, we identified PSMB5 as a direct target of miR-383. Increased expression of miR-383 resulted in decreased PSMB5 expression and increased sensitivity to bortezomib in OS cells.

CONCLUSIONS:

In summary, our findings present the initial comprehensive analysis of the function of miR-383 in OS. The outcomes indicate that miR-383 may augment the anticancer effect of bortezomib through PSMB5 repression, offering a novel therapeutic approach in OS and a fresh pathway for proteasome regulation.

01 Mar 2024·Oncology and therapy

Long Term Remission of Capillary Leak Syndrome Associated with Monoclonal Gammopathy with Progression to Multiple Myeloma After Autologous Stem Cell Transplantation: a Case Report and Review of the Literature

Article

Author: González-Quijada, Santiago ; Hermida, Gerardo ; González-López, Tomás José ; Alvarez-Nuño, Rodolfo ; San Miguel-Izquierdo, Jesús

BACKGROUND:

Clarkson's disease is a very rare entity characterised by acute episodes of systemic oedema and severe hypotension associated with paraproteinaemia. Its classical treatment relies on methylxanthine combined with terbutaline. Although this prophylactic therapy reduces the mortality rate, relapses are frequent. Eighty percent of patients with Clarkson's disease present with monoclonal gammopathy of unknown significance (MGUS). The risk of progression to multiple myeloma is 1% per year.

CASE DESCRIPTION:

Here, we present a 49-year-old woman who suffered multiple such episodes requiring treatment in the intensive care unit. Treatment with terbutaline and theophylline was ineffective. She was diagnosed with multiple myeloma (MM) 8 years after the first of these acute episodes. Antimyeloma treatment with bortezomib and dexamethasone was started, followed by autologous haemopoietic transplantation, with no further acute episodes since then.

CONCLUSION:

Our case is, to our knowledge, unique because eradication of MM was followed by complete disappearance of acute episodes of capillary leakage. Our case report is also the first to support the use of bortezomib and dexamethasone in this setting. Furthermore, autologous peripheral blood progenitor cell transplantation consolidated the MM stringent complete remission achieving a very long progression-free survival (> 11 years) of both MM and Clarkson's disease.

273

News (Medical) associated with Bortezomib

27 Jun 2024

·www.prnewswire.com

American Cancer Society Projects Over 2 Million New Cases in 2024: Biotech Innovations Respond

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 27, 2024 /PRNewswire/ -- USA News Group News Commentary – According to the American Cancer Society, 2024 will be the first year the USA expects to have more than 2 million new cancer cases. In order to respond to the rising rates of cancer, the National Cancer Institute is making calls for change in how cancer clinical research is performed "Because our patients can't wait." According to Spherical Insights, the Global Oncology Drugs Market is projected to grow by 11.5% CAGR through 2033 to US$564.5 billion, highlighting the need for more effective therapies and incentives for those who develop them. The biotech sector is actively addressing this need, with recent notable developments from several companies, including: O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), GSK plc (NYSE: GSK), Guardant Health, Inc. (NASDAQ: GH), Exelixis, Inc. (NASDAQ: EXEL), and Gilead Sciences, Inc. (NASDAQ: GILD). The article continued: According to the World Health Organization, the global cancer burden is growing amidst a mounting need for services. As well, an alarming trend is emerging, where cancer cases in younger people are rising sharply. Oncolytics Biotech® Announces Productive FDA Type C Meeting on its Metastatic Breast Cancer Program Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that the Company received productive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). The FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. The Company's proposed study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy. "Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep's immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options." Wayne Pisano, Interim CEO and Chair of the Board of Oncolytics, commented, "We are appreciative of the thoughtful dialog with the FDA and are pleased to have reached an important regulatory milestone that provides a clear path forward for pelareorep's advancement towards registration in HR+/HER2- mBC. Looking ahead, initiating a registration-enabling trial has become a major corporate objective, and in parallel, we remain on track to report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year. We believe these data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep. We remain committed to improving the standard of care and addressing the high unmet medical needs of these patients." CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments and happenings in the market this week include: GSK plc (NYSE: GSK), a global biopharma company, recently released positive results from an interim analysis of the DREAMM-8 phase III head-to-head trial evaluating belantamab mafodotin, in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex, as a second line and later treatment for relapsed or refractory multiple myeloma. As per the release, the drug combination reduced the risk of disease progression or death by nearly 50% versus standard of care. "With the robust results from the DREAMM-8 phase III head-to-head trial, we now have consistent data from two phase III trials supporting the potential for belantamab mafodotin combinations to redefine the treatment of multiple myeloma at or after first relapse," said Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, of GSK. "This is exciting news given the high unmet need for new and efficacious combinations once patients relapse or stop responding to initial treatments. We continue to share data and discuss our path forward with regulators." Guardant Health, Inc. (NASDAQ: GH), a leading precision oncology company, recently announced the launch of a new version of its Guardant360 TissueNext test that expanded the number of genes it identifies in a tumor tissue sample to 498. In addition to the panel expansion, Guardant has improved the test's operational workflow for a faster turnaround time. "The launch of the new Guardant360 TissueNext test is another step forward in our mission to conquer cancer with data," said Helmy Eltouky, Chairman and co-CEO of Guardant Health. "In addition to identifying guideline-recommended biomarkers, the upgraded test now provides more comprehensive gene coverage, so oncologists can make better informed decisions about the optimal treatment strategy for their patients with advanced cancer and help improve their outcomes." Exelixis, Inc. (NASDAQ: EXEL), a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care, recently settled two patent litigations with Cipla Ltd. and Cipla USA, Inc. (collectively Cipla) in response to Cipla's Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of CABOMETYX® (cabozantinib) tablets prior to the expiration of the applicable patents. Prior to the settlement earlier this year, Exelixis also announced detailed results of its Phase 3 CONTACT-02 pivotal trial evaluating the above-mentioned cabozantinib in combination with atezolizumab in metastatic castration-resistant prostate cancer at this year's ASCO GU 2024 event. As per the results, the combination reduced the risk of disease progression or death by 35%. "Given there are limited options after progression on novel hormonal therapy, we recognize the need for a regimen that can delay disease progression, that has an acceptable tolerability profile and that is widely available to patients who may not have the means or desire to travel to specialized centers for other therapies," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We look forward to discussing these important results with the U.S. Food and Drug Administration, and to learning more in the next analysis of overall survival, anticipated this year." Through its recently-acquired Kite subsidiary, Gilead Sciences, Inc. (NASDAQ: GILD) recently announced results from three new analyses for Yescarta (axicabtagene ciloleucel) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL), including both new clinical research and real-world evidence highlighting manufacturing and product characteristics of Yescarta, and outpatient administration of both Yescarta and Tecartus® (brexucabtagene autoleucel) at the 2024 European Hematology Association (EHA) Annual Congress, June 13-16, Madrid. "We are committed to improving survival outcomes for people living with difficult-to-treat blood cancers," said Ibrahim Elhoussieny, Vice President, Medical Affairs, of Kite. "These new data support the potential benefit of utilizing Yescarta in earlier lines of treatment, both in terms of manufacturing success and product characteristics. Additional data support the safety and feasibility of administering CAR T-cell therapy in the outpatient setting. These data contribute to the body of evidence for efficient utilization and delivery of Yescarta and Tecartus and further support our ambition for patients." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group

Phase 3Clinical ResultImmunotherapy

21 Jun 2024

·www.biospace.com

Starton Therapeutics Announces 100% Partial Response or Better in Multiple Myeloma Patients in Interim, Top-line Data from STAR-LLD Phase 1b Clinical Trial

100% of patients enrolled achieved a partial response or better Milder and less frequent drug-related adverse events were observed compared to those associated with Revlimid® No grade 3 or greater adverse events in neutropenia, thrombocytopenia, or diarrhea reported PARAMUS, N.J., June 21, 2024 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary dermal technologies, announced today positive interim top-line data from its low-dose lenalidomide STAR-LLD Phase 1b clinical trial in multiple myeloma (MM). The study, designed to assess the safety, pharmacokinetics, and efficacy of the Company’s STAR-LLD in combination with dexamethasone and bortezomib (Velcade®), met the primary objective of safety and tolerability while being administered by continuous subcutaneous (SC) infusion. All six patients achieved a partial response (PR) or better within 1-3 cycles. “These interim results are encouraging,” stated Dr. Jamie Oliver, Starton’s Chief Medical Officer. “To date, lenalidomide is a cornerstone in treating MM. As a standard of care, Revlimid® is widely used due to its effectiveness in combination with other therapies. However, its toxicity pro unbearable for some, leaving a notable percentage of patients’ intolerant to lenalidomide. STAR-LLD is demonstrating lower toxicity at therapeutic doses, which could potentially improve lenalidomide’s use in MM.” “Lenalidomide intolerance adversely affects treatment efficacy and overall survival, often leading to dose modifications or treatment discontinuation. By successfully demonstrating continuous delivery at a tolerable dose, we are directly addressing the needs of patients and their loved ones,” stated Pedro Lichtinger, Starton’s Chairman and CEO. Tolerance measures a patient's ability to endure minimal adverse effects from a certain drug. Severe intolerance may lead to discontinuity of treatment. The most common side effects associated with Revlimid® during continuous maintenance treatment and contributing to intolerance include neutropenia (79%), thrombocytopenia (72%), anemia (21%), and gastrointestinal issues (40%). The hematologic adverse events lead to treatment interruptions in approximately 30% of patients. By contrast, Starton’s Phase 1b study resulted in no grade 3 or greater adverse events of neutropenia or thrombocytopenia. Although diarrhea was reported by 33% of the patients in Starton’s Phase 1b study at grades 1 and 2 adverse events, this was favorable compared to oral Revlimid®, where diarrhea was observed in approximately 50% or more patients, of which close to 20% of those patients experienced grades 3 or 4 toxicity. Half of the Phase 1b patients reported a confined rash at the injection site, and one patient reported a rash with grade 3, which was treated. Nausea and fatigue were reported at grades 1 and 2. The majority of events reported in the study were not drug-related. The Company will prepare a summary of data on safety and activity for the U.S. Food and Drug Administration (FDA) while patients continue treatment for efficacy endpoints. Phase 2 studies in MM and chronic lymphocytic leukemia (CLL) are planned for 2025. About STAR-LLD STAR-LLD is a continuous delivery lenalidomide (LLD) in development to expand and replace the standard of care for the most common blood cancers, multiple myeloma (MM), and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, grew five-fold when treated with daily lenalidomide, and shrank by 80% with STAR-LLD over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous delivery LLD and 20% of animals in this cohort were tumor-free after 100 days, compared to a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1 bioavailability study in healthy men comparing STAR-LLD to Revlimid® demonstrated the drug is well tolerated and is >91% bioavailable by the subcutaneous route. It was also observed that the Cmax is <90% lower with STAR-LLD than with oral Revlimid®. About Starton Therapeutics Starton Therapeutics is a clinical-stage biotechnology platform company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase the efficacy of approved drugs, make them more tolerable, and expand their potential use. To learn more, visit Forward Looking Statements All statements other than statements of historical facts included in this press release, including, without limitation, statements regarding our plans and objectives for future operations and expectations about current and future clinical trials, constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions and known and unknown risks and uncertainties that could cause our actual results or events to differ materially and adversely from those included within the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements and, except as required by law, the Company undertakes no obligation to disclose any revision to these forward-looking statements whether as a result of new information, future events, or otherwise. Contact Investors@startontx.com

Clinical ResultPhase 1Phase 2

18 Jun 2024

·www.biospace.com

GSK Reignites Blenrep Blockbuster Aspirations With Data from Phase III Studies

Pictured: GSK's office in Dresden, Germany/iStock, 13threephotography After a brief market exit in November 2022, GSK appears to be giving its multiple myeloma treatment Blenrep (belantamab mafodotin) a second chance, with company executives touting its “multi-blockbuster” potential in a virtual oncology-focused investor event on Monday. Much of GSK’s renewed enthusiasm for the antibody-drug conjugate (ADC) comes from promising data from two Phase III studies—DREAMM-7 and DREAMM-8—which saw strong signals of efficacy in Blenrep-based treatment regimens when used in multiple myeloma patients who had undergone at least one prior line of treatment. In DREAMM-7, which compared Blenrep against Johnson & Johnson’s Darzalex (daratumumab), GSK reported a “significant increase” in progression-free survival (PFS) in patients treated with the ADC. The Blenrep regimen resulted in a nearly 60% drop in the risk of disease progression or death versus Darzalex. The PFS benefit was statistically significant, with a p-value of less than 0.00001. In addition, median PFS in the Blenrep arm was 36.6 months, compared to those patients treated with Darzalex who only saw a median PFS of 13.4 months. The difference of approximately 23 months was “statistically significant and clinically meaningful,” according to GSK. At the time of analysis, Blenrep also showed an “early, strong, and clinically meaningful trend” toward better overall survival (OS) versus Darzalex. DREAMM-7 will continue its follow-up for OS. The Blenrep regimen also had superior depth of response than the Darzalex treatment, resulting in more than double the percentage of patients achieving at least complete response. Results from DREAMM-8—which compared a Blenrep-based regimen versus a corresponding treatment schedule that used Takeda’s Velcade (bortezomib)—were similarly promising. Patients treated with GSK’s ADC saw a “statistically significant and clinically meaningful” decrease in the risk of disease progression or death, which was almost 50% lower than in the Velcade group. Median PFS for Velcade treatment was 12.7 months, while it had not yet been reached at the time of analysis in the Blenrep patients. The Blenrep regimen also elicited deeper treatment responses than the Velcade schedule. More than twice the percentage of patients in the Blenrep arm achieved complete response or better than those treated with Velcade. Given these promising data, GSK Chief Commercial Officer Luke Miels estimated during Monday’s investor event that Blenrep could reach peak sales of more than $3 billion, driven mostly by the second-line opportunity in multiple myeloma. Blenrep could eventually dislodge Darzalex as the standard of care in this setting, Miels said. Blenrep, an ADC that targets the BCMA protein, was originally approved under the FDA’s accelerated pathway in August 2020. At the time, it was authorized as a monotherapy for relapsed or refractory multiple myeloma patients who had progressed after prior treatment with a proteasome inhibitor, anti-CD38 antibody and immunomodulatory agent. In November 2022, after falling short of its primary efficacy endpoint in its confirmatory Phase III trial DREAMM-3, GSK decided to pull Blenrep from the U.S. market. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Clinical ResultPhase 3Drug ApprovalImmunotherapyADC

100 Deals associated with Bortezomib

External Link

KEGG	Wiki	ATC	Drug Bank
D03150	Bortezomib	L01XX32	DB00188

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Immunoglobulin Light-Chain Amyloidosis	JP	Janssen Pharmaceutical KK	20 Oct 2006
Waldenstrom Macroglobulinemia	JP	Janssen Pharmaceutical KK	20 Oct 2006
Mantle-Cell Lymphoma	EU	Janssen-Cilag International NV	26 Apr 2004
Mantle-Cell Lymphoma	IS	Janssen-Cilag International NV	26 Apr 2004
Mantle-Cell Lymphoma	LI	Janssen-Cilag International NV	26 Apr 2004
Mantle-Cell Lymphoma	NO	Janssen-Cilag International NV	26 Apr 2004
Multiple Myeloma	US	Takeda Pharmaceuticals U.S.A., Inc.	13 May 2003

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Plasma cell myeloma refractory	Phase 3	CN	Janssen Research & Development LLC	27 Sep 2016
Relapse multiple myeloma	Phase 3	CN	Janssen Research & Development LLC	27 Sep 2016
Acute cellular graft rejection	Phase 3	KR	Asan Medical Center	01 Feb 2015
Diffuse large B-cell lymphoma recurrent	Phase 3	IT	Janssen-Cilag Ltd.	04 Feb 2013
Diffuse large B-cell lymphoma recurrent	Phase 3	IT	Janssen Pharmaceutica NV	04 Feb 2013
Diffuse large B-cell lymphoma refractory	Phase 3	IT	Janssen Pharmaceutica NV	04 Feb 2013
Diffuse large B-cell lymphoma refractory	Phase 3	IT	Janssen-Cilag Ltd.	04 Feb 2013
Diffuse Large B-Cell Lymphoma	Phase 3	CH	Janssen-Cilag Ltd.	01 Apr 2011
Diffuse Large B-Cell Lymphoma	Phase 3	GB	Janssen-Cilag Ltd.	01 Apr 2011
B-Cell Lymphoma	Phase 3	US	Millennium Pharmaceuticals, Inc.	01 Mar 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03319667 (IMROZ, ASCO2024) Manual	Phase 3	Multiple Myeloma First line anti-CD38 monoclonal antibody	446	Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd)	ifubwftrky(myytjnifpc) = locwdvlioj exjxlyyiek (qbywuakcen, 0.406 - 0.876) View more	Positive	24 May 2024
				bortezomib, lenalidomide, and dexamethasone(VRd)	ifubwftrky(myytjnifpc) = omfvjohlqj exjxlyyiek (qbywuakcen ) View more
NCT04751877 (BENEFIT/IFM2020-05, ASCO2024)	Phase 3	high-risk cytogenetic \| impaired renal function	270	Isatuximab (Isa) plus lenalidomide and dexamethasone (Rd) with bortezomib	qmnmgjbbea(nmqyzdpdbw) = 33% vs 20% nxcyqnpvkk (dgxbjgojgz ) View more	Positive	24 May 2024
				Isatuximab (Isa) plus lenalidomide and dexamethasone (Rd)
EHA2024	Not Applicable	Immunoglobulin Light-Chain Amyloidosis	-	CyBorD alone	dycafcizig(wwrufydxla) = wrocetsdlp ipyhqlybfu (lolreqpivr ) View more	Positive	14 May 2024
				Bortezomib	dycafcizig(wwrufydxla) = dlgqpdmdvp ipyhqlybfu (lolreqpivr ) View more
DREAMM-7 and DREAMM-8 (EHA2024)	Not Applicable	Second line lenalidomide-refractory	-	DaraVd	dpdzxbwcgu(jxhskeffda) = kvqywcblqc wfpptcqkhd (cdxzrsihmn ) View more	Positive	14 May 2024
EHA2024	Phase 3	del(17p) \| t(4;14) \| t(14;16) ... View more	709	D-VRd	fhuusnvweu(xqbiiqqxqi) = dfxantzexc outarywovv (xnlzzddpcs ) View more	Positive	14 May 2024
				VRd	fhuusnvweu(xqbiiqqxqi) = xczkmvgobb outarywovv (xnlzzddpcs ) View more
EHA2024	Phase 2	Multiple Myeloma Maintenance	71	Isatuximab-CyBorD	rfmasbtuuk(vsgwcrayfa) = 7% kkgawkfeis (cuqefcumha ) View more	-	14 May 2024
NCT03110562 (BOSTON, EHA2024)	Phase 3	Multiple Myeloma	402	Selinexor 100 mg QW, Bortezomib 1.3 mg/m2 QW, Dexamethasone 20 mg BIW (SVd)	mfywjdcpjb(msgakfesln) = cnhiwsqtxz nawdnquygq (tdzjtyvjsd ) View more	Positive	14 May 2024
				Standard Bortezomib and Dexamethasone (Vd)	mfywjdcpjb(msgakfesln) = uyrzexxfat nawdnquygq (tdzjtyvjsd )
NCT02211755 (AACR2024) Manual	Phase 1	Solid tumor	25	Bortezomib+Clofarabine	cshwqudvbz(syczavzmev) = ouftyrhszf yxfvnfkpaj (mqeqfjinrv ) View more	Negative	05 Apr 2024
NCT02211755 (AACR2024) Manual	Phase 1	Solid tumor	25	Bortezomib+Clofarabine	fsirnistxn(ywgdusxcwl) = luadxyoghr ozrjsleavv (vqpxmyvjhn ) View more	Negative	05 Apr 2024
NCT01439750 (AACR2024) Manual	Phase 1	Mantle-Cell Lymphoma	13	velcade + cladribine+ rituximab	aaaxngqbvq(mwzxnzgdun) = No subject experienced dose limited toxicity (DLT) at either level 1 or 2, one possible DLT (infectious colitis) was observed on a subject during 2nd cycle at level 3. Then no additional DLTs were seen in 3 subjects added to level 3 bwmoairefa (nsqqhoawqk ) View more	Positive	05 Apr 2024

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