Last update 05 Sep 2024

Copanlisib dihydrochloride

Last update 05 Sep 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Copanlisib, Copanlisib Hydrochloride, 可泮利塞

+ [9]

Target

PI3Kα x PI3Kδ

Mechanism

PI3Kα inhibitors(Phosphatidylinositol 3 kinase alpha inhibitors), PI3Kδ inhibitors(Phosphatidylinositol 3 kinase delta inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [7]

Active Indication

Follicular LymphomaRefractory Indolent Non-Hodgkin LymphomaB-cell lymphoma recurrent+ [44]

Inactive Indication

Adult Acute Lymphocytic LeukemiaAdvanced breast cancerAdvanced HER2-Positive Breast Carcinoma+ [37]

Originator Organization

Bayer AG

Active Organization

Bayer AG

National Cancer Institute

Optimapharm doo

+ [2]

Inactive Organization

Bayer Healthcare Co., Ltd.

Bayer Pharma AG

Drug Highest PhaseApproved

First Approval Date

US (14 Sep 2017),

Follicular Lymphoma

RegulationFast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN), Special Review Project (CN)

Structure

Molecular FormulaC23H29ClN8O4

InChIKeyCLMVIXVYZUJPOI-UHFFFAOYSA-N

CAS Registry1402152-13-9

Clinical Trials associated with Copanlisib dihydrochloride

NCT05687721 / Not yet recruitingPhase 1/2

A Phase II Trial With Copanlisib Plus Avelumab as a Maintenance Therapy for Metastatic Bladder Cancer After Platinum-based Chemotherapy

Patients with metastatic bladder cancer are usually treated with chemotherapy. If their cancers do not progress after chemotherapy, they can be enrolled into this study and receive a standard-of-care immunotherapy medication named avelumab plus a study drug named copanlisib.

Start Date01 Nov 2024

Sponsor / Collaborator

VA Office of Research and Development

[+1]

NCT06218667 / RecruitingPhase 1/2IIT

CHARIOT: A Phase 1b/2 Study of Androgen Deprivation Therapy and Copanlisib in High-Risk Localized Prostate Cancer Patients Prior to Radical Prostatectomy

The researchers are doing this study to find out whether copanlisib in combination with degarelix, given before standard surgical treatment (radical prostatectomy), is a safe and effective treatment that causes few or mild side effects for people who have localized high-risk prostate cancer.

Start Date11 Jan 2024

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

NCT05082025 / Active, not recruitingPhase 2IIT

Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations

The purpose of this study is to evaluate the efficacy and safety of copanlisib in combination with fulvestrant in advanced hormone receptor-positive (HR+) solid tumors harboring alterations that activate the Phosphatidylinositol-3 kinase (PI3K) pathway.

Start Date27 Sep 2022

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

100 Clinical Results associated with Copanlisib dihydrochloride

100 Translational Medicine associated with Copanlisib dihydrochloride

100 Patents (Medical) associated with Copanlisib dihydrochloride

157

Literatures (Medical) associated with Copanlisib dihydrochloride

01 May 2024·PharmacoEconomics

Budget Impact of Introducing Fixed-Duration Mosunetuzumab for the Treatment of Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy in the USA

Article

Author: Shapouri, Sheila ; Matasar, Matthew ; Parisé, Hélène ; Bercaw, Eric ; Wu, Mei ; Kim, Eunice ; Lin, Shih-Wen

OBJECTIVE:

This study aimed to assess the budget impact of introducing fixed-duration mosunetuzumab as a treatment option for adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies and to estimate the total cumulative costs per patient in the USA.

METHODS:

A 3-year budget impact model was developed for a hypothetical 1-million-member cohort enrolled in a mixed commercial/Medicare health plan. Comparators were: axicabtagene ciloleucel, tisagenlecleucel, tazemetostat, rituximab plus lenalidomide, copanlisib, and older therapies (rituximab or obinutuzumab ± chemotherapy). Costs per patient comprised treatment-associated costs including the drug, its administration, adverse events, and routine care. Dosing and safety data were ascertained from respective package inserts and clinical trial data. Drug costs (March 2023) were estimated based on the average wholesale acquisition cost reported in AnalySource^®, and all other costs were based on published sources and inflated to 2022 US dollars. Market shares were obtained from Genentech internal projections and expert opinion. Budget impact outcomes were presented on a per-member per-month basis.

RESULTS:

Compared with a scenario without mosunetuzumab, its introduction over 3 years resulted in a budget increase of $69,812 (1% increase) and an average per-member per-month budget impact of $0.0019. Among the newer therapies, mosunetuzumab had the second-lowest cumulative per patient cost (mosunetuzumab = $202,039; axicabtagene ciloleucel = $505,845; tisagenlecleucel = $476,293; rituximab plus lenalidomide = $263,520; tazemetostat = $250,665; copanlisib = $127,293) and drug costs, and its introduction only increased total drug costs by 0.1%. By year 3, the cumulative difference in the per patient cost with mosunetuzumab was -$303,805 versus axicabtagene ciloleucel, -$274,254 versus tisagenlecleucel, -$61,481 versus rituximab plus lenalidomide, -$48,625 versus tazemetostat, and $74,747 versus copanlisib. Older therapies were less costly with 3-year cumulative costs that ranged from $36,512 to $147,885.

CONCLUSIONS:

Over 3 years, the estimated cumulative per patient cost of mosunetuzumab is lower than most available newer therapies, resulting in a small increase in the budget after its formulary adoption for the treatment of relapsed or refractory follicular lymphoma.

01 Feb 2024·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

β1 integrin mediates unresponsiveness to PI3Kα inhibition for radiochemosensitization of 3D HNSCC models

Article

Author: Elser, Marc ; Korovina, Irina ; Borodins, Olegs ; Cordes, Nils ; Willers, Henning ; Seifert, Michael

Phosphoinositide 3-kinase (PI3K)-α represents a key intracellular signal transducer involved in the regulation of key cell functions such as cell survival and proliferation. Excessive activation of PI3Kα is considered one of the major determinants of cancer therapy resistance. Despite preclinical and clinical evaluation of PI3Kα inhibitors in various tumor entities, including head and neck squamous cell carcinoma (HNSCC), it remains elusive how conventional radiochemotherapy can be enhanced by concurrent PI3K inhibitors and how PI3K deactivation mechanistically exerts its effects. Here, we investigated the radiochemosensitizing potential and adaptation mechanisms of four PI3K inhibitors, Alpelisib, Copanlisib, AZD8186, and Idelalisib in eight HNSCC models grown under physiological, three-dimensional matrix conditions. We demonstrate that Alpelisib, Copanlisib and AZD8186 but not Idelalisib enhance radio- and radiochemosensitivity in the majority of HNSCC cell models (= responders) in a manner independent of PIK3CA mutation status. However, Alpelisib promotes MAPK signaling in non-responders compared to responders without profound impact on Akt, NFκB, TGFβ, JAK/STAT signaling and DNA repair. Bioinformatic analyses identified unique gene mutations associated with extracellular matrix to be more frequent in non-responder cell models than in responders. Finally, we demonstrate that targeting of the cell adhesion molecule β1 integrin on top of Alpelisib sensitizes non-responders to radiochemotherapy. Taken together, our study demonstrates the sensitizing potential of Alpelisib and other PI3K inhibitors in HNSCC models and uncovers a novel β1 integrin-dependent mechanism that may prove useful in overcoming resistance to PI3K inhibitors.

22 Jan 2024·Cancer research communications

Lung Fibroblasts Take up Breast Cancer Cell-derived Extracellular Vesicles Partially Through MEK2-dependent Macropinocytosis

Article

Author: Hsueh, Brent W ; Song, Zhixuan ; Tran, Sheila V ; Wang, Shizhen Emily ; Cao, Minghui ; Wang, Jingyi ; Wan, Yuhao ; Zhao, Yue

Abstract:

Extracellular vesicles (EV) have emerged as critical effectors in the cross-talk between cancer and normal cells by transferring intracellular materials between adjacent or distant cells. Previous studies have begun to elucidate how cancer cells, by secreting EVs, adapt normal cells at a metastatic site to facilitate cancer cell metastasis. In this study, we utilized a high-content microscopic screening platform to investigate the mechanisms of EV uptake by primary lung fibroblasts. A selected library containing 90 FDA-approved anticancer drugs was screened for the effect on fibroblast uptake of EVs from MDA-MB-231 breast cancer cells. Among the drugs identified to inhibit EV uptake without exerting significant cytotoxicity, we validated the dose-dependent effect of Trametinib (a MEK1/2 inhibitor) and Copanlisib (a PI3K inhibitor). Trametinib suppressed macropinocytosis in lung fibroblasts and inhibited EV uptake with a higher potency comparing with Copanlisib. Gene knockdown and overexpression studies demonstrated that uptake of MDA-MB-231 EVs by lung fibroblasts required MEK2. These findings provide important insights into the mechanisms underlying lung fibroblast uptake of breast cancer cell-derived EVs, which could play a role in breast cancer metastasis to the lungs and suggest potential therapeutic targets for preventing or treating this deadly disease.

Significance::

Through a phenotypic screen, we found that MEK inhibitor Trametinib suppressed EV uptake and macropinocytosis in lung fibroblasts, and that EV uptake is mediated by MEK2 in these cells. Our results suggest that MEK2 inhibition could serve as a strategy to block cancer EV uptake by lung fibroblasts.

News (Medical) associated with Copanlisib dihydrochloride

08 Aug 2024

·www.echemi.com

Regulatory Challenges of Gene Therapy and Cancer Drugs: Industry Trends Behind the Withdrawal of Zydelig and FDA's Response

In 2022, Gilead announced that it would voluntarily withdraw Zydelig from the U.S. market for two lymphoma treatments, a full six years after it suspended the trial due to patient deaths. A Gilead spokesperson clarified that the withdrawal was not due to safety concerns, but rather because of insurmountable obstacles to recruiting subjects for additional research trials required by the FDA. Nevertheless, Zydelig retains its eligibility for the treatment of chronic lymphocytic leukemia and remains on the market for patients. Notably, the withdrawal of Zydelig coincides with the withdrawal of several other PI3K inhibitors used to treat follicular lymphoma: Secura Bio's duvelisib (trade name Copiktra) withdrawn in December 2021, TG's umbralisib (trade name Ukoniq) withdrawn in 2022 (here may be a clerical error, read "February" or adjusted to another month), Bayer's copanlisib (trade name Aliqopa) also withdrew from the market in November 2023. Together, these events outline an industry trend. A study published in JAMA Internal Medicine reveals an interesting data point: Before Gilead decided to withdraw some uses of Zydelig from the U.S. market, its global sales had reached a staggering $842 million. This reflects the wide application and high recognition of the drug in the market, although it ultimately failed to fully meet all expectations for various reasons. Interestingly, the pharmaceutical industry sometimes employs a series of ingenious strategies to speed up the process of bringing a product to market. Eli Lilly, for example, successfully used all four avenues of acceleration to bring oncology product Lartruvo to market in 2016. The key clinical data for the product is based only on the results of a trial involving 133 patients, and while the results showed a possible positive impact on survival outcomes for sarcoma, a cancer that affects muscles and other soft tissues, the specific effect on slowing cancer growth is unclear. However, just over two years later, a larger study revealed that Lartruvo had no significant impact on patient survival, and Eli Lilly had to withdraw it from the market. Despite this, Lartruvo still managed to achieve a whopping $500 million in sales during its short market life. Among the many drugs approved for accelerated marketing, oncology products have become the hardest hit by ineffective drugs. However, as the development of therapies continues to deepen and progress, new questions continue to emerge and are presented to the FDA. In particular, advanced therapies represented by cell and gene therapies, when they meet with the accelerated approval system, have brought unprecedented challenges to this "old revolution". Given the complexity of cell and gene therapies and the relative lack of understanding of their safety, once ineffective advanced therapies are released to the market, the consequences and impacts will be far beyond the scope of small molecule ineffective drugs. For example, the tragic death of a three-year-old boy in a clinical trial of Pfizer's fordadistrogene movaparvovec, a gene therapy for Duchenne muscular dystrophy, highlights the shortcomings and limitations of researchers in predicting the potential for serious adverse events. As vectors of ssRNA (single stranded RNA), viruses (such as AAV) play a critical role in gene therapy, but can also cause a series of serious adverse events including cardiopulmonary failure, myocarditis, thrombotic microangiopathy, and acute liver failure. These potential risks have forced the FDA to be more cautious and rigorous in approving gene therapies. Speaking at the annual meeting of the American Society for Gene and Cell Therapy, CBER director Peter Marks said speeding up the withdrawal of approved gene therapies could be easier and faster than for small-molecule therapies. At the same time, he stressed that "accelerated approval of gene therapy is not a get-out-of-jail-free ticket." The FDA will not hesitate to withdraw accelerated approval of rare disease gene therapies if they fail subsequent confirmatory trials." Marks further points out that the "one-size-fits-all" nature of gene therapy makes confirmatory studies easier to follow and monitor patients over time. It also makes for greater clarity and clarity on the question of whether to withdraw gene therapy. In contrast, there may be more controversy and disagreement in the decision process of withdrawing cancer therapy. Marks, however, said the FDA would only withdraw gene therapy if it was clear that the patient benefit was likely to be "minimal" but the side effects were significant. He cited a case in which Bluebird Bio's sickle cell gene therapy Lyfgenia (lovotibeglogene autotemcel) caused patients to develop myelodysplastic syndrome and leukemia during treatment. The product was approved by the FDA in December 2023 with a boxed warning about hematologic malignancies. Marks said it is unclear whether these malignancies are related to the preconditioning regimen associated with Lyfgenia treatment, the underlying disease, or the gene therapy itself. In addition, the case of drug manufacturers refusing to voluntarily withdraw the market is not unique in the history of FDA accelerated approval. Everything from the withdrawal of Makena, a drug that reduced the risk of preterm birth, after 12 years on the market, to the legal battle between Pepaxto and the FDA highlights the complexity and seriousness of the issue. In the face of these challenges, FDA has to seek the support of legislation to strengthen its regulatory power and capability. Fortunately, the introduction of the FDORA (Comprehensive Food and Drug Reform Act) bill provides the FDA with greater flexibility and autonomy to act without public hearings.

Drug ApprovalGene Therapy

18 Jan 2024

·www.biospace.com

Bayer Rolls Out New Operating Model, Eliminates Managerial Staff

Pictured: Bayer's office in Berlin, Germany/iStock, Elenasfotos Bayer on Wednesday revealed a new operating model meant to cut back on bureaucracy and hierarchies, as well as streamline the company’s structures, in an effort to boost its operational efficiency. The model, dubbed Dynamic Shared Ownership (DSO), is designed to “make the company much more agile,” according to Bayer’s announcement. The restructuring initiative will include job cuts over the next couple of months to be completed by the end of 2025, at the latest. “In line with the principles of DSO, the implementation will be largely decentralized, meaning that its scope cannot be quantified for the time being,” according to the company. Bayer employs some 22,200 staff in Germany and, as of the end of 2023, had a global headcount of more than 101,000. Though Bayer has not specified how many posts the layoffs will affect, Barbara Gansewendt, chairwoman of the Group Executives’ Committee at the company, said in a statement that it “will come at the expense of many managerial employees.” The committee represents the interests of manager-level staff at Bayer. Gansewendt called these layoffs an “extremely bitter development” for Bayer, adding that there is “no viable alternative” for the company. Affected staff will receive an “attractive” severance pay and will be given adequate support to help them find “new employment as quickly as possible,” she said. The new DSO operating model comes after new Bayer CEO Bill Anderson hinted at major structural changes during its third-quarter earnings report in November 2023. At the time, Anderson was expressed disappointment in the company’s performance, pointing to its “zero cash flow” which he called “simply not acceptable.” A Roche alum, Anderson won his seat at Bayer in February 2023, with the unanimous support of the company’s supervisory board. He formally assumed the helm in June 2023. Anderson inherits from the previous CEO—Werner Baumann, who had served Bayer for 35 years—a company reeling from the disastrous acquisition of the agricultural giant Monsanto. The buyout, signed in September 2016 for $66 billion, was at the time touted by Baumann as a “major step forward” for the company’s crop science business. In the years that followed, however, Monsanto’s weed-killer Roundup would be plagued by claims of cancer, ultimately racking up more than 42,000 lawsuits for Bayer. In its third-quarter 2023 financial report, Bayer posted a net debt of around $42.18 billion. Beyond the Monsanto debacle, Bayer’s pharmaceuticals business also suffered major setbacks last year. In November 2023, the company voluntarily pulled its follicular lymphoma therapy Aliqopa (copanlisib) from the U.S. market after it failed its confirmatory Phase III study. Aliqopa was given accelerated approval in September 2017. A few days later, Bayer decided to pull the plug on the Phase III OCEANIC-AF study of its inhibitor factor XIa asundexian after an Independent Data Monitoring Committee found that it had “inferior efficacy” to BMS and Pfizer’s Eliquis (apixaban). Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Phase 3Acquisition

07 Dec 2023

·www.businesswire.com

BostonGene Announces Ten Presentations at the 65th American Society of Hematology Annual Meeting & Exposition

WALTHAM, Mass.--( BUSINESS WIRE )-- BostonGene , a leading provider of AI-driven molecular and immune profiling solutions, today announced the selection of four abstracts for oral presentation, four abstracts as poster presentations, and two abstracts for online publication at the 65 th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023, in San Diego, California and virtually. BostonGene will exhibit in booth #2350. “ We look forward to showcasing compelling data at ASH, which will underscore the pivotal role of molecular and immune profiling alongside advanced analytics in propelling precision medicine for individuals battling cancer,” said Nathan Fowler, MD, Chief Medical Officer at BostonGene. Details of the presentations are below: Oral presentations: Abstract: 601 Title: Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up Date & time: Sunday, December 10, 2023 | 4:30 PM Location: Room 6CF - San Diego Convention Center Presenter: Stephen J Schuster, MD , Abramson Cancer Center, University of Pennsylvania This presentation highlights results from the Phase 2 ELARA trial that show efficacy, safety, pharmacokinetic, and exploratory biomarker analyses in relapsed/refractory follicular lymphoma patients treated with tisagenlecleucel after a median follow-up of more than 3 years. Higher baseline levels of CD8+ naive T cells are associated with improved long-term clinical outcomes. Research conducted in collaboration with The University of Texas MD Anderson Cancer Center, Abramson Cancer Center, University of Pennsylvania, The University of Melbourne, Hospital Universitario, Oslo University Hospital, Royal Brisbane Hospital, University of Michigan, City of Hope National Medical Center, Moffitt Cancer Center, Hospices Civils de Lyon and Claude Bernard Lyon 1 University, Kyushu University Hospital, Tohoku University Graduate School of Medicine, University of Amsterdam, University of California San Francisco, University of Chicago, Royal Prince Alfred Hospital, Universidad de Sevilla, Oregon Health and Science University, University of Cologne, West German Cancer Center, University of Duisburg-Essen, IRCCS San Raffaele Scientific Institute, Hokkaido University, King’s College London, University of Kansas Medical Center, Ordensklinikum Linz Barmherzige Schwestern-Elisabethinen, Universitair Ziekenhuis Gent, University Hospital of Ulm, University of Bologna, Cambridge University, Novartis Pharmaceuticals Corporation, Novartis Pharma AG, Hôpital Saint-Louis, Ludwig-Maximilians-University Hospital Abstract: 851 Title: A CD5 Gene Signature Identifies Diffuse Large B-Cell Lymphomas Sensitive to Bruton's Tyrosine Kinase Inhibition Date & time: Monday, December 11, 2023: 3:45 PM Location: Room 6DE - San Diego Convention Center Presenter: Alan Cooper, University of Chicago This study highlights the discovery of a novel transcriptomic-based biomarker of BTK inhibitors (BTK-i) response in DLBCL patients. The biomarker, a CD5 gene signature, expands upon existing genetic DLBCL classifications by identifying DLBCL patients that can benefit from BTK-i, warranting further prospective validation in BTK-i clinical trials. Research conducted in collaboration with the University of Chicago, City of Hope National Medical Center, The University of British Colombia, Janssen Research & Development, Centre for Lymphoid Cancer Abstract: 905 Title: Machine Learning (ML)-Enabled Automation for High-Throughput Data Processing in Flow Cytometry Date & time: Monday, December 11, 2023 | 3:45 PM Location: Room 6CF - San Diego Convention Center Presenter: Anna Kamysheva, MSc, BostonGene This presentation describes BostonGene’s development of an ML-based algorithm for automated cell-type labeling that enables the detection of rare and/or new cell populations with high speed and accuracy. This algorithm is applicable in clinical settings, particularly for detecting hematological abnormalities and cancers. Abstract: 983 Title: Addition of Acalabrutinib to Lenalidomide and Rituximab Induces High Complete Response Rates in Patients with Previously Untreated Follicular Lymphoma: Results of a Phase II Study Date & time: Monday, December 11, 2023 | 5:30 PM Location: Grand Hall C - Manchester Grand Hyatt San Diego Presenter: Paolo Strati, MD, MD Anderson The study demonstrates the safety and efficacy of lenalidomide and rituximab treatment in combination with acalabrutinib in previously untreated FL patients and highlights the use of bulk RNA sequencing with deconvolution to analyze the biological effects of this treatment combination on peripheral blood immune cells. Research conducted in collaboration with The University of Texas MD Anderson Cancer Center Poster presentations: Abstract: 1676 Title: Preliminary Analysis of an Ongoing Phase II Study of Response-Adapted Therapy with Copanlisib and Rituximab for Untreated Follicular Lymphoma Date & time: Saturday, December 9, 2023 | 5:30 PM - 7:30 PM Location: Halls G-H - San Diego Convention Center Presenter: Rahul Lakhotia, MBBS, National Cancer Institute, National Institutes of Health This study describes the preliminary analysis (including safety and efficacy) of an ongoing “window of opportunity” study of copanlisib, followed by response-adapted copanlisib and rituximab in treatment-naïve patients with follicular lymphoma (FL). Gene expression profiling was used to identify high-risk patients and find a predictive signature of response to PI3K inhibitor. Research conducted in collaboration with the National Cancer Institute, National Institutes of Health and Mayo Clinic Abstract : 3644 Title: A Novel Comprehensive Tumor-Informed Plasma cfDNA Assay to Monitor Minimal Residual Disease for Hematological and Solid Malignancies Date & time: Sunday, December 10, 2023 |6:00 PM - 8:00 PM Location: Halls G-H - San Diego Convention Center Presenter: Anastasiya Yudina, MSc, BostonGene This presentation describes our cell-free DNA (cfDNA) testing platform for minimal residual disease (MRD) monitoring. It encompasses all major clinically reliable genetic hotspots events and can detect clinically relevant mutations in plasma samples before clinical manifestation. Abstract: 3001 Title: Genomic and Transcriptomic Profiles of Blastoid and Pleomorphic Mantle Cell Lymphoma Are Distinct from Classic Histology Mantle Cell Lymphoma Date & time: Sunday, December 10, 2023 |6:00 PM - 8:00 PM Location: Halls G-H - San Diego Convention Center Presenter: Preetesh Jain, MD, MBBS, PhD, DM, MD Anderson This presentation highlights the use of BostonGene’s integrated genomic and transcriptomic analysis platform to provide a comprehensive portrait of the molecular differences between blastoid and pleomorphic mantle cell lymphoma (MCL), revealing mechanistic insights that can be used for the development of more effective therapeutic strategies. Research conducted in collaboration with The University of Texas MD Anderson Cancer Center Abstract: 4872 Title: Long-Term Durable Responses in Relapsed/Refractory (r/r) ALL, DLBCL, and FL Patients Treated with Tisagenlecleucel and Its Association with Persistence of CAR T-Cells Date & time: Monday, December 11, 2023: 6:00 PM - 8:00 PM Location: Halls G-H - San Diego Convention Center Presenter: Rakesh Awasthi, PhD , Novartis Institutes for BioMedical Research This study highlights a positive association between chimeric antigen receptor (CAR) persistence in peripheral blood post tisagenlecleucel (tisa-cel) infusion and durable clinical responses across three indications. Research conducted in collaboration with Novartis Institutes for BioMedical Research, Novartis Pharmaceuticals Corporation, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Intermountain Primary Children’s Hospital, Huntsman Cancer Institute, Spencer Fox Eccles School of Medicine at the University of Utah, Goethe University Frankfurt, University Hospital, Knight Cancer Institute, Oregon Health & Science University, Emory University School of Medicine, Medical University of Vienna, Université de Paris, Klinikum der Universität, LMU München, MD Anderson Cancer Center Online publications: Title: Test-the-Test: Clinical Utility of Comprehensive Whole Exome Sequencing and RNA-Seq for Patients with Lymphoma This study shows an acceptable turn-around-time (TAT) of 8 days for the delivery of clinical reports that include clinically relevant findings and matched clinical trials, demonstrating the feasibility of using comprehensive WES and RNA-seq molecular profiling for lymphoma patients. Research conducted in collaboration with The University of Texas MD Anderson Cancer Center Title: Molecular Findings on Plasma Cell-Free DNA Analysis Among Adults with Histiocytic Neoplasms This study describes the use of cell-free DNA (cfDNA) analysis to evaluate the molecular findings in adults with histiocytic neoplasms, highlighting cfDNA as a potential viable tool for discovering driver mutations in multiple cancers. Research conducted in collaboration with The University of Alabama, Mayo Clinic In addition to the poster presentations, the abstracts have been published online in the November supplemental issue of “ Blood .” For more information, please visit the 65th ASH Annual Meeting and Exposition website at https://www.hematology.org/meetings/annual-meeting/abstracts . About BostonGene Corporation BostonGene has a mission to provide transformative, AI-integrated molecular analytics and biomarker discovery for precision matching of therapies to improve the lives of patients living with cancer and other immune-related diseases. BostonGene’s concierge-service model provides customized client solutions using a multi-omic approach prioritized for real-world impact to optimize standard-of-care therapies, accelerate research and provide cost-effective, measurable data-driven results. BostonGene’s tests reveal key drivers of each patient’s unique disease profile, including an in-depth profile of the immune microenvironment, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies. Through these comprehensive analyses, BostonGene’s tests generate a personalized roadmap for therapeutic decision-making for each patient. For more information, visit BostonGene at http://www.BostonGene.com.

Phase 2ASHClinical Result

100 Deals associated with Copanlisib dihydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Copanlisib dihydrochloride	L01XX61	DB12483

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Follicular Lymphoma	US	Bayer HealthCare Pharmaceuticals, Inc.	14 Sep 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Marginal Zone B-Cell Lymphoma	NDA/BLA	EU	Bayer AG	12 Jun 2021
Non-Hodgkin Lymphoma	NDA/BLA	CN	Bayer AG	10 Mar 2021
Indolent Non-Hodgkin Lymphoma	Phase 3	US	Bayer Pharma AG	06 Jan 2016
Indolent Non-Hodgkin Lymphoma	Phase 3	US	Bayer Healthcare Co., Ltd.	06 Jan 2016
Indolent Non-Hodgkin Lymphoma	Phase 3	AR	Bayer Healthcare Co., Ltd.	06 Jan 2016
Indolent Non-Hodgkin Lymphoma	Phase 3	AR	Bayer Pharma AG	06 Jan 2016
Indolent Non-Hodgkin Lymphoma	Phase 3	AU	Bayer Pharma AG	06 Jan 2016
Indolent Non-Hodgkin Lymphoma	Phase 3	AU	Bayer Healthcare Co., Ltd.	06 Jan 2016
Indolent Non-Hodgkin Lymphoma	Phase 3	AT	Bayer Healthcare Co., Ltd.	06 Jan 2016
Indolent Non-Hodgkin Lymphoma	Phase 3	AT	Bayer Pharma AG	06 Jan 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03939897 (CTgov)	Phase 1/2	Breast cancer recurrent \| Hormone Receptor Positive Breast Adenocarcinoma \| Metastatic breast cancer ... View more	24	Multigated Acquisition Scan+Copanlisib Hydrochloride+Fulvestrant+abemaciclib (Phase I Part A Dose Level 1 (Copanlisib, Abemaciclib, Fulvestrant))	htuhehsqqn(pkcoevpteu) = txozbohsvu ljhvnaxino (ktftnobqbu, hnnvgbvdwh - kumhuxzivm) View more	-	30 Jul 2024
NCT03939897 (CTgov)	Phase 1/2		24	Multigated Acquisition Scan+Copanlisib Hydrochloride+Fulvestrant+abemaciclib (Phase I Part A Dose Level 2 (Copanlisib, Abemaciclib, Fulvestrant))	htuhehsqqn(pkcoevpteu) = mqwsildgsh ljhvnaxino (ktftnobqbu, kquqmthjov - vbgjhuddjx) View more	-	30 Jul 2024
NCT04933617 (CTgov)	Phase 1	High grade B-cell lymphoma \| T-cell/histiocyte rich large B-cell lymphoma \| Burkitt Lymphoma	8	copanlisib (All Participants)	cehpkyntpb(rcsxrnaqku) = mcrkpmeqot kowyjwqqxl (qhafgfqswg, gvbobplxtm - zfdufdzxaa)	-	09 Jul 2024
NCT04933617 (CTgov)	Phase 1		8	Copanlisib (Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib)	iqojqugcwi(kpwmqoevjj) = idhctjyxyw jsbkmhgwgz (kvwvhyanix, sfjsbwdkmw - xqcevcvnjh) View more	-	09 Jul 2024
NCT03484819 (ASH2023)	Phase 2	Mediastinal large B-cell lymphoma \| Diffuse large B-cell lymphoma recurrent	106	Copanlisib	howggtecjo(dpbywveliz) = ldzcgsstyy rjtuoziugm (hpgbffbqki, 5 - 57)	-	11 Dec 2023
NCT04572763 (ASH2023)	Phase 1	Diffuse large B-cell lymphoma recurrent	12	Copanlisib	vlntlqqauy(wrwxervhop) = hzbwhkxosn smneaixhwv (mjjtrujaxt ) View more	-	09 Dec 2023
ASH2023	Phase 2	Follicular Lymphoma	28	Copanlisib 60mg + Rituximab 375mg	hdscxwtgnp(koywezrntx) = etvimzgaiu celebrglhw (dbyywrxdyt ) View more	-	09 Dec 2023
NCT04433182 (FIL Copa-RB, ASH2023)	Phase 2	Diffuse large B-cell lymphoma recurrent	37	Copanlisib + Rituximab + Bendamustine	nmmfkltmge(tcxkfvrlep) = qzpklwmobs xfsbiuhhpt (euuwgmcklh, 13.6 - 38.5) View more	-	09 Dec 2023
ASH2023	Phase 1	Non-Hodgkin Lymphoma \| Richter's syndrome	25	Copanlisib+Nivolumab	guhixeotde(mdixmjnqnc) = jsioqgcvvy lckuytbdtg (vxgctypwev ) View more	-	09 Dec 2023
NCT02369016 (CHRONOS-2, CTgov)	Phase 3	Refractory Indolent Non-Hodgkin Lymphoma	25	Copanlisib (Copanlisib (BAY80-6946, Aliqopa))	bwegdvgfol(yxjpamggzn) = dhbxdrwnxs dpgbyoawdr (bbcoycgddy, yybrxzaadl - nkfsvglfoj) View more	-	18 Nov 2023
NCT02369016 (CHRONOS-2, CTgov)	Phase 3	Refractory Indolent Non-Hodgkin Lymphoma	25	placebo (Placebo)	bwegdvgfol(yxjpamggzn) = niasycioot dpgbyoawdr (bbcoycgddy, dxwtowshdz - fozmeyukph) View more	-	18 Nov 2023
NCT04317105 (NCI10221, ESMO2023)	Phase 2	Advanced Malignant Solid Neoplasm	-	Copanlisib	ddzmokevkj(hkorruosng) = helewyqfsx blpisufbhj (hcmmbxxuwj )	-	23 Oct 2023
NCT01660451 (CHRONOS-1, ASCO2023) Manual	Phase 2	Refractory Follicular Lymphoma	104	copanlisib	masjfiipom(ilojpvknmj) = bofiprnpwt tbkwvwtsaw (pssemdcdzf ) View more	Positive	26 May 2023

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