Dublin, July 30, 2020 (GLOBE NEWSWIRE) -- The "Peripheral T-Cell Lymphoma (PTCL) - Market Insights, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
This report delivers an in-depth understanding of the PTCL, historical and forecasted epidemiology as well as the PTCL market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The PTCL market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM PTCL market size from 2017 to 2030. The report also covers current PTCL treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of PTCL, Stage-specific Incident Cases of PTCL, and Subtype-specific Cases of PTCL, a scenario of PTCL in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.
Key Findings
Drug Chapters
This segment of the PTCL report encloses the detailed analysis of the mid- and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.
Emerging Drugs
Denileukin diftitox: Eisai
Denileukin diftitox (DD) is a recombinant cytotoxic fusion protein which is being developed by Eisai. The drug is administered intravenously, that binds the enzymatically active portion of the diphtheria toxin to the receptor-binding domain of the interleukin-2 molecule, thereby targeting cells producing the IL-2 receptor. Denileukin diftitox is already approved with name, Ontak for Cutaneous T-cell Lymphoma. The drug candidate is in Phase II stage of development for Peripheral T-cell lymphoma (PTCL) in Japan.
Azacitidine (CC-486): Celgene Corporation
Azacitidine (CC-486) is being developed by Celgene Corporation. Azacitidine (CC-486) is an oral hypomethylating agent that incorporates into DNA and RNA, allowing sustained epigenetic regulation due to prolonged exposure. The main mechanism of action is thought to be hypomethylation of DNA, as well as direct cytotoxicity to abnormal hematopoietic cells in the bone marrow. Currently, the company is investigating the molecule in two phase III clinical trial for Relapsed or Refractory AITL, and phase II clinical trial for Previously Untreated PTCL.
HBI-8000: HUYA Bioscience International/Quintiles
HBI-8000 (Chidamide/CS055), is a member of the benzamide class of histone deacetylase inhibitors (HDACIs), and HUYA Bioscience International is developing this molecule, as the first approved, oral class I selective HDACI. It works by controlling how tightly DNA is wound around histone proteins, which regulate gene expression. HHBI-8000 became the first benzamide HDAC inhibitor approved worldwide when the drug was approved for the treatment of PTCL in China, where it is now marketed under the trade name Epidaza. Currently, the company is investigating the molecule in phase II clinical trial in Japan, in patients with relapsed or refractory PTCL.
Copiktra (Duvelisib): Verastem
Copiktra (Duvelisib), is a targeted oral inhibitor of phosphoinositide 3-kinase developed by Verastem. The phosphoinositide 3-kinase (PI3K) signaling pathway is a key regulator of cancer proliferation (rapid increase or spread) and metastasis (development of secondary growths away from a primary site of cancer). Currently, the company is investigating the molecule in phase II PRIMO Study in patients with relapsed or refractory PTCL. The company is planning to build upon their existing Fast Track Designation and Orphan Drug Designation and submit a regulatory package to the US FDA to broaden the use of COPIKTRA and to include treatment of PTCL.
Tislelizumab: BeiGene
Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti-PD-1 monoclonal antibody, administered intravenously that is specifically designed to minimize binding to FcR on macrophages. Currently, the molecule is under investigation in phase II clinical study, relapsed or refractory mature T- and NK- Neoplasms (nasal or non-nasal type, peripheral T-cell lymphoma - not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, mycosis fungoides, or Sezary syndrome).
Keytruda: Merck Sharp & Dohme Corp
Keytruda is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype against PD-1, designed to block its interaction with PD-L1 and PD-L2 directly which is developed by Merck. Moreover, pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the antitumor immune response.
SP-02 (Darinaparsin, ZIO-101): Solasia Pharma
A novel mitochondrial-targeted agent (organic arsenic) SP-02 is being developed by Solasia Pharma for the treatment of various hematologic and solid cancers. It is being developed to administer intravenously for the treatment of PTCL. The exact mechanism of darinaparsin is not known, but it appears to generate volatile cytotoxic arsenic compounds when glutathione (GSH) concentrations are low.
Ruxolitinib: Incyte/Novartis
Ruxolitinib is an orally administered selective kinase inhibitor that inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2. Incyte and Novartis together are developing Ruxolitinib, which is in phase II stage development for PTCL in collaboration with the University of Nebraska. Ruxolitinib is marketed under the brand name Jakafi for the treatment of Myelofibrosis, including Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis and post-essential Thrombocythemia Myelofibrosis.
Market Outlook
Treatment for PTCL aims to cure and includes the use of combination chemotherapy regimens, localized radiotherapy, stem cell transplants and steroid therapy, etc. It is most often treated with a combination of chemotherapies which includes CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) and CHOEP or EPOCH (etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone). In some cases, stem cell or bone marrow transplant is recommended at the end of combination chemotherapy.
There are only five FDA approved products for PTCL treatment, including Beleodaq (Belinostat, Acrotech Biopharma); Istodax (Romidepsin, Celgene), Folotyn (Pralatrexate, Acrotech Biopharma), Arranon (Nelarabine, GlaxoSmithKline), and Adcetris (Brentuximab vedotin, Seattle Genetics).
In the past years, with no current standard of care for patients with PTCL, there were no approved therapies for the first-line treatment. But recent approval of Adcetris (Brentuximab vedotin) in November 2018 from the US FDA has changed the market landscape. It is now the only FDA-approved regimen in first-line therapy used in combination with chemotherapy for adults with previously untreated systemic ALCL or other CD30-expressing PTCL.
Apart from the available approved therapies, there are some off-label therapies and other emerging therapies that are available for PTCL treatment. Some of the off-label therapies which have been listed in the NCCN guidelines for Relapsed PTCL are MabThera (Rituxan), Bortezomib, Bendamustine, Lenalidomide, and Alemtuzumab.
A study conducted by Abramson et al. (2014), determined the impact of PTCL therapies. The study included a retrospective analysis of 341 newly diagnosed PTCL patients from nine US academic centers diagnosed from January 2000 to December 2010. The outcome was compared with a matched cohort of diffuse large B-cell lymphoma (DLBCL) patients, and prognostic factors were assessed using unilabiate and multivariate analyses.
The study shows that 7% of the patients received only palliative care whereas 318 received chemotherapy: CHOP-like regimens (70%), hyperCVAD/MA (hyperfractionated cyclophosphamide, vincristine, adriamycin, dexamethasone/methotrexate, cytarabine) (6%), or other (18%). The termed other' was given to EPOCH, CMED (cyclophosphamide, methotrexate, etoposide, and dexamethasone), gemcitabine-based, ifosfamide-based, and other therapies. Ten percent of patients underwent stem-cell transplantation (SCT) in the first remission. The overall response rate was 73% (61% complete), and 24% had the primary refractory disease (Abramson et al., 2014).
In Japan, the primary treatment of PTCL is CHOP that has a response rate of 5065% (Kitazume et al., 2019). However, patients who are resistant to this therapy have an extremely poor prognosis. Standard line therapy for R/R PTCL is not established; however, pralatrexate, combination chemotherapy, brentuximab, and romidepsin are used.
The approved therapies for the treatment of PTCL in Japan includes Istodax (romidepsin), Folotyn (pralatrexate), Poteligeo (mogamulizumab), Adcetris (brentuximab vedotin), Mundesine (forodesine hydrochloride), and Arranon (nelarabine).
Key Findings
Drugs Uptake
This section focusses on the rate of uptake of the potential drugs that are expected to get launched in the market during the study period 2017-2030. The analysis covers PTCL market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for PTCL emerging therapies.
Competitive Intelligence Analysis
The publisher performs competitive and market intelligence analysis of the PTCL market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
Report Highlights
Companies Mentioned
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