Cancer Immunotherapy Review
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Enumeral Biomedical: An Undiscovered And Undervalued Biotechnology Company

Enumeral Biomedical: An Undiscovered And Undervalued Biotechnology Company | Cancer Immunotherapy Review | Scoop.it
Enumeral Biomedical (OTCQB:ENUM) is a biotechnology company focused on discovering and developing novel immunotherapies for the treatment of cancer and autoimmune diseases.
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Krishan Maggon 's curator insight, December 8, 2014 1:54 AM

http://www.enumeral.com/r-and-d/r-and-d-overview.php

 

Enumeral is enabling and accelerating the discovery and development of novel antibody immunotherapies, or immunomodulators, which are validated with our human-driven immune profiling platform. The core technology behind our platform was developed at and licensed from the Massachusetts Institute of Technology, Harvard University, Whitehead Institute for Biomedical Research and Massachusetts General Hospital.

 

Our antibodies are rapidly generated directly from the platform using proprietary cellular libraries derived from target-specific immunized sources or from human patient donors.

 

We perform sensitive measurements on single immune cells using our proprietary technology in order to mine the immune system’s rich collection of cells for information that is difficult to obtain using other methods and that may guide the development of effective therapeutics and diagnostics. The efficiency and sensitivity provided through our platform increases the probability of finding rare antibody-secreting cells associated with disease or drug response, as well as rare and previously unknown antibodies that may have the characteristics essential to becoming safe and effective drugs.

Studying rare immune cells obtained directly from human patients for their functional responses can potentially lead to selection of best-in-class antibody drug candidates that may have a higher likelihood of successful development. Such knowledge generated from our platform is also being applied to better understand which drug candidates might work in which patients, and, at what stage of disease.

 

Our current antibody discovery and development programs target the checkpoint proteins PD-1, OX40 and Lag3.

 

Enumeral’s immunoprofiling platform harnesses The Power of Human™.

Cancer Immunotherapy Review
A magic life saving cure for advanced metastatic melanoma.  
Curated by Krishan Maggon
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Ipilimumab (BMS) Review: A Cancer Breakthrough? - un knol de Krishan Maggon

Ipilimumab (BMS) Review: A Cancer Breakthrough? - un knol de Krishan Maggon | Cancer Immunotherapy Review | Scoop.it
FDA has approved Yervoy (ipilimumab, BMS) under REMS for the treatment of metastatic melanoma. The European expert panel CHMP...
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Cancer Immunotherapy Market is expected to reach USD 119.39 Billion by 2021
Download Free Brochure @ http://bit.ly/2cHlrFH
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’ Tab-cel™ Achieves Positive Long-Term Outcomes in Phase 2 Studies of Patients with Epstein-Barr Virus Associated Post-Transplant Lymphomas

’ Tab-cel™ Achieves Positive Long-Term Outcomes in Phase 2 Studies of Patients with Epstein-Barr Virus Associated Post-Transplant Lymphomas | Cancer Immunotherapy Review | Scoop.it

Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, today announced positive long-term outcomes including durable remissions and encouraging safety findings from two Phase 2 studies of tab-cel™ (tabelecleucel), Atara’s most advanced off-the-shelf T-cell immunotherapy.  These single center, open-label studies enrolled patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) following allogeneic hematopoietic cell transplant (HCT) or solid organ transplant (SOT) who failed first-line therapy. Atara and its collaborating investigators at Memorial Sloan Kettering Cancer Center (MSK) reported the Phase 2 results in a poster presentation at the 23rd Congress of the European Hematology Association (EHA), being held in Stockholm, Sweden, June 14-17, 2018.

 

Tab-cel™ demonstrated durable remissions and encouraging safety profile in patients with EBV+ PTLD who failed first line therapy

Median survival in SOT patients was 21.3 months and was not reached in the HCT population after 23.3 months

None of the responders (CR or PR) to tab-cel™ died of EBV+ PTLD; Two-year overall survival for these responding patients was 83% and 86% following HCT and SOT, respectively

Krishan Maggon 's insight:

FDA granted tab-cel™ Breakthrough Therapy Designation for EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT) and in October 2016, tab-cel™ was accepted into the EMA Priority Medicines (PRIME) regulatory pathway for the same indication, providing enhanced regulatory support. Atara also received positive regulatory feedback from Health Canada in September 2017 supporting the submission of tab-cel™ for an expedited approval pathway. In addition, tab-cel™ has orphan status in the U.S. and EU.

Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study), and Atara is planning a Phase 1/2 study in NPC. Tab-cel™ is also available to eligible patients with EBV associated hematologic and solid tumors through an ongoing multicenter expanded access protocol clinical study, positive interim results of which were presented in December 2017 at the 59th American Society of Hematology (ASH) Annual Meeting.

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T-cell Homing Therapy for Reducing Regulatory T Cells and Preserving Effector T-cell Function in Large Solid Tumors

T-cell Homing Therapy for Reducing Regulatory T Cells and Preserving Effector T-cell Function in Large Solid Tumors | Cancer Immunotherapy Review | Scoop.it
Purpose: Infused autologous tumor-infiltrating lymphocytes (TIL) and tumor-targeted chimeric antigen receptor (CAR) T cells typically surround malignant lesions or penetrate small tumor nodules but fail to penetrate large solid tumors, significantly compromising their antitumor impact.
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Trends and advances in tumor immunology and lung cancer immunotherapy | Journal of Experimental & Clinical Cancer Research | Full Text

Trends and advances in tumor immunology and lung cancer immunotherapy | Journal of Experimental & Clinical Cancer Research | Full Text | Cancer Immunotherapy Review | Scoop.it
Among several types of tumor, lung cancer is considered one of the most fatal and still the main cause of cancer-related deaths. Although chemotherapeutic agents can improve survival and quality of life compared with symptomatic treatment, cancers usually still progress after chemotherapy and are often aggravated by serious side effects. In the last few years there has been a growing interest in immunotherapy for lung cancer based on promising preliminary results in achieving meaningful and durable treatments responses with minimal manageable toxicity. This article is divided into two parts, the first part discusses the role of human immune system in controlling and eradicating cancer and the mechanisms of immune response evasion by tumor. The second part reviews the recent progress made in immunotherapy for lung cancer with results from trials evaluating therapeutic vaccines in addition to immune checkpoint blockade, specifically cytotoxic T lymphocyte associated protein 4, programmed death receptor 1 pathway, using monoclonal antibodies.

Keywords
Lung cancerTumor immunologyImmunotherapyCancer vaccinesClinical trialsImmune checkpoint inhibitors
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Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC | NEJM

Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC | NEJM | Cancer Immunotherapy Review | Scoop.it
The addition of atezolizumab to bevacizumab plus chemotherapy significantly improved progression-free survival and overall survival among patients with metastatic nonsquamous NSCLC, regardless of PD-L1 expression and EGFR or ALK genetic alteration status. (Funded by F. Hoffmann–La Roche/Genentech; IMpower150 ClinicalTrials.gov number, NCT02366143.)
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CAR T-Cell Therapy: The Sticker Price Is Just for Openers

CAR T-Cell Therapy: The Sticker Price Is Just for Openers | Cancer Immunotherapy Review | Scoop.it
CMS has proposed a different way to handle payment for chimeric antigen receptor T-cell therapy, one that the medical and manufacturing community thinks is unworkable.
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Chimeric Antigen Receptor T Cell (CAR T) Therapy

Chimeric Antigen Receptor T Cell (CAR T) Therapy | Cancer Immunotherapy Review | Scoop.it
Individualized CAR T therapy uses a patient’s own immune system to fight certain types of cancers. A patient’s T cells are extracted and reprogrammed outside of the body to recognize and fight cancer cells and other cells expressing a particular antigen.
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A Versatile Safeguard for Chimeric Antigen Receptor T-Cell Immunotherapies

A Versatile Safeguard for Chimeric Antigen Receptor T-Cell Immunotherapies | Cancer Immunotherapy Review | Scoop.it
CAR T-cell therapies hold great promise for treating a range of malignancies but are however challenged by the complexity of their production and by the adverse events related to their activity. Here we report the development of the CubiCAR, a tri-functional CAR architecture that enables CAR T-cell detection, purification and on-demand depletion by the FDA-approved antibody Rituximab. This novel architecture has the potential to streamline the manufacturing of CAR T-cells, allow their tracking and improve their overall safety.
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Rapid Progression of Adult T-Cell Leukemia–Lymphoma after PD-1 Inhibitor Therapy | NEJM

Rapid Progression of Adult T-Cell Leukemia–Lymphoma after PD-1 Inhibitor Therapy | NEJM | Cancer Immunotherapy Review | Scoop.it
Correspondence from The New England Journal of Medicine — Rapid Progression of Adult T-Cell Leukemia–Lymphoma after PD-1 Inhibitor Therapy

 

The consistent and rapid amplification of cancer in all 3 patients after a single dose of nivolumab in our trial provides support for the probable role of PD-1 functioning as a tumor suppressor in humans. It is unclear whether this finding is specific to ATLL. In a previous study, 4 of 23 patients with other forms of T-cell lymphoma had a response to nivolumab.4 It is noteworthy that the HTLV-1 basic zipper factor (HBZ) protein interferes with PD-1 signaling, which may have contributed to our findings.5Nevertheless, despite the recent recommendation to consider the use of PD-1 inhibitor therapy for ATLL,2 our clinical experience provides examples of cases in which this treatment may have led to rapid disease progression.

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Surgical Oncologist Dr. Steven Rosenberg Receives the 2018 Jacobson Innovation Award

Surgical Oncologist Dr. Steven Rosenberg Receives the 2018 Jacobson Innovation Award | Cancer Immunotherapy Review | Scoop.it
Steven A. Rosenberg, MD, PhD, was honored for his role in in developing effective immunotherapies and gene therapies for patients with advanced cancers.
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Immunity War: A Novel Therapy for Lymphoma Using T-cell Bispecific Antibodies

Immunity War: A Novel Therapy for Lymphoma Using T-cell Bispecific Antibodies | Cancer Immunotherapy Review | Scoop.it
The activity of T cell mediated immunotherapies in B cell lymphoma has been limited to date. The novel bi-specific antibody CD20-TCB, has a 2:1 antibody design to maximize T cell engagement, and demonstrates activity in preclinical models. This may represent a novel therapeutic approach for patients with relapsed/refractory NHL.
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JCI Insight - Compensation between CSF1R+ macrophages and Foxp3+ Treg cells drives resistance to tumor immunotherapy

JCI Insight - Compensation between CSF1R+ macrophages and Foxp3+ Treg cells drives resistance to tumor immunotherapy | Cancer Immunotherapy Review | Scoop.it
These findings identify CSF1R+ TAMs and PI3Kδ-driven Foxp3+ Treg cells as the dominant compensatory cellular components of the immunosuppressive tumor microenvironment, with implications for the design of combinatorial immunotherapies.
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EMA advises against use of pembrolizumab and atezolizumab in UC with low PD-L1 expression

EMA advises against use of pembrolizumab and atezolizumab in UC with low PD-L1 expression | Cancer Immunotherapy Review | Scoop.it
The European Medicines Agency restricts use of pembrolizumab (Keytruda, Merck) and atezolizumab (Tecentriq, Roche) in initial urothelial cancer treatment, advancing that they may not work as well as chemotherapy in some patients.
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CD22 CAR T-cell Therapy Effective After CD19 CAR Therapy Failure in Children With B-ALL

CD22 CAR T-cell Therapy Effective After CD19 CAR Therapy Failure in Children With B-ALL | Cancer Immunotherapy Review | Scoop.it
A CAR T-cell therapy specific for CD22 was safe and provided high response rates for pediatric patients with B-cell acute lymphoblastic leukemia who had failed chemotherapy and/or a CD19-targeted CAR T-cell treatment.
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Co‐expression of LAG3 and TIM3 identifies a potent Treg population that suppresses macrophage functions in colorectal cancer patients - Ma - - Clinical and Experimental Pharmacology and Physiology ...

Co‐expression of LAG3 and TIM3 identifies a potent Treg population that suppresses macrophage functions in colorectal cancer patients - Ma - - Clinical and Experimental Pharmacology and Physiology ... | Cancer Immunotherapy Review | Scoop.it
Macrophages incubated with LAG3+TIM3+ CD4+CD25+/hi T cells presented lower expression of MHC class II, CD80, CD86, and tumor necrosis factor alpha (TNFα) but higher expression of IL‐10, than macrophages incubated with LAG3‐TIM3‐ CD4+CD25+/hi T cells. Together, our investigations demonstrated that CRC patients presented an enrichment of circulating Treg cells, in which the LAG3+TIM3+ subset exhibited more potent expression of inhibitory molecules, and furthermore, the LAG3+TIM3+ Treg cells could suppress the proinflammatory activation of macrophages more potently than the LAG3‐TIM3‐ Treg cells.
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Inactivation of CDK12 Delineates a Distinct Immunogenic Class of Advanced Prostate Cancer

Inactivation of CDK12 Delineates a Distinct Immunogenic Class of Advanced Prostate Cancer | Cancer Immunotherapy Review | Scoop.it
Loss of both alleles of the CDK12 gene defines a molecular subtype of metastatic castration-resistant
prostate cancer that is potentially targetable with immune checkpoint inhibitors.
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Cancer: More targeted use of immunotherapy - SNF

Cancer: More targeted use of immunotherapy - SNF | Cancer Immunotherapy Review | Scoop.it
Doctors are increasingly fighting cancer by stimulating patients’ immune systems. SNSF-supported researchers have now discovered a method for predicting the likelihood of treatment success.
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Relapsed/Refractory DLBCL Added to Approved CAR-T Cell Therapy Indications

Relapsed/Refractory DLBCL Added to Approved CAR-T Cell Therapy Indications | Cancer Immunotherapy Review | Scoop.it
Tisagenlecleucel is the only FDA-approved chimeric antigen receptor (CAR)-T cell therapy indicated for non-Hodgkin lymphomas (NHL) and B-cell acute lymphocytic leukemia (ALL)....
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A transcriptionally and functionally distinct PD-1 + CD8 + T cell pool with predictive potential in non-small-cell lung cancer treated with PD-1 blockade

A transcriptionally and functionally distinct PD-1 + CD8 + T cell pool with predictive potential in non-small-cell lung cancer treated with PD-1 blockade | Cancer Immunotherapy Review | Scoop.it
We compared transcriptional, metabolic and functional signatures of intratumoral CD8+ T lymphocyte populations with high (PD-1T), intermediate (PD-1N) and no PD-1 expression (PD-1–) from non-small-cell lung cancer patients. PD-1T T cells showed a markedly different transcriptional and metabolic profile from PD-1N and PD-1– lymphocytes, as well as an intrinsically high capacity for tumor recognition. Furthermore, while PD-1T lymphocytes were impaired in classical effector cytokine production, they produced CXCL13, which mediates immune cell recruitment to tertiary lymphoid structures. Strikingly, the presence of PD-1T cells was strongly predictive for both response and survival in a small cohort of non-small-cell lung cancer patients treated with PD-1 blockade. The characterization of a distinct state of tumor-reactive, PD-1-bright lymphocytes in human cancer, which only partially resembles that seen in chronic infection, provides potential avenues for therapeutic intervention.
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Universal Chimeric Antigen Receptors for Multiplexed and Logical Control of T Responses

Universal Chimeric Antigen Receptors for Multiplexed and Logical Control of T  Responses | Cancer Immunotherapy Review | Scoop.it
A chimeric antigen receptor system that can integrate signals from multiple antigens
and fine-tune T cell activation in a cell-type-specific manner holds promise for enhancing
the safety and specificity of CAR T cell therapies for cancer treatment.
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Doctors Call Off Clinical Trial After Experimental Cancer Treatment Has Tragic Results

Doctors Call Off Clinical Trial After Experimental Cancer Treatment Has Tragic Results | Cancer Immunotherapy Review | Scoop.it
An experimental treatment to fight a rare type of cancer backfired, when the drug made the disease more aggressive.
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Weighing the Cost and Value of CAR T-Cell Therapy - The ASCO Post

Weighing the Cost and Value of CAR T-Cell Therapy - The ASCO Post | Cancer Immunotherapy Review | Scoop.it
Weighing the Cost and Value of CAR T-Cell Therapy A Roundtable Discussion With Carl H. June, MD; Sagar Lonial, MD; David G. Maloney, MD, PhD; and Pascal Touchon By Jo Cavallo May 25, 2018 Tweet this page How It Works.

 

The above image illustrates the process of making CAR T cells for each individual patient from collecting the patient’s T cells from their blood, shipping the cells to the laboratory for modification and manufacturing, to infusing the engineered CAR-containing T cells into the patient. © 2017 Terese Winslow LLC. U.S. Govt. has certain rights.

 

This past year’s approval by the U.S. Food and Drug Administration (FDA) of two chimeric antigen receptor (CAR) T-cell therapies heralded a new era in both effective cancer treatments and the most expensive cancer drugs ever. Tisagenlecleucel (Kymriah) was initially approved for the treatment of relapsed or refractory pediatric and young adult acute lymphoblastic leukemia (ALL; and has since been approved for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy), and axicabtagene ciloleucel (Yescarta) was approved for the treatment of several types of relapsed or refractory large B-cell non-Hodgkin lymphomas (NHLs), including diffuse large B-cell lymphoma (DLBCL). Additional analysis of data from the ELIANA clinical trial shows impressive results in 75 patients treated with tisagenlecleucel. The analysis found the overall remission rate within 3 months was 81%; the rates of event-free survival were 73% at 6 months and 50% at 12 months; overall survival was 90% and 76% over the same time intervals.1 Follow-up analysis of results from the ZUMA-1 trial investigating the effectiveness of axicabtagene ciloleucel in patients with refractory NHL also shows impressive outcomes. According to the analysis, more than 1 year after treatment, 42% of the 108 patients enrolled in the trial had maintained remission, and 40% of the patients exhibited no evidence of cancer. In addition, more than half of the patients were alive at the median follow-up of 15.4 months—more than double the median survival of 6.6 months for patients treated with conventional therapy.2,3 Sticker Shock However, although these promising findings are generating much enthusiasm for CAR T-cell therapy—ASCO named adoptive-cell immunotherapy its 2018 Advance of the Year4—it is tempered by their hefty price tags: $475,000 for tisagenlecleucel and $373,000 for axicabtagene ciloleucel. And these prices reflect just the cost of extracting a patient’s T cells, engineering them to produce CARs on the surface of the cells, and infusing the cells back into the patient. They do not include fees for hospital stays, supportive care, or physician visits, which could drive the total cost to stratospheric levels of more than $1 million per patient, according to some reports.5 This past April, the Centers for Medicare and Medicaid (CMS) said it would reimburse hospitals about $400,000 for axicabtagene ciloleucel and $500,000 for tisagenlecleucel. Although outpatients usually have a 20% copayment on Medicare B services, which would mean a copayment of $79,076 for axicabtagene ciloleucel and $100,168 for tisagenlecleucel, the Social Security Act statute requires CMS to cap outpatient copayments at the amount of the inpatient deductible, which is $1,340 in 2018. When tisagenlecleucel was approved in August 2017, Novartis made an outcomes-based agreement with the CMS, which calls for payment to the company for patients who show a morphologic remission within a month after receiving their CAR T-cell infusion. If the patient does not respond within the first month—a majority of patients, about 80%, have an initial response to the therapy—Novartis will not bill those medical facilities that opted in to the outcomes-based agreement. Still, challenges associated with the pricing and reimbursement of CAR T-cell therapies remain and could become heightened as additional indications for these therapies are granted FDA approval and the population of eligible patients increases. For example, on May 1, 2018, the FDA expanded approval of tisagenlecleucel to the treatment of adult patients with relapsed or refractory large B-cell lymphoma, including DLBCL, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, after two or more lines of systemic therapy. And the manufacturer has announced plans to launch clinical trials in 2018 investigating tisagenlecleucel and other CAR T cells, in the treatment of multiple myeloma, DLBCL after first relapse, and follicular lymphoma, as well as solid tumors (including glioblastoma, advanced ovarian cancer, and mesothelioma). Financial toxicity is not the only concern with this therapy. Both tisagenlecleucel and axicabtagene ciloleucel carry a black box warning for cytokine-release syndrome (CRS) and for neurologic events. To treat CAR T-cell–induced severe or life-threatening CRS, the FDA expanded the approval of tocilizumab (Actemra) and has required that CAR T-cell therapy be performed only in cancer centers that have completed training in Risk Evaluation and Mitigation Strategy to support its safe use. Currently, about 40 cancer centers are certified to offer CAR T-cell therapy to patients. (See sidebar on “Treatment Centers Authorized to Administer CAR T-Cell Therapy” on pages 49–50.) Carl H. June, MD Sagar Lonial, MD David G. Maloney, MD Pascal Touchon To learn more about the clinical impact of CAR T-cell immunotherapies on patients with cancer; how oncologists, patients, and society should evaluate their cost vs value; and the future direction of cell immunotherapies in oncology care,

 

 

The ASCO Post held a roundtable discussion with four leading experts in the field. They include Carl H. June, MD, Richard W. Vague Professor in Immunotherapy, Department of Pathology and Laboratory Medicine; Director, Center for Cellular Immunotherapies; and Director, Parker Institute for Cancer Immunotherapy, Perelman School of Medicine, University of Pennsylvania (in April, Dr. June was named one of TIME magazine’s 100 most influential people of 2018); Sagar Lonial, MD, Professor and Chair of Hematology and Medical Oncology; Chief Medical Officer, Winship Cancer Institute, Emory University School of Medicine; David G. Maloney, MD, PhD, Medical Director, Cellular Immunotherapy, Fred Hutchinson Cancer Research Center; Service Medical Director, Cellular Immunotherapy, Bezos Family Immunotherapy Clinic, Seattle Cancer Care Alliance; and Pascal Touchon, Senior Vice President and Global Head, Cell & Gene, Novartis Oncology. 

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Financial toxicity of CAR-T immunotherapy?

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HPV vaccines for cancer prevention

HPV vaccines for cancer prevention | Cancer Immunotherapy Review | Scoop.it
For technological advances that enabled development of HPV vaccines for prevention of cervical cancer and other tumors caused by human papillomaviruses...
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Spot the Nobelist in the photo?

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The Golden Age of Immunotherapy - AACC.org

The Golden Age of Immunotherapy - AACC.org | Cancer Immunotherapy Review | Scoop.it
Immunotherapies like checkpoint inhibitors and CAR T cell therapies are transforming cancer care. Clinical labs are on the forefront of deploying currently available tests that help determine which immunotherapies patients should receive, and help monitor their treatment response.
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Princess Margaret Immunotherapy

Princess Margaret Immunotherapy | Cancer Immunotherapy Review | Scoop.it
This is considered to be a therapeutic vaccine as it is designed to be used after a cancer has appeared. This is a different concept from vaccines that prevent something from occurring in the first place, such as the vaccine against the virus (HPV) that causes cervical cancer. Other cancer research seeks to stimulate the immune system by using a type of immune cell that helps spur T-cells into action – the dendritic cell. Dendritic cells can be loaded with cancer-specific substances that are recognized by the immune system triggering an anti-cancer immune response.
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A Phase II Study of Pembrolizumab in EGFR-mutant, PD-L1+, Tyrosine Kinase Inhibitor (TKI) Naïve Patients with Advanced NSCLC

A Phase II Study of Pembrolizumab in EGFR-mutant, PD-L1+, Tyrosine Kinase Inhibitor (TKI) Naïve Patients with Advanced NSCLC | Cancer Immunotherapy Review | Scoop.it

Pembrolizumab’s lack of efficacy in TKI naïve, PD-L1+, EGFR-mutant patients with advanced NSCLC, including those with PD-L1 expression >50%, suggests that it is not an appropriate therapeutic choice in this setting.

Krishan Maggon 's insight:

Pembrolizumab fails Phase II trial in EGFR-mutant, PD-L1+, Tyrosine Kinase Inhibitor (TKI) Naïve Patients with Advanced NSCLC 

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