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Showing posts with the label Immunotherapy

Nivolumab Immunotherapy (OPDIVO) For Solid Tumors: Indication, Side Effect & Mechanism of Action

Nivolumab a-k-a OPDIVO is a FDA-approved checkpoint inhibitor drug for the treatment of a subset of cancer types.  It is a human monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Nivolumab is an IgG4 kappa immunoglobulin that has a calculated molecular mass of 146 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line.  Indication of Nivolumab Immunotherapy Nivolumab (OPDIVO) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of:  Patients with BRAF V600 wild-type unresectable or metastatic melanoma, as a single agent.   Patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, as a single agent. Patients with unresectable or metastatic melanoma, in combination with ipilimumab. Patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting. Patients with meta...

RYBREVANT Amivantamab Immunotherapy For Non-Small Cell Lung Cancer

RYBREVANT / Amivantamab-vmjw is FDA approved Bispecific Antibodies Immunotherapy For Non-Small Cell Lung Cancer RYBREVANT / Amivantamab-vmjw is a low-fucose human immunoglobulin G1-based bispecific antibody directed against the EGF and MET receptors, produced by mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology that has a molecular weight of approximately 148 kDa. Indication of RYBREVANT/Amivantamab: RYBREVANT/Amivantamab is a bispecific EGF receptor-directed and MET receptor directed antibody indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.  This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be con...

FDA Approved Immune Check Point Inhibiting Antibody Therapies That Target PD-1, PD-L1 or CTLA-4

Immune checkpoint inhibiting immunotherapies: These are the class of monoclonal antibody therapies that prevents T-cell inhibition and promotes the activation and proliferation of effector T cells. Two such receptors CTLA-4 & PD-1 that are expressed in T cells transduce inhibitory signals after binding to its ligand.  The monoclonal antibodies targeted against these receptors or their ligands have been shown to increase the tumor-killing activity of T cells.  Figure 1: Immune Check Point Inhibiting Monoclonal Antibodies and its Target in T cells and Tumors. Pembrolizumab (Keytruda), Nivolumab (Opdivo), and cemiplimab (Libtayo) block PD-1 expressed in T cells. Atezolizumab (Tecentriq), Avelumab (Bavencio), and Durvalumab (Imfinzi) block PD-L1 expressed in tumor cells. Ipilimumab (Yervoy) blocks CTLA-4 antigen present in T cells   PD-1 inhibiting antibodies:  These monoclonal antibodies block the PD-1 signaling by binding to its ligand PD-1 expressed i...

Avelumab Immunotherapy (BAVENCIO®) For Merkel Cell Carcinoma, Urothelial Carcinoma & Renal Cell Carcinoma

Avelumab is FDA approved Immunotherapy that blocks a programmed death ligand1 (PD-L1)  Avelumab (BAVENCIO)- is a human IgG1 lambda monoclonal antibody produced in Chinese hamster ovary cells and has a molecular weight of approximately 147 kDa.  Indication of Aveluman (BAVENCIO) BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for: Merkel Cell Carcinoma (MCC)  • Adults and pediatric patients 12 years and older with metastatic MCC. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Urothelial Carcinoma (UC)  Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy.   Patients with locally advanced or metastatic UC who:  Have disease progressio...

Atezolizumab Immunotherapy (TECENTRIQ) for Metastatic Urothelia Carcinoma & Metastatic Non-Small Cell Lung cancer

Atezolizumab is a checkpoint inhibiting immunotherapy Atezolizumab is an Fc-engineered, humanized, monoclonal antibody that binds to PD-L1 and blocks interactions with the PD-1 and B7.1 receptors. Atezolizumab is a non-glycosylated IgG1 kappa immunoglobulin that has a calculated molecular mass of 145 kDa. Indication of Atezolizumab (TECENTRIQ) TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with:  Advanced or metastatic urothelial carcinoma: Locally advanced or metastatic urothelial carcinoma who:  have disease progression during or following platinum-containing chemotherapy. have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in ...

Ipilimumab Immunotherapy (YERVOY) for Metastatic Melanoma , Cutaneous Melanoma & Advanced Renal Cell Carcinoma: Indication, Side Effects and Mechanism of Action

Ipilimumab (Yervoy) is FDA Approved Immune Check Point Inhibitors For Certain Cancers Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T lymphocyte-associated antigen 4 (CTLA-4). Ipilimumab is an IgG1 kappa immunoglobulin with an approximate molecular weight of 148 kDa. Ipilimumab is produced in mammalian (Chinese hamster ovary) cell culture.  Indication of Ipilimumab (YERVOY) Ipilimumab (YERVOY) is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for:  Metastatic Melanoma - treatment of unresectable or metastatic melanoma in adults and pediatric patients (12 years and older).   Cutaneous Melonama - adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.  Advanced Renal Cell Carcinoma : Treatment of patients with intermediate or poor risk, previously untrea...

Cemiplimab Immunotherapy (LIBTAYO): Indication, Side Effects and Mechanism of Action

Cemiplimab a-k-a LIBTAYO FDA-approved checkpoint inhibitor drug for the treatment of certain cancers Cemiplimab-rwlc a-k-a LIBTAYO is a human programmed death receptor-1 (PD-1) blocking antibody. Cemiplimab-rwlc is a recombinant human IgG4 monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2. Cemiplimab-rwlc is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. Cemiplimab-rwlc has an approximate molecular weight of 146 kDa. LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated:  Cutaneous Squamous Cell Carcinoma (CSCC):  for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.  Basal Cell Carcinoma (BCC):  for the treatment of patients with locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a...

KEYTRUDA-Pembrolizumab Immunotherapy for Solid Tumors: Mechanism of Action, Indication, Side Effects

KEYTRUDA a-k-a Pembrolizumab is a programmed death receptor-1 (PD 1)-blocking antibody Pembrolizumab is a humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells.  KEYTRUDA (Pembrolizumab) Indications KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:  Melanoma- for the treatment of patients with unresectable or metastatic melanoma Non-Small Cell Lung Cancer (NSCLC) Small Cell Lung Cancer (SCLC)- for the treatment of patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy Head and Neck Squamous Cell Cancer (HNSCC) -in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC Classical Hodgkin Lymphoma (cHL)- for the treatment of adult patients with relapsed or refractory cHL & for the...

KYMRIAH (tisagenlecleucel): Treatment of B-cell precursor acute lymphoblastic leukemia (ALL)

KYMRIAH (tisagenlecleucel) For Treatment of B-cell precursor acute lymphoblastic leukemia (ALL) INDICATIONS AND USAGE KYMRIAH is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of:   Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.  Limitation of Use: KYMRIAH is not indicated for the treatment of patients with primary central nervous system lymphoma.  MECHANISM OF ACTION KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy that involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) to i...

BLINCYTO® (blinatumomab): Treatment of Acute Lymphoblastic Leukemia (ALL)

BLINCYTO® (blinatumomab): Bispecific CD19-Directed CD3 T-cell Engager   BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adults and children with:  • B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.  • Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).  Mechanism of Action: Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. It activates endogenous T cells by connecting CD3 in the T-cell receptor (TCR) c...

Predictive Biomarkers For Cytokine Release Syndrome (CRS) by CAR T-Cells & Immune Cell Engagers

Cytokine Release Syndrome Cytokine Release Syndrome (CRS) is a supraphysiological response following any immune therapy that results in the activation or engagement of endogenous or infused T cells and or other immune effector cells. Symptoms can be progressive, must include fever at the onset, and may include hypotension, capillary leak, hypoxia, and end-organ dysfunction.  Classification/Stages of CRS  Grade 1 CRS:  Grade 1 CRS is defined as fever (> 38 degrees celsius) with or without constitutional symptoms of CRS include myalgia, arthralgia, and malaise with the coincidence of fever.  Grade 2 CRS:  Grade 2 CRS is defined as fever (>38 degrees celsius) with hypotension not requiring vasopressin and or hypoxia requiring the use of a low-flow nasal canula or blow-by. Grade 3 CRS: Grade 3 CRS is defined as fever (>38 degrees celsius)  with hypotension requiring 1 vasopressor with or without vasopressin and hypoxia requiring high flow nasal ca...

Cullinan Oncology Focuses on Immuno-oncology Therapeutic Target

  About Cullinan Oncology Cullinan Oncology is a biopharmaceutical company that strives to deliver results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk-taking and creative business development. The company seeks to drive shareholder returns by focusing on the patient. The Company’s strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes   About CLN-049 CLN-049 is a humanized bispecific antibody being developed for relapsed/refractory AML. CLN-049 is designed to simultaneously bind to FLT3 on target leukemic cells and to CD3 on T cells, triggering the T cells to kill the targeted cancer cells via their intrinsic cytol...

Autolus Therapeutics plc is Pioneering Programmed T cell Therapies

    About Autolus Therapeutics plc Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors.  Pipeline AUTO1 / AUTO1-AL1 – Adult Acute Lymphoblastic Leukemia (ALL) and Pediatric ALL AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety - while maintaining similar levels of efficacy - compared to current CD19 CAR T cell therapies. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AU...