For any dosing strategy, wastage and cost savings may vary from site to site based on patient numbers, sterile compounding procedures, and purchasing practices. Pembrolizumab and nivolumab are the only IO drugs that have been approved for adjuvant therapy… This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Hodgkin lymphoma. Several clinical studies have shown that any dose of pembrolizumab between 2 mg/kg and 10 mg/kg every three weeks is safe and effective. It is given every 2 weeks as an IV infusion. 4,720 immuno-oncology agents in six main classes were identified in August 2020, an increase of 233% since 2017. This provides a non-collapsible entry point into the systemic venous system. }. IO drugs are generating excitement within the NSCLC community, as they provide a much-needed alternative to chemotherapy in the second-line setting, especially for squamous NSCLC patients. Contact us. They’re multiplied in a lab and put back into your body where they destroy cancer cells. "Cancer Research", Targeted therapy refers to treatment with drugs that have been developed to “target” these differences within the cell. Combination immunotherapy promises to deliver long-term survival benefits that may be unavailable with current approaches. Greater understanding of tumour immunobiology has led to a new era of cancer treatment in which immuno-oncology (IO) therapies are used to boost anti-cancer immune responses. "@type": "Organization", The future of IO looks brighter than ever, and IO drugs are now in a position to compete as monotherapies against traditional SOC chemotherapy regimens in the first line of the metastatic setting. Do you want more information on the Clinical Accelerator? { IO therapy might also be available to you via a clinical trial, though most (but not all) trials require that you first have received prior therapy or an established standard of care. "name": "Cancer Research Institute" The analytical algorithm and visualizations are developed by and therefore sole property of Cancer Research Institute. "url": "https://www.cancerresearch.org/scientists/clinical-accelerator/landscape-of-immuno-oncology-drug-development", } AstraZeneca is leading the field in this area, delivering the first cross-industry data sets to enable the right treatment decisions to be made for patients. Intraosseous infusions allow for the administered medications and fluids to go directly into the vascular system. Fixed doses of 240 mg every two weeks or 480 mg every four weeks have been proposed to improve ease of use and administration, as well as to reduce prescription errors. They tend to have different (and sometimes less severe) side effects than chemo. Learn more about tumor-agnostic treatments. Over the past decade, immuno-oncology (IO) has emerged as a novel and important approach to cancer treatment through the stimulation of the body’s own immune system to kill cancer cells. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. IOP therapy is also a more science-based approach to addiction recovery. For pembrolizumab, the dosage that would result in the least wastage appears to be 2 mg/kg every three weeks with a 200 mg dose cap for patients weighing 100 kg or more. To obtain evidence related to IO drug dosing, CADTH searched the published literature and a researcher screened the results and selected articles for review. "keywords": [ 1-3 I-O has progressed considerably in the last 30 years with approvals for the use of various I-O therapies An option to cap dosing at 240 mg for patients weighing more than 80 kg would be acceptable from a regulatory and clinical standpoint. Immuno-oncology drug development forges on despite COVID-19. © 2021 Canadian Agency for Drugs and Technologies in Health, In Brief: Dosing and Timing of Immuno-Oncology Drugs, Dosing and Timing of Immuno-Oncology Drugs. For evidence, tools, and resources related to COVID-19, visit our COVID-19 Evidence Portal. A fixed dose of 240 mg every two weeks appears to be more wasteful compared with the 3 mg/kg dose for patients weighing less than 80 kg, depending on a given site’s volume of patients, sterile compounding procedures, and purchasing practices. GTOnco™ Platform for Gene Therapy-based I-O Drug Development. CRI highlights some of the many women who are and have been integral to our organization and the field of cancer immunotherapy. However, the relatively wide efficacy and safety profiles of nivolumab (between 1 mg/kg and 10 mg/kg) allow for several possible dosing strategies to be considered. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar … Unlike chemotherapy, targeted therapy drugs alter the inner workings of the cell focusing on the part of the cancer cell that makes it different from the normal, healthy cell. This technique is used to provide fluids and medication when intravenous access is not available or not feasible. Donations are tax-deductible to the fullest extent allowable under the law. Currently, IO drugs can be used in the metastatic setting for the treatment of melanoma, non–small cell lung cancer, squamous cell carcinoma of the head and neck, and renal cell carcinoma. 29 Broadway, Floor 4 | New York, NY 10006-3111. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar … The future of immuno-oncology drug development is positioned in combination therapies, where immunotherapy modalities are tested in rational combinations with other immunotherapies or targeted therapies for synergistic effects. A comparison of global IO pipelines in 2017 and 2020. Some of today’s newer cancer treatments target certain mutated genes or proteins that cancer needs to thrive or survive. With an unprecedented number of new investigational agents and companies in immuno-oncology (IO), it has been difficult to track and understand the current IO agents in clinical development and the clinical trials testing these agents. Where pembrolizumab is available as a 50 mg powder for solution and 100 mg/4 mL solution for infusion, capping the dosing regimen of this drug at 200 mg could limit wastage for patients weighing more than 100 kg; however, the 50 mg vial is discontinued in Canada. This amount of time, called the “washout period,” is uncertain. Fixed dosing of pembrolizumab and nivolumab, using exact multiples of commercial vial sizes, is often preferred over weight-based dosing because it is more convenient to prepare. "Immunotherapy", Intensive outpatient programs or IOPs are treatment programs that are used to target addictions, depression, eating disorders, or other dependencies that do not need detoxification or 24/7 supervision. The timing of dosing (e.g., every three weeks versus six weeks) can also vary. It can be based on a patient’s weight (e.g., 3 mg/kg every two weeks), it can be a fixed (or “flat”) dose (e.g., 200 mg every three weeks), or it can be weight-based up to a fixed maximum dose. Immuno‑Oncology is a unique approach that uses the body's immune system to help fight cancer. Immuno-oncology (IO) describes the treatment of various cancers with the use of bispecific-antibodies, cancer vaccines, cell therapies, checkpoint modulators and oncolytic viruses. PD-1/PD-L1 Immune Checkpoint Inhibitors Landscape, FDA Approval Timeline of Active Immunotherapies. In CAR T cell therapy, T cells are modified and equipped with chimeric antigen receptors (CARs) that enable superior anti-cancer activity. An IO drug might already be approved for your type and stage of cancer, including as first-line standard of care or for second- and third-line therapy or later. in Nature Reviews Drug Discovery (September 2020). Copyright © 2021 Cancer Research Institute | Privacy Policy | Accessibility Statement, A comparison of global IO pipelines in 2017 and 2020. Possible side effects. Download a PDF of the latest CRI landscape figures. For additional information, review our Privacy Policy. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. CADTH is committed to supporting Canada’s health care decision-makers through this challenging and uncertain time. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. "Cancer Immunotherapy", Methods: All Food and Drug Administration approved oncology drugs from 01/2011-11/2017 and randomized control trials (RCTs) used for approval were identified. In addition, these treatments have shown efficacy in a wide variety of indications offering a less toxic treatment alternative. "Cancer", Immuno‑Oncology Is a Different Type of Cancer Treatment Approach. In addition, will payors convince Pharma to compete on price: “offer your PDx with massive rebates/discounts, and we’ll use it as foundation therapy in our pool of cancer patients”. A separate search of the published literature for pharmacokinetics and clinical studies was conducted to find evidence on the timing of IO re-treatment. After this time, a patient is considered eligible for the same or similar treatment because their new tumour would have grown in the absence of exposure to the drug and, therefore, is not likely to be refractory (resistant) to it. The residual biological activity of the drug after the washout period is not known. IO102 and IO103 are IO Biotech’s lead immuno-oncology candidates. The drug names link to NCI's Cancer Drug Information summaries. The product monograph for nivolumab specifies a dose of 3 mg/kg every two weeks. The rapid co-evolution of tumor cells and immune responses may also result in immunoediting resulting in loss of antigen-specific immunity explaining, in part, IO drug resistance and the need to reconsider the pharmacologic drug class, dosing, schedule and combination to optimize anti-tumor activity . An evaluation of exposure-response relationships and multiple dosing regimens of pembrolizumab suggests that, for patients of any weight, the most efficient dosage is 2 mg/kg every three weeks with a 200 mg upper dose cap. Targeted therapy is used to treat many types of cancer, but it's still fairly new in the treatment of endometrial cancer. Only a few of these drugs are in use at this time. A review of the pharmacometric literature on nivolumab and pembrolizumab can help guide decisions regarding optimal dosing schedules, and a review of the evidence on the effectiveness and timing of immuno-oncology re-treatment after adjuvant IO can help guide decisions regarding re-treatment. When it comes to combinations of these cancer drugs, 1+1 will not likely equal 2 in the eyes of payers. "url": "https://www.cancerresearch.org/", If a patient’s cancer has progressed during adjuvant IO therapy, it is generally not advised to treat the patient again with the same IO drug (or a similar one). Intraosseous infusion (IO) is the process of injecting directly into the marrow of a bone. "Cancer Research Institute", The objective response rate in the study was 17%, and the median duration of response has not yet been reached. Full-text publications of population pharmacokinetics and modelling studies were evaluated for final article selection according to predetermined selection criteria (population, intervention, comparator , outcomes, and study designs). Subscribe to our email newsletter to receive the latest updates on our landscape analyses. The fixed 240 mg dose would be less costly compared with the weight-based dose for patients weighing less than 80 kg. Targeted therapy drugs work differently from standard chemotherapy (chemo) drugs. The effectiveness of re-treatment after adjuvant immunotherapy is also unknown and, therefore, evidence from future well-conducted clinical studies is needed to confirm the effectiveness of re-treatment. Pembrolizumab and nivolumab are the only IO drugs that have been approved for adjuvant therapy, and specifically for melanoma. Currently, IO drugs can be used in the metastatic setting for the treatment of melanoma, non–small cell lung cancer, squamous cell carcinoma of the head and neck, and renal cell carcinoma. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Immuno-oncology (I-O) drug development is a growing and young field on the frontier of immunotherapy, marked by stimulating the body’s immune system to target and attack the pathogens. *Immunotherapy results may vary from patient to patient. But if a patient has relapsed while off treatment, re-treatment with the IO drug might be appropriate, as long as a sufficient amount of time has elapsed since the initial treatment to ensure that the patient has no remaining drug in their system. For example, in a retrospective study, ORR was higher for patients previously treated with combination of two ICI compared with ICI plus anti-VEGF combination, although this was not statistically significant ( p = 0.678) [ 24 ]. From a policy and practice perspective, suggested washout values should be viewed as theoretical and somewhat arbitrary. a Calculated by multiplying the half-life of each drug by 10, in accordance with Canadian regulatory guidance. Adoptive cell therapy: Your doctor removes your T cells and treats them with cancer-fighting chemicals. Data Sources: Cancer Research Institute (CRI) analytics derive from public data sources, including trade news, company press releases, academic publications, FDA announcements, clinicaltrials.gov, and conference reports, and proprietary data sources including, but not limited to, GlobalData. "Immunology" Because these drugs impede the ability of a tumour to disrupt its detection by the immune system, they can elicit an exceptional therapeutic response, allowing for significant regression, and sometimes resolution, of several cancer types. 4,720 immuno-oncology agents in six main classes were identified in August 2020, an increase of 233% since 2017. Success in IO will hinge on the ability to identify which therapy may be best for each patient. "@type": "Dataset", Durvalumab has been approved only for consolidation therapy following curative-intent chemo-radiation therapy for non–small cell lung cancer. A complementary approach is dose banding — using round doses based on weight ranges to facilitate calculations and preparation. More details can be found in the, CRI Anna-Maria Kellen Clinical Accelerator. "license" : "https://creativecommons.org/publicdomain/zero/1.0/", – Immuno-Oncology therapy (or I-O therapy) is an emerging pillar of cancer treatment that utilizes the body’s own immune system to fight diseases. Immuno-oncology therapeutics is leading to a transformational shift in treatment paradigms for patients with cancer. Immuno-oncology (IO) drugs (also called immune checkpoint inhibitors or immunotherapy drugs) have transformed the field of medical oncology. IO drugs that have been approved by Health Canada and recommended for reimbursement by CADTH’s pan-Canadian Oncology Drug Review Expert Review Committee for a variety of indications include nivolumab, pembrolizumab, atezolizumab, durvalumab, and ipilimumab. Patients may be considered eligible to receive a second immuno-oncology treatment after a sufficient washout period based on the time it takes for the drug to leave the body — that is, 201 days for nivolumab, 237 days for pembrolizumab, and 209 days for durvalumab. Unfortunately, there appears to be little association between the success of a drug in metastatic cancer and effectiveness as adjuvant therapy. Based on the substantive pharmacokinetic literature on pembrolizumab, nivolumab, and durvalumab, washout periods are calculated per the following table. Prominent among these therapies are immune checkpoint inhibitors (ICIs), antibody-based drugs that can unleash the power of tumour-specific CD8 + T-cells. ], IOP therapy allows the patient to have a more normal daily routine. IO drugs can be given either in the adjuvant or the consolidation setting (to prevent recurrence after surgery or as intensive therapy with a curative intent), or in the metastatic setting (after cancer has spread to other parts of the body). "clinical accelerator", However, it also means that many patients are given more of the drug than they need. "@context": "http://schema.org/", This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Abstract: Until recently, cancer therapy comprised of four main types of treatment: surgery, radiotherapy, chemotherapy and targeted therapy. Avelumab can be used with the targeted drug axitinib as the first treatment for people with advanced kidney cancer. Prior use of IO-IO vs. IO-VEGF combination may also impact the efficacy of subsequent treatment with a TKI.