Diarrhea 6. Atezolizumab was first evaluated in a phase I study that included patients with advanced incurable cancer, including NSCLC, melanoma, renal cell carcinoma, colorectal cancer, gastric cancer, and head and neck squamous cell carcinoma. D’Addio et al.241 inform us that “Acceptance of the … fetus by the mother during pregnancy represents a physiologic model of in vivo immune tolerance … [o]ur group has … shown that the PD1-PDL1 … pathway plays a key role in inducing and maintaining fetomaternal tolerance in a mouse model … expression of PDL1 on the surface of Tregs is essential to exert their suppressive effect and to control the maternal immune response. Grade 1 or grade 2 pneumonitis developed in four patients (3%). Abnormal Sensations Of The Skin 2. Grade 3 or grade 4 immune-related adverse events occurred in 5.3% of patients, mainly thyroid abnormalities. Biopsies of the left and right colon showed questionable wall thickening. As human IgG is excreted in human milk, the potential for … harm to the infant is unknown. Drug Type: Atezolizumab … The most common atezolizumab-related grade 3 events (there were no grade 4 events) were pneumonia (2%) and AST elevation (2%). For use in animal studies, the Sponsor prepared a specially engineered version of atezolizumab consisting of the constant region of mouse IgG2a plus the variable region (PD-L1 binding region) of the humanized antibody. Patients received atezolizumab 1200 mg or docetaxel 75 mg/m2 once every 3 weeks. Leena Gandhi, ... Frances A. Shepherd, in IASLC Thoracic Oncology (Second Edition), 2018. There is a general impression that anti-PD-L1 antibodies are less toxic then anti-PD-1 antibodies. The data from meta-analysis shown in Table 11.7 confirms this impression. Consistent with the above studies, the safety profile favored atezolizumab. FDA’s labeling recommendation took the form, “Labeling … the Division recommended that patients should not breastfeed during treatment … due to the potential for serious adverse reactions in breastfed infants from atezolizumab. Immune-related adverse events of all grades, including rash (12%), pruritus (9%), diarrhea (11%), transaminitis (3% or less), thyroid abnormalities (3% or less), and infusion-related reaction (3% or less), occurred in 41% of patients. Is atezolizumab (Tecentriq) a chemotherapy or immunotherapy drug? The Warnings and Precautions section of the package label for atezolizumab (Tecentriq®) warned against harm to the fetus. Atezolizumab is approved to treat: 1. trattamento con atezolizumab può essere ripreso se l’evento registra un miglioramento a un grado ≤ 1 entro 12 settimane e la dose di corticosteroidi è stata ridotta a ≤ 10 mg/die di prednisone o equivalente. Nausea 10. Survival benefit was more pronounced with increasing expression of PD-L1 on tumor cells, tumor-infiltrating immune cells, or both. Cerner Multum, Inc. "UK Summary of Product Characteristics." Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab. FDA cited D’Addio et al.239 and Taglauer et al.240 who describe the mechanism for preventing harm to the fetus. The most common adverse events in the atezolizumab group were decreased appetite, dyspnea, and pyrexia, whereas patients in the docetaxel group experienced decreased appetite, nausea, and diarrhea most frequently.73, Bhavisha A. Patel MD, Stephen V. Liu MD, in Pulmonary Adenocarcinoma: Approaches to Treatment, 2019. [Ref], Very common (10% or more): Urinary tract infection (22%), Common (1% to 10%): Urinary obstruction[Ref], Common (1% to 10%): Anemia, lymphopenia, increased alkaline phosphatase, increased alkaline phosphatase[Ref], Common (1% to 10%): Acute kidney injury, liver enzyme increase, increased ALT, increased AST, Very common (10% or more): Immune related colitis (19.7%), Common (1% to 10%): Immune related pneumonitis, immune related hepatitis, sepsis, Frequency not reported: Immune related endocrinopathies[Ref], Frequency not reported: Infusion related reactions[Ref], Very common (10% or more): Decreased appetite (26%), Common (1% to 10%): Hyponatremia, hyperglycemia, hypoalbuminemia[Ref], Very common (10% or more): Back/neck pain (15%), arthralgia (14%)[Ref], Frequency not reported: Meningoencephalitis, myasthenic syndrome/myasthenia gravis, Guillain-Barre[Ref], Frequency not reported: Ocular inflammatory toxicity[Ref], Very common (10% or more): Fatigue (52%), pyrexia (21%), peripheral edema (18%), Common (1% to 10%): Increased creatinine[Ref], Common (1% to 10%): Confusional state[Ref], Very common (10% or more): Dyspnea (16%), cough (14%), Common (1% to 10%): Dyspnea, pneumonia[Ref], 1. Reviewer note: Anti-PD-1/PD-L1 drugs can induce colitis, which may plausibly predispose to volvulus. James Chih-Hsin Yang, ... Chia-Yu Chu, in IASLC Thoracic Oncology (Second Edition), 2018, NSCLC is now known to be an immunologically targetable cancer. Unlikely.”, “Is the drug an inhibitor and/or an inducer of CYP enzymes? In caso di polmonite di grado 3 o 4, il trattamento con atezolizumab … He received prednisone with resolution of liver enzyme elevation by day 51.125, FDA’s Medical Review further described colitis, “Patient 1090 experienced Grade 2 microscopic colitis. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. pembrolizumab, lenvatinib, methotrexate, Arimidex, Keytruda, Ibrance, Faslodex, Femara, Avastin, Xeloda. Popolazioni … Bevacizumab 15 mg/kg IV on Day 1 . The design of the atezolizumab clinical trial excluded subjects already suffering from autoimmune disorders. Patients’ median age was 53 years (range, 29–82 years), they had an ECOG PS of 0 (48%) or 1 (50%), they were exposed to > 4 systemic therapies (89%), and they had received prior therapy with either an anthracycline- (85%), a taxane- (74%), or a platinum-based chemotherapy (57%). Response to atezolizumab was associated with increasing tumor-infiltrating immune cell PD-L1 expression (P = .015) but not significantly associated with tumor cell PD-L1 expression across all tumors (P = .079) or NSCLC (P = .92).72, Atezolizumab was further evaluated in the second-line with the Poplar Trial,73 a phase II randomized controlled trial of atezolizumab versus docetaxel in NSCLC patients who had progressed on platinum-containing chemotherapy. A literature-based assessment of the effects on reproduction demonstrated that a … function of the PD-L1/PD-1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to a fetus. Efficacy results are not yet evaluable for PD-L1 diagnostic-negative patients. Atezolizumab è un anticorpo monoclonale umanizzato IgG1 ingegnerizzato Fc diretto contro il ligando 1 (L1) del recettore di morte cellulare programmata (Programmed cell Death, PD) ed è prodotto in cellule … Fifty-seven patients (18.3%) received systemic corticosteroids within 30 days of an adverse event … [t]wenty of these patients (6.4%) were considered to have experienced an immunological AE … [o]ne patient died from subileus, which was considered to be an immunological AE.127”, The importance of correlating corticosteroid use with immune-related AEs, as a means for identifying safety signals, is highlighted by the fact that FDA’s Cross Discipline Team Leader Review observation that, “Adverse events that were likely to be immune-mediated and were treated with corticosteroids occurred in 6% of patients.128”. Breast cancer that is triple negative and has the PD-L1 protein. In fact, blocking PDL1 resulted in a loss of regulatory function and reduction in fetal survival rate.”, The term “Tregs,” which is pronounced “tee-regs,”242 refers to T-regulatory cells. Drug class: anti-PD-1 monoclonal antibodies, general feeling of tiredness and weakness, ulcers, sores, or white spots in the mouth, difficulty with chewing, swallowing, or talking, sudden numbness and weakness in the arms and legs, Blistering, peeling, or loosening of the skin, pains in the stomach, side, or abdomen, possibly radiating to the back, red skin lesions, often with a purple center, swelling of the eyelids, face, lips, hands, or feet, weakness in the arms, hands, legs, or feet. FDA observed various inflammatory disorders associated with atezolizumab, including inflammatory disorders of the lungs (pneumonitis), liver (hepatitis), gut (colitis), and eye (optic neuritis). Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus resulting in fetal death … [a]dvise females of reproductive potential to use effective contraception during treatment with TECENTRIQ.248. There was a statistically significant improvement in response rate with higher PDL1 expression (p = 0.015) on ICs, but not with tumoral PDL1 expression (p = 0.920).84 A T-helper type 1 like gene signature was also associated with response. Dopo diluizione (vedere paragrafo 6.6), la concentrazione finale della soluzione diluita deve essere tra 3,2 e 16,8 mg/mL. Other studies showed a similar toxicity profile as well [48,49].The other anti-PDL1 is Durvalumab, which has shown similar toxicity profile as well [50,51]. Immune-Related Pneumonitis: Withhold for moderate and permanently discontinue for severe or life-threatening pneumonitis … Immune-Related Hepatitis: Monitor for changes in liver function. The constant region (Fc region) of the antibody is what binds to FcRn receptor. Pneumonitis (any grade) developed in nine patients (3%); grade 3 or grade 4 pneumonitis developed in three (1%). Peripheral Sensory Nerve Disorder 12. But unfortunately, releasing the inhibitions also increases inflammation and autoimmunity in various tissues and organs in the body. Con atezolizumab non sono stati effettuati studi formali di interazione farmacocinetica tra medicinali. There was no significant difference in PFS (2.7 months with atezolizumab, 3.0 months with docetaxel) or response rate (15% in both arms), but the duration of response heavily favored atezolizumab (14.3 months vs. 7.2 months). Log in to print or send this list to … Chemotherapy-naïve patients high-intermediate TMB (TMB≥10 mutations/MB) and with locally advanced or metastatic non-squamous non-small cell lung cancer patients will be selected. Immunotherapy Drug Tecentriq (Atezolizumab) Boosts Survival for Lung Cancer Patients, We comply with the HONcode standard for trustworthy health information -. Fever 7. The patient’s death due to septic shock and respiratory failure, occurred in close temporal proximity to pneumonitis. 2. are being explored in ongoing research, with the hope to select the right patients more effectively for immunotherapy. Ogni mL contiene 60 mg di atezolizumab. Along with its needed effects, atezolizumab may cause some unwanted effects. In some cases, health care professionals may use the generic name atezolizumab when referring to the trade drug name Tecentriq™. Genentech, South San Francisco, CA. Three patients recorded as PD appeared to experience pseudoprogression with durable shrinkage of both target and new lesions. Low Energy 9. Patients with nonsquamous histology also had an improved survival with atezolizumab (HR 0.73, 95% CI 0.60–0.89). In a phase I study, atezolizumab demonstrated responses across several tumor types including a response rate of 23% in 53 patients with NSCLC and 21% in the 42 patients with nonsquamous histology.49 There was an association between response and expression of PD-L1, although the assay used to assess PD-L1 expression was different from the ones used above. Atezolizumab was temporarily interrupted. The Use in Specific Populations section included a separate warning about lactation: USE IN SPECIFIC POPULATIONS … Lactation … There is no information regarding … atezolizumab in human milk, the effects on the breastfed infant, or the effects on milk production. Anti-PD1 antibodies (e.g., nivolumab, pembrolizumab [MK-3475]) and anti-PD-L1 antibodies (e.g., atezolizumab [MPDL3280A], durvalumab [MEDI4736]) have shown effectiveness in treating NSCLC.95,96. Copyright © 2020 Elsevier B.V. or its licensors or contributors. Median overall survival was 13.8 months with atezolizumab and 9.6 months with docetaxel (HR 0.73, 95% CI 0.62–0.87). Unlikely.”, “Are there metabolic/transporter pathways that may be important? Atezolizumab is the generic name for the trade drug name Tecentriq™. The Use in Specific Populations section referred to mechanism of action and to animal toxicity studies: USE IN SPECIFIC POPULATIONS … Animal reproduction studies have not been conducted with TECENTRIQ to evaluate its effect on reproduction and fetal development. Comments by FDA reviewers on AEs of individual patients included remarks attributing the AE to inflammation or autoimmunity and relatedness to the study drug. See below for a comprehensive list of adverse effects. Three patients died of pneumonitis. Cough 4. Atezolizumab is a recombinant humanized antibody that binds to PD-L1 and prevents binding of PD-L1 (ligand) to PD-1 (receptor). In the subset of patients with any PD-L1 expression (on tumor cells or immune cells), survival favored atezolizumab with a median survival of 15.7 months compared with 10.3 months with docetaxel (HR 0.74, 95% CI 0.58–0.93). Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Common (1% to 10%): Venous thromboembolism[Ref], Very common (10% or more): Rash (15%), pruritus (13%)[Ref], Frequency not reported: Immune-related thyroid disorders (e.g., hyperthyroidism, hypothyroidism)[Ref], Very common (10% or more): Nausea (25%), constipation (21%), diarrhea (18%), abdominal pain (17%), vomiting (17%), Common (1% to 10%): Dehydration, intestinal obstruction[Ref], The most common adverse reactions (greater than 20%) were fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, and constipation. Package label. As proteins are degraded into amino acids that are subsequently recycled into other proteins, the classical biotransformation studies for small molecule drugs are not applicable.”. Two PRs were observed in the PD-L1 IHC IC2 group. Atezolizumab prevents cancer cells from using this tactic to evade the immune system. FDA’s Pharmacology Review stated that “The Applicant submitted a non-product … literature-based assessment to characterize the … risk of reproductive and developmental toxicity … the scientific literature demonstrates that interference with PD-L1 leads to loss of fetal tolerance and increases risk of immune-mediated abortion. It is an immunotherapy drug made by the biotech company Genentech. Treatment-related adverse events, grade 3 or higher, were noted in 15% of patients receiving atezolizumab and 43% of patients receiving docetaxel. The lack of significance of the anti-atezolizumab antibodies found a place in the Clinical Trials Experience section of atezolizumab’s package label: CLINICAL TRIALS EXPERIENCE…Immunogenicity. No cases of grade 3–5 pneumonitis was observed. A total of 2 CRs were observed: 1 CR was observed in the PD-L1 IHC IC2 group and the other in the PD-L1 IHC IC3 group. There were additional delayed responses after RECIST-determined progressive disease. Grade 3 or grade 4 immune-related adverse events occurred in 6% of patients, which mainly included diarrhea, rash, transaminitis, and thyroid abnormalities. TNBC patients (n = 54) enrolled in this phase 1a trial (Emens et al., 2015) with a dose escalation and expansion cohort. In adults whose disease has gotten worse during or after treatment with platinum chemotherapy. Any grade toxicity occurred in 69% of patients and most commonly Fatigue (30%), nausea (14%), decreased appetite (12%), pruritus (10%), pyrexia (9%), diarrhea (8%), rash (7%), arthralgia (7%), and vomiting (6%). The Sponsor had conducted a drug class analysis based on the mechanism of action to predict AEs in humans. Responses were evaluated in the context of PDL1 expression (based on an assay using the Sp142 antibody on a VENTANA platform) on TCs and immune cells (ICs). Grade 3–4 immune-mediated AEs occurred in 16% of patients, and each toxicity was mostly 1%–2%. We use cookies to help provide and enhance our service and tailor content and ads. From: IASLC Thoracic Oncology (Second Edition), 2018, Bing Xia MD, Roy S. Herbst MD, PhD, in Lung Cancer: A Practical Approach to Evidence-Based Clinical Evaluation and Management, 2018, Atezolizumab, a high affinity–specific humanized IgG1 antibody against PD-L1, is FDA approved for use in metastatic NSCLC after disease progression on platinum-containing chemotherapy. Human placentas were perfused … to measure transfer of [antibodies] … from the maternal to fetal circulation. The ORR in patients with NSCLC was 21%, whereas ORR across all tumor types was 18%. This … provides evidence that atezolizumab can cause fetal harm … to a pregnant woman.”238. Withhold for moderate and permanently discontinue for severe or life threatening transaminase or total bilirubin elevation … Immune-Related Colitis: Withhold for moderate or severe, and permanently discontinue for life-threatening colitis … Ocular Inflammatory Toxicity: Withhold for moderate and permanently discontinue for severe ocular inflammatory toxicity.129. A randomized phase II study compared atezolizumab 1200 mg with docetaxel 75 mg/m2, both given in a 21-day cycle. Aipazienti trattati con KEYTRUDA deve essere consegnatala scheda di allerta per il pazientee devono essere date informazionisui rischi di KEYTRUDA (vedere anche il foglio illustrativo). The PD-L1 to PD-1 signaling pathway is used by cancer cells to prevent CD8+ T-cells from killing cancer cells and to dampen the body’s immune response against the cancer. Constipation 3. Embryo-Fetal Toxicity. The randomized phase III OAK study also compared atezolizumab 1200 mg with docetaxel 75 mg/m2 in patients with NSCLC (any histology, no PD-L1 expression required) who had received 1–2 prior chemotherapy regimens.50 This large study of 1225 patients had a primary endpoint of overall survival, and survival was improved with atezolizumab, in both the intention to treat population and in the PD-L1 expression subpopulations. If experienced, these tend to have a Severe expression 1. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Reviewer note: Pneumonitis is a known toxicity from anti-PD-1 and anti-PD-L1 drugs. The trial also showed improvement in overall survival in patients who had preexisting immunity defined as high T-effector-interferon-Y-associated gene expression. Repeat every 3 weeks until disease progression or unacceptable toxicity. Popolazioni … Immune-related toxicities were equally low at 5% and no treatment-related deaths occurred during the study [28]. Six patients (1.9%) developed pneumonitis … [t]he median day of onset for the first event for these six patients was day 81 (range: 14-127) … [f]ive of these patients were treated with corticosteroids.124”. Blockage of PD-L1 signaling has been shown in murine models of pregnancy to disrupt tolerance to a fetus and to result in … fetal loss, therefore … risks of administering TECENTRIQ during pregnancy include … abortion or stillbirth.249. The most common Grade 3 to 4 adverse reactions (greater than 2%) were urinary tract infection, anemia, fatigue, dehydration, intestinal obstruction, urinary obstruction, hematuria, dyspnea, acute kidney injury, abdominal pain, venous thromboembolism, sepsis, and pneumonia. *Atezolizumab è un anticorpo monoclonale umanizzato IgG1 ingegnerizzato Fc diretto contro il ligando 1 (L1) del recettore di morte cellulare programmata (Programmed cell Death, PD) ed è prodotto in cellule … Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Anti-PD1 antibodies (e.g., nivolumab, pembrolizumab [MK-3475]) and anti-PD-L1 antibodies (e.g.. Treatment-related grade 3 or grade 4 adverse events were reported in 11% of patients, with no patient having grade 3 or higher pneumonitis and only 1% of patients having diarrhea. (atezolizumab) injection, for intravenous use Initial U.S. Approval: 2016 INDICATIONS AND USAGE TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of … In Summary. Atezolizumab is a humanized IgG1 monoclonal antibody targeting PDL1. What type of cancer is Tecentriq used to treat? FcRn binding affinity (KD) was 132 nM, 225 nM and 1500 nM for infliximab, adalimumab and etanercept, respectively. Immune-related adverse events of any grade occurred in 15.9% of patients; these events included rash (4.5%), influenza (3.0%), pruritus (2.2% or less), eczema (2.2% or less), vitiligo (2.2% or less), and hypothyroidism (2.2% or less). The median DOR had not been reached (range, 18–56 + weeks). In the subset of patients with nonsquamous histology, survival was 15.5 months with atezolizumab (95 patients) and 10.9 months with docetaxel (95 patients). Atezolizumab is a humanized IgG1 MAb with an engineered Fc-domain targeting PD-L1, thereby preventing binding to its receptors programmed death-1 (PD-1) and B7.1 (Chen et al., 2012). Generalized Weakness 8. Treatment-related Grade 3/4 AEs included nausea (2%), vomiting (2%), anemia (2%), and neutropenia (2%) (Emens et al., 2015). On this point, FDA stated, “Corticosteroid use. Atezolizumab agisce come immunomodulatore, bloccando il ligando della proteina della morte cellulare, nello specifico l’interazione fra PD-L1 e PD-1 Boves (Cuneo) via Roncaia, 123 12012 , 348-6955350 Higher expression of T-effector and interferon-γ gene signature (comprising CD8A, GZMA, GZMB, IFNγ, EOMES, CXCL9, CXCL10, TBX21 genes), reflecting preexisting immune competency, was associated with improved OS (HR 0.43) in patients treated with atezolizumab from the POPLAR study.61 Similarly in patients from the randomized OAK study, T-effector (Teff) signature (comprising three genes PD-L1, CXCL9, and IFNγ) >median was associated with superior PFS (HR 0.73) and OS (HR 0.59).68 With bigger magnitude of benefit and similar prevelance of Teff signature > median (50% of patients), Teff appears to be a more sensitive biomarker than PD-L1 expression in predicting benefit from atezolizumab.68 The clinical value of Teff signature was further evaluated prospectively in the IMPOWER 150 study. Tecentriq (atezolizumab) belongs to a class of immunotherapy drugs known as checkpoint inhibitors. In a publication describing AEs from a clinical study on atezolizumab, pneumonitis was described as “an immune-mediated adverse event.117” Another publication on AEs resulting from drugs that block PD-L1/PD-1 signaling stated that “immune-related AEs” include colitis, pneumonitis, and rash.118. Of note, no cases of pneumonitis were reported in the clinical trials of the anti-PD-L1 antibodies BMS-936559 and MPDL3280A.98. The ORR was 15% in both the atezolizumab and docetaxel groups, but the response was more durable with atezolizumab, with median duration of 14.3 months (95% CI 11.6-nonestimable) compared with 7.2 months with docetaxel (5.6–12.5 months). Refer to prescribing information for bevacizumab for recommended dosing information . In normal physiology, Tregs dampen immune responses in the body and prevent the immune system from inflicting damage on the body’s own tissues, that is, to prevent autoimmunity.243, Further addressing harm to the fetus, FDA observed that atezolizumab can bind to the FcRn receptor. Numbness And Tingling 11. Generalized Disorder Of Peripheral Nerves If experienced, these tend to have a Less Severe expression 1. Atezolizumab is an antibody that binds to PD-L1, thereby blocking the PD-L1/PD-1 signaling pathway. Treatment-related AEs in the safety-evaluable population (n = 54) occurred in 63% of patients, most of which were Grade ≤2. Other potential biomarkers including DNA repair mismatch defect, immune competency in tumor microenvironment, other ligands to immune checkpoint inhibitors, etc. In the PD-L1 low or undetectable cohort, survival still favored atezolizumab with a median survival of 12.6 months compared with 8.9 months (HR 0.75, 95% CI 0.59–0.96). Treatment discontinuation from adverse event occurred in 8% of patients receiving atezolizumab and 19% with docetaxel. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. It is used with paclitaxel albumin-stabilized nanoparticle formulation in adults whose cancer is locally advanced, metastatic, or cannot be removed by surgery.¹ 2. Atezolizumab received a breakthrough therapy designation in 2015 for the treatment of PDL1 expression–positive NSCLC progressing after first-line chemotherapy. "Product Information. He received prednisone for possible autoimmune hepatitis and his liver enzymes and encephalopathy resolved by days 42 and 47 respectively. ... degli anti PD-L1 (atezolizumab… Increasing PD-L1 expression in both tumor and tumor-infiltrating immune cells was associated with improvement in overall survival. There was no measurable certolizumab pegol binding affinity.”, FDA’s Pharmacology Review warned against risk of atezolizumab to the fetus: “Atezolizumab maintains binding to the FcRn receptor, so fetal exposure may occur if a patient is treated during pregnancy … [i]t is unclear whether fetal exposure to atezolizumab would occur at levels sufficient to cause adverse effects on the developing immune system [of the fetus] … there is a … risk of developing immune-mediated disorders … in the offspring due to the mechanism of action.”246, FDA then turned its attention to the package label and made recommendations regarding pregnancy as well as for lactation and breast feeding. The goal of this engineered version of atezolizumab was to prevent the administered antibody from generating, in the mouse, an immune response against the antibody.236, FDA described the antibody, “The Applicant generated mouse IgG2a/human chimeric antibodies for murine in vivo studies in order to reduce immunogenicity, which was observed in prior mouse studies … [a]tezolizumab was immunogenic in mice, resulting in significantly reduced exposures by Week 3.”237. Scheda tecnica (RCP) Composizione: Un flaconcino da 20 mL di concentrato contiene 1.200 mg di atezolizumab*. Con atezolizumab è stato osservato un miglioramento della OS rispetto a docetaxel sia nei pazienti affetti da NSCLC non squamoso (hazard ratio [HR] pari a 0,73, intervallo di confidenza al 95%: 0,60; 0,89; OS mediana di 15,6 versus 11,2 mesi rispettivamente con atezolizumab … Sixty-nine percent of patients enrolled were PD-L1 diagnostic-positive. Atezolizumab was resumed on day 163 and the colitis resolved by day 203.126”. Gli altri ingredienti sono L-istidina, acido acetico glaciale, … Among 275 patients…114 patients (41.5%) tested positive for treatment-emergent…anti-therapeutic antibodies…at one or more post-dose time points…the presence of anti-therapeutic antibodies did not appear to have a clinically significant impact on pharmacokinetics, safety or efficacy.78, Rina Hui MBBS, PhD, Michael Millward MBBS, MA, in Pulmonary Adenocarcinoma: Approaches to Treatment, 2019, Another biomarker was also investigated in several atezolizumab studies. How effective is atezolizumab (Tecentriq)? This was included to be consistent with labels for FDA-approved products inhibiting PD-1 … the Division recommends that females … should use effective contraception during treatment.”247. AST/ALT worsened to Grade 2 and he developed Grade 1 hyperbilirubinemia … [a]tezolizumab was not withheld. Medically reviewed by Drugs.com. Atezolizumab 1200 mg IV on Day 1 (administered before bevacizumab), plus . Educational Resources. Porter et al. Atezolizumab (MPDL3280A) is an IgG1 antagonist antibody targeting PD-L1 that has been engineered to avoid antibody-dependent cell-mediated cytotoxicity. Atezolizumab is the generic name for a drug with the brand name Tecentriq ®. Un flaconcino da 14mL di concentrato contiene 840 mg di atezolizumab*. The relevant drug class is drugs that block PD-L1 to PD-1 interactions (“interference with PD-L1”). 1 ALLEGATO I RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO Documento reso disponibile da AIFA il 11/12/2020 Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di … The median PFS was 18 weeks across all tumor types.