{"id":53878,"date":"2023-02-13T23:05:34","date_gmt":"2023-02-13T22:05:34","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/new-analyses-reinforce-survival-benefit-of-bavencio-first-line-maintenance-treatment-in-patients-with-advanced-urothelial-carcinoma-2\/"},"modified":"2023-02-13T23:05:34","modified_gmt":"2023-02-13T22:05:34","slug":"new-analyses-reinforce-survival-benefit-of-bavencio-first-line-maintenance-treatment-in-patients-with-advanced-urothelial-carcinoma-2","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/new-analyses-reinforce-survival-benefit-of-bavencio-first-line-maintenance-treatment-in-patients-with-advanced-urothelial-carcinoma-2\/","title":{"rendered":"New Analyses Reinforce Survival Benefit of BAVENCIO First-Line Maintenance Treatment in Patients With Advanced Urothelial Carcinoma"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<b>Long-term follow-up of the Phase III JAVELIN Bladder 100 study demonstrated median overall survival from start of chemotherapy of 29.7 months among patients receiving BAVENCIO, establishing a new reference point for treatment outcomes in clinical studies<\/b>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\n<b>Similar OS benefit seen for patients who were progression-free following either carboplatin- or cisplatin-based chemotherapy<\/b>\n<\/li>\n<li>\n<b>Evidence from non-interventional studies in France and also Italy shows consistent benefit for the JAVELIN Bladder regimen in real-world settings<\/b>\n<\/li>\n<\/ul>\n<p>\n<b><span class=\"bwuline\">Not intended for UK-based media<\/span><\/b>\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230213005103\/en\/1711212\/4\/EMD_Logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230213005103\/en\/1711212\/21\/EMD_Logo.jpg\"><\/a><\/p>\n<p>ROCKLAND, Mass.&#8211;(BUSINESS WIRE)&#8211;EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced findings of a new analysis of long-term follow-up data from the Phase III JAVELIN Bladder 100 trial. These analyses reinforce the proven survival benefits of BAVENCIO<sup>\u00ae<\/sup> (avelumab) in the first-line maintenance setting for patients with locally advanced or metastatic urothelial carcinoma (UC). With median follow-up of at least 38 months from randomization, patients who were progression-free following platinum-based chemotherapy who received BAVENCIO first-line maintenance plus best supportive care (BSC) had longer median overall survival (OS) than those who received BSC alone in the maintenance setting. This benefit was seen regardless of whether their initial chemotherapy regimens included cisplatin or carboplatin. This analysis, as well as multiple studies of BAVENCIO in the real-world setting, are being presented at the 2023 American Society of Clinical Oncology\u2019s annual Genitourinary Cancers Symposium, February 16-18, 2023.\n<\/p>\n<p>\n\u201cBased on the significant improvement in overall survival demonstrated in the Phase III JAVELIN Bladder 100 study, platinum-based chemotherapy followed by avelumab maintenance treatment, in patients without evidence of disease progression, has become a standard of care for advanced urothelial carcinoma. The findings presented today reinforce that all patients eligible for platinum-based chemotherapy, either cisplatin or carboplatin, can benefit from avelumab maintenance therapy. These findings reported here provide a reference point for outcomes of ongoing and future clinical trials in advanced bladder cancer,\u201d said Srikala Sridhar, MD, MSc, FRCPC, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.\n<\/p>\n<p>\nIn the overall population, patients who received BAVENCIO plus BSC had a median OS of 29.7 months (95% CI, 25.2-34.0) as measured from the start of first-line chemotherapy, compared with 20.5 months (95% CI, 19.0-23.5) in patients who received BSC alone (HR, 0.77; 95% CI, 0.636-0.921). This result further supports the JAVELIN Bladder 100 regimen of BAVENCIO first-line maintenance in patients with advanced UC who are progression-free following first-line platinum-based chemotherapy as standard of care.\n<\/p>\n<p>\nThe analysis also confirmed that the overall survival of BAVENCIO first-line maintenance were similar regardless of whether patients received cisplatin- or carboplatin-based chemotherapy.\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nIn patients who received cisplatin plus gemcitabine (n=389), median OS from start of chemotherapy was 31.0 months (95% CI, 24.9-37.1) in the BAVENCIO plus BSC arm (n=183), compared with 23.0 months (95% CI, 19.2-30.9) for BSC alone (n=206) (HR, 0.79; 95% CI, 0.613-1.024).\n<\/li>\n<li>\nIn patients who received carboplatin plus gemcitabine (n=269), median OS from start of chemotherapy was 25.8 months (95% CI, 22.8-33.3) for BAVENCIO plus BSC (n=147), compared with 17.6 months (95% CI, 14.8-21.3) for BSC alone (n=122) (HR, 0.69; 95% CI, 0.514-0.920).\n<\/li>\n<\/ul>\n<p>\nLong-term safety was similar in both the cisplatin plus gemcitabine and carboplatin plus gemcitabine subgroups, with no new safety concerns identified. Grade 3 or greater treatment-related adverse events were 16 percent and 23 percent for cisplatin and carboplatin cohorts, respectively.\n<\/p>\n<p>\n\u201cBAVENCIO remains the only immunotherapy to show improved overall survival in advanced UC patients in the first-line maintenance setting in a Phase III trial. The large, randomized Phase III JAVELIN Bladder 100 trial established BAVENCIO first-line maintenance treatment following platinum-based chemotherapy as a standard of care, and long-term and real-world data such as these presented at ASCO GU 2023 continue adding to the evidence supporting its benefits for patients with advanced bladder cancer,\u201d said Tamas S\u00fct\u00f6, MD, PhD, Senior Vice President &amp; Head of Medical Unit Oncology, Merck KGaA, Darmstadt, Germany.\n<\/p>\n<p>\nAdditional data presented at the meeting include updates from real-world studies of patient populations in France, Italy, Germany, and the U.S. This includes the first full analysis from the AVENANCE real-world study investigating the efficacy and safety of BAVENCIO first-line maintenance therapy in advanced UC patients in France, and the READY study of real-world data from a compassionate use program in Italy, which supports the findings of JAVELIN Bladder 100 in real-world settings.\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nIn the ongoing (median follow-up 15.2 months) noninterventional AVENANCE study of 593 patients in France with advanced UC that had not progressed with first-line platinum-based chemotherapy who received BAVENCIO as a first-line maintenance treatment, median OS from start of BAVENCIO treatment was 20.7 months (95% CI, 17.1-not estimable) and the 12-month OS rate was 65.4% (95% CI, 61.0-69.4). Median progression-free survival (PFS) was 5.7 months (95% CI, 5.3-7.0).\n<\/li>\n<li>\nIn the READY study of 464 patients in Italy who received BAVENCIO first-line maintenance treatment following platinum-based chemotherapy, median OS was not reached and the 12-month OS rate from the start of BAVENCIO treatment was 69.2% (95% CI, 64.8%-73.7%). The median PFS was 8.1 months (95% CI, 6.1-10.4) with a 12-month PFS rate of 44.3% (95% CI, 39.5-49.1).\n<\/li>\n<\/ul>\n<p>\nData for BAVENCIO as well as real-world analyses in urothelial cancer being presented at ASCO GU include:\n<\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl\">\n<tr>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwleftsingle bwrightsingle bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Title<\/b>\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwrightsingle bwnowrap bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Lead Author, Abstract # and<br \/>\n<br \/>Session Details (all times PT)<\/b>\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nAvelumab first-line (1L) maintenance for advanced<br \/>\n<br \/>urothelial carcinoma (UC): long-term follow-up from<br \/>\n<br \/>the JAVELIN Bladder 100 trial in subgroups defined<br \/>\n<br \/>by 1L chemotherapy regimen and analysis of overall<br \/>\n<br \/>survival (OS) from start of 1L chemotherapy\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwnowrap bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nSS Sridhar\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<b>Abstract #508<br \/>\n<br \/><\/b><b>Poster Session B:<\/b> Prostate<br \/>\n<br \/>Cancer and Urothelial Carcinoma<br \/>\n<br \/>Friday, Feb 17, 2023<br \/>\n<br \/>12:30-2:00 PM; 5:15-6:15 PM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nFull analysis from AVENANCE: A real-world study of<br \/>\n<br \/>avelumab first-line (1L) maintenance treatment in<br \/>\n<br \/>patients (pts) with advanced urothelial carcinoma<br \/>\n<br \/>(aUC)\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwnowrap bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP Barth\u00e9l\u00e9my\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<b>Abstract #471<br \/>\n<br \/><\/b><b>Poster Session B:<\/b> Prostate<br \/>\n<br \/>Cancer and Urothelial Carcinoma<br \/>\n<br \/>Friday, Feb 17, 2023<br \/>\n<br \/>12:30-2:00 PM; 5:15-6:15 PM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTreatment patterns, indicators of receiving systemic<br \/>\n<br \/>treatment, and clinical outcomes in metastatic<br \/>\n<br \/>urothelial carcinoma: a retrospective analysis of real-<br \/>\n<br \/>world data in Germany\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwnowrap bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nG Niegisch\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<b>Abstract #464<br \/>\n<br \/><\/b><b>Poster Session B:<\/b> Prostate<br \/>\n<br \/>Cancer and Urothelial Carcinoma<br \/>\n<br \/>Friday, Feb 17, 2023<br \/>\n<br \/>12:30-2:00 PM; 5:15-6:15 PM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nReal-world treatment patterns and sequencing in<br \/>\n<br \/>patients with locally advanced or metastatic urothelial<br \/>\n<br \/>cancer (la\/mUC) in the US\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwnowrap bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nM Kearney\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<b>Abstract #572<br \/>\n<br \/><\/b><b>Poster Session B:<\/b> Prostate<br \/>\n<br \/>Cancer and Urothelial Carcinoma<br \/>\n<br \/>Friday, Feb 17, 2023<br \/>\n<br \/>12:30-2:00 PM; 5:15-6:15 PM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nBaseline characteristics from a retrospective,<br \/>\n<br \/>observational, US-based, multicenter, \u2018real-world\u2019<br \/>\n<br \/>(RW) study of avelumab first-line maintenance (1LM)<br \/>\n<br \/>in locally advanced\/metastatic urothelial carcinoma<br \/>\n<br \/>(la\/mUC) (PATRIOT-II)\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwnowrap bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP Grivas\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<b>Abstract #465<br \/>\n<br \/><\/b><b>Poster Session B:<\/b> Prostate<br \/>\n<br \/>Cancer and Urothelial Carcinoma<br \/>\n<br \/>Friday, Feb 17, 2023<br \/>\n<br \/>12:30-2:00 PM; 5:15-6:15 PM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nREADY: REAL-world Data from an Italian<br \/>\n<br \/>compassionate use program of avelumab first-line<br \/>\n<br \/>maintenance (1LM) treatment for locally advanced or<br \/>\n<br \/>metastatic urothelial carcinoma (la\/mUC)\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwnowrap bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nL Antonuzzo\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<b>Abstract #469<br \/>\n<br \/><\/b><b>Poster Session B:<\/b> Prostate<br \/>\n<br \/>Cancer and Urothelial Carcinoma<br \/>\n<br \/>Friday, Feb 17, 2023<br \/>\n<br \/>12:30-2:00 PM; 5:15-6:15 PM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nAssessment of treatment patterns and real-world<br \/>\n<br \/>outcomes following changes in the treatment<br \/>\n<br \/>paradigm for locally advanced\/metastatic urothelial<br \/>\n<br \/>carcinoma (la\/mUC) in the US\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwnowrap bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nM Kirker\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<b>Abstract #468<br \/>\n<br \/><\/b><b>Poster Session B:<\/b> Prostate<br \/>\n<br \/>Cancer and Urothelial Carcinoma<br \/>\n<br \/>Friday, Feb 17, 2023<br \/>\n<br \/>12:30-2:00 PM; 5:15-6:15 PM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nSPADE: Design of a real-world observational study of<br \/>\n<br \/>avelumab first-line (1L) maintenance in advanced<br \/>\n<br \/>urothelial carcinoma (UC) in the Asia-Pacific (APAC)<br \/>\n<br \/>region\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwnowrap bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP-J Su\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<b>Abstract #TPS577<br \/>\n<br \/><\/b><b>Trials in Progress Poster<br \/>\n<br \/>Session B: <\/b>Urothelial Carcinoma<br \/>\n<br \/>Friday, Feb 17, 2023<br \/>\n<br \/>12:30-2:00 PM; 5:15-6:15 PM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nC-reactive protein (CRP) as a predictive marker for<br \/>\n<br \/>outcomes with avelumab + axitinib (A + Ax) in<br \/>\n<br \/>patients with poor-risk advanced renal cell carcinoma<br \/>\n<br \/>(aRCC): exploratory analysis from JAVELIN Renal 101\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwnowrap bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nY Tomita\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<b>Abstract #670<br \/>\n<br \/><\/b><b>Poster Session C: <\/b>Renal Cell<br \/>\n<br \/>Cancer; Adrenal, Penile, Urethral<br \/>\n<br \/>and Testicular Cancers<br \/>\n<br \/>Saturday, Feb 18, 2023<br \/>\n<br \/>7:00-8:00 AM; 12:30-2:00 PM\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nA UK real-world observational study of avelumab +<br \/>\n<br \/>axitinib (A + Ax) in advanced renal cell carcinoma<br \/>\n<br \/>(aRCC): 24-month interim results\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwnowrap bwpadl1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nP Nathan\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<b>Abstract #631<br \/>\n<br \/><\/b><b>Poster Session C:<\/b> Renal Cell<br \/>\n<br \/>Cancer; Adrenal, Penile, Urethral<br \/>\n<br \/>and Testicular Cancers<br \/>\n<br \/>Saturday, Feb 18, 2023<br \/>\n<br \/>7:00-8:00 AM; 12:30-2:00 PM\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n<b>About JAVELIN Bladder 100<\/b>\n<\/p>\n<p>\nJAVELIN Bladder 100 (NCT02603432) is a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with BAVENCIO plus BSC versus BSC alone in patients with locally advanced or metastatic UC. The primary endpoint was OS in the two primary populations of all patients and patients with PD-L1+ tumors defined by the Ventana SP263 assay. Secondary endpoints included progression-free survival, anti-tumor activity, safety, pharmacokinetics, immunogenicity, predictive biomarkers and patient-reported outcomes in the co-primary populations. All primary and secondary endpoints are measured from the time of randomization.\n<\/p>\n<p>\n<b>About Urothelial Carcinoma<\/b>\n<\/p>\n<p>\nBladder cancer is the tenth most common cancer worldwide.<sup>1<\/sup> In 2020, there were over half a million new cases of bladder cancer diagnosed, with around 200,000 deaths from the disease globally.<sup>1<\/sup> In the US, an estimated 83,730 cases of bladder cancer were diagnosed in 2021, with around 10,000 locally advanced or metastatic cases presented annually.<sup>2<\/sup> UC, which accounts for about 90% of all bladder cancers,<sup>3<\/sup> becomes harder to treat as it advances, spreading through the layers of the bladder wall.<sup>4<\/sup> Only 25% to 55% of patients receive any second-line therapy after first-line chemotherapy.<sup>5<\/sup> In the US and EU5 markets, approximately 40% to 50% of patients receive an immune checkpoint inhibitor in second-line therapy.<sup>2 <\/sup>For patients with advanced UC, the five-year survival rate is 6.4%.<sup>2<\/sup>\n<\/p>\n<p>\n<b>About BAVENCIO<sup>\u00ae <\/sup>(avelumab)<\/b>\n<\/p>\n<p>\nBAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.<sup>6-8<\/sup> In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.\n<\/p>\n<p>\n<b>BAVENCIO Approved Indications<\/b>\n<\/p>\n<p>\nBAVENCIO<sup>\u00ae<\/sup> (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.\n<\/p>\n<p>\nBAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).\n<\/p>\n<p>\nIn the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.\n<\/p>\n<p>\nBAVENCIO is currently approved for at least one indication for patients in more than 50 countries.\n<\/p>\n<p>\n<b>BAVENCIO Important Safety Information from the US FDA-Approved Label<\/b>\n<\/p>\n<p>\nBAVENCIO can cause <b>severe and fatal immune-mediated adverse reactions<\/b> in any organ system or tissue and at any time after starting treatment with a PD-1\/PD-L1 blocking antibody, including after discontinuation of treatment.\n<\/p>\n<p>\n<b>Early identification and management of immune-mediated adverse reactions are essential<\/b> to ensure safe use of PD-1\/PD-L1 blocking antibodies. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.\n<\/p>\n<p>\n<b>No dose reduction for BAVENCIO is recommended. For immune-mediated adverse reactions, withhold or permanently discontinue BAVENCIO depending on severity.<\/b> In general, withhold BAVENCIO for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue BAVENCIO for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating corticosteroids. In general, if BAVENCIO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg\/kg\/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic corticosteroids (eg, endocrinopathies and dermatologic reactions) are discussed in subsequent sections.\n<\/p>\n<p>\nBAVENCIO can cause <b>immune-mediated pneumonitis<\/b>, including fatal cases. Monitor patients for signs and symptoms of pneumonitis and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for Grade 2 and permanently discontinue for Grade 3 or Grade 4 pneumonitis. Immune-mediated pneumonitis occurred in 1.2% (21\/1738) of patients, including fatal (0.1%), Grade 4 (0.1%), Grade 3 (0.3%) and Grade 2 (0.6%) adverse reactions. Systemic corticosteroids were required in all (21\/21) patients with pneumonitis.\n<\/p>\n<p>\nBAVENCIO can cause <b>immune-mediated colitis<\/b>. The primary component of immune-mediated colitis consisted of diarrhea. Cytomegalovirus infection\/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Withhold BAVENCIO for Grade 2 or Grade 3, and permanently discontinue for Grade 4 colitis. Immune-mediated colitis occurred in 1.5% (26\/1738) of patients, including Grade 3 (0.4%) and Grade 2 (0.7%) adverse reactions. Systemic corticosteroids were required in all (26\/26) patients with colitis.\n<\/p>\n<p>\nBAVENCIO can cause <b>hepatotoxicity and<\/b> <b>immune-mediated hepatitis<\/b>. Withhold or permanently discontinue BAVENCIO based on tumor involvement of the liver and severity of aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin elevation. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% (16\/1738) of patients, including fatal (0.1%), Grade 3 (0.6%), and Grade 2 (0.1%) adverse reactions. Systemic corticosteroids were required in all (16\/16) patients with hepatitis.\n<\/p>\n<p class=\"bwmarginl1\">\n<b><i>BAVENCIO in combination with INLYTA<\/i><\/b><i> <\/i>can cause <b>hepatotoxicity<\/b> with higher than expected frequencies of Grade 3 and 4 ALT and AST elevation compared to BAVENCIO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold or permanently discontinue both BAVENCIO and INLYTA based on severity of AST, ALT, or total bilirubin elevation, and consider administering corticosteroids as needed. Consider rechallenge with BAVENCIO or INLYTA, or sequential rechallenge with both BAVENCIO and INLYTA, after recovery. In patients treated with BAVENCIO in combination with INLYTA in the advanced RCC trials, increased ALT and increased AST were reported in 9% (Grade 3) and 7% (Grade 4) of patients. Immune-mediated hepatitis was reported in 7% of patients including 4.9% with Grade 3 or 4 immune-mediated hepatitis. Thirty-four patients were treated with corticosteroids and one patient was treated with a non-steroidal immunosuppressant.\n<\/p>\n<p>\nBAVENCIO can cause primary or secondary <b>immune-mediated adrenal insufficiency<\/b>. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement, as clinically indicated. Withhold BAVENCIO for Grade 3 or Grade 4 endocrinopathies until clinically stable or permanently discontinue depending on severity. Immune-mediated adrenal insufficiency occurred in 0.5% (8\/1738) of patients, including Grade 3 (0.1%) and Grade 2 (0.3%) adverse reactions. Systemic corticosteroids were required in all (8\/8) patients with adrenal insufficiency.\n<\/p>\n<p>\nBAVENCIO can cause <b>immune-mediated hypophysitis<\/b>. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement, as clinically indicated. Withhold BAVENCIO for Grade 3 or Grade 4 endocrinopathies until clinically stable or permanently discontinue depending on severity. Immune-mediated pituitary disorders occurred in 0.1% (1\/1738) of patients, which was a Grade 2 (0.1%) adverse reaction.\n<\/p>\n<p>\nBAVENCIO can cause <b>immune-mediated thyroid disorders<\/b>. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism, as clinically indicated. Withhold BAVENCIO for Grade 3 or Grade 4 endocrinopathies until clinically stable or permanently discontinue depending on severity. Thyroiditis occurred in 0.2% (4\/1738) of patients, including Grade 2 (0.1%) adverse reactions. Hyperthyroidism occurred in 0.4% (7\/1738) of patients, including Grade 2 (0.3%) adverse reactions. Systemic corticosteroids were required in 29% (2\/7) of patients with hyperthyroidism. Hypothyroidism occurred in 5% (90\/1738) of patients, including Grade 3 (0.2%) and Grade 2 (3.7%) adverse reactions. Systemic corticosteroids were required in 7% (6\/90) of patients with hypothyroidism.\n<\/p>\n<p>\nBAVENCIO can cause <b>immune-mediated type I diabetes mellitus<\/b>, which can present with diabetic ketoacidosis. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold BAVENCIO for Grade 3 or Grade 4 endocrinopathies until clinically stable or permanently discontinue depending on severity. Immune-mediated type I diabetes mellitus occurred in 0.1% (2\/1738) of patients, including Grade 3 (0.1%) adverse reactions.\n<\/p>\n<p>\nBAVENCIO can cause <b>immune-mediated nephritis with renal dysfunction<\/b>. Withhold BAVENCIO for Grade 2 or Grade 3, and permanently discontinue for Grade 4 increased blood creatinine. Immune-mediated nephritis with renal dysfunction occurred in 0.1% (1\/1738) of patients, which was a Grade 2 (0.1%) adverse reaction. Systemic corticosteroids were required in this patient.\n<\/p>\n<p>\nBAVENCIO can cause <b>immune-mediated dermatologic adverse reactions<\/b>, including rash or dermatitis. Exfoliative dermatitis including Stevens Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1\/PD-L1 blocking antibodies. Topical emollients and\/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Withhold BAVENCIO for suspected and permanently discontinue for confirmed SJS, TEN, or DRESS. Immune-mediated dermatologic adverse reactions occurred in 5% (90\/1738) of patients, including Grade 3 (0.1%) and Grade 2 (2.0%) adverse reactions. Systemic corticosteroids were required in 29% (26\/90) of patients with dermatologic adverse reactions.\n<\/p>\n<p>\nBAVENCIO can result in other <b>immune-mediated adverse reactions<\/b>. Other clinically significant immune-mediated adverse reactions occurred at an incidence of &lt;1% in patients who received BAVENCIO or were reported with the use of other PD-1\/PD-L1 blocking antibodies. For myocarditis, permanently discontinue BAVENCIO for Grade 2, Grade 3, or Grade 4. For neurological toxicities, withhold BAVENCIO for Grade 2 and permanently discontinue for Grade 3 or Grade 4.\n<\/p>\n<p>\nBAVENCIO can cause <b>severe or life-threatening infusion-related reactions<\/b>. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent infusions based upon clinical judgment and presence\/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 infusion-related reactions. Permanently discontinue BAVENCIO for Grade 3 or Grade 4 infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) Grade 4 and nine (0.5%) Grade 3 infusion-related reactions. Eleven (92%) of the 12 patients with Grade \u22653 reactions were treated with intravenous corticosteroids.\n<\/p>\n<p>\nFatal and other serious <b>complications of allogeneic hematopoietic stem cell transplantation (HSCT) <\/b>can occur in patients who receive HSCT before or after being treated with a PD-1\/PD-L1 blocking antibody. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1\/PD-L1 blocking antibody prior to or after an allogeneic HSCT.\n<\/p>\n<p>\nBAVENCIO <b>in combination with INLYTA<\/b> can cause <b>major adverse cardiovascular events (MACE)<\/b> including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Permanently discontinue BAVENCIO and INLYTA for Grade 3-4 cardiovascular events. MACE occurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with INLYTA compared to 3.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<a target=\"_blank\" href=\"&#x6d;&#x61;&#105;&#108;to&#x3a;&#x6e;&#x6f;&#101;ll&#x65;&#x2e;&#x70;&#105;&#115;c&#x69;&#x74;&#x65;&#108;&#108;i&#x40;&#x65;&#x6d;&#100;&#115;er&#x6f;&#x6e;&#x6f;&#46;co&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x6e;&#x6f;&#x65;&#x6c;&#108;&#101;&#46;pi&#x73;&#x63;&#x69;&#x74;&#101;&#108;li&#64;&#x65;&#x6d;&#x64;&#x73;&#101;&#114;&#111;no&#x2e;&#x63;&#x6f;&#x6d;<\/a><b><br \/><\/b>Phone: +1 (781) 427-4351\n<\/p>\n<p> <a href=\"http:\/\/www.businesswire.com\/news\/home\/20230213005103\/en\/New-Analyses-Reinforce-Survival-Benefit-of-BAVENCIO-First-Line-Maintenance-Treatment-in-Patients-With-Advanced-Urothelial-Carcinoma\/?feedref=Zd8jjkgYuzBwDixoAdXmJgT1albrG1Eq4mAeVP392103_ypKzv-7ah0oHKWbnuHnevRMp3sIgu8q3wq1OF24lT93qbEzrwa15HGbLqMObxZM7XiMhduiSeKMTNDLRqI_doMC3CVAuyHo5cJ7XfDuvA==\"> Read full story here <\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Long-term follow-up of the Phase III JAVELIN Bladder 100 study demonstrated median overall survival from start of chemotherapy of 29.7 months among patients receiving BAVENCIO, establishing a new reference point for treatment outcomes in clinical studies Similar OS benefit seen for patients who were progression-free following either carboplatin- or cisplatin-based chemotherapy Evidence from non-interventional studies &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/new-analyses-reinforce-survival-benefit-of-bavencio-first-line-maintenance-treatment-in-patients-with-advanced-urothelial-carcinoma-2\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-53878","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New Analyses Reinforce Survival Benefit of BAVENCIO First-Line Maintenance Treatment in Patients With Advanced Urothelial Carcinoma - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/new-analyses-reinforce-survival-benefit-of-bavencio-first-line-maintenance-treatment-in-patients-with-advanced-urothelial-carcinoma-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New Analyses Reinforce Survival Benefit of BAVENCIO First-Line Maintenance Treatment in Patients With Advanced Urothelial Carcinoma - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Long-term follow-up of the Phase III JAVELIN Bladder 100 study demonstrated median overall survival from start of chemotherapy of 29.7 months among patients receiving BAVENCIO, establishing a new reference point for treatment outcomes in clinical studies Similar OS benefit seen for patients who were progression-free following either carboplatin- or cisplatin-based chemotherapy Evidence from non-interventional studies ... 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