Friday, July 19, 2024

Nivolumab Fda Approval Bladder Cancer

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About The Phase Iii Checkmate 274 Clinical Trial

Dr. Lopes on the FDA Approval of Nivolumab/Ipilimumab in NSCLC

The trial evaluated the use of post-surgery Opdivo in 709 patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or renal pelvis who underwent radical surgery with or without pre-surgery cisplatin-based chemotherapy. Patients with a high risk for recurrence based on the tumor stage at surgery were treated with either Opdivo or placebo every other week for 1 year and directly compared.

Opdivo treatment significantly delayed the time to cancer recurrence. Opdivo treated patients survived on average 21 months without cancer recurrence compared to only 11 months for those receiving placebo. The benefit from Opdivo treatment was irrespective of PD-L1 status. In patients whose tumors had a PD-L1 expression of 1% or higher Opdivo immunotherapy resulted in a 45% reduction in the risk of disease recurrence or death

Overall therapy was well tolerated, and the most common treatment-related side effects were diarrhea, colitis, and pneumonitis.

Opdivo is the first immune therapy to be used in the adjuvant setting that provides clinically meaningful improvement in disease-free survival for patients with high-risk muscle-invasive urothelial carcinoma after radical surgery with curative intent. This trial led to FDA approval of Opdivo for use as adjuvant treatment of patients with urothelial carcinoma who are at high risk of cancer recurrence after undergoing surgical removal of their cancer in August 2021.

Bladder Cancer And Hodgkin Lymphoma Fda Approvals Expand Immunotherapys Reach

Last week, the U.S. Food and Drug Administration increased the number of cancer types for which immunotherapeutics known as checkpoint inhibitors are an approved treatment option. On Tuesday, the agency expanded the use of nivolumab to include the treatment of certain patients with Hodgkin lymphoma. The following day, it approved a new immunotherapeutic known as atezolizumab for certain patients with bladder cancer, a disease for which there have been no new treatments approved in more than three decades.

Immunotherapeutics work by harnessing the power of a patients immune system to fight cancer the way it fights disease-causing microbes such as the influenza virus.

Nivolumab and atezolizumab work in different ways to release a brake called PD-1 on cancer-fighting immune cells called T cells. Once the PD-1 brake is released, the T cells are able to carry out their natural function and can destroy cancer cells.

Nivolumab targets PD-1 itself, preventing the brake from being triggered. Atezolizumab targets PD-L1, which is one of two proteins that can attach to PD-1, triggering its brake function. By targeting PD-L1, atezolizumab prevents this protein from triggering the PD-1 brake on T cells, it also prevent PD-L1 from triggering another brake on T cells called B7.1. Atezolizumab is the first PD-L1 inhibitor to be approved by the FDA.

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More advances on the horizon

Top Story In Bladder Cancer: Adjuvant Nivolumab Vs Placebo In Muscle

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    Nivolumab Gets Additional Adjuvant Indication For Bladder Cancer

    M. Alexander Otto, MMS, PA

    The US Food and Drug Administration has approved nivolumab for the adjuvant treatment of urothelial carcinoma in cases in which there is a high risk for recurrence following radical resection, according to an announcement from its maker, Bristol-Meyers Squibb .

    The new indication builds on the PD-1 inhibitor’s prior approvals for advanced or metastatic UC that’s progressed during or following platinum-containing chemotherapy or that’s progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

    The new indication is based results from the CheckMate -274 trial, which found an almost doubling of median disease-free survival with nivolumab compared with placebo.

    BMS noted that the new approval makes nivolumab “the first and only PD-1 inhibitor approved for urothelial carcinoma in the adjuvant setting,” regardless of prior neoadjuvant chemotherapy, nodal involvement, or PD-L1 status.

    It “has the potential to become a new standard-of-care option in this setting,” said CheckMate-274’s primary investigator, Matthew Galsky, MD, a genitourinary medical oncologist at the Icahn School of Medicine at Mount Sinai, in New York City, in the company press release.

    Median DFS was 20.8 months with nivolumab, vs 10.8 months in the placebo arm. Among patients with PD-L1 expression of 1% or more, median DFS was 8.4 months in the placebo group it was not reached with nivolumab.

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    Clinical Study Of Nivolumab

    FDA approves first targeted therapy for locally advanced or metastatic ...

    The approval was based on the results of a phase II clinical trial of 270 patients with unresectable locally advanced or metastatic bladder cancer that had worsened or come back after treatment with at least one platinum-based chemotherapy regimen.

    All patients in the trial were treated with the same dose of nivolumab. Of the 265 patients that could be evaluated, 52 had a confirmed objective response, meaning their tumors shrank measurably. Of those patients, 46 had a partial response and six had a complete response.

    This is an improvement compared with the 10-15% objective response rate historically observed among patients treated with second-line chemotherapy, the investigators noted.

    In other clinical studies, expression of PD-L1 by tumor cells has been used to predict patient response to treatment with checkpoint inhibitors. The research team found that treatment with nivolumab produced measurable responses among patients with all levels of PD-L1 expression. For example, 28% of patients whose tumors were considered to have the highest PD-L1 expression and 16% of patients whose tumors had the lowest PD-L1 expression had an objective response.

    However, it is not surprising that some patients with low PD-L1 expressing-tumors had responses to nivolumab, said Dr. Apolo.

    There are a lot of variables with the PD-L1 test, and the immune system is very dynamic, she explained. We cant really say that PD-L1 is a perfect biomarker to predict response.

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    Checkpoint Inhibitors And Bladder Cancer

    Long-term survival for people diagnosed with advanced bladder cancer is poor, with approximately 5% of patients with metastatic bladder cancer surviving for 5 years or more.

    Checkpoint inhibitors have shown activity in patients with metastatic bladder cancer in both the second-line setting and the first-line setting , explained Andrea B. Apolo, M.D., who heads the Bladder Cancer Section in NCIs Center for Cancer Researchs Genitourinary Malignancies Branch.

    But we still needand are awaitingthe results of ongoing randomized trials comparing checkpoint inhibitors and chemotherapy in the first-line setting for patients with metastatic bladder cancer, she continued. The results will allow us to adequately compare patient outcome in terms of survival and quality of life with these therapies.

    With the exception of pembrolizumab, the drugs covered by these approvals target a protein known as PD-L1 that is expressed at high levels on some cancer cells. Pembrolizumab targets PD-1, the receptor protein for PD-L1, on immune cells. Normally, binding of PD-L1 to PD-1 tamps down immune activity. By preventing the interaction between PD-L1 and PD-1, all four drugs can allow the immune system to be more active against tumor cells.

    The other checkpoint inhibitor approved by the FDA for the treatment of patients with bladder cancer, nivolumab , targets PD-1.

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    Nivolumab Approved For Locally Advanced Or Metastatic Bladder Cancer

    The US Food and Drug Administration has approved intravenous nivolumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma 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.1

    This indication is approved under accelerated approval based on tumor response rate and duration of response. Verification and description of clinical benefit in confirmatory trials may be needed for continued approval for this indication.

    Most people dont know how common bladder cancer is and that it is the fifth most diagnosed cancer, Stephanie Chisolm, director of Education and Research at Bladder Cancer Advocacy Network, said in a press release. This approval is another exciting step forward for the bladder cancer community and provides needed hope to patients and their families.

    The recommended dose and schedule of nivolumab for urothelial carcinoma is 240 mg administered over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

    The most common adverse events occurring in 20% of patients or more are asthenia/fatigue, lymphopenia, anemia, musculoskeletal pain, decreased appetite, and nausea. The most frequent grade 3 to 4 adverse events are asthenia/fatigue, urinary tract infection, lymphopenia, and anemia.

    Reference

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    Opdivo Treatment Of Bladder Cancer

    The US Food and Drug Administration has approved Opdivo, for the treatment of patients with high risk early stage and locally advanced or metastatic urothelial carcinoma whose disease has progressed during a period of up to 1 year after first-line platinum-containing chemotherapy. Since approval clinical trials have demonstrated that Opdivo delays recurrence and improves outcomes when used in earlier stage disease and in the adjuvant setting.1,2

    Bladder cancer will be diagnosed in approximately 77,000 people in the United States this year alone. The average age that patients are diagnosed with bladder cancer is 70 years, with 80% of these patients being former smokers. The most common type of bladder cancer is urothelial carcinoma, whereby cancer begins in the cells that line the bladder.

    Fda Approval Summary: Nivolumab For The Adjuvant Treatment Of Adults With Completely Resected Esophageal/gastroesophageal Junction Cancer And Residual Pathologic Disease

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    *Corresponding Author:Corresponding Author:

    Clin Cancer Res 2022 28:15

    Clin Cancer Res

  • Accepted Manuscript August 12 2022
  • M. Naomi Horiba, Sandra J. Casak, Pallavi S. Mishra-Kalyani, Pourab Roy, Julia A. Beaver, Richard Pazdur, Paul G. Kluetz, Steven J. Lemery, Lola A. Fashoyin-Aje FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease. Clin Cancer Res 2022

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    Fda Approves Nivolumab For Urothelial Carcinoma

    The FDA has granted an accelerated approval to nivolumab as a treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma following progression on a platinum-containing therapy, based on findings from a phase II CheckMate-275 study.

    Jonathan E. Rosenberg, MD

    The FDA has granted an accelerated approval to nivolumab as a treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma following progression on a platinum-containing therapy, based on findings from a phase II CheckMate-275 study.

    In the study, which was presented at the 2016 ESMO Annual Meeting, the objective response rate was 19.6% for nivolumab in patients with platinum-refractory metastatic urothelial carcinoma. The complete response rate was 3%. Across the 270-patient study, the median progression-free survival was 2.0 months and the median overall survival was 8.74 months.

    A nearly 20% response rate in advanced and metastatic bladder cancer is extremely encouraging and clinically meaningful in this patient population, Jonathan E. Rosenberg, MD, Memorial Sloan Kettering Cancer Center, said in a statement.

    The open-label study enrolled 270 patients with metastatic or unresectable urothelial carcinoma. Patients had received a platinum-based agent in the metastatic setting or were within one year of neoadjuvant/adjuvant platinum therapy.

    Approval In Advanced Disease

    Opdivo,, which is a programmed cell death receptor1 inhibitor was the second immunotherapy approved to treat advanced bladder cancer. The FDA also approved Tecentriq , which acts as a programmed cell death ligand1 inhibitor, in May 2016.

    The approval was based on a study in 270 patients with locally advanced or metastatic urothelial carcinoma who experienced disease progression during or following platinum-containing chemotherapy, or whose disease progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

    The objective response rate following Opdivo treatment was 19.6% 7 patients had complete responses, and 46 had partial responses. The estimated median duration of response was 10.3 months. The FDA notes that some responses were ongoing at data cutoff.

    For this Opdivo, application, the FDA granted a breakthrough therapy designation and priority review status. The application was approved about 1 month ahead of schedule.

    Reference:

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    Fda Approves Immunotherapy Drug For Advanced Bladder Cancer

    Bladder cancer patients with advanced disease have a new option for treatment after the Food and Drug Administration this week approved a drug that launches an immune response against the disease.

    The FDA approval of the checkpoint inhibitor nivolumab, known commercially as Opdivo, was based on a Phase II multi-center clinical trial led by Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology at MD Anderson.

    Nearly 20 percent of patients had their tumors shrink substantially, with some complete responses, which is a significant improvement over other second-line options for these patients, Sharma said.

    Under its breakthrough therapy designation and priority review status, the FDA granted accelerated approval of nivolumab for patients with locally advanced urothelial carcinoma whose disease progresses during or after platinum-based chemotherapy treatment, which remains frontline standard of care.

    The trial was a single-arm study of 270 patients. Of 265 patients who were able to be evaluated, six had complete response, 46 had a partial response, defined as tumor shrinkage of at least 30%, and 60 had stable disease, meaning their cancer neither grew nor shrunk.

    Responses have been durable, with 40 of 52 responding patients still confirmed at the time of analysis. Median duration of response, a common measure noting the point in time in which half of patients still respond to treatment, had not been reached.

    Bms Obtains Fda Approval For Opdivo As Bladder Cancer Treatment

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    The regulatory agency approved the drug based on positive data from the Phase III CheckMate -274 trial.

    The US Food and Drug Administration has approved Bristol Myers Squibbs Opdivo as an adjuvant therapy for urothelial carcinoma patients at increased risk of recurrence following radical resection.

    A programmed death-1 immune checkpoint inhibitor, Opdivo can specifically harness the immune system to aid in restoring anti-tumour immune response.

    The FDA accepted dosage is intravenous 240mg Opdivo administered every two weeks or 480mg every four weeks in UC patients, irrespective of previous neoadjuvant chemotherapy, nodal involvement or PD-L1 status.

    Based on data from Phase III CheckMate -274 clinical trial, the FDA approved the drug under the agencys Real-Time Oncology Review pilot programme.

    The randomised, double-blind, placebo-controlled, multi-centre trial compared 240mg Opdivo to placebo.

    According to the trial data, median disease-free survival in patients receiving Opdivo was 20.8 months as against 10.8 months in the placebo arm.

    Furthermore, the drug lowered the risk of disease recurrence or mortality by 30% versus placebo.

    Median DFS was not attained in patients with tumours expressing PD-L1 1% receiving Opdivo compared to 8.4 months with placebo.

    The drug also lowered the disease recurrence risk or mortality by 45% in this subpopulation in the study, the company noted.

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    Fda Approves Adjuvant Nivolumab For Surgically Resected High

    The FDA has granted approval to nivolumab as an adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.

    The FDA has granted approval to nivolumab as an adjuvant treatment for patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status, according to a press release issued by Bristol Myers Squibb.1

    Approval was granted based on the first positive phase 3 trial of an immunotherapy in the adjuvant setting of surgically-resected, high-risk MIUC, CheckMate-274 , which investigated nivolumab versus placebo in randomized, double-blind, multicenter fashion.

    In the study, adjuvant nivolumab achieved a statistically significant and clinically meaningful improvement in disease-free survival compared with placebo in patients with MIUC treated in both the intention-to-treat population as well as in the subgroup with a PD-L1 1%, meeting its co primary and end point.2,3

    A total of 140 patients in the study were positive for PD-L1 expression and in these patients, the median DFS not reached) in the immunotherapy arm versus 10.8 months in the placebo arm , showing a 47% reduction in the risk of disease recurrence or death with nivolumab.

    References

    Fda Approves Nivolumab For Adjuvant Treatment Of Urothelial Carcinoma

    On August 19, the U.S. Food and Drug Administration approved the antiPD-1 therapy nivolumab for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of disease recurrence after undergoing radical resection. This is the first FDA approval for adjuvant treatment of patients with high-risk urothelial carcinoma. The data supporting this approval also supported the conversion of nivolumabs accelerated approval for advanced/metastatic urothelial carcinoma to a regular approval.

    CheckMate 274

    Nivolumab was investigated in CheckMate 274, a randomized, double-blind, placebo-controlled trial in patients who were within 120 days of radical resection of urothelial carcinoma of the bladder or upper urinary tract at high risk of recurrence. Patients were randomly assigned 1:1 to receive nivolumab at 240 mg or placebo by intravenous infusion every 2 weeks until recurrence or until unacceptable toxicity, for a maximum treatment duration of 1 year.

    The primary efficacy endpoint was investigator-assessed disease-free survival in the intent-to-treat population and in patients with tumors expressing PD-L1 1%. Disease-free survival was defined as time to first recurrence or death.

    The most common adverse reactions reported in 20% of patients who received nivolumab in CheckMate 274 were rash, fatigue, diarrhea, pruritus, musculoskeletal pain, and urinary tract infection.

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