Bristol Myers Keeps The Perioperative Ball Rolling With Opdivo Nod In Postsurgery Bladder Cancer
In the next frontier of immuno-oncology competition focusing on treatment around surgery, Bristol Myers Squibb has snatched another U.S. license for Opdivothis time in bladder cancer.
The FDA has waved through Opdivo for treatment of bladder cancer thats at high risk of recurrence after radical surgical resection, Bristol Myers said on Friday. This new use isnt restricted by prior presurgery treatment, lymph node involvement or PD-L1 status, the company added.
The nod marks Opdivos third indication in the so-called adjuvant setting, following a 2017 approval in melanoma and a recent go-ahead in esophageal or gastroesophageal junction cancer.
Opdivo, already approved for previously treated metastatic bladder cancer, is now also the first PD-1/L1 drug to target early bladder cancer after surgery. Thanks to an FDA green light in early 2020, Merck & Co.s rival checkpoint inhibitor Keytruda is allowed to treat superficial but high-risk non-muscle invasive bladder cancer among patients who dont undergo surgery.
Urothelial carcinoma is the most common type of bladder cancer. Although it can be diagnosed early and treated with surgery, the rates of recurrence and progression remain high at about 50%, Nick Botwood, senior vice president of BMSs U.S. medical affairs team, explained in a recent interview.
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Bristol Myers Scores Fda Approval For Opdivo In Postsurgery Bladder Cancer
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Bristol Myers Squibb & Co has snatched another U.S. license for Opdivo , this time in bladder cancer.
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The FDA has granted approval for Opdivo for the treatment of bladder cancer at high risk of recurrence after radical surgical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement, or PD-L1 status.
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The nod marks Opdivos third indication in the adjuvant setting, following a 2017 approval in melanoma and a recent go-ahead in esophageal or gastroesophageal junction cancer.
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The approval is based on data from the CheckMate-274 trial.
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Opdivo reduced the risk of disease recurrence or death by 30% in patients with muscle-invasive bladder cancer compared with placebo.
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The drug nearly doubled disease-free survival as patients who received it lived a median of 20.8 months without recurrence, compared with 10.8 months for the placebo group.
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The efficacy in PD-L1 expressing tumors saw a risk reduction on the disease-free survival marker was 45% over placebo.
Bristol Myers’ Opdivo Extends Disease
Bristol-Myers Squibb Company BMY
- Preliminary data from a Phase 3 clinical trial, CheckMate-274, evaluating Bristol Myers Squibb’s PD-1 inhibitor Opdivo after surgery in patients with high-risk, muscle-invasive urothelial carcinoma demonstrated that the study met the primary endpoint of disease-free survival compared to placebo in the overall study group and in patients with PD-L1-expressing cancer.
- The study will continue as planned to allow for analyses of secondary endpoints, including overall survival and disease-specific survival. The estimated completion date is November 2026.
- Compete results will be submitted for presentation at an upcoming medical conference.
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Cg Oncology Announces Clinical Trial Collaboration With Bristol Myers Squibb To Evaluate Oncolytic Immunotherapy Cg0070 In Combination With Opdivo In Metastatic Urothelial Cancer
IRVINE, Calif., September 9, 2021 CG Oncology, Inc. today announced a clinical trial collaboration to evaluate the safety and efficacy of CG0070, an oncolytic immunotherapy, in combination with OPDIVO® , Bristol Myers Squibbs anti-PD-1 therapy, for the treatment of metastatic urothelial cancer in a Phase 1/2 clinical study.
CG0070, CG Oncology’s lead immuno-oncology candidate, is in an ongoing Phase 3 monotherapy study and has been administered in over 100 patients to date for the treatment of high-risk, non-muscle invasive bladder cancer . CG0070 is based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroying various cancer cells, including bladder tumor cells, through their defective retinoblastoma pathway.
We are excited to initiate this important clinical trial with our lead oncolytic immunotherapy, CG0070, in combination with OPDIVO in metastatic urothelial cancer, said Arthur Kuan, CEO of CG Oncology. The clinical results to date for CG0070 make it a potential promising agent in bladder cancer and other tumor types, as monotherapy or in combination with immune checkpoint inhibitors.
CG Oncology will sponsor the study and Bristol Myers Squibb will provide nivolumab. Additional details of the collaboration were not disclosed.
OPDIVO® is a trademark of Bristol-Myers Squibb Company.
Bristol Myers Gets Fda Priority Review For Opdivo To Treat Bladder Cancer
The company filed its sBLA application based on the Phase 3 CheckMate -274 trial, in which Opdivo increased disease-free survival
Bristol-Myers Squibb facility in Wirral, England.
Bristol Myers Squibb has received the US Food and Drug Administration priority review for Opdivo to treat a type of urothelial carcinoma.
The drug is indicated as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.
FDA has accepted the companys supplemental Biologics License Application for Opdivo and assigned a Prescription Drug User Fee Act goal date of 3 September 2021.
Bristol Myers Squibb vice president and genitourinary cancers development programme lead Dana Walker said: After patients undergo surgery for muscle-invasive urothelial carcinoma, they continue to face uncertainties given the high rate of disease recurrence and the lack of safe and effective treatment options.
Based on the ground-breaking disease-free survival results from CheckMate -274, we believe Opdivo has the potential to change the future of treatment for muscle-invasive urothelial carcinoma.
We look forward to working with the FDA towards the goal of bringing the first adjuvant immunotherapy option to these patients in the US.
The FDA priority review is based on results from the CheckMate -274 trial, a randomised, double-blind, multi-centre study evaluating Opdivo compared to placebo.
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Asco Gu: Bristol Myers Touts First
In the PD-1/L1 field, Merck & Co.s Keytruda, Roches Tecentriq, and Pfizer and Merck KGaAs Bavencio all have their clinical wins in different bladder cancer populations. Now, Bristol Myers Squibbs Opdivo has one of its own.
In high-risk muscle-invasive urothelial carcinoma, the use of Opdivo after surgery cut patients risk of disease returning or death by 30% over placebo. The data was released for presentation at the American Society of Clinical Oncology Genitourinary Cancers Symposium.
Bristol Myers was quick to point out that the CheckMate-274 win marks the first positive phase 3 readout for a checkpoint inhibitor in this particular bladder cancer setting.
RELATED:Keytruda wins FDA nod to tackle early bladder cancer with gene therapy rival closely behind
Its estimated that about 50% of patients diagnosed with muscle-invasive bladder cancer will see their cancer return after surgery. In CheckMate-274, though, Opdivo almost doubled the time patients lived without recurrence the BMS drug helped patients stay disease-free for a median of 21.0 months, versus 10.9 months for placebo.
The benefit was even more pronounced in patients whose tumors expressed biomarker PD-L1, with the risk reduction expanding to 47%. In that subpopulation, the median time before the disease returned hadnt been reached for Opdivo, compared with 10.8 months for placebo.
RELATED: Bristol Myers Squibb’s Opdivo cuts relapse risk in muscle-invasive bladder cancer
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Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer
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Bms A Pioneer In Muscle
Bristol Myers Squibbs adjuvant immunotherapy Opdivo is taking a chink from the armor of muscle-invasive urothelial carcinoma , a particularly impervious bladder cancer, with Phase III results showing significant improvement in disease-free survival rates.
Urothelial carcinoma is the tenth most common cancer worldwide and steals the lives of close to 200,000 patients each year. While relatively treatable in the early stages, it is persistent, with a more than 50% relapse rate.
Immune checkpoint inhibitors like Opdivo block checkpoint proteins from binding with their partner proteins. This prevents communication of the off signal, thereby allowing the T cells to kill cancer cells.
BMSs ongoing Phase III randomized, double-blind, multi-center study named CheckMate-274 compares Opdivo against a placebo in 709 participants deemed to be at a high risk of recurrence after radical surgery. At a 1:1 ratio, the patients were given either Opdivo or the placebo for up to a year.
The primary endpoints BMS was looking to attain were disease-free-survival in all randomized patients, as well as in a specific subset whose tumors express PD-L1 1%. On Thursday, the company announced in an interim analysis that these endpoints had been met.
With the results, BMS becomes a pioneer in the adjuvant treatment of bladder cancer.
Importantly, Opdivos safety profile was on par with previously reported studies in solid tumors.