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European Union: Opdivo approved for previously treated locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior Platinum-containing therapy


The European Commission ( EC ) has approved Opdivo ( Nivolumab ) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma ( mUC ) in adults after failure of prior Platinum-containing therapy.

The approval was based on results from CheckMate -275, a phase 2, open-label, single-arm, multicenter study evaluating Nivolumab in patients with locally advanced or mUC who have disease progression during or following treatment with a Platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with Platinum-containing chemotherapy.

In this study, 270 patients received Nivolumab 3 mg/kg administered intravenously every two weeks until disease progression or unacceptable toxicity.
The primary endpoint of the trial was objective response rate ( ORR ). Secondary endpoints included progression free survival ( PFS ) and overall survival ( OS ).
In the trial, 20.0% ( 95% CI: 15.4, 25.3; 54/270 ) of patients responded to treatment with Nivolumab.
The percentage of patients with a complete response was 3.0% ( 8/270 ) and the percentage of patients with a partial response was 17% ( 46/270 ).

Half of the overall patient population ( 46% ) in CheckMate -275 had a tumor PD-L1 expression of greater than or equal to 1% and efficacy was observed across tumor PD-L1 expressors and non-expressors.
The response rate was 25% in patients with tumor PD-L1 expression greater than or equal to 1% ( 95% CI: 17.7, 33.6 ) and 15.8% ( 95% CI: 10.3, 22.7 ) in those with tumor PD-L1 expression less than 1%.
In all treated patients, the median progression-free survival was 2.0 months, the 12-month overall survival rate was 41% ( 95% CI: 34.8, 47.1 ) and the median overall survival was 8.6 months ( 95% CI: 6.1, 11.3 ).

Among the 270 patients who received Nivolumab in CheckMate -275, 17.8% experienced a grade 3 or 4 treatment-related adverse event.
The most frequently reported treatment-related adverse events of any grade included fatigue ( 16.7% ), pruritis ( 9.3% ), diarrhea ( 8.9% ), decreased appetite ( 8.1% ), hypothyroidism ( 7.8% ), nausea ( 7.0% ), asthenia ( 5.9% ), rash ( 5.9% ) and pyrexia ( 5.6% ).
The most frequent treatment-related grade 3-4 adverse effects were fatigue ( 1.9% ), diarrhea ( 1.9% ), asthenia ( 1.5% ) and rash ( 1.1% ).
Overall, 4.8% of patients discontinued therapy due to treatment-related adverse effects of any grade, and 3.0% discontinued therapy due to grade 3-4 treatment-related adverse effects.
Treatment-related death occurred in four patients due to pneumonitis or cardiovascular failure.

Bladder cancer, which typically begins in the cells that line the inside of the bladder, is the fifth most commonly diagnosed cancer in Europe, with an estimated 151,000 new cases diagnosed per year and over 52,000 deaths per year.
Urothelial carcinoma is the most common type of bladder cancer, accounting for approximately 90% of cases.
The majority of bladder cancers are diagnosed at an early stage, but rates of recurrence and progression are high, and approximately 78% of patients will experience a recurrence within five years.
Survival rates vary depending on the stage, type of the cancer and when it is diagnosed. For stage IV bladder cancer, the five-year survival rate is 15%. ( Xagena )

Source: BMS, 2017

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