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Oncology Xagena

Nivolumab in metastatic urothelial cancer: response rate was 24.4% in previously treated patients


The results for Nivolumab ( Opdivo ) in the cohort of patients with metastatic urothelial cancer ( n=78 ), the most common type of bladder cancer, after Platinum-based therapy from CheckMate -032, a phase 1/2 open-label trial were presented at the 52nd Annual Meeting of the American Society of Clinical Oncology ( ASCO ).

In the trial, the primary endpoint of investigator-assessed confirmed objective response rate ( ORR ), was 24.4% ( 95% CI: 15.3-35.4 ) in patients treated with Nivolumab, with a minimum follow-up of nine months.
Response rates by tumor PD-L1 expression, evaluated as an exploratory endpoint, were similar regardless of PD-L1 expression levels.
In patients with PD-L1 less than 1%, the ORR was 26.8%, and in patients with PD-L1 greater than or equal to 1%, the ORR was 24%.
At one year, patients treated with Nivolumab had an overall survival ( OS, a secondary endpoint ) rate of 45.6%, with a median overall survival of 9.72 months ( 95% CI: 7.26-16.16 ).
The safety profile of Nivolumab in CheckMate -032 was consistent with the known safety profile of Nivolumab in other tumor types.

Urothelial carcinoma is the most common type of bladder cancer, accounting for approximately 90% of bladder cancer cases.
Bladder cancer is the ninth most commonly diagnosed cancer in the world, with an estimated 430,000 new cases diagnosed per year and over 165,000 deaths per year.
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 and type of the cancer and when it is diagnosed. For stage IV bladder cancer, the five-year survival rate is 15%.

CheckMate -032 is an ongoing phase 1/2 open-label trial, evaluating the safety and efficacy of Nivolumab monotherapy, or Nivolumab combined with Ipilimumab ( Yervoy ) in advanced or metastatic solid tumors.
The trial enrolled patients regardless of PD-L1 expression.
The primary endpoint was investigator-assessed confirmed objective response rate. Secondary endpoints included safety, duration of response, overall survival and progression-free survival.

Data presented at ASCO specific to metastatic or locally advanced urothelial cancer were from a cohort of 78 patients who have received one or more prior lines of Platinum-based therapy.
In this analysis, patients received Nivolumab monotherapy ( 3 mg/kg administered intravenously every two weeks ) until progression or discontinuation.
Patients treated with Nivolumab monotherapy were allowed to continue treatment beyond progression if Nivolumab was tolerated and clinical benefit was noted, or patients could cross over to receive the combination of Nivolumab and Ipilimumab if they met prespecified criteria.

In the trial, the investigator-assessed confirmed ORR was 24.4% ( 95% CI: 15.3-35.4 ) for the cohort of patients treated with Nivolumab.
Median duration of response was not estimable ( 9.92-NE ).
In addition, the one-year overall survival rate reported for the Nivolumab-cohort was 45.6%, based on Kaplan-Meier estimates, with a median overall survival of 9.72 months ( 95% CI: 7.26-16.16 ).
Median progression-free survival was 2.78 months ( 95% CI: 1.45-5.85 ).

Of randomized patients, 67 patients had quantifiable tumor PD-L1 expression, with 37.3% expressing PD-L1 at greater than or equal to 1%.
Objective response rate was 26.8% ( 14.2-42.9 ) in patients with PD-L1 less than 1%, and 24% ( 9.4-45.1 ) in patients with PD-L1 greater than or equal to 1%.
Efficacy of Nivolumab by PD-L1 expression was an exploratory endpoint in CheckMate -032.

The safety profile of Nivolumab in CheckMate -032 was consistent with the known safety profile of Nivolumab in other tumor types.
Grade 3-4 treatment-related adverse events occurred in 22% of patients receiving Nivolumab, with the most frequent adverse events of any grade reported in greater than or equal to 10% of patients being fatigue ( 36% ), pruritus ( 30% ), maculopapular rash ( 18% ), increased lipase ( 14% ), nausea ( 13% ), arthralgia ( 12% ), and anemia ( 10% ).
Two grade 5 treatment-related adverse events occurred in patients treated with Nivolumab ( pneumonitis [ n=1 ] and thrombocytopenia [ n=1 ] ).
No grade 3 or 4 pneumonitis or thrombocytopenia was reported. ( Xagena )

Source: BMS, 2016

XagenaMedicine_2016



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