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Updated results from the phase 3 CheckMate -214 study evaluating the combination of Nivolumab ( Opdivo ) plus Ipilimumab ( Yervoy ) versus Sunitinib( Sutent ) in patients with previously untreated advanced or metastatic renal cell carcinoma ( RCC ) were presented.

With a minimum follow-up of 42 months, the combination of Nivolumab plus Ipilimumab continues to show superior overall survival ( OS ), objective response rates ( ORR ), duration of response ( DOR ) and complete response ( CR ) rates.
The safety profile for Nivolumab plus Ipilimumab was consistent with prior findings and no new safety signals or drug-related deaths occurred with extended follow-up.

A significant OS benefit was observed in both patients from the intermediate- and poor-risk ( IP ) and the intent-to-treat ( ITT, i.e. all randomized ) populations treated with Nivolumab plus Ipilimumab compared to those treated with Sunitinib alone.
Of the patients treated with Nivolumab plus Ipilimumab who experienced a complete response, per independent review, that response was ongoing in 84% and 86% of patients in the IP and ITT populations, respectively.

In the IP populations, patients treated with Nivolumab plus Ipilimumab demonstrated significantly improved:

overall survival: at 42 months, the OS rate was 52% for patients treated with Nivolumab plus Ipilimumab and 39% for patients treated with Sunitinib alone [ hazard ratio ( HR ) 0.66 ( 95% Confidence Interval [ CI ]: 0.55-0.80 ) ];

objective response rate: per independent review, ORR was 42% with Nivolumab plus Ipilimumab and 26% for Sunitinib ( p=0.0001 );

duration of response: median DOR was not reached for patients treated with Nivolumab plus Ipilimumab and was 19.7 months ( 95% CI: 16.4-26.4 ) for patients treated with Sunitinib;

complete response: per independent review, 10% of patients treated with Nivolumab plus Ipilimumab experienced a CR compared to 1% with Sunitinib alone.

Results were similar for the ITT population, where patients treated with Nivolumab plus Ipilimumab experienced significantly improved:

overall survival: at 42 months, the OS rate for the ITT population was 56% for patients treated with Nivolumab plus Ipilimumab and 47% for patients treated with Sunitinib alone [ HR 0.72 ( 95% CI: 0.61-0.86 ) ];

objective response rate: per independent review, ORR was 39% with Nivolumab plus Ipilimumab and 33% for Sunitinib ( p=0.02 );

duration of response: median DOR was not reached for patients treated with Nivolumab plus Ipilimumab and was 24.8 months ( 95% CI: 19.4-27.3 ) for patients treated with Sunitinib;

complete response: per independent review, 11% of patients treated with Nivolumab plus Ipilimumab experienced a CR compared to 2% with Sunitinib alone.

Results from this 42-month follow-up from the CheckMate -214 study reinforce the previously observed findings and add to the growing body of evidence suggesting that Nivolumab plus Ipilimumab has the potential to significantly improve long-term survival for patients with advanced renal cell carcinoma, a population with high unmet needs.
Particularly noteworthy is that a consistently higher proportion of patients treated with the combination of Nivolumab plus Ipilimumab achieved a complete response and the majority of these complete responses were durable.

In CheckMate -214, patients in the combination group received Nivolumab 3 mg/kg plus Ipilimumab 1 mg/kg every three weeks for four doses followed by Nivolumab 3 mg/kg every two weeks.
Patients in the comparator group received Sunitinib 50 mg once daily for four weeks, followed by two weeks off before continuation of treatment.
Patients were treated until progression or unacceptable toxic effects.
The primary endpoints of the trial are overall survival, progression-free survival, and objective response rate in an intermediate to poor-risk patient population ( approximately 75% of patients ).

Renal cell carcinoma is the most common type of kidney cancer in adults, accounting for more than 140,000 deaths worldwide each year.
RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe.
Globally, the five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 12.1%. ( Xagena )

Source: BMS, 2020

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