19 February 2020 - - US-based Bristol-Myers Squibb Company (NYSE: BMY) has released updated results from the Phase 3 CheckMate -214 study evaluating the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma, the company said.

With a minimum follow-up of 42 months, the combination of Opdivo plus Yervoy continues to show superior overall survival, objective response rates, duration of response and complete response rates.

The safety profile for Opdivo plus Yervoy was consistent with prior findings and no new safety signals or drug-related deaths occurred with extended follow-up.

The data will be featured in an oral presentation (Abstract #609) on Saturday, February 15, 2020 at the American Society of Clinical Oncology 2020 Genitourinary Cancers Symposium in San Francisco.

A significant OS benefit was observed in both patients from the intermediate- and poor-risk and the intent-to-treat (ITT, i.e. all randomized) populations treated with Opdivo plus Yervoy compared to those treated with sunitinib alone.

Of the patients treated with Opdivo plus Yervoy 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 Opdivo plus Yervoy demonstrated significantly improved:

OS: At 42 months, the OS rate was 52% for patients treated with Opdivo plus Yervoy and 39% for patients treated with sunitinib alone [Hazard Ratio 0.66 (95% Confidence Interval [CI]: 0.55-0.80)].
ORR: Per independent review, ORR was 42% with Opdivo plus Yervoy and 26% for sunitinib (p=0.0001).

DOR: Median DOR was not reached for patients treated with Opdivo plus Yervoy and was 19.7 months (95% CI: 16.4-26.4) for patients treated with sunitinib.

CR: Per independent review, 10% of patients treated with Opdivo plus Yervoy experienced a CR compared to 1% with sunitinib alone.
Results were similar for the ITT population, where patients treated with Opdivo plus Yervoy experienced significantly improved:

OS: At 42 months, the OS rate for the ITT population was 56% for patients treated with Opdivo plus Yervoy and 47% for patients treated with sunitinib alone [HR 0.72 (95% CI: 0.61-0.86)].

ORR: Per independent review, ORR was 39% with Opdivo plus Yervoy and 33% for sunitinib (p=0.02).

DOR: Median DOR was not reached for patients treated with Opdivo plus Yervoy and was 24.8 months (95% CI: 19.4-27.3) for patients treated with sunitinib.

CR: Per independent review, 11% of patients treated with Opdivo plus Yervoy experienced a CR compared to 2% with sunitinib alone.

CheckMate -214 is a Phase 3, randomised, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma.

Patients in the combination group received Opdivo 3 mg/kg plus Yervoy 1 mg/kg every three weeks for four doses followed by Opdivo 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%.