Bristol-Myers Squibb (BMY) Presents Strong Data from Opdivo + Yervoy Combo Phase 1 in mRCC

October 10, 2016 6:33 AM EDT

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Bristol-Myers Squibb Company (NYSE: BMY) announced updated results from the Phase 1 CheckMate -016 trial, which evaluated the safety and tolerability (primary endpoint) of Opdivo at different doses as part of a regimen with Yervoy, sunitinib or pazopanib in previously treated and treatment-naïve patients with metastatic renal cell carcinoma (mRCC). These updated results include findings for the Opdivo and Yervoy combinations [Opdivo 3 mg/kg plus Yervoy 1 mg/kg arm and Opdivo 1 mg/kg plus Yervoy 3 mg/kg arm] with approximately two years of follow-up, which showed the overall response rate (ORR; secondary endpoint) was 40.4% (n=47) in both arms. Of the 38 responders in both treatment arms, 39.5% (n=15) had an ongoing response, with a median duration of response of 20.4 months (95% CI: 8.54 – NE) in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg arm and 19.7 months (95% CI: 8.08 – NE) in the Opdivo 1 mg/kg plus Yervoy 3 mg/kg arm. The overall survival rate at 12 months was 81% and 85% for Opdivo 3 mg/kg plus Yervoy 1 mg/kg arm and Opdivo 1 mg/kg plus Yervoy 3 mg/kg arm, respectively, and at 24 months was 67% and 70%, respectively. There were fewer Grade 3/4 treatment-related adverse events reported in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg arm (38.3%) than with Opdivo 1 mg/kg plus Yervoy 3 mg/kg arm (61.7%).

These results will be presented at the 2016 European Society for Medical Oncology (ESMO) Congress during a poster session on Sunday, October 9 from 1:00 – 2:00 p.m. CEST (Abstract #1062P).

“There remains a significant unmet need for treatment options that offer ongoing responses and increase survival for patients with renal cell carcinoma, the most common type of kidney cancer,” said Asim Amin, M.D., Ph.D., Levine Cancer Institute, Carolinas HealthCare System. “The results from CheckMate -016 are encouraging and warrant further study, as they show with nearly two years of follow-up, patients in each Opdivo and Yervoy combination arm had a response that is ongoing in almost 40% of the patients.”

Nearly a third of renal cell carcinoma (RCC) diagnoses occur once the disease has metastasized, or spread, to other parts of the body. At Stage IV, survival rates are low, with approximately 12% of advanced kidney cancer patients alive at five years.

“The findings reported at ESMO for CheckMate -016 validate our approach to studying the combination of our two Immuno-Oncology agents, Opdivo and Yervoy, to improve patient outcomes in metastatic renal cell carcinoma,” said Vicki Goodman, M.D., development lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb. “Our Phase 3 program for the Opdivo and Yervoy combination in the first line metastatic renal cell carcinoma is ongoing, and we hope to confirm these early findings through our continued research.”

About CheckMate -016

CheckMate -016 is a multicenter, open-label, Phase 1 trial of Opdivo in combination with Yervoy, sunitinib or pazopanib in previously treated and treatment-naïve patients with metastatic renal cell carcinoma (mRCC). In the arms evaluating the combination regimen of Opdivo and Yervoy, which included 47 patients each, patients were randomized to receive Opdivo 3 mg/kg and Yervoy 1 mg/kg or Opdivo 1 mg/kg and Yervoy 3 mg/kg by intravenous infusion every three weeks for four doses, followed by Opdivo 3 mg/kg by intravenous infusion every two weeks until progression or toxicity. Prior systemic therapy was administered in 46.8% and 55.3% in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg and Opdivo 1 mg/kg plus Yervoy 3 mg/kg arms, respectively. The primary endpoints were to assess the safety and tolerability, and secondary endpoints were to assess objective response rate (ORR), duration of response (DOR), overall survival (OS) and progression-free survival (PFS).

In the study, fewer patients in the Opdivo 3 mg/kg and Yervoy 1 mg/kg arm experienced Grade 3/4 treatment-related adverse events (AEs) than those in the Opdivo 1 mg/kg plus Yervoy 3 mg/kg arm (38.3% and 61.7%). Increased lipase was the most common Grade 3/4 treatment-related AE in both arms (14.9% with Opdivo 3 mg/kg and Yervoy 1 mg/kg; and 27.7% with Opdivo 1 mg/kg and Yervoy 3 mg/kg). Grade 3/4 treatment-related select AEs in the Opdivo 3 mg/kg and Yervoy 1 mg/kg and Opdivo 1 mg/kg and Yervoy 3 mg/kg arms were, respectively, gastrointestinal (4.3% and 23.4%), hepatic (6.4% and 21.3%), renal (4.3% and 4.3%), endocrinopathy (4.3% and 0.0%) and skin (0.0% and 2.1%). Discontinuations due to treatment-related AEs included five and 13 patients in the Opdivo 3 mg/kg and Yervoy 1 mg/kg and Opdivo 1 mg/kg and Yervoy 3 mg/kg arms, respectively. Treatment-related AEs leading to discontinuation in >5% of patients were increased alanine aminotransferase (ALT; 10.6%) and colitis (6.4%) in the Opdivo 1 mg/kg and Yervoy 3 mg/kg arm. No treatment-related deaths occurred in either arm. Based on these results, further development of the Opdivo 1 mg/kg and Yervoy 3 mg/kg regimen was not pursued.

Key efficacy results in previously treated and treatment-naïve mRCC patients are summarized below.

Opdivo 3 mg/kg plusYervoy 1 mg/kg(n=47) Opdivo 1 mg/kg plusYervoy 3 mg/kg(n=47)
Confirmed ORR, n (%); 95% CI 19 (40.4)

26.4 – 55.7

19 (40.4)

26.4 – 55.7

Best overall response,a n (%)

Complete response

Partial response

Stable disease

Disease progression

5 (10.6)

14 (29.8)

19 (40.4)

8 (17.0)

0 (0.0)

19 (40.4)

17 (36.2)

8 (17.0)

Median DOR, mos. (range) 20.4

(95% CI: 8.54 – NE)

19.7

(95% CI: 8.08 – NE)

12-month OS rate (%) 81 85
24-month OS rate 67 70
Median OS, mos. (range); 95% CI Not reached 32.6 (25.99–NE)
Median PFS, mos. (range) 6.6 (3.55 – 14.9) 9.1 (5.62 – 15.67)

a Best overall response was indeterminate in one patient (2.1%) in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg arm and in two patients (4.3%) in the Opdivo 1 mg/kg plus Yervoy 3 mg/kg arm.



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