Yervoy(ipilimumab/nivolumab)
Oncology· 3811 cited findings· 4 source documents
Company: Bristol-Myers Squibb Company →
What the regulatory reviews say
Yervoy (ipilimumab/nivolumab) is approved for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. The drug received approval on May 26, 2020. The dosing regimen involves Nivolumab 360 mg every 3 weeks with YERVOY 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy.
Efficacy findings include an overall survival improvement of 3 months (HR 0.79, p-value 0.0180) and overall survival of 10 months. Best overall response rates (BORR) were observed at 5.7% and 10.9%, with a median duration of response of 11.5 months. The trial design was randomized (3:1:1), double-blind, and double-dummy, involving 676 randomized patients.
Safety concerns include immune-mediated adverse events such as Hypothyroidism/thyroiditis (18.7%) and Rash (15.4%). Severe, life-threatening, or fatal immune-mediated enterocolitis (Grade 3 to 5) occurred in 7% of patients, with moderate (Grade 2) in 5%. Intestinal perforation was reported in 1% of patients. A pediatric study requirement was waived.
Key figures — cited to the source page
| OS improvement | 3 months | Bristol-Myers Squibb Company — Yervoy EMA EPAR variation ass, p.147 |
| OS HR | 0.79 | Bristol-Myers Squibb Company — Yervoy EMA EPAR variation ass, p.147 |
| overall survival | 10 months | BRISTOL MYERS SQUIBB — Yervoy FDA Review (NDA/BLA 125377, 20, p.67 |
| best overall response rate (BORR) | 10.9 % | BRISTOL MYERS SQUIBB — Yervoy FDA Review (NDA/BLA 125377, 20, p.68 |
| IMAEs Hypothyroidism/thyroiditis | 18.7 % | Bristol-Myers Squibb Company — Yervoy EMA EPAR variation ass, p.146 |
| severe, life-threatening, or fatal immune-mediated enterocolitis (Grade 3 to 5) | 7 % | BRISTOL MYERS SQUIBB — Yervoy FDA Review (NDA/BLA 125377, 20, p.24 |
| Approval Date | May 26, 2020 | BRISTOL MYERS SQUIBB — Yervoy FDA Review (NDA/BLA 125377, 20, p.1 |
| Approval Status | Approved | BRISTOL MYERS SQUIBB — Yervoy FDA Review (NDA/BLA 125377, 20, p.4 |
Source documents
- BRISTOL MYERS SQUIBB — Yervoy FDA Review (NDA/BLA 125377, 2021) (2021)
- BRISTOL MYERS SQUIBB — Yervoy FDA Review (NDA/BLA 125377, 2020) (2020)
- Bristol-Myers Squibb Company — Yervoy EMA EPAR public assessment report (EMEA/H/C/002213, 2011) (2011)
- Bristol-Myers Squibb Company — Yervoy EMA EPAR variation assessment report (EMEA/H/C/002213, 2011) (2011)
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.