Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinom
PRINCETON, N.J.--(BUSINESS WIRE)--?Bristol Myers Squibb?(NYSE: BMY) today announced that the European Commission (EC) has approved?Opdivo?(nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based combination chemotherapy.
The EC?s decision is based on results from the Phase 3 ATTRACTION-3 trial, a study sponsored by Ono Pharmaceutical Co., Ltd. of Japan, which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) in patients who received?Opdivo?versus chemotherapy. The safety profile for?Opdivo?was favorable compared with chemotherapy and consistent with previously reported studies of?Opdivo?in other solid tumors.
?Today?s approval marks a critically important milestone for those living with esophageal squamous cell carcinoma, as this is the first time an immunotherapy treatment option has been approved in the European Union for this patient population,? said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. ?We are proud of our work in advancing treatment options for people living with upper gastrointestinal cancers, and we look forward to working with European stakeholders to bring?Opdivo?to more eligible patients who may benefit.?
In addition to this approval in the EU,?Opdivo?has been approved in five countries, including the United States and Japan, for the second-line treatment of patients with unresectable advanced, recurrent or metastatic ESCC. Bristol Myers Squibb thanks the patients and investigators involved in the ATTRACTION-3 clinical trial for their important contributions.
ATTRACTION-3 Efficacy and Safety Results
In the Phase 3 ATTRACTION-3 trial, which had a primary endpoint of OS:
- Opdivo?reduced risk of death by 23%, compared to chemotherapy alone [Hazard Ratio (HR) 0.77; 95% Confidence Interval (CI): 0.62 to 0.96; p=0.019].
- Median OS with?Opdivo?was 10.9 months (95% CI: 9.2 to 13.3) compared to 8.4 months (95% CI: 7.2 to 9.9) with chemotherapy alone, demonstrating a 2.5-month improvement.
- The?Opdivo?arm showed 12- and 18-month OS rates of 47% (95% CI: 40 to 54) and 31% (95% CI: 24 to 37), respectively, versus 34% (95% CI: 28 to 41) and 21% (95% CI: 15 to 27) among patients in the chemotherapy arm. Survival benefit with?Opdivowas observed regardless of tumor PD-L1 expression levels.
- Objective response rates (ORR) between the?Opdivo?and chemotherapy arms were comparable at 19% (95% CI: 14 to 26) and 22% (95% CI: 15 to 29), respectively.
- Median duration of response (DoR) for patients was substantially increased in the?Opdivo?arm at 6.9 months (95% CI: 5.4 to 11.1) versus 3.9 months (95% CI: 2.8 to 4.2) in the chemotherapy arm.
- An exploratory analysis of patient-reported outcomes showed significant overall improvement in quality of life with?Opdivo?versus chemotherapy. Fewer treatment-related adverse events (TRAEs) were reported with?Opdivo?versus chemotherapy, with a rate of 66% for any grade TRAEs in patients receiving?Opdivo?compared to 95% for those patients receiving chemotherapy. Patients in the?Opdivo?arm also experienced a lower incidence of Grade 3 or 4 TRAEs compared to those in the chemotherapy arm (18% versus 63%), and the percentage of patients experiencing TRAEs leading to discontinuation was the same in both arms (9%).