On November 24th BMS announced that the European Commission (EC) had approved Opdivo (nivolumab, Navuliyu monoantigen) for the treatment of adult patients with non-removable, advanced, relapsed or metastatic esophageal squamous cell carcinoma (ESCC) who had previously received a combination of fluorine and platinum chemotherapy.
the approval makes Opdivo the first immunotherapy in the European Union to treat gastroesopaedic cancer.
addition to the EU's approval, Opdivo has been approved in five countries, including the United States and Japan, for second-line treatment in patients with advanced, relapsed or metastasis ESCC who cannot be removed.
approval is based on the results of Phase 3 ATTRACTION-3 trials.
the trial, sponsored by Japanese drugmaker Ono Pharmaceuticals, showed that the Opdivo treatment group showed statistically significant and clinically significant improvements in total survival (OS) compared to the chemotherapy group.
the study, Opdivo's safety was good, consistent with previously reported opdivo's treatment of other solid tumors.
ATTRACTION-3 (ONO-4538-24/CA209-473; NCT02569242) is a Phase 3, Multi-Center, Randomized, Open Label, Global Study that compares Opvodi to chemotherapy (dossylol or yew alcohol) in patients with first-line combination therapies (fluorine-platinum) that are difficult to treat or insatiable.
study, the patients were admitted mainly in Asia, with the rest in the United States and Europe.
, patients continue to receive treatment until their condition worsens or becomes unconceressiblely toxic.
end point of the test is total lifetime (OS).
secondary endpoints include objective mitigation rate (ORR), progress-free lifetime (PFS), disease control rate (DCR), mitigation duration (DOR), and safety assessed by the study investigator.
results showed that the study reached the main OS endpoint: Opdivo reduced the risk of death by 23% compared to chemotherapy (HR-0.77, 95% CI: 0.62-0.96; p-0.019).
OS in the Opdivo treatment group was 10.9 months (95% CI: 9.2-13.3) and 8.4 months (95% CI:7.2-9.9) in the chemotherapy group, showing an improvement of 2.5 months.
12-month and 18-month OS rates were 47% (95% CI: 40-54) and 31% (95% CI:24-37), respectively, in the Opdivo group, while the OS rates in the chemotherapy group were 34% (95% CI: 28-41) and 21% (95% CI:15-27), respectively.
opdivo was able to observe survival benefits regardless of tumor PD-L1 expression levels.
19% (95% CI: 14-26) and 22% (95% CI:15-29), respectively, in the Opdivo and chemotherapy groups.
DOR in the Opdivo group was significantly extended to 6.9 months (95%CI:5.4-11.1) and 3.9 months (95% CI:2.8-4.2) in the chemotherapy group.
exploratory analysis of patient reporting results showed a significant improvement in the quality of life of the Opdivo group compared to the chemotherapy group.
less adverse events (TRAEs) associated with Opdivo treatment than chemotherapy.
rate of TRAE at any level in the Opdivo group was 66%, compared with 95% in the chemotherapy group.
the Opdivo group also had a lower rate of level 3 or 4 TRAE (18% vs. 63%) than in the chemotherapy group, with the same rate of TRAE-causing drug suspension in both groups (9%).
source: Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma