First immunotherapy for esophageal cancer (ESCC)! Best-in-the-hundred Opdivo approved by the European Union: second-line treatment significantly extends survival!

November 27, 2020 // -- BMS recently announced that the European Commission (EC) has approved the anti-PD-1 therapy Opdivo (Eu Divo, generic name: nivolumab, Navuliyu monomatics) A new adaptive condition used to treat adult patients with non-excisive, advanced, relapsed or metastatic esophageal squamous cell carcinoma (ESCC) who had previously underwent a combination of fluorine and platinum-based chemotherapy.
is the first immunotherapy approved by the European Union for the treatment of gastroesoesic cancer.
addition to the European Union, Opdivo has been approved in five countries, including the United States and Japan, for second-line treatment of non-excisive, late-stage, relapsed or metastasis ESCC patients.
note that Opdivo is the first tumor immunotherapy approved for use in the above-mentioned ESCC patient population, regardless of PD-L1 expression level.
clinical data show that Opdivo significantly extends total lifetime compared to chemotherapy, and that the benefit does not depend on PD-L1 expression.
patients with advanced ESCC have poor prognostication and very limited treatment options.
Opdivo will provide ESCC patients with an important second-line treatment option that extends survival while improving quality of life.
this approval, based on phase III ATTRACTION-3 (ONO-4538-24/CA209-473; NCT02569242) study results.
data show that Opdivo showed better total lifetime (OS) results (HR-0.77; 95% CI:0.62-0.96; p-0.0189) compared to yew-algen chemotherapy (the researchers chose dosi yew alcohol or yew alcohol).
OS was 8.4 months (95%CI:7.2-9.9) in the esother chemotherapy group, while the mid-OS in the Opdivo treatment group was 10.9 months (95% CI:9.2-13.3), regardless of PD-L1 expression level. "Today's approval by the European Commission marks an extremely important milestone in the treatment of esophageal squamous cell carcinoma, as this is the first time the European Union has approved an immunotherapy for the treatment of such patients," said Dr. Ian M. Waxman, M.D., Director of Gastrointestinal Tumor Development at
Centennia Mercer.
we are proud of our work in advancing treatment options for patients with digestive cancer.
look forward to working with European stakeholders to bring Opdivo to more eligible patients who may benefit.
"ATTRACTION-3 is a multi-center, randomized, open-label, global study that assessed the efficacy and safety of Opdivo relative to chemotherapy (docetaxel or yew alcohol) in patients with non-removable late-stage or recurring non-removable therapies with a combination of first-line fluorine and platinum drugs.
were admitted to the group mainly in Asia, where up to 96% of patients in the two treatment groups were from Asia.
, patients are treated until the disease worsens or is unacceptable for toxicity.
end point of the study was total lifetime (OS), and secondary endpoints included total mitigation rate (ORR), progress-free lifetime (PFS), disease control rate (DCR), mitigation duration (DOR), and safety assessed by investigators.
the study was sponsored by Ono Pharma, an Opdivo partner at Pershing.
results showed that the study reached the main end point of OS: Opdivo's treatment group OS showed a significant improvement in statistical significance and a 23% reduction in death risk compared to the chemotherapy group (HR=0.77,95% CI:0.62-0.96, p=0.) 0189), the mid-OS extended by 2.5 months (10.9 months (95% CI: 9.2-13.3) vs 8.4 months (95% CI: 7.2-9.9) ).
12- and 18-month survival rates (OS rates) were 47% (95% CI:40-54) and 31% (95% CI:24-37), respectively, in the Opdivo treatment group (95% CI: 28-41) and 21% (95% CI:15-27).
the survival benefits of Opdivo regardless of tumor PD-L1 expression level.
exploratory analysis of patient reporting results showed significant overall improvement in the quality of life of patients treated with Opdivo compared to chemotherapy.
orR, the Opdivo treatment group and the chemotherapy group were 19% (95% CI:14-26) and 22% (95% CI:15-29), respectively.
, however, the study showed that Opdivo significantly extended the duration of the mid-level remission compared to chemotherapy (DOR:6.9 months (95% CI: 5.4-11.1) vs 3.9 months (95% CI: 2.8-4.2).
at the end of the data cut-off, seven patients in the Opdivo treatment group remained in remission and two in the chemotherapy group.
no significant difference between the Opdivo treatment group and the chemotherapy group (HR=1.08 (95% CI: 0.87-1.34) in terms of non-progression lifetime (PFS).
, Opdivo's safety is consistent with previous studies in ESCC and other solid tumors.
less adverse events (TRAEs) associated with Opdivo treatment than chemotherapy, with a 60 percent chance of TREA at any level in Opdivo patients and 95 percent in chemotherapy patients.
Opdivo treatment group had a lower rate of level 3 or 4 TREA than the chemotherapy group (18% vs. 63%), and the proportion of patients who experienced TREA-caused drug suspension was the same in both groups (9%).
esophageal cancer is the seventh most common cancer in the world and the sixth leading cause of death.
of patients diagnosed with metastasis had a five-year relative survival rate of 8% or less.
two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for about 90 and 10 percent of all esophageal cancer.
esophageal cancer (Photo: medindia.net) It is estimated that 572,000 new cases are diagnosed each year and about half a million people die from esophageal cancer.
most cases are already terminally ill at the time of diagnosis and should affect the daily lives of patients, including their ability to eat.
the highest prevalence of esophageal cancer in Asia, with 444,000 cases diagnosed each year, accounting for 80 per cent of esophageal cancer cases worldwide.
It's worth noting that at the end of July 2019, the Merca East PD-1 oncology immunotherapy Keytruda (Nerida, common name: pembrolizumab, Pabli Pearl Mono-Resistance) was awarded FDA approved the treatment of patients with PD-L1-positive esophageal squamous cell carcinoma (ESCC), specifically: patients with tumor expression PD-L1 (combined positive score (CPS) ≥10), relapsed, localized late stage, or metastatic ESCC patients with disease progression after receiving one or more systemic therapies.
Keytruda is the first anti-PD-1 therapy approved for the treatment of patients with relapsed localized late stage or metastasis ESCC (tumor expression PD-L1, CPS≥10).
this approval is based on data from 2 clinical studies, KEYNOTE-181 (NCT02564263) and KEYNOTE-180 (NCT02559687).
data from the KEYNOTE-181 study show that in patients with ESCC tumor expression PD-L1 (CPS≥10), keytruda treated patients with OS showed an improvement compared to chemotherapy patients (medium OS: 10.3 months. 7.0-13.5' vs 6.7 months (95%CI: 4.8-8.6) and HR=0.64 (95% CI: 0.46-0.90) ).
ESCC patients with 35 tumor expression PD-L1 (CPS≥10) had ANR of 20% (95% CI: 8.0, 37.0), according to data from the KEYNOTE-180 study.
7 patients with remission, DOR ranged from 4.2 months to 25.1 plus months, 71% of patients (5 cases≥ DOR≥6 months, 57% of patients (3 cases≥ DOR≥12 months.
Origin: Bristol Myers Squibb Receives European Commission approval for Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma<!--/ewebeditor:page->