Peppa's Opdivo has won EU second-tier esophageal cancer approval

the European Commission approved the centenny of the
BMS
)
PD-1
inhibitor
Opdivo
for the treatment of patients with advanced esophageal cancer after initial chemotherapy.
Opdivo
(
nivolumab
) first received this approval in
February
after japan's Ministry of Health, Labour and Labour (
MHLW
) approved a checkpoint inhibitor for non-removable advanced or relapsed esophageal cancer that progresses after chemotherapy.
The U.S. Food and Drug Administration (
DA
) has approved
Opdivo
for second-line advanced esophageal cancer treatment, an immunotherapy that was approved
June
. The new EU approves the introduction of important new treatments for patients with metastatic esophageal cancer with a five-year survival rate of no more than
10
%.

after testing positive
ATTRACTION-3
in the third stage,
EC
approved
Opdivo
, a trial that looked at the comparison of
PD-1
inhibitors with chemotherapy docetaxel or yew alcohol
-
as an irreversible treatment for patients with advanced or reoccessive esophageal squamous cell carcinoma (
ESCC
).Patients involved in the trial were not responsive or insatiable to the combined treatment of fluorine and platinum drugs.
Opdivo
reached the primary endpoint of total survival (
OS
), reducing the risk of death by
23
% and increasing total survival time by
2.5
months compared to chemotherapy.


12
months and
18
months
OS
rate was
47
% and
31
%, respectively, in the Opdivo treatment group, compared with
34
% and
21
% in the placebo group. Regardless of
level of expression
PD-L1, the survival benefits of treatment with
Opdivo
can be observed.
"This approval marks a critical milestone for patients with esophageal squamous cell carcinoma, as this is the first immunotherapy approved in the European Union for this patient population, " said
Ian

.
Vauxman (
Ian Waxman
) said
"opdivo
's main competitor in the treatment of esophageal cancer is merck
MSD
's heavy bomb checkpoint inhibitor
Keytruda
(
pembrolizumab
).
”In September, Merck presented the results
of the
KEYNOTE-590
trial, which evaluated the effectiveness of
Keytruda
in combination with chemotherapy to treat first-line esophageal cancer, at the virtual conference of the European Society of Medical Oncology (
ESMO
) in
2020.In the study, the
Keytruda
combined chemotherapy had a medium total survival of
12.4
months, while patients who received chemotherapy alone had a total survival of
9.8
months.In addition, the

12
-month
OS
rate of
51
% for
keytruda
combined chemotherapy, while the
OS
rate for
24
months
28
% and
16
%.
Opdivo
is also seeking approval in first-line treatments, and
BMS
has revealed promising data on
PD-1
inhibitors during the treatment phase of
ESMO 2020
. In the
CheckMate-577
trial, patients with esophageal or gastroesophageal junction cancer had previously under received new assisted chemical radiotherapy (
CRT
) and tumor excision, doubling the median disease-free survival rate of
Opdivo
compared to placebo. In addition, the
treatment time was
10.1
months in patients in the Opdivo
group, while the placebo group was
9
months, which was considered a moderate improvement. (
cyy123.com
)original source: