A new targeted cancer treatment, given in combination with a
standard chemotherapy, for adults with stomach (gastric) or
gastro-oesophageal junction cancer has today 14 August 2024, been
approved by the Medicines and Healthcare products Regulatory
Agency (MHRA). The gastro-oesophageal junction is the place where
the gullet (oesophagus) joins the stomach.
Zolbetuximab (Vyloy) is a monoclonal antibody that can recognise
and attach itself to certain cancer cells to destroy them.
Zolbetuximab is prescribed for patients whose tumours are
positive for the “Claudin18.2 (CLDN18.2)”, and negative for the
“Human epidermal growth factor receptor 2 (HER2)” proteins. It is
given to patients whose gastric or gastro-oesophageal junction
cancer cannot be removed by surgery or has spread to other parts
of the body.
Zolbetuximab is prescribed as a combination treatment with other
anti-cancer medicines. It is given intravenously (by a drip into
a vein) over at least 2 hours in a hospital or clinic under the
supervision of a doctor experienced in cancer treatment.
The patient's doctor will decide how much of this medicine the
patient will receive. The patient will usually receive
zolbetuximab every 2 or 3 weeks based on the other anti-cancer
medicines chosen by their doctor. The patient's doctor will
decide how many treatments are needed.
Beach, MHRA Interim Executive
Director, Healthcare Quality and Access said, “This new targeted
medicine can extend survival for adults with this type of cancer.
“MHRA is assured that the appropriate regulatory standards of
quality, efficacy and safety for the approval of this new
medicine have been met.
“As with all products, we will keep its safety under close
review”.
Zolbetuximab has been studied in two main Phase 3 clinical trials
– SPOTLIGHT and GLOW. The SPOTLGHT study investigated the
efficacy and safety of first-line zolbetuximab plus mFOLFOX6
(modified folinic acid [or levofolinate], fluorouracil, and
oxaliplatin regimen) versus placebo (a dummy treatment) plus
mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative,
stomach or gastro-oesophageal junction cancer that could not be
removed by surgery or had spread to other parts of the body.
The study included 283 patients in the zolbetuximab group and 282
patients in the placebo group. The results showed an improved
overall survival for those exposed to zolbetuximab versus
placebo. Overall survival was 67.7%, 50.5% and 38.8% at 12, 18
and 24 and months respectively, for the zolbetuximab group.
Overall survival in the placebo group was 60.0%, 38.1% and 28.4%
at 12, 18 and 24 and months respectively.
The GLOW study investigated the efficacy and safety of first-line
zolbetuximab plus CAPOX (capecitabine and oxaliplatin) versus
placebo (a dummy treatment) plus CAPOX in patients with
CLDN18.2-positive, HER2-negative, stomach or gastro-oesophageal
junction cancer that could not be removed by surgery or had
spread to other parts of the body.
The study included 254 patients in the zolbetuximab group and 253
patients in the placebo group. The results showed an improved
overall survival for those exposed to zolbetuximab versus
placebo. Overall survival was 57.5%, 38.1% and 28.9% at 12, 18
and 24 and months respectively, for the zolbetuximab group.
Overall survival in the placebo group was 50.8%, 28.1% and 17.4%
at 12, 18 and 24 and months respectively.
Zolbetuximab increased median overall survival for adults with
stomach (gastric) or gastro-oesophageal junction cancer by about
4 months compared to those administered placebo.
The most common serious side effect with zolbetuximab are nausea
and vomiting (which may affect more than 1 in 10 people). Other
serious side effects (which may affect up to 1 in 10 people) are
hypersensitivity (allergic) reactions (including hypersensitivity
and anaphylactic reaction) and infusion related reactions.
The most common other side effects (which may affect more than 1
in 10 people) are decreased appetite; low levels of albumin in
the blood (hypoalbuminaemia); and swelling of the lower legs or
hands (oedema peripheral).
As with any medicine, the MHRA keeps the safety and effectiveness
of zolbetuximab under close review. Anyone who suspects they are
having a side effect from this medicine is encouraged to talk to
their doctor, pharmacist or nurse and report it directly to the
Yellow Card scheme, either through the website or by searching
the Google Play or Apple App stores for MHRA Yellow Card.
