What is Immunotherapy?

Immunotherapy is a treatment that activates or suppresses the immune system and by that assist the immune system in attacking the tumor. This type of treatment is very different from chemotherapy, for example, which directly attacks the cancerous cells but unfortunately also damages healthy tissues.

The immune system has “immune barriers” which serve to regulate the immune system and prevent it from attacking the body. In cancer these functions are readily activated and as a result, the immune system ceases to attack cancerous cells, enabling the tumor to grow and proliferate in the body.

Barriers known as PD-L1, PD-1 and CTLA-4 are found on T-cells and cancer cells. For example, the biological drug Opidivo® (generic name: Nivolumab) activates the immune system against the tumor.

Immunotherapy is a revolutionary strategy, and one of the most widely studied worldwide for its application to numerous types of cancer and various stages of the disease’s development. Treatment is generally provided in the form of an intravenous infusion.

Immunotherapy drugs examples:

PD-1 drugs:
• Keytruda® (Pembrolizumab)
• Opdivo® (Nivolumab)

PD-L1 drugs:
• Tecentriq® (Atezolizumab)
• Imfinzi® (Durvalumab)

What are the most common side effects?

Reaction of the skin

Redness, blisters and dryness. The skin can become sensitive when exposed to sunlight. Inflammation around the fingernails can occur and cause pain when dressing, for example.

Flu-like symptoms

Fatigue, fever, chills, nausea, vomiting, dizziness, body pain and high or low blood pressure

Other side effects may be:

  • Muscle Pain
  • Difficulties in breathing
  • Swelling of the legs
  • Sinus congestion
  • Headaches
  • Weight gain due to accumulation of fluids
  • Diarrhea
  • Hormonal changes
  • Cough

And there could be more

Most of the side effects will disappear at the end of the immunotherapy treatment, but some can occur months and even years later.

It is important to consult with your healthcare professional about coping with side effects.

TRIAL-IN-Pharma offers a unique, personalized research and analysis for patients with metastatic cancer and brain tumors, which reveals innovative and advanced oncologic treatments around the world and support the process of achieving them.

Read our publications on immunotherapy and other innovative treatments for stage 4 metastatic cancer:

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Gastric Cancer – Zolbetuximab Prolongs Survival

About Locally Advanced Unresectable Metastatic Gastric Cancer and Gastroesophageal Junction Cancer (GEJ)

Gastric cancer is the fifth most diagnosed cancer worldwide.

Signs and symptoms can include indigestion or heartburn; pain or discomfort in the abdomen; nausea and vomiting; diarrhea or constipation; bloating of the stomach after meals; and loss of appetite and sensation of food getting stuck in the throat while eating.

Signs of more advanced gastric cancer can include unexplained weight loss; weakness and fatigue; and vomiting blood or having blood in the stool.

Risk factors associated with gastric cancer can include older age, male gender, family history, H. pylori infection, smoking and gastroesophageal reflux disease (GERD).

Because early-stage gastric cancer symptoms frequently overlap with more common stomach-related conditions, the disease is often diagnosed in the advanced or metastatic stage, or once it has spread from the tumor’s origin to other body tissues or organs.

Gastric and GEJ cancers still have very limited treatment options available for patients with an advanced diagnosis.

About the Spotlight Study

Spotlight is a global, multicenter, double-blind, randomized study that is investigating the efficacy and safety of zolbetuximab.

Approximately 566 patients have been enrolled in the study.

In arm A, patients received combination with zolbetuximab and mFOLFOX6.

After mFOLFOX6 is complete, patients are permitted to receive fluorouracil (5-FU) and folinic acid until the patient meets the study treatment discontinuation criteria.

Patients in arm B are administered matching placebo and mFOLFOX6 and may also receive 5-FU and folinic acid after mFOLFOX6 completion.

The study is ongoing at 220 locations worldwide.

It is expected to be completed in January 2025.

In addition to Spotlight, zolbetuximab is also being investigated in combination with capecitabine and oxaliplatin (CAPOX) vs placebo and CAPOX in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric adenocarcinoma (GLOW; NCT03653507).

Spotlight Results in Gastric Cancer and Gastroesophageal Junction Cancer

Initial results from the phase 3 spotlight study show that the study met its primary and key secondary end point of the duration of the period patients did not progress (also called “Progression-Free Survival, PFS) and Survival.

Treatment with zolbetuximab plus chemotherapy led to statistically significant progression-free survival (PFS) improvement in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

These topline results further support the role of CLDN18.2 as an emerging biomarker in gastric and GEJ cancer.

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Because we, do not give up on life!

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Improving therapeutic success, extending life and quality of life are our main business. We extend to metastatic cancer patients and patients with brain tumors, the most advanced treatment options in the world and the best experts in Israel and abroad.

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