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Rbl027.2

A new clinical trial is underway to investigate the effectiveness and safety of a novel drug combination for advanced non-small cell lung cancer (NSCLC). The study focuses on RBL027.2, a component of the cancer vaccine BNT116, used in combination with cemiplimab, an anti-PD-1 antibody. This trial aims to evaluate how well this combination works compared to cemiplimab alone in patients whose tumors express high levels of PD-L1.

Table of Contents

What is RBL027.2?

RBL027.2 is one of the active substances in a new cancer vaccine called BNT116[1]. It is classified as a nucleic acid, which means it’s a type of genetic material. In this case, RBL027.2 is likely a specific messenger RNA (mRNA) molecule that carries instructions for making a protein that may help fight cancer.

BNT116 Cancer Vaccine

BNT116 is an experimental cancer vaccine being developed by BioNTech SE[1]. It contains several active substances, including:

  • Enomimeran (also known as RBL003.3 or 5′-capped mRNA encoding MAGE-A3)
  • RBL005.3
  • RBL007.2
  • RBL012.2
  • RBL027.2
  • RBL035.2

These substances are all mRNA molecules that likely encode for different proteins associated with cancer cells. The vaccine is designed to stimulate the immune system to recognize and attack cancer cells more effectively.

Target Disease: Advanced Non-Small Cell Lung Cancer

BNT116, which includes RBL027.2, is being studied for the treatment of advanced non-small cell lung cancer (NSCLC)[1]. NSCLC is the most common type of lung cancer, accounting for about 80-85% of all lung cancers. “Advanced” means the cancer has spread beyond the lungs to other parts of the body (stage IV) or cannot be treated with surgery or radiation alone (stages IIIB or IIIC).

Clinical Trial Details

A Phase 2 clinical trial called EMPOWERVAX Lung 1 is currently underway to study BNT116 in combination with another drug called cemiplimab[1]. The main goals of this study are:

  1. To see how well the combination of BNT116 and cemiplimab works in treating advanced NSCLC compared to cemiplimab alone.
  2. To assess the safety of this combination treatment.

The study is focusing on patients whose tumors express high levels of a protein called PD-L1, which is found in 50% or more of their tumor cells.

How the Treatment Works

BNT116, containing RBL027.2 and other mRNA molecules, is given as an intravenous (IV) injection. Once in the body, these mRNA molecules instruct cells to produce specific proteins that are typically found on cancer cells. This helps “train” the immune system to recognize and attack these cancer-specific proteins.

Cemiplimab, the drug being used in combination with BNT116, is an anti-PD-1 antibody. It works by blocking a protein called PD-1 on immune cells, which helps the immune system better recognize and attack cancer cells.

Potential Benefits

The researchers hope that this combination treatment will lead to better outcomes for patients with advanced NSCLC. They will be measuring several factors to determine the treatment’s effectiveness[1]:

  • Objective response rate (ORR): The percentage of patients whose tumors shrink or disappear after treatment.
  • Duration of response (DOR): How long the cancer remains controlled after treatment.
  • Progression-free survival (PFS): How long patients live without their cancer getting worse.
  • Overall survival (OS): How long patients live overall.

Eligibility Criteria

To participate in this clinical trial, patients must meet certain criteria[1]. Some key requirements include:

  • Having advanced NSCLC (stage IIIB, IIIC, or IV) that has not been treated with systemic therapy before.
  • Having tumors that express PD-L1 in 50% or more of tumor cells.
  • Having at least one measurable tumor that can be assessed by CT or MRI scans.
  • Being in relatively good overall health (ECOG performance status of 0 or 1).

There are also several factors that would exclude a patient from participating, such as having certain other medical conditions or having received specific previous treatments.

Safety Considerations

As with any experimental treatment, there may be risks and side effects associated with BNT116 and RBL027.2. The clinical trial is designed to carefully monitor patients for any adverse effects[1]. Some potential areas of concern include:

  • Immune-related side effects, as the treatment stimulates the immune system.
  • Cardiovascular issues, as patients with significant heart problems are excluded from the study.
  • Lung-related problems, as patients with a history of certain lung conditions are not eligible.

It’s important to note that the full safety profile of this treatment is still being studied, and patients in the trial will be closely monitored for any unexpected side effects.

Aspect Details
Study Type Phase 2 clinical trial
Main Treatment BNT116 (including RBL027.2) + Cemiplimab vs. Cemiplimab alone
Target Condition Advanced Non-Small Cell Lung Cancer with PD-L1 ≥50%
Primary Endpoint Objective Response Rate (ORR) assessed by independent review
Secondary Endpoints Duration of Response, Progression-Free Survival, Overall Survival, Safety
Treatment Duration Up to 108 weeks
Follow-up Period Up to 7 months
Key Inclusion Criteria No prior systemic treatment, measurable disease, ECOG status ≤1
Key Exclusion Criteria Never-smokers, active brain metastases, certain gene mutations, autoimmune diseases

FAQ

  • What is RBL027.2 and how is it being used in this trial? RBL027.2 is one of the active substances in BNT116, a cancer vaccine being tested in this trial. It's combined with cemiplimab and compared to cemiplimab alone to treat advanced non-small cell lung cancer.
  • Who can participate in this clinical trial? The trial is for adults with advanced non-small cell lung cancer whose tumors express PD-L1 in 50% or more of tumor cells. Participants must not have received prior systemic treatment for their cancer and must meet other specific criteria.
  • What is the main goal of this study? The main goal is to assess how well the combination of BNT116 (which includes RBL027.2) and cemiplimab works compared to cemiplimab alone. This is measured by the objective response rate, which shows how many patients' tumors shrink or disappear after treatment.
  • How long does the treatment last in this trial? The treatment period in this trial lasts up to 108 weeks, which is about 2 years. After that, there's a follow-up period of up to 7 months.
  • What are some of the key things the researchers will be looking at? Besides the main goal, researchers will look at how long the treatment effects last, how long patients live without their cancer getting worse, overall survival, and any side effects or safety concerns that may arise during the treatment.

Ongoing Clinical Trials on Rbl027.2

  • Study on the Effects and Safety of Cemiplimab and BNT116 in Adults with Advanced Non-Small Cell Lung Cancer

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Poland Spain

Glossary

  • Non-Small Cell Lung Cancer (NSCLC): A type of lung cancer that is the most common form, accounting for about 80-85% of all lung cancers. It grows and spreads more slowly than small cell lung cancer.
  • PD-L1: Programmed Death-Ligand 1, a protein found on some cancer cells that can help them evade the immune system. High levels of PD-L1 may indicate that a cancer is more likely to respond to certain immunotherapy treatments.
  • Cemiplimab: An immunotherapy drug that belongs to a class called PD-1 inhibitors. It works by helping the immune system recognize and attack cancer cells.
  • BNT116: A cancer vaccine being tested in this trial. It contains several active substances, including RBL027.2, aimed at stimulating the immune system to fight cancer cells.
  • Objective Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment. It's a way to measure how well a cancer treatment is working.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer treatment is working by looking at changes in tumor size.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-and-safety-of-cemiplimab-and-bnt116-in-adults-with-advanced-non-small-cell-lung-cancer/