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Rbl005.3

This article discusses a Phase 2 clinical trial investigating the use of BNT116 (also known as Rbl005.3), a cancer vaccine, in combination with cemiplimab for the treatment of advanced non-small cell lung cancer (NSCLC). The study aims to assess the effectiveness and safety of this combination therapy compared to cemiplimab alone in patients whose tumors express high levels of PD-L1.

Table of Contents

What is RBL005.3?

RBL005.3 is an active substance that is part of a new cancer treatment called BNT116[1]. BNT116 is being developed as a potential treatment for advanced non-small cell lung cancer (NSCLC). It belongs to a class of treatments known as cancer vaccines, specifically referred to as “FIXVAC Lung” in this context[1].

BNT116 is a combination of several substances, including RBL005.3, RBL007.2, RBL012.2, RBL027.2, and RBL035.2[1]. These substances are all nucleic acids, which are the building blocks of genetic material in our bodies. In this treatment, they are used to create a specialized form of genetic material called messenger RNA (mRNA).

Target Condition: Advanced Non-Small Cell Lung Cancer

Non-small cell lung cancer (NSCLC) is a type of lung cancer that accounts for about 80-85% of all lung cancers. It’s called “non-small cell” to distinguish it from another type of lung cancer called small cell lung cancer[1]. When we say “advanced” NSCLC, we’re referring to cancer that has spread beyond the lungs to other parts of the body (stage IV) or cannot be treated with surgery (some stage III cases).

Clinical Trial Details

RBL005.3, as part of BNT116, is currently being studied in a Phase 2 clinical trial[1]. This trial is comparing two treatment approaches:

  1. BNT116 (which includes RBL005.3) combined with another drug called cemiplimab
  2. Cemiplimab alone

The main goal of this study is to see how well these treatments work in patients with advanced NSCLC whose tumors have a high level of a protein called PD-L1[1]. PD-L1 is a marker that can help predict how well certain cancer treatments might work.

How RBL005.3 Works

RBL005.3 and the other components of BNT116 are designed to work as a cancer vaccine. Unlike vaccines you might be familiar with that prevent diseases, cancer vaccines are meant to treat existing cancer[1]. Here’s a simplified explanation of how it might work:

  1. The mRNA in BNT116 contains instructions for making specific proteins found in lung cancer cells.
  2. When injected into the body, this mRNA enters cells and instructs them to produce these cancer-associated proteins.
  3. The immune system recognizes these proteins as foreign and mounts an attack against them.
  4. This “trains” the immune system to recognize and attack actual lung cancer cells in the body that have these same proteins.

In the clinical trial, BNT116 is being combined with cemiplimab, which is an immunotherapy drug that helps the immune system fight cancer in a different way[1].

Eligibility Criteria

Not everyone with advanced NSCLC is eligible for this clinical trial. Some key eligibility criteria include[1]:

  • Having advanced NSCLC (stage IIIB, IIIC, or IV) that hasn’t been treated with systemic therapy before
  • Having a tumor that expresses high levels of PD-L1 (50% or more)
  • Having at least one tumor that can be measured by CT or MRI scans
  • Being in relatively good overall health (ECOG performance status of 0 or 1)

There are also several conditions that would make a person ineligible for the trial, such as having certain other cancers, severe heart problems, or autoimmune diseases[1].

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks to participating in this clinical trial:

Potential benefits:

  • Access to a new treatment that isn’t available outside of clinical trials
  • Possibility of the treatment being more effective than standard treatments
  • Contributing to the advancement of cancer research

Potential risks:

  • Unknown side effects
  • The treatment may not be effective
  • Time commitment for medical visits and tests

The researchers will be closely monitoring participants for any side effects or adverse events throughout the trial[1].

It’s important to remember that RBL005.3 and BNT116 are still experimental treatments. While they show promise, more research is needed to determine their safety and effectiveness in treating advanced NSCLC.

Aspect Details
Study Type Phase 2 clinical trial
Main Treatment BNT116 (Rbl005.3) in combination with cemiplimab
Comparison Treatment Cemiplimab monotherapy
Target Condition Advanced Non-Small Cell Lung Cancer (NSCLC)
Key Eligibility Criteria – Stage IIIB, IIIC, or IV NSCLC
– No prior systemic treatment
– PD-L1 expression ≥50% in tumor cells
Primary Endpoint Objective Response Rate (ORR) assessed by BIRC
Secondary Endpoints – Duration of Response (DOR)
– Progression-Free Survival (PFS)
– Overall Survival (OS)
– Safety and tolerability
Treatment Duration Up to 108 weeks
Follow-up Period Up to 7 months

FAQ

  • What is BNT116 (Rbl005.3)? BNT116 (Rbl005.3) is a cancer vaccine that is being studied as a potential treatment for advanced non-small cell lung cancer. It is administered through intravenous injection and is being tested in combination with cemiplimab, an immunotherapy drug.
  • Who is eligible for this clinical trial? Eligible participants include adults with advanced non-small cell lung cancer (stage IIIB, IIIC, or IV) who have not received prior systemic treatment for their condition. Patients must have tumors that express PD-L1 in 50% or more of tumor cells and meet other specific criteria outlined in the study protocol.
  • What is the main goal of this clinical trial? The main goal of this trial is to assess the objective response rate (ORR) of the combination of BNT116 and cemiplimab compared to cemiplimab alone in patients with advanced non-small cell lung cancer. This will be evaluated by a blinded independent review committee.
  • How long does the treatment last in this trial? The treatment period in this trial lasts up to 108 weeks (approximately 2 years). After the treatment period, there is a follow-up period of up to 7 months.
  • What are the potential benefits and risks of participating in this trial? Potential benefits include access to a new combination therapy that may be effective against advanced non-small cell lung cancer. Risks may include side effects from the treatment, which will be closely monitored. The study will assess the safety and tolerability of the combination therapy compared to cemiplimab alone.

Ongoing Clinical Trials on Rbl005.3

  • 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.
  • BNT116 (Rbl005.3): A cancer vaccine being studied for the treatment of advanced non-small cell lung cancer. It is administered intravenously and contains genetic material (mRNA) that may help stimulate the immune system to fight cancer cells.
  • 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.
  • 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 patient is more likely to respond to certain immunotherapy treatments.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment. It is a measure of how well a cancer treatment is working.
  • Blinded Independent Review Committee (BIRC): A group of experts who evaluate the results of a clinical trial without knowing which treatment each patient received, to ensure unbiased assessment.
  • 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 or diagnosis that patients are still alive.
  • Treatment-Emergent Adverse Events (TEAEs): Side effects or complications that occur or worsen during the course of treatment in a clinical trial.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standardized set of rules used to measure how well a cancer patient responds to treatment.

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/