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Rbl035.2

This article discusses a phase 2 clinical trial investigating the use of BNT116, a cancer vaccine containing Rbl035.2, in combination with cemiplimab for treating 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 RBL035.2?

RBL035.2 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, RBL035.2 is likely a specific type of messenger RNA (mRNA) that carries instructions for producing certain proteins in the body[1].

BNT116 Cancer Vaccine

BNT116 is an experimental cancer vaccine being developed by BioNTech SE. It contains several active substances, including RBL035.2, along with other components like ENOMIMERAN (also known as RBL003.3), RBL005.3, RBL007.2, RBL012.2, and RBL027.2[1]. This combination of substances is designed to stimulate the immune system to fight against cancer cells.

The vaccine is formulated as a concentrate for dispersion for injection, which means it needs to be diluted before it can be administered to patients. It is given through intravenous injection, meaning it’s delivered directly into the bloodstream[1].

Target Disease: Advanced Non-Small Cell Lung Cancer

BNT116, which includes RBL035.2, is being studied for the treatment of advanced non-small cell lung cancer (NSCLC)[1]. NSCLC is a type of lung cancer that accounts for about 80-85% of all lung cancers. “Advanced” typically means the cancer has spread beyond the lungs to other parts of the body (stage IV) or cannot be surgically removed (some stage III cases).

Clinical Trial Details

A clinical trial called EMPOWERVAX Lung 1 is currently underway to study the effectiveness and safety of BNT116 (containing RBL035.2) in combination with another drug called cemiplimab[1]. This is a Phase 2 study, which means it’s testing the drug in a larger group of patients to further evaluate its effectiveness and monitor side effects.

The main goal of the study is to see how well the combination of BNT116 and cemiplimab works compared to cemiplimab alone in treating advanced NSCLC. Researchers will measure this by looking at how many patients’ tumors shrink or disappear (called the “objective response rate”)[1].

Eligibility Criteria

To participate in this study, patients must meet certain criteria, including:

  • Having advanced NSCLC that has not been treated with systemic therapy before
  • Having a tumor that expresses high levels of a protein called PD-L1
  • Having at least one tumor that can be measured by CT or MRI scans
  • Being in relatively good overall health

There are also several factors that would prevent a person from participating, such as having certain other medical conditions or having received specific previous treatments[1].

Treatment Process

The study will last up to 108 weeks (about 2 years) for each participant. Patients will be randomly assigned to one of two groups:

  1. Cemiplimab alone (given by IV infusion)
  2. BNT116 (containing RBL035.2) plus cemiplimab (BNT116 given by IV injection, cemiplimab by IV infusion)

The maximum daily dose of BNT116 is 90 micrograms[1].

Potential Benefits

While it’s important to note that the effectiveness of BNT116 (including RBL035.2) is still being studied, the hope is that it will help the immune system recognize and attack cancer cells more effectively. By combining it with cemiplimab, which is already known to help the immune system fight cancer, researchers are aiming to improve outcomes for patients with advanced NSCLC[1].

Safety Considerations

As with any experimental treatment, there may be risks and side effects that are not yet fully known. The study will closely monitor patients for any adverse effects. Some potential risks could include immune-related side effects, as the treatment is designed to stimulate the immune system[1].

It’s crucial for patients to discuss all potential risks and benefits with their healthcare provider before considering participation in this or any clinical trial.

Aspect Details
Study Type Phase 2 clinical trial
Treatment Arms 1. Cemiplimab monotherapy
2. BNT116 + Cemiplimab combination
Main Eligibility Criteria – Advanced NSCLC (stage IIIB, IIIC, or IV)
– PD-L1 expression ≥50% in tumor cells
– No prior systemic treatment for recurrent or metastatic NSCLC
Primary Endpoint Objective Response Rate (ORR) assessed by BIRC using RECIST 1.1
Key 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 and how does it work? BNT116 is a cancer vaccine that contains several active substances, including Rbl035.2. It works by stimulating the immune system to recognize and attack cancer cells in non-small cell lung cancer patients.
  • Who is eligible for this clinical trial? Eligible participants include adults with advanced non-small cell lung cancer (stage IIIB, IIIC, or IV) whose tumors express PD-L1 in 50% or more of tumor cells. Patients must not have received prior systemic treatment for recurrent or metastatic NSCLC.
  • What are the main objectives of this study? The main objective is to assess the objective response rate (ORR) of the combination therapy (BNT116 + cemiplimab) compared to cemiplimab alone. Secondary objectives include evaluating other anti-tumor activities, safety, and tolerability of the treatments.
  • How long does the treatment last in this trial? The treatment period lasts up to 108 weeks (about 2 years), followed by 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 more effective than current treatments. Risks may include side effects from the treatments and the possibility that the combination therapy may not be more effective than cemiplimab alone. It's important to discuss potential risks and benefits with the study doctor.

Ongoing Clinical Trials on Rbl035.2

  • 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 patient is more likely to respond to certain immunotherapy treatments.
  • Cemiplimab: An immunotherapy drug that works by blocking PD-1, a protein on immune cells, which helps the immune system recognize and attack cancer cells.
  • BNT116: A cancer vaccine containing multiple active substances, including Rbl035.2, designed to stimulate the immune system to fight against non-small cell lung cancer.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment. It's a measure of how well a cancer treatment works.
  • 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 patient responds to treatment.
  • Blinded Independent Review Committee (BIRC): A group of experts who review clinical trial data without knowing which treatment each patient received, to ensure unbiased assessment of results.

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/