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Rbl012.2

A groundbreaking clinical trial is underway to evaluate the effectiveness and safety of BNT116, a cancer vaccine containing RBL012.2, in combination with cemiplimab for treating advanced non-small cell lung cancer (NSCLC). This phase 2 study aims to compare the combination therapy with cemiplimab monotherapy in patients whose tumors express high levels of PD-L1. The trial offers hope for improved treatment options in the fight against this challenging form of lung cancer.

Table of Contents

What is RBL012.2?

RBL012.2 is an experimental drug that is being studied as a potential treatment for advanced non-small cell lung cancer (NSCLC). It is part of a larger medication called BNT116, which is classified as a cancer vaccine[1]. BNT116 is made up of several components, including RBL012.2, which work together to potentially fight cancer.

How does RBL012.2 work?

RBL012.2 is a type of drug known as a nucleic acid. Specifically, it is a form of messenger RNA (mRNA)[1]. mRNA is a molecule that carries instructions for making proteins in our cells. In the case of RBL012.2, these instructions are designed to help the body’s immune system recognize and fight cancer cells.

The exact mechanism of how RBL012.2 works is not fully described in the available information. However, as part of the BNT116 cancer vaccine, it likely helps to stimulate the immune system to target specific features of lung cancer cells.

What condition does RBL012.2 treat?

RBL012.2, as part of the BNT116 treatment, 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 that the cancer has spread beyond the lungs to other parts of the body (stage IV) or cannot be surgically removed (some stage III cases).

Current Research on RBL012.2

RBL012.2 is currently being studied in a clinical trial called EMPOWERVAX Lung 1[1]. This is a Phase 2 study, which means it’s designed to test how well the treatment works and gather more information about its safety. The study is comparing two treatment approaches:

  1. BNT116 (which includes RBL012.2) combined with another drug called cemiplimab
  2. Cemiplimab alone

The main goal of the study is to see how many patients’ tumors shrink or disappear in response to the treatment. This is called the objective response rate (ORR)[1].

Who can participate in the study?

The study is looking for adults with advanced NSCLC who meet specific criteria. Some key points include:

  • Patients must have NSCLC that has spread or cannot be surgically removed[1]
  • They must not have received any previous treatment for their advanced cancer[1]
  • Their cancer cells must have high levels of a protein called PD-L1 (50% or more)[1]
  • Patients must be in relatively good overall health[1]

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

What to expect during the study

If a patient qualifies for the study, they will be randomly assigned to one of two groups:

  1. Arm A: Patients receive cemiplimab alone through an intravenous (IV) infusion[1]
  2. Arm B: Patients receive both BNT116 (which includes RBL012.2) through an IV injection and cemiplimab through an IV infusion[1]

The treatment period lasts up to 108 weeks (about 2 years), followed by a follow-up period of up to 7 months[1].

Potential Benefits and Risks

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

Potential benefits:

  • Patients may receive a new treatment that could be more effective than current options
  • Even if patients don’t benefit directly, their participation helps advance cancer research

Potential risks:

  • The treatment may not work as well as hoped
  • There may be side effects, some of which could be serious
  • Participating in the study requires time and effort, including hospital visits and medical tests

It’s important to note that the full range of potential side effects for RBL012.2 is not yet known, as it is still being studied. Patients considering participating in this or any clinical trial should discuss the potential risks and benefits thoroughly with their healthcare provider.

Aspect Details
Study Type Phase 2 clinical trial
Main Treatment BNT116 (containing RBL012.2) + Cemiplimab
Comparison Treatment Cemiplimab monotherapy
Target Condition Advanced Non-Small Cell Lung Cancer (NSCLC)
Key Eligibility Criteria PD-L1 expression ≥50%, no prior systemic treatment for recurrent/metastatic NSCLC
Primary Endpoint Objective Response Rate (ORR) assessed by BIRC
Treatment Duration Up to 108 weeks
Follow-up Period Up to 7 months
Administration Route BNT116: Intravenous injection, Cemiplimab: Intravenous infusion

FAQ

  • What is RBL012.2 and how is it used in this clinical trial? RBL012.2 is one of the active substances in BNT116, a cancer vaccine being tested in this trial. It is a nucleic acid component that, along with other substances, forms the BNT116 vaccine. In the trial, BNT116 is administered through intravenous injection in combination with cemiplimab to treat advanced non-small cell lung cancer.
  • Who is eligible to participate in this clinical trial? Eligible participants include adults with advanced non-small cell lung cancer (NSCLC) who have not received prior systemic treatment for recurrent or metastatic NSCLC. They must have tumors expressing PD-L1 in 50% or more of tumor cells and at least one measurable lesion. Participants should have an ECOG performance status of 1 or better.
  • What is the main goal of this clinical trial? The main objective of this trial is to assess the objective response rate (ORR) of the combination therapy (BNT116 + cemiplimab) compared to cemiplimab monotherapy in patients with advanced NSCLC. This will be evaluated by a blinded independent review committee using specific criteria called RECIST 1.1.
  • 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 to monitor the participants' progress and any long-term effects of the treatment.
  • Are there any specific exclusions for participating in this trial? Yes, there are several exclusions. Some key ones include: never-smokers, those with other progressing malignancies, patients who have received certain prior therapies for NSCLC, those with significant cardiovascular disease, active or untreated brain metastases, and patients with specific gene mutations (EGFR, ALK, ROS1). Additionally, people with a history of interstitial lung disease or significant autoimmune diseases are excluded.

Ongoing Clinical Trials on Rbl012.2

  • 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.
  • BNT116: A cancer vaccine being tested in this clinical trial. It contains several active substances, including RBL012.2, and is administered intravenously.
  • RBL012.2: One of the active substances in the BNT116 cancer vaccine. It is a nucleic acid component that plays a role in the vaccine's mechanism of action.
  • Cemiplimab: An immunotherapy drug that works by blocking a protein called PD-1, helping the immune system to better fight 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 could benefit from certain immunotherapies.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment. It's a key measure of a cancer treatment's effectiveness.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a set of rules used to measure how well a cancer patient responds to treatment.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • 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.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.

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/