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Rbl007.2

This article discusses the ongoing clinical trial investigating the use of RBL007.2, a component of the cancer vaccine BNT116, in combination with cemiplimab for the treatment of advanced non-small cell lung cancer (NSCLC). The study aims to evaluate the effectiveness and safety of this combination therapy compared to cemiplimab alone in patients with tumors expressing high levels of PD-L1.

Table of Contents

What is RBL007.2?

RBL007.2 is a component of an experimental cancer vaccine called BNT116, which is being developed to treat advanced non-small cell lung cancer (NSCLC). This vaccine is part of a class of treatments known as FixVac, which uses genetic material (RNA) to stimulate the immune system to fight cancer cells[1].

BNT116 contains several active substances, including RBL007.2, which are all forms of nucleic acids. These substances work together to potentially enhance the body’s immune response against lung cancer cells[1].

How is RBL007.2 Being Studied?

RBL007.2, as part of BNT116, is currently being investigated in a Phase 2 clinical trial called EMPOWERVAX Lung 1. This study is comparing the effectiveness and safety of BNT116 in combination with another drug called cemiplimab (an anti-PD-1 antibody) against cemiplimab alone in patients with advanced NSCLC[1].

The study focuses on patients whose tumors express high levels of a protein called PD-L1, which is found in 50% or more of their tumor cells. PD-L1 is a molecule that cancer cells sometimes use to evade the immune system[1].

Who Can Participate in the Study?

The study has specific criteria for who can participate. Some key inclusion criteria are:

  • Patients with advanced NSCLC (stage IIIB, IIIC, or IV) who haven’t received prior systemic treatment for their cancer[1]
  • Tumors must express PD-L1 in 50% or more of cells[1]
  • Patients must have at least one measurable tumor[1]
  • Patients must be in relatively good overall health (ECOG performance status ≤1)[1]

Some key exclusion criteria include:

  • Never-smokers (defined as smoking ≤100 cigarettes in a lifetime)[1]
  • Patients with certain gene mutations (EGFR, ALK, ROS1)[1]
  • Patients with untreated brain metastases[1]
  • Patients with a history of certain autoimmune diseases or interstitial lung disease[1]

What Are the Study Goals?

The main goal of the study is to assess how well the combination of BNT116 (containing RBL007.2) and cemiplimab works compared to cemiplimab alone. This is primarily measured by the objective response rate (ORR), which refers to the proportion of patients whose tumors shrink or disappear after treatment[1].

Other important goals include:

  • Measuring how long the treatment effects last (duration of response)[1]
  • Assessing how long patients live without their cancer getting worse (progression-free survival)[1]
  • Evaluating overall survival[1]
  • Monitoring the safety of the treatments by tracking side effects[1]

How is the Study Designed?

The study is divided into three main periods:

  1. Screening Period: Up to 28 days where patients are evaluated to see if they qualify for the study[1].
  2. Treatment Period: Lasting up to 108 weeks (about 2 years). Patients are randomly assigned to one of two groups:
    • Arm A: Patients receive only cemiplimab through an intravenous (IV) infusion[1].
    • Arm B: Patients receive both BNT116 (which includes RBL007.2) through an IV injection and cemiplimab through an IV infusion[1].
  3. Follow-up Period: Lasting up to 7 months after the treatment period ends[1].

Potential Benefits and Risks

While the potential benefits of RBL007.2 as part of BNT116 are still being studied, it’s hoped that this treatment could improve outcomes for patients with advanced NSCLC. However, as with all experimental treatments, there may be risks and side effects that are not yet fully known[1].

The study is carefully monitoring for any side effects or safety concerns. Patients considering participating in this or any clinical trial should discuss the potential risks and benefits thoroughly with their healthcare provider[1].

Aspect Details
Study Type Phase 2 clinical trial
Main Treatment BNT116 (containing RBL007.2) + Cemiplimab
Comparison Treatment Cemiplimab alone
Target Condition Advanced Non-Small Cell Lung Cancer (NSCLC)
Key Eligibility PD-L1 expression ≥50%, no prior systemic treatment for recurrent/metastatic NSCLC
Primary Endpoint Objective Response Rate (ORR) assessed by blinded independent review
Treatment Duration Up to 108 weeks
Follow-up Period Up to 7 months

FAQ

  • What is RBL007.2 and how is it being used in this clinical trial? RBL007.2 is one of the active substances in BNT116, a cancer vaccine being tested in combination with cemiplimab for treating advanced non-small cell lung cancer. It's part of a new approach to stimulate the immune system to fight cancer cells.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults with advanced non-small cell lung cancer whose tumors express PD-L1 in 50% or more of tumor cells. They must not have received prior systemic treatment for recurrent or metastatic NSCLC and meet other specific criteria outlined in the study protocol.
  • What is the main goal of this clinical trial? The main goal is to assess the objective response rate (ORR) of the combination of cemiplimab and BNT116 (which contains RBL007.2) compared to cemiplimab alone in treating advanced NSCLC patients with high PD-L1 expression.
  • How long does the treatment last in this clinical trial? The treatment period in this clinical trial lasts up to 108 weeks (about 2 years), followed by a follow-up period of up to 7 months.
  • What are some of the key exclusion criteria for this trial? Key exclusion criteria include never-smokers, patients with active brain metastases, those with certain gene mutations (EGFR, ALK, ROS1), history of interstitial lung disease, and significant autoimmune diseases. Patients who have received certain prior therapies may also be excluded.

Ongoing Clinical Trials on Rbl007.2

  • 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 that helps keep immune cells from attacking nonharmful cells in the body. Some cancer cells have large amounts of PD-L1, which helps them hide from an immune attack.
  • Cemiplimab: An immunotherapy drug that works by blocking PD-1, a protein on immune cells that normally helps keep these cells from attacking other cells in the body.
  • BNT116: A cancer vaccine being tested in this trial, which contains several active substances including RBL007.2. It's designed to stimulate the immune system to fight cancer cells.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • 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.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.

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/