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Rbl016.2

This article discusses an ongoing clinical trial investigating the use of BNT113, a novel drug, in combination with pembrolizumab for treating patients with advanced head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses PD-L1. The study aims to compare this combination therapy with pembrolizumab alone in terms of safety, tolerability, and effectiveness in improving overall survival and tumor response rates.

Table of Contents

What is BNT113?

BNT113 is an investigational drug being developed for the treatment of a specific type of head and neck cancer[1]. It is a combination of two active substances called RBL015.2 and RBL016.2[1]. These substances are classified as nucleic acids, which are molecules that carry genetic information in our cells.

Target Condition: HPV16-Positive Head and Neck Cancer

BNT113 is specifically designed to treat head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16) and expresses a protein called PD-L1[1]. This type of cancer can affect various parts of the head and neck, including the:

  • Oropharynx (part of the throat behind the mouth)
  • Oral cavity (mouth)
  • Hypopharynx (lower part of the throat)
  • Larynx (voice box)

The cancer targeted by BNT113 is considered unresectable (cannot be completely removed by surgery), recurrent (has come back after initial treatment), or metastatic (has spread to other parts of the body)[1].

How BNT113 Works

BNT113 is being studied in combination with another drug called pembrolizumab[1]. While the exact mechanism of action is not fully described in the provided information, it’s likely that BNT113 works by stimulating the immune system to recognize and attack cancer cells. Pembrolizumab is known to be an immunotherapy drug that helps the immune system fight cancer.

Clinical Trial Details

A clinical trial is currently underway to evaluate the effectiveness and safety of BNT113 in combination with pembrolizumab[1]. This trial has two main parts:

  1. Safety run-in phase (Part A): This phase aims to assess the safety and tolerability of BNT113 when used with pembrolizumab.
  2. Randomized phase (Part B): This phase compares BNT113 plus pembrolizumab to pembrolizumab alone. The main goals are to see if the combination improves overall survival and increases the number of patients whose tumors shrink or disappear (called objective response rate).

Eligibility Criteria

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

  • Age 18 or older
  • Confirmed diagnosis of HPV16-positive head and neck squamous cell carcinoma
  • Cancer that expresses the PD-L1 protein
  • No prior systemic anticancer therapy for recurrent or metastatic disease
  • Measurable disease according to specific criteria
  • Adequate organ function (bone marrow, liver, kidney)

There are also several exclusion criteria, such as certain medical conditions or prior treatments that would make a patient ineligible for the study.

Potential Benefits

While the effectiveness of BNT113 is still being studied, the researchers hope to see the following benefits[1]:

  • Improved overall survival (patients living longer)
  • Higher objective response rate (more tumors shrinking or disappearing)
  • Longer progression-free survival (more time before the cancer grows or spreads)
  • Longer duration of response (tumors staying smaller for a longer time)

Safety Considerations

As with any investigational treatment, there are potential risks and side effects associated with BNT113[1]. The clinical trial is carefully monitoring for:

  • Treatment-emergent adverse events (side effects that occur during treatment)
  • Serious or severe side effects
  • Side effects that may require dose reduction, delay, or discontinuation of treatment

Patients considering participation in this clinical trial should discuss the potential risks and benefits with their healthcare provider.

Aspect Details
Trial Type Phase II, open-label, randomized
Study Drug BNT113 (containing RBL015.2 and RBL016.2) in combination with pembrolizumab
Condition Unresectable recurrent or metastatic HPV16+ Head and Neck Squamous Cell Carcinoma (HNSCC) expressing PD-L1
Primary Objectives Assess safety and tolerability (Part A), evaluate overall survival and objective response rate (Part B)
Key Eligibility Criteria Adults with confirmed HPV16+ HNSCC, PD-L1 expression, no prior systemic therapy for advanced disease
Main Exclusion Criteria Pregnancy, active infections, certain autoimmune diseases, prior immunotherapy
Primary Endpoints Overall survival, objective response rate
Secondary Endpoints Progression-free survival, duration of response, safety assessments

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this trial is to assess whether combining BNT113 with pembrolizumab is more effective than pembrolizumab alone in treating patients with advanced HPV16+ head and neck cancer that expresses PD-L1. The study focuses on improving overall survival and tumor response rates.
  • Who is eligible to participate in this trial? Eligible participants are adults (18 years or older) with confirmed recurrent or metastatic HPV16+ head and neck squamous cell carcinoma that cannot be cured by local therapies. The cancer must express PD-L1 and be located in the oropharynx, oral cavity, hypopharynx, or larynx. Patients must not have had prior systemic therapy for their advanced disease and must have measurable tumors.
  • What are the main exclusion criteria for this trial? Key exclusion criteria include pregnancy, breastfeeding, recent major surgery, active infections, uncontrolled medical conditions, history of certain autoimmune diseases, prior treatment with immune-modulating agents, and known allergies to the study drugs. Patients with brain metastases may be eligible under certain conditions.
  • How is the trial structured? The trial is divided into two parts: Part A is a safety run-in phase to assess the safety and tolerability of BNT113 combined with pembrolizumab. Part B is a randomized phase comparing BNT113 plus pembrolizumab to pembrolizumab alone, focusing on overall survival and objective response rate as primary endpoints.
  • What are the main outcomes being measured in this trial? The main outcomes include overall survival, objective response rate (the proportion of patients whose tumors shrink or disappear), progression-free survival (time until the cancer grows or spreads), duration of response, and safety measures such as the occurrence and severity of side effects.

Ongoing Clinical Trials on Rbl016.2

  • A study comparing BNT113 combined with pembrolizumab versus pembrolizumab alone for patients with HPV16-positive head and neck cancer that cannot be removed by surgery

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Hungary +5

Glossary

  • Head and Neck Squamous Cell Carcinoma (HNSCC): A type of cancer that begins in the flat cells that line the moist surfaces inside the head and neck, such as the mouth, nose, and throat.
  • Human Papillomavirus 16 (HPV16): A specific type of human papillomavirus that is associated with an increased risk of certain cancers, including some head and neck cancers.
  • PD-L1: A protein found on some cancer cells that helps them evade the immune system. Some cancer treatments target PD-L1 to help the immune system recognize and attack cancer cells.
  • Pembrolizumab: An immunotherapy drug that helps the immune system recognize and fight cancer cells by blocking the PD-1 pathway.
  • BNT113: An investigational drug being studied in this trial, which contains RBL015.2 and RBL016.2 as active substances.
  • Overall Survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Objective Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • 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.
  • Metastatic: Cancer that has spread from its original location to other parts of the body.

References

  1. http://clinicaltrials.eu/trial/study-of-bnt113-and-pembrolizumab-for-patients-with-hpv16-head-and-neck-cancer-expressing-pd-l1/