BerGenBio Announces Selection of 2nd Dose in Phase 2a First Line STK11m Non-Small Lung Cancer Trial

BerGenBio Announces Selection of 2nd Dose in Phase 2a First Line STK11m Non-Small Lung Cancer Trial

By, Admin 31 July 2024

Overview

BerGenBio ASA, a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced that the independent Data and Safety Monitoring Board (DSMB) for BerGenBio’s phase 1b/2a BGBC016 study confirmed acceptable safety at the highest dose tested in the phase 1b. As a result, the DSMB also recommended that under the study protocol, no additional patients will be required for phase 1b.

The recommendation of the DSMB allows BerGenBio to proceed per study protocol and open the second dose level in the phase 2a part of the study in NSCLC patients with STK11 mutations. This portion of the study is already open for enrollment and is designed to evaluate the efficacy of the combination of bemcentinib with pembrolizumab (Keytruda) and doublet chemotherapy.

Words from CMO: BerGenBio

Cristina Oliva, chief medical officer of BerGenBio commented, “We continue to be reassured by the safety profile of bemcentinib when combined with the standard of care for 1L NSCLC patients.  Opening the second dose level in the Phase 2a portion of the BGBC016 study will allow us to carefully evaluate the dose response to bemcentinib, an important goal to guide the dose optimization for future trials.”

Words from CEO: BerGenBio

Martin Olin, chief executive officer of BerGenBio added, “The BGBC016 clinical trial is our highest priority, and I am happy to see it continues to progress as planned. NSCLC STK11m patients are not currently eligible for targeted therapy and unfortunately face a very poor prognosis. The medical need is significant, and so are the commercial opportunities.

Assessment of Safety and Efficacy

  • The phase 2a is assessing the safety and efficacy of two different doses of bemcentinib in the same treatment combination. 
  • As previously communicated, the company expects to present an interim analysis in the second half of this year.

Minimal Response to Current Therapies

  • Patients with STK11m NSCLC have a significantly poorer response to current therapies, including immune checkpoint inhibitors, when compared with patients with wild-type (non-mutated) STK11. 
  • AXL plays a significant role in the survival and spread of cancer and STK11m NSCLC patients have a high expression of AXL suggesting that AXL is an important target to prevent disease progression and resistance to existing therapies. 
  • Bemcentinib’s selective inhibition of AXL has been shown to improve the response to immune checkpoint inhibition in STK11m patient-derived preclinical models and in early clinical studies.  
  • There are currently no targeted therapies available for the STK11m NSCLC patient population, which represents up to 20% of 1L NSCLC patients.

About BerGenBio

BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including cancer and severe respiratory infections.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!