BerGenBio plans to add a synthetic control arm to its ongoing Phase Ib/IIa trial investigating bemcentinib in non-small-cell lung cancer (NSCLC), CEO Martin Olin told Clinical Trials Arena.

The Norway-based biopharma company is going to have a digital twin to look at real-world data and match Phase IIa trial participants with a synthetic control. The real-world match will be NSCLC patients with the same status as the trial subjects but only receiving standard-of-care treatments.

“It is quite an innovative way of not creating randomised data but strengthening the data set that we’re going to generate,” Olin said.

The Phase Ib/IIa trial (NCT05469178) is evaluating bemcentinib, which is an oral AXL inhibitor, in combination with Merck (MSD)’s Keytruda (pembrolizumab) and doublet chemotherapy as the first line of treatment. While the first part of the study looks at NSCLC with or without STK11 mutation, the second part will only focus on patients with the gene mutation.

The Phase Ib trial is evaluating safety as the primary endpoint and other signals such as overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). The Phase IIb trial will measure ORR, median PFS and OS.

In addition to the primary endpoints, the company will complete an extensive biomarker analysis to look at some secondary endpoints in relation to the genetic mutation status of the patients, Olin shared.

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BerGenBio plans to initiate the Phase IIb part at the beginning of 2024, with initial data expected towards the end of the year or the beginning of 2025. The Phase Ib data is likely to be announced in the middle of 2024.

Bemcentinib in second line NSCLC

BerGenBio also investigated bemcentinib in a Phase II trial (NCT03184571) as a second-line treatment with NSCLC patients who had received at least one prior line of chemotherapy, immunotherapy or a combination of the two.

The company recently released a biomarker analysis showing that the median overall survival was 14.1 months in AXL-positive patients compared to 6.5 months in AXL-negative subjects.

When asked if BerGenBio will look back at later lines of treatment again, Olin explained that the company will not exclude other lines but believes it can make the biggest difference in frontline therapy.