24 October 2017
BerGenBio Announces Start of Ph II Trial Assessing Selective AXL Inhibitor BGB324 in Combination with KEYTRUDA® for Patients with Advanced Lung Cancer
Bergen, Norge, 24 oktober 2017 – BerGenBio ASA (OSE: BGBIO) ( http://www.bergenbio.com ), er et bioteknologiselskap i klinisk fase som utvikler nye, selektive Axl kinase hemmere til bruk i flere kreftindikasjoner. Selskapet kunngjør at den første pasienten har blitt dosert i fase 2 studiet, som evaluerer selskapets mest avanserte legemiddelkandidat mot kreft, BGB324, i kombinasjon med KEYTRUDA® (pembrolizumab) i pasienter med tidligere behandlet, fremskreden adenokarsinom i lungene (ikke-småcellet lungekreft). BerGenBio sponser studien, der MSD (Merck&Co., Inc., Kenilworth, N.J., USA) leverer KEYTRUDA, en anti-PD-1 terapi, til bruk i studien ifølge en samarbeidsavtale mellom selskapene som ble inngått i mars 2017. I følge planene vil studien registrere opp til 48 pasienter i sykehus i Norge, Spania, Storbritannia og USA (ClinicalTrials.gov identifier: NCT03184558).
Den kliniske studien vil primært evaluere anti-kreft aktivitet, objective response rate og hvor godt pasientene tåler kombinasjonen av de to medikamentene. I tillegg vil studiet vurdere den farmakokinetiske profilen av BGB324 når den blir gitt i kombinasjon med KEYTRUDA. Omfattende utforskende studier vil evaluere biomarkører i svulsten og blod som indikerer immun modulasjon og Axl signaler, inkludert uttrykksnivåer for PD-L1 og Axl. Studien er forventet å levere preliminære resultater mot slutten av 2018.
Richard Godfrey, Chief Executive Officer i BerGenBio, kommenterer: “Dette er den andre studien i samarbeid med MSD der vi evaluerer kombinasjonen av vår selektive Axl-inhibitor BGB324 med MSDs anti-PD-1-behandling, KEYTRUDA, som er en godkjent og registrert medisin mot NSCLC. Ved hjelp av denne studien i avansert NSCLC og vår andre studie med BGB324 / KEYTRUDA i avansert brystkreft håper vi å generere overbevisende kliniske bevis for at blokkering av Axl-signalering kan reversere og forhindre tumorresistens mot anti-PD-1-behandlinger og føre til forbedrede kliniske utfall. Resultatene fra disse studiene samt de fra vårt bredere fase II-program med BGB324, som vi forventer å rapportere i løpet av året 2018, vil være avgjørende for å etablere potensialet til BGB324 som en sentral faktor i behandlingen av mange aggressive kreftformer.”
Om NSCLC
Det er anslått at mer enn 220 000 nye tilfeller av lungekreft vil bli diagnostisert i USA i 2017, og lungekreft er den ledende årsaken til kreftdødsfall. 65% av NSCLC regnes som adenokarsinom. Selv om ulike behandlinger eksisterer for NSCLC er det vanlig at kreften utvikler motstand mot terapi og angrep av immunsystemet. Derfor er det svært viktig med nye behandlinger som kan bekjempe disse mekanismene i NSCLC.
About BerGenBio ASA
BerGenBio ASA is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class Axl kinase inhibitors to treat multiple cancer indications. The Company is a world leader in understanding the essential role of Axl kinase in mediating cancer spread, immune evasion and drug resistance in multiple aggressive haematological and solid cancers.
BerGenBio’s lead product, BGB324, is a selective, potent and orally bio-available small molecule Axl inhibitor in four Company sponsored Phase II clinical trials in major cancer indications, with read-outs anticipated in the second half of 2018. It is the only selective Axl inhibitor in clinical development.
The Company sponsored clinical trials are:
- BGB324 as a single agent and combination therapy in acute myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)
- BGB324 with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small cell lung cancer (NSCLC)
- BGB324 with KEYTRUDA® (pembrolizumab) in advanced adenocarcinoma of the lung, and
- BGB324 with KEYTRUDA® in triple negative breast cancer (TNBC).
The clinical trials combining BGB324 with KEYTRUDA in adenocarcinoma of the lung and TNBC are conducted in collaboration with Merck & Co. Inc. (MSD), through a subsidiary.
In addition, a number of investigator-sponsored trials are underway, including a trial to investigate BGB324 with either MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial combining BGB324 with docetaxel in advanced NSCLC.
BerGenBio is simultaneously developing a companion diagnostic test to identify patient subpopulations most likely to benefit from treatment with BGB324. This will facilitate more efficient registration trials and support a precision medicine based commercialisation strategy.
The Company is also developing a diversified pre-clinical pipeline of drug candidates, including BGB149, an anti-AXL monoclonal antibody.
For further information, please visit: www.bergenbio.com
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, TARCEVA® is a registered trademark of OSI Pharmaceuticals, LLC., marketed by Roche-Genentech. TAFLINAR® is a registered trademark of Novartis International AG and MEKINIST® is a registered trademark of GSK plc.
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About Oncoinvent
Oncoinvent is developing Radspherin®, a receptor-independent alpha radiation therapy that leverages the unique anatomy of the abdominal cavity to destroy residual micrometastases using a single, highly localized dose of alpha radiation. The initial clinical focus is treatment of ovarian and colorectal cancer patients after surgical removal of the primary tumor and visible metastases in the peritoneum, the thin membrane lining the abdominal cavity and covering the abdominal organs.
This radiopharmaceutical is designed to prevent or delay recurrence in the peritoneal cavity, keeping patients disease-free for longer than the current standard of care and thereby also impacting overall survival. It is broadly applicable to any cancer that spreads to the peritoneum, e.g. ovarian, colorectal, and gastric cancers. Radspherin® stands out for its simplicity, excellent safety profile, and seamless integration into existing surgical workflows. Oncoinvent’s product is easy to use, avoids systemic delivery and significant toxicity. It is also differentiated in being simple to manufacture, scalable, and supply de-risked.
Data from two trials in ovarian (phase 1) and colorectal (phase 1/2a) cancers, are highly promising, showing an excellent safety profile and meaningful signals of efficacy. Interim data from an ongoing, randomized, controlled phase 2 ovarian cancer trial is expected in 2026. With cost-effective manufacturing, blockbuster potential, active pharma partnership momentum, plus strong endorsements from leading experts, Oncoinvent is built for scale and commercial success, and is set to become the new standard for post-surgical cancer care. The Company was founded by the originators of Algeta and Xofigo (acquired by Bayer).
