BerGenBio: Updated phII clinical data with selective AXL inhibitor bemcentinib strengthens its potential to improve NSCLC patient outcomes
• Overall response rate of 40% with the bemcentinib/KEYTRUDA combination observed in AXL-positive, previously treated NSCLC patients, including PD-L1 negative patients who are not expected to benefit from KEYTRUDA monotherapy
• Median PFS of patients receiving the bemcentinib/TARCEVA combination in first line has surpassed that of TARCEVA monotherapy
• Encouraging efficacy reported for bemcentinib in combination with docetaxel chemotherapy in patients who had exhausted all available therapy options including anti-PD-(L)1
• Phase II trial design revealed combining bemcentinib and KEYTRUDA in previously treated malignant mesothelioma, funded by the British Lung Foundation with support from Merck Sharp and Dohme Limited and BerGenBio ASA
• Data presented at the 19th Annual World Conference on Lung Cancer
Bergen, Norway, 25 September 2018: BerGenBio ASA (OSE:BGBIO) presented clinical data from its phase II programme with bemcentinib, a first-in-class highly selective oral AXL inhibitor, in non-small cell lung cancer (NSCLC) at the 19thWorld Conference on Lung Cancer (WCLC) in Toronto, Canada (23-26 September 2018).
Richard Godfrey, CEO of BerGenBio, commented: “We are extremely encouraged by the data presented at WCLC today. The expanded results from our study combining bemcentinib with the blockbuster immunotherapy KEYTRUDA were particularly promising. In this study, we saw increased response rates in tumours that were positive for AXL versus those that were not. Importantly, we also saw positive responses in tumours that had low or no PD-L1 expression, where we would expect to see little or no effect from KEYTRUDA therapy alone. We are now advancing this study into the second expansion stage.
“Lung cancer remains the largest cancer killer and, despite recent advances with immune-, targeted and combination therapies, many patients are still not benefitting from these treatments. By selectively inhibiting AXL activity with bemcentinib, we aim to block a fundamental survival mechanism that enables cancer cells to evade the immune system and become resistant to therapy. We believe that this approach has the potential to improve patient outcomes to treatment with established and emerging therapies. The encouraging clinical data presented at WCLC investigating bemcentinib with the three major treatment approaches in advanced lung cancer strengthens our belief in bemcentinib and we look forward to providing further updates at leading medical conferences.”
The posters presented at WCLC are available on the BerGenBio website in the Investors / Presentations section and a summary of key findings is provided below.
Ph II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in Combination with Pembrolizumab in Patients with Advanced NSCLC(BerGenBio study reference: BGBC008), James Lorens et al
The BGBC008 study is investigating whether adding bemcentinib to KEYTRUDA (pembrolizumab) in previously treated, PD-L1 unselected and immunotherapy naïve patients with advanced adenocarcinoma of the lung is well tolerated and improves patient outcomes. The study will also assess the combination in the subset of PD-L1 negative patients for whom KEYTRUDA is not indicated. A total of 48 patients across two stages will be enrolled.
• The first stage is fully enrolled with 24 patients, of which 7 remain on treatment or in follow-up
• The biomarker analysis revealed that:
o 10 of 21 evaluable patients were AXL positive (48%)
o Of 20 patients evaluated for PD-L1 expression, 11 (55%) were PD-L1 negative, 7 (35%) were weakly positive and 2 (10%) were strongly positive
o 40% overall response rate (ORR) was reported in AXL-positive patients with a disease control rate (DCR) of 70%
o 7 of 10 patients with no PD-L1 expression showed clinical benefit, of which there were 3 PRs (ORR 30%) and 4 SD (DCR 70%). This compares with an ORR of 9% in the Keynote-001 study of KEYTRUDA monotherapy in PD-L1 negative patients
o PR (n) SD (n) PD (n) ORR (%) DCR (%)
Intention-to-treat population (n=24) 5 8 10 21 54
AXL positive patients (n=10) 4 3 3 40 70
AXL negative patients (n=11) 1 4 5 9 45
PR: partial response, SD: stable disease, PD: progressive disease.

Ph I/II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in Combination with Erlotinib in Patients with EGFRm NSCLC (BerGenBio study reference: BGBC004), Lauren Byers et al
TARCEVA (erlotinib) is indicated for NSCLC that is driven by a mutation in the EGFR gene, the most common mutation in NSCLC. Although response rates to TARCEVA are high initially, nearly all patients develop resistance over time. The BGBC004 study is designed to test if adding bemcentinib to TARCEVA in first- or second-line EGFR mutation-driven NSCLC may prevent or reverse acquired resistance to TARCEVA, respectively.
• Patient recruitment into BGBC004 is complete, with 39 patients enrolled across three arms
• Arm A – a safety cohort – confirmed a bemcentinib phase II dose (200mg daily) that was well tolerated in combination with full dose TARCEVA over extended periods of time (over two years and ongoing)
• Arm B is designed to test whether the addition of bemcentinib to TARCEVA in second line may reverse disease progression in patients whose cancer has become resistant to erlotinib treatment. Arm B met its first primary endpoint, with tumour shrinkage and objective response observed in patients who were negative for the T790M resistance mutation and thus not eligible for any approved targeted therapy (ORR of 20% and a DCR of 40% including 1 PR and 1 SD out of five T790M negative patients)
• Arm C is designed to evaluate the ability of bemcentinib to prevent acquired resistance to TARCEVA and improve outcomes in patients who had been responding/stable to first-line TARCEVA therapy. Arm C reported tumour shrinkage in 6 of 9 patients (67%). Importantly, median Progression-Free Survival (PFS), while not mature, had already surpassed median PFS for TARCEVA monotherapy given as a first-line treatment of 10 months.

A Ph I/II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) with Docetaxel in Patients with Previously Treated NSCLC (BerGenBio study reference: BGBIL005), David Gerber et al
Single agent chemotherapy is the last treatment option for NSCLC patients if they fail targeted, immune- and platinum-based chemotherapy regimes. Around 10% of patients show responses to docetaxel single agent chemotherapy with a median PFS of 3-4 months commonly reported. The investigator-sponsored study BGBIL005 is designed to evaluate if combining bemcentinib with docetaxel chemotherapy is safe and can improve outcomes in up to 30 NSCLC patients who have failed up to three lines of therapy.
• Among 11 patients evaluated, the combination was generally well tolerated and 2 PRs (18%) and 6 SDs (55%) were reported

A Phase II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in Combination with Pembrolizumab in Patients with Malignant Mesothelioma (trial not active yet), Dean Fennell et al
The poster described a proposed design for an investigator-sponsored trial (MiST3) evaluating bemcentinib in combination with KEYTRUDA in patients with relapsed malignant mesothelioma. Mesothelioma is a cancer that develops from the thin layer of tissue that covers many of the internal organs and most commonly affects the lining of the lungs and chest wall.
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About WCLC
The 19th World Conference on Lung Cancer (WCLC 2018) is the leading meeting on Thoracic Oncology. It is organised by the International Association for the Study of Lung Cancer and will gather more than 7,000 international delegates. WCLC 2018 will take place in Toronto Canada, 23 – 26 September 2018. https://wclc2018.iaslc.org/
About the BGBC008 trial
The BGBC008 trial is a phase II multi-centre open-label study of bemcentinib in combination with KEYTRUDA (pembrolizumab) in previously treated, immunotherapy naïve, patients with advanced adenocarcinoma of the lung, the most common form of non-small cell lung cancer (NSCLC). The objective of the trial is to determine the anti-tumour activity of this novel drug combination and responses will be correlated with biomarker status (including AXL kinase and PD-L1 expression).
For more information please access trial NCT03184571 at www.clinicaltrials.gov.
About the BGBC004 trial
The BGBC004 trial is a phase I/II multi-centre open-label study of bemcentinib in combination with TARCEVA (erlotinib) in patients with EGFR mutation driven (EGFRm) Stage IIIb or Stage IV NSCLC. The trial is designed to evaluate reversal of resistance to EGFR targeted therapy in later line patients who are negative for the T790M resistance mutation (arm B) as well as prevention of resistance to TARCEVA in patients receiving the EGFR inhibitor first line (arm C).
For more information please access trial NCT02424617 at www.clinicaltrials.gov.
About the BGBIL005 trial
The BGBIL005 trial is an investigator-led phase I/II study of bemcentinib in combination with docetaxel chemotherapy in previously treated, relapsed / resistant NSCLC patients.
For more information please access trial NCT02922777 at www.clinicaltrials.gov.
About the MiST3 trial
The MiST3 trial is an investigator-led phase II study of bemcentinib in combination with KEYTRUDA in patients with relapsed mesothelioma. The trial, which is not active as of September 2018, is sponsored by the University of Leicester (Leicester, UK), and funded by the British Lung Foundation with support from Merck Sharp and Dohme Limited and BerGenBio. Up to 25 patients are planned to be enrolled at 3 clinical research sites in the UK.
For more information please access trial NCT03654833 at www.clinicaltrials.gov
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential corner

Her er snarversjonen som kan forklare det plutselige bykset:

BRIEF-BerGenBio: Updated PhII Clinical Data With Selective AXL Inhibitor Bemcentinib Strengthens Its Potential To Improve NSCLC Patient Outcomes

Innkommet 25.09.2018 16:04

Sept 25 (Reuters) - Bergenbio ASA :
* BERGENBIO: UPDATED PHII CLINICAL DATA WITH SELECTIVE AXL
INHIBITOR BEMCENTINIB STRENGTHENS ITS POTENTIAL TO IMPROVE NSCLC
PATIENT OUTCOMES
* OVERALL RESPONSE RATE OF 40% WITH BEMCENTINIB/KEYTRUDA
COMBINATION OBSERVED IN AXL-POSITIVE, PREVIOUSLY TREATED NSCLC
PATIENTS

Korsar tenke seg at jeg kom deg i forkjøpet. Det som er svakt er at ikke dette er meldt inn raskere. Jeg kunne handle på denne informasjonen flere minutter før dere andre fikk muligheten.

Dette må da være kjempebra.

Stiger kraftig imrg på dette

Overaskende positive resultater!

Men for et tidspunkt å slippe all denne informasjonen!!

Dette var bull! Opp 20-30% i morgen!

Veldig Bull også. Veldig dumt tidspunkt å melde på..

Bare vent, kommer til å åpne over 40kr i morgen.

Kommer ikke til å gå lang tid før Merck sluker BergenBio.

Jaggu det ser ut som Bgbio innfrir forventningene , og gratulerer til pasientene :)
Vi er vel heller ikke ferdig med presentasjonen i Toronto

Blir en usedvanlig spennende dag i morgen

Og til dere som kjenner Targovax. Oncos skal gjøre kalde tumorer varme, slik at de responderer på CPI.


Dette er det BergenBio nå har klart å få til!
Denne meldingen er stålbull, BergenBIo klarer å få kalde tumorer varme!! Jeg tror faktisk denne meldingen kan dra BergenBio mot 100kr!

Vil faktisk tørre å påstå at de dataene vi har sett i dag kan trigge et bud på BergenBio fra Merck!

Når man sitter long i Bgbio så er det veldig godt å se når den tar av og leverer , med en positiv voldgiftsdom som kan komme så Bgbio får en rettferdig del av forskningen sin og att de har en kompetent ledelse som ivaretar aksjonærene så kan Bgbio komme svært langt

er tydelegvis ikke tilfeldig att Bgbio vil ha en voldgiftsdom med Rigel og det for å forhandle om eventuell partner eller oppkjøp
Eller å klarlegge egne muligheter som selvstendig selskap å ha kontroll selv på sine egne forskningsresultater
Noen som har meninger om dette?

Ingen små biotechs vil stå alene, aksjonærene ønsker selvfølgelig oppkjøp!
Men BergenBio ønsker selvfølgelig kontroll over sitt eget produkt, da må Merck grave dypere i lommene hvis de ønsker å kjøper selskapet.

Markedet tolket gårsdagens meldinger positivt, og kjørte kursen opp rundt 15%. Meldingen kom bardus på markedet rundt kl. 16, slik at det trolig er svært sprikende mht hvor mange som rakk å hoppe inn for å få med seg i alle fall deler av rallyet.
I dag er dermed BGBIO-aksjonærene spente på den videre utvikling:
- har markedet ennå ikke helt fordøyd hva som ble meldt, og kjører videre i dag?
- eller trenger markedet å omrømme seg litt i dag?

Vel, den siste offisielle meldingen (av det korte, forståelige slaget) er denne fra i går:

BGBIO:OPPDATERT FASE 2 KLINISK DATA STYRKER POTENSIALE FOR FORBEDRET NSCLC-PASIENTUTFALL
Oslo (TDN Direkt): Oppdatert fase 2 klinisk data for den AXL-hemmende medisinen Bemcentinib ble presentert på World Conference on Lung Cancer tirsdag og dataene styrker dens potensiale for å forbedre utfallet for pasienter med fremskreden lungekreft.

Det opplyses i en melding tirsdag.

Median-PFSen (Progression-free survival) for Bemcentinib i kombinasjon med Keytruda har gått forbi TARCEVA-monoterapi, skriver blant annet selskapet.

-Vi er ekstremt oppmuntret av dataene presentert på WCLC i dag. De utvidede resultatene fra studien vår som kombinerer bemcentinib med "blockbuster" immunterapien keytruda var spesielt lovende. I denne studien så vi økt responsrater i kreft som var positiv for AXL mot de som ikke var det. Det som også var viktig var at vi så positiv respons i kreft som hadde lav eller ingen PD-L1-uttrykk, der vi ville ventet å se liten eller ingen effekt fra keytruda-terapi alene. Vi fremskynder nå denne studien inn i andre utvidelsesfase, sier konsernsjef Richard Godfrey i Bergenbio i meldingen.
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Kommentar: Ingen av analytikermiljøene eller media klarte å presentere en kommentar til dette i går. Vi får håpe at noen av disse har klart å spørre seg litt rundt i fagmiljøene slik at de snart tør å kommentere hva som faktisk sies her :-)

De har forklart dette i Bergens tidende i går: og det de vel sa er at resultatene er bedre enn de kunne forvente. Det er vel derfor de sier at de er ekstremt oppmuntret...

ORR=40% betyr at pasienter behandlet med bemcentinib+Keytruda reduserte kreftvolum med mer en 50% på pasienter hvor bare Keytruda ikke var ventet å ha effekt. BergenBio får da CPI`n Keytruda til å virke der den uten Bemcentinib ikke virker som vel er selve målsettingen.

Overall response rate of 40% with the bemcentinib/KEYTRUDA combination observed in AXL-positive, previously treated NSCLC patients, including PD-L1 negative patients who are not expected to benefit from KEYTRUDA monotherapy

Det er ganske RÅTT!

Bakke11,
det er også mitt inntrykk at de foreløpige resultatene vi fikk her er ganske RÅ :-)
Men vi får se hvordan markedet fungerer i dag, førhandelen er som vanlig ikke en sikker rettesnor, men indikerer ansett videre oppgang en halv time før åpning.

Er en responsrate på 40% rå?
Ville hatt den mye høyere dersom jeg skulle bruke sånne superlativer.
Men spennende kursutvikling blir det uansett i dagene fremover.

Ja, når referansen er 7% så er 40% rått ja.

Det er ikke rått. D r bra så langt

Ikke uventet er det noen som gevinstsikrer i åpningen.
Men nå er det i alle fall mer likviditet i aksjen :-)