Jeg tror de 20 er de pasientene hvor de i tillegg til responsdata har biomarkørdata, så en subanalyse.’
Edit: jeg sendte dem en tweet om melanoma resultatene. Er jo helt utolkelig slik de forekommer nå 
Med størst mulig forsiktighet vil jeg si.
Er vel en grunn til at det på asco twitterfeeden etterspørres flere randomiserte studier for å kunne være mer sikker.
Klart, dette rettes ikke så veldig mot selskaper som bgbio som fremdeles er tidlig i løpet da.
Jeg har et håp om at BGBIO kan være med på å sprøyte ny entusiasme inn i norsk biotech, snarlig etterfulgt av PCIB.
What to make of this?
Fra april 2018. Se Keytruda Monoterapi.
Fra data sluppet i dag.
Kanskje på grunn av?
Hva har forandret seg?
Vi trenger en vinner for å stimulere interesse for sektoren. Det er jo knapt analytikere som som gidder å klippe og lime fra børsmeldingene.
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Ja akkurat nå så pirker jeg på de mest negative tingen! Dox pluss bemcentinib i NSCLC og AML monoterapi ser skikkelig bra ut!
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Overskriften på hegnar i morgen: “BerGenBio går fremdeles med tap”
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Det må være en skrivefeil fra de. Jeg dobbelsjekket tallene når jeg så over. 18% ORR for monoterapi med Keytruda i advanced NSCLC i Keynote 010 (pasienter med PD-L1 > 1% .
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01281-7/fulltext
Men det er kun ~10% ORR hos pasienter med PD-L1 <1%.
Så de foreløpige resultatene innenfor PD-L1 <1% ser veldig lovende ut.
https://www.nejm.org/doi/10.1056/NEJMoa1501824
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Man skal være forsiktig med å trekke for mye ut av preeliminære resultater basert på få pasienter, men jeg syns både R/R AML, Pembro-kombo i NSCLC og Docetaxel-kombo i NSCCL ser veldig lovende ut. Jeg syns dette lover bra for BergenBio generelt.
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Jeg tror vi kan forvente mer info på posterene. Jeg vil gjerne se noe DoR som ikke er med i presentasjonen. I tillegg så tror jeg både NSCLC med EGFRi og resultatene fra melanomstudiet trenger mer informasjon. Og jeg tror det kommer i morgen.
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BerGenBio provides interim update on Phase II clinical programme with selective oral AXL inhibitor bemcentinib
Chicago, IL, USA, June 3 2018- BerGenBio ASA (OSE:BGBIO) announces that interim data from its Phase II clinical development programme with bemcentinib, a selective AXL inhibitor, was presented at a reception hosted yesterday by the company in Chicago, IL, USA. The reception, which coincides with the annual American Society of Clinical Oncology (ASCO) meeting, provided stakeholders, including clinicians, investors, analysts and media, with interim data from the ongoing clinical trials of bemcentinib alone and in combination with standard of care drugs in multiple cancer indications. Presentations were made by key opinion leaders, clinical trial principle investigators and members of the BerGenBio team.
All materials presented at the reception are available on the BerGenBio website in the Investors / Presentations section. A conference call to discuss the presentations and updates will be held on Monday 4thJune at 8:30 AM CEST (details below).
Key Findings
Note that all Phase II trials are ongoing and results presented are preliminary and subject to change as the trials progress to completion. Updated data will be presented throughout 2018.
· Bemcentinib plus KEYTRUDA® (pembrolizumab) shows early promise in advanced lung cancer (NSCLC) patients who failed previous treatment (study BGBC008):
· Tumour shrinkage was reported in 8 of 15 evaluable patients to date, including three Partial Responses (PR) and one mixed response,
· Response assessment according to biomarker expression analysis available thus far:
· 6 of 7 PD-L1 negative patients reported clinical benefit, including 2 PRs and 2 patients with evidence of tumour shrinkage.
· 5 of 6 patients thus far tested for AXL expression with BerGenBio’s proprietary immunohistochemistry assay, were AXL positive.
· 4 of 5 AXL positive patients reported clinical benefit including 1 PR and 2 patients with evidence of tumour shrinkage.
· All 4 AXL positive patients reporting clinical benefit were found to be PD-L1 negative.· An acceptable safety profile of the combination was reported with only a minority of patients experiencing fully reversible adverse events.
· Analysis of metastatic triple-negative breast cancer (TNBC) patients who had failed previous treatment and who were enrolled to receive bemcentinib plus KEYTRUDA (study BGBC007) showed low prevalence of AXL and PD-L1:
· 14 of 18 patients tested for AXL expression were AXL negative and reported no benefit.
· 12 of 15 patients tested for PD-L1 expression were PD-L1 negative; 6 were evaluable for efficacy with 1 reporting tumour shrinkage.· Superior response rates to bemcentinib monotherapy in relapsed/refractory (R/R) acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) could be predicted by soluble AXL (plasma sAXL) levels as determined by liquid biopsy (study BGBC003):
· 20 R/R AML and MDS patients who were evaluable for response were analysed for pre-treatment plasma sAXL
· 12 of 13 patients reporting sAXL levels below pre-defined thresholds at pre-treatment experienced clinical benefit, including 3 Complete Remissions, 3 Partial Remissions.
· 6 of 7 patients with sAXL above the threshold experienced a best response of progressive disease.· Bemcentinib in combination with established first-line therapies (KEYTRUDA or MEKINIST (dabrafenib) plus TAFINLAR (trametinib) in unresectable melanoma was well tolerated and showed encouraging tumour responses:
· 15 of 19 evaluable patients showed evidence of tumour shrinkage and to date there were 2 CRs, 8 PRs and a further 6 patients with a best overall response of stable disease.
· Blood-based biomarker candidates were identified.· Bemcentinib in combination with targeted therapy TARCEVA® (erlotinib) or docetaxel chemotherapy (trials BGBC004 and BGBIL005, respectively) continue to show promising activity in heavily pre-treated patients:
· Part C of the BGBC004 trial of bemcentinib in combination with EGFR targeted therapy introduces bemcentinib in a first-line setting in patients who have achieved their optimum benefit from TARCEVA monotherapy. 5 of 6 evaluable patients showed evidence of tumour shrinkage including 1 PR and 1 mixed response. In parts A and B, patients who achieved an objective response continue on treatment.
· 3 of 7 (43%) evaluable patients in a trial combining bemcentinib and docetaxel (BGBIL005) achieved durable PRs in a disease setting where the response rate to docetaxel monotherapy is expected to be 10-20%.· BerGenBio continues to develop a Bemcentinib companion diagnostic
· A standardised AXL immunohistochemistry (IHC) assay, has reported strong correlation with tumour response to bemcentinib treatment.
· Blood-based biomarkers continue to report correlation with tumour response to bemcentinib treatment with particularly encouraging results in R/R AML and MDS.Richard Godfrey, BerGenBio CEO, commented: “We are excited to present these very encouraging interim results from our broad Phase II clinical development programme in a variety of tumour types with a significant unmet medical need. These results continue to support our view that bemcentinib could become a cornerstone of future cancer therapy. This data provides further evidence of bemcentinib’s activity in patients whose cancer progression is mediated by AXL. In addition, we are making good progress with our studies to identify predictive biomarkers that we anticipate may be developed as companion diagnostics for personalized therapy. We look forward to advancing these studies to completion and defining the future development strategy of bemcentinib with the greatest value for patients.”
Abstracts to be presented at ASCO
Monday 4 June, 8:00 AM - 11:30 AM Central Daylight Time
· Interim data from BGBC008 - Poster Board: #292, Abstract 3078
· Interim data from BGBC003 - Poster Board: #80, Abstract 7020
· To be discussed at the Poster Discussion Session. 11:30 AM - 12:45 PM· Biomarker study - Poster Board: #385, Abstract 2559
Monday 4 June, 1:15 PM - 4:45 PM CDT
· Interim data from BGBIL006 - Poster Board: #375, Abstract 9548
The posters presented at ASCO will be made available www.bergenbio.comin the Investors / Presentations section following the sessions.
Conference call
A conference call to discuss the presentations from the reception and those to be presented at ASCO will take place on Monday 4 June 2018 at 08:30 AM CEST. Details of the call are available in the Investors section of the BerGenBio website (www.bergenbio.com). A recording of the call will be available shortly after the event at the same place. A presentation will be available at www.bergenbio.com in the section: Investors/Reports and presentations from 8:00 am CEST the same day.
-End-
About BerGenBio ASA
BerGenBio ASA is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors as a potential cornerstone of combination cancer therapy. 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 solid and haematological cancers.
BerGenBio’s lead product, bemcentinib (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 during 2018. It is the only selective AXL inhibitor in clinical development.
The Company sponsored clinical trials are:
· Bemcentinib with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small cell lung cancer (NSCLC)
· Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the lung, and
· Bemcentinib with KEYTRUDA in triple-negative breast cancer (TNBC).
· Bemcentinib as a single agent and combination therapy in acute myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)The clinical trials combining bemcentinib with KEYTRUDA in adenocarcinoma of the lung and TNBC are conducted in collaboration with Merck & Co., Inc. (Kenilworth, NJ, USA), through a subsidiary.
In addition, a number of investigator-sponsored trials are underway, including a trial to investigate bemcentinib with either MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial combining bemcentinib with docetaxel in advanced NSCLC.
BerGenBio is simultaneously developing a companion diagnostic test to identify patient subpopulations most likely to benefit from treatment with bemcentinib. This will facilitate more efficient registration trials and support a precision medicine based commercialization 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.
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513Media Relations in Norway
Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891International Media Relations
David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44 207 638 9571This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
Nyheten er levert av Cision.
http://www.netfonds.no/quotes/release.php?id=20180603.Cision.20180603:BIT:4932:0
Noen som hører på presentasjonen nå?
Richard var positiv under presentasjonen, med unntak av TNBC.
TNBC
Han sa at de var overrasket over det lave antallet AXL-positive pasienter. Det var ikke i linje med pre-kliniske resultater. Kunne være en “statistical quirk”, eller noe annet. De ville gjøre “more research before we treat more patients”.
Spørmål fra Patrick Ling, angående definisjonen CBR/DCR som er brukt litt om hverandre.
Svar: Dette er det samme
Spørsmål fra Mick Cooper(trinity): Kan det være aktuelt å endre inklusjonskriteriene nå som man vet at AXL-negative pasienter ikke responderer?
Svar: Dagens forsøk blir ikke modifisert, de vil ha enda mer data.
Alt i alt veldig positiv, utenom til TNBC.
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Presentasjonen var positiv ladet. Kursen var opp kr 2,80 i åpningen, men er etter 4 minutter handel tilbake på sluttkurs fra i går. Det synes som om mye av oppturen ble tatt ut på forhånd. Nå var det heller ikke overraskende at selskapet skulle komme med positive nyheter, så derfor kan man heller ikke forvente at oppturen skulle bli like stor og rå som om disse dataene hadde blitt sluppet på markedet uten forvarsel.
Men det som ble levert gjør det så absolutt ikke fristende å selge mine BGBIO aksjer.
At det var kun det spm Patrick Ling hadde å stille er jo nesten flaut…
Hva med å ta opp at forskning i AXL og TNBC har vist at kun 30% av pasientene er AXL-positive.
Eller hva med et spørsmål til AML resultatene? Hvilket regulatorisk løp legger de opp til med de resultatene de har nå? Vil de søke om BTD, AA eller Fast-Track?
Det er mildt sagt mye han kunne spurt om, men han landet på den… Nesten litt flaut for analytiker-norge at det var eneste spørsmål fra dette landet.
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Det er vel representativt for hvilke interesse det er for farmasiaksjer i Norge. OSE er tross alt en børs der investorene har fokus på olje, fisk, shipping, industri og finans. Interessen rundt farmasi er mildt sagt minimal. Og når BP begynner å plukke opp norske farmasi knupper, så vil mange på OSE få hakaslepp, sa brura…
Ser ikke ut til at resultatene lever opp til de optimistiske forventningene i forkant. Aksjen ned 5 % så langt idag.
Du Londonmannen er en evig optimist uansett selskap du sitter i:rofl:! Ikke feil å være optimistisk bare man er klar over at å være i overkant euforisk medfører også en del skuffelser:worried:!
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Biotech-aksjene pumpes opp i forkant av news uten unntak. En del kortsiktige selger like før news slippes og tar gevinsten. Andre kortsiktige sitter over news og håper på et lite rally før de selger samme dag. Det blir ikke en veldig stabil kurs av slikt.
Nå vet ikke jeg om du lyttet inn på presentasjonen, men såvidt jeg kan bedømme var ikke resultatene de har oppnådd så dårlige at det skal forsvare en kursnedgang på over 5%. Men det kan jo hende at en del investorer forventet enda bedre resultater og ble skuffet over det som kom. Det er lov.
Hva angår meg og min optimisme i de selskapene jeg er investert i, så kan jeg berolige deg med at jeg ikke investerer i selskaper jeg ikke har tro på. Og har man tro på et selskap, så følger det vel naturlig at man samtidig er optimistisk på selskapets vegne. Eller?
Men jeg nekter ikke deg Erna, eller andre, å investere i selskaper du ikke har tro på, men det virker unektelig litt rart å følge en slik strategi.
Samtidig kan jeg berolige deg med at jeg ikke engasjerer meg i selskaper jeg ikke er investert i. Joda, jeg leser om dem, men skriver ikke.
Og dersom man bor i en regnby som Bergen, så må man nødvendigvis være optimist. Det er en forferdelig dårlig kombinasjon å være pessimistisk og samtidig våkne til regn de aller, aller fleste dager i året. For et trist liv det ville blitt.