GlobeNewswire by notified

Basilea presents full safety and efficacy data set on derazantinib in patients with FGFR2 fusion-positive iCCA at ESMO congress

Share

 –      Progression-free survival (PFS) of derazantinib monotherapy
increased to eight months

Basel, Switzerland, September 17, 2021

Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today the reporting of the updated efficacy and safety results from cohort 1 of the phase 2 study FIDES-01, which evaluated its fibroblast growth factor receptor (FGFR) inhibitor, derazantinib, in patients with FGFR2 fusion-positive advanced or metastatic intrahepatic cholangiocarcinoma (iCCA), a type of bile duct cancer, at the Congress of the European Society for Medical Oncology (ESMO), taking place as a virtual meeting from 16 to 21 September 2021.

Patients with advanced iCCA have a poor prognosis. With the current chemotherapy standard-of-care, the median overall survival is less than one year.1

Cohort 1 of FIDES-01 enrolled 103 iCCA patients with confirmed FGFR2 fusions.2 Since the reporting of first topline results in early February 2021, more patient follow-up data has been obtained, showing improvements in efficacy outcomes over time. At the cut-off date in early August, for the data presented at the ESMO congress, the disease control rate (DCR) was 75.7%, including 22 patients with a partial response as the best objective response, corresponding to an objective response rate (ORR) of 21.4%. Importantly, the progression-free survival (PFS) further increased to 8.0 months (previously: 7.8 months). The time to progression (TTP) with derazantinib was 8.1 months and thus markedly longer when compared to a TTP of only 4.5 months with the previous anti-cancer treatment the patients had received prior to entering the study.
Median overall survival was 15.9 months, with follow-up ongoing. As reported at ESMO, derazantinib had a notably well manageable adverse event profile, with a low incidence of class effects such as nail toxicities, stomatitis, hand-foot syndrome and retinal effects.

Dr. Marc Engelhardt, Chief Medical Officer, said: “The further improved efficacy data and confirmed good safety and tolerability profile presented at ESMO are very encouraging and further strengthen the evidence for the efficacy of derazantinib and its differentiation in iCCA to other FGFR inhibitors from a safety perspective.”

Derazantinib ePoster at ESMO Congress 2021,
published on September 16
–  Derazantinib for patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusions/rearrangements: Primary results from the Phase 2 study FIDES-01 – M. Droz dit Busset, W. L. Shaib, K. Mody, N. Personeni, N. Damjanov, W. P. Harris, F. Bergamo, G. Brandi, G. Masi, T. Halfdanarson, V. Tam, L. W. Goff, J. Knox, A. Hollebecque, T. Macarulla Mercade, F. Cantero, M. Saulay, S. Braun, M. Javle, M. Borad; abstract 47P

For further information please visit esmo.org/meetings/esmo-congress-2021.

About derazantinib

Derazantinib is an investigational orally administered small-molecule FGFR inhibitor with strong activity against FGFR1, 2, and 3.3 FGFR kinases are key drivers of cell proliferation, differentiation and migration. FGFR genetic aberrations, e.g. gene fusions, mutations or amplifications, have been identified as potentially important therapeutic targets for various cancers, including intrahepatic cholangiocarcinoma (iCCA), urothelial, breast, gastric and lung cancers.4 In these cancers, FGFR genetic aberrations are found in a range of 5% to 30%.5
Derazantinib also inhibits the colony-stimulating-factor-1-receptor kinase (CSF1R).3, 6 CSF1R-mediated signaling is important for the maintenance of tumor-promoting macrophages and therefore has been identified as a potential target for anti-cancer drugs.7 Pre-clinical data has shown that tumor macrophage depletion through CSF1R blockade renders tumors more responsive to T-cell checkpoint immunotherapy, including approaches targeting PD-L1/PD-1.8, 9
Derazantinib has demonstrated antitumor activity and a manageable safety profile in a previous biomarker-driven phase 1/2 study in iCCA patients,10 and has received U.S. and EU orphan drug designation for iCCA. Basilea is currently conducting three clinical studies with derazantinib. The first study, FIDES-01, is a phase 2 study in patients with inoperable or advanced iCCA. It comprises one cohort of patients with FGFR2 gene fusions and another cohort of patients with mutations or amplifications.2 The second study, FIDES-02, is a phase 1/2 study evaluating derazantinib alone and in combination with Roche's PD-L1 checkpoint inhibitor, atezolizumab, in patients with advanced urothelial cancer, including metastatic, or recurrent surgically unresectable disease, expressing FGFR genetic aberrations.11 The third study, FIDES-03, is a phase 1/2 study evaluating derazantinib alone and in combination with Lilly’s anti-VEGFR2 antibody ramucirumab and paclitaxel, or with Roche’s PD-L1 checkpoint inhibitor atezolizumab, in patients with advanced gastric cancer with FGFR genetic aberrations.12 Basilea has in-licensed derazantinib from ArQule Inc., a wholly-owned subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.

About intrahepatic cholangiocarcinoma

Intrahepatic cholangiocarcinoma (iCCA) is a cancer originating from the biliary system. The age-adjusted incidence rate of iCCA in the United States has been increasing over the past decade and is currently estimated to be approximately 1.2 per 100,000.13 Patients are often diagnosed with advanced or metastatic disease that cannot be surgically removed. Current first-line standard of care is the chemotherapy combination of gemcitabine and platinum-derived agents. The prognosis for patients with advanced disease is poor, with a median survival of less than one year.14

About Basilea

Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the medical needs of patients with cancer and infectious diseases. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of severe bacterial infections. We are conducting clinical studies with two targeted drug candidates for the treatment of a range of cancers and have a number of preclinical assets in both cancer and infectious diseases in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd. and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. Derazantinib and its use is investigational and has not been approved by a regulatory authority for any use. Efficacy and safety have not been established. The information presented should not be construed as a recommendation for use. The relevance of findings in nonclinical/preclinical studies to humans is currently being evaluated.

For further information, please contact:

Peer Nils Schröder, PhD

Head of Corporate Communications & Investor Relations
Phone +41 61 606 1102
E-mail media_relations@basilea.com
investor_relations@basilea.com

This press release can be downloaded from www.basilea.com.

References

  1. S. Rizvi, S. A. Khan, C. L. Hallemeier et al. Cholangiocarcinoma — evolving concepts and therapeutic strategies. Nature reviews Clinical oncology. 2018 (15), 95-111
  2. FIDES-01: ClinicalTrials.gov identifier: NCT03230318.
  3. T. G. Hall, Y. Yu, S. Eathiraj et al. Preclinical activity of ARQ 087, a novel inhibitor targeting FGFR dysregulation. PLoS ONE 2016, 11 (9), e0162594
  4. R. Porta, R. Borea, A. Coelho et al. FGFR a promising druggable target in cancer: Molecular biology and new drugs. Critical Reviews in Oncology/Hematology 2017 (113), 256-267
  5. T. Helsten, S. Elkin, E. Arthur et al. The FGFR landscape in cancer: Analysis of 4,853 tumors by next-generation sequencing. Clinical Cancer Research 2016 (22), 259-267
  6. P. McSheehy, F. Bachmann, N. Forster-Gross et al. Derazantinib (DZB): A dual FGFR/CSF1R-inhibitor active in PDX-models of urothelial cancer. Molecular Cancer Therapeutics 2019 (18), 12 supplement, pp. LB-C12
  7. M. A. Cannarile, M. Weisser, W. Jacob et al. Colony-stimulating factor 1 receptor (CSF1R) inhibitors in cancer therapy. Journal for ImmunoTherapy of Cancer 2017, 5:53
  8. Y. Zhu, B. L. Knolhoff, M. A. Meyer et al. CSF1/CSF1R Blockade reprograms tumor-infiltrating macrophages and improves response to T cell checkpoint immunotherapy in pancreatic cancer models. Cancer Research 2014 (74), 5057-5069
  9. E. Peranzoni, J. Lemoine, L. Vimeux et al. Macrophages impede CD8 T cells from reaching tumor cells and limit the efficacy of anti–PD-1 treatment. Proceedings of the National Academy of Science of the United States of America 2018 (115), E4041-E4050
  10. V. Mazzaferro, B. F. El-Rayes, M. Droz dit Busset et al. Derazantinib (ARQ 087) in advanced or inoperable FGFR2 gene fusion-positive intrahepatic cholangiocarcinoma. British Journal of Cancer 2019 (120), 165-171. ClinicalTrials.gov identifier: NCT01752920
  11. FIDES-02: ClinicalTrials.gov identifier: NCT04045613
  12. FIDES-03: ClinicalTrials.gov identifier: NCT04604132
  13. S. K. Saha, A. X. Zhu, C. S. Fuchs et al. Forty-year trends in cholangiocarcinoma incidence in the U.S.: intrahepatic disease on the rise. The Oncologist 2016 (21), 594-599
  14. A. Lamarca, D. H. Palmer, H. S. Wasa et al. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. Lancet Oncology 2021 (22):690-701

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Palette Life Sciences Announces Completion of $30 Million Equity Financing and Expansion of the Board of Directors20.10.2021 23:45:00 CEST | Press release

-Funds will be used for expansion of commercial US footprint and acceleration of clinical development of Barrigel®- SANTA BARBARA, Calif. and STOCKHOLM, Sweden, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Palette Life Sciences, a Swedish domiciled, fully integrated global life sciences company dedicated to improving patient outcomes, announced today that the company has completed a $30 million equity financing during the spring and also expanded its Board of Directors by five members. “This capital raise allows for Palette Life Sciences’ to continue to expand our commercial presence in the United States and other key markets and bring products like Barrigel® to the global marketplace,” said Per G. Langö, Chief Executive Officer and Board Director of Palette Life Sciences. “We are excited to strengthen our team with the appointment of exceptional leaders. Each will provide significant expertise in their respective functions as we expand our product portfolio and deliver best in class care to our

The New England Journal of Medicine publishes the results of the NATIVE Phase IIb clinical trial with lanifibranor in NASH20.10.2021 23:07:18 CEST | Press release

In the Phase IIb NATIVE, lanifibranor met both the primary and key secondary endpoints, including NASH resolution with no worsening of fibrosis and improvement of liver fibrosis with no worsening of NASHNATIVE was the first clinical trial demonstrating an effect on the composite histology endpoint of NASH resolution and improvement of fibrosisNATiV31, a pivotal phase III trial of lanifibranor in NASH is currently ongoing with first clinical trial sites initiated and patients screened in the United States and if topline results, expected H2 2024, are positive, intent is to seek U.S. accelerated approval and EU conditional approval Daix (France), Long Island City (New York, United States), October 20, 2021 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical

Zoom Named a Leader in 2021 Gartner® Magic Quadrant™ for Unified Communications as a Service20.10.2021 19:00:00 CEST | Press release

SAN JOSE, Calif., Oct. 20, 2021 (GLOBE NEWSWIRE) -- Zoom Video Communications, Inc. (NASDAQ: ZM), today announced that analyst firm Gartner has named Zoom a Leader in the 2021 Magic Quadrant for UCaaS. This is the second time Zoom has been named in the Gartner Magic Quadrant for UCaaS (2020 was the first year that Zoom was recognized) and its second consecutive time as a Leader. The report analyzed 14 companies in the UCaaS space, naming Zoom as a Leader. “We are honored that Gartner has named Zoom a Leader in the Magic Quadrant for UCaaS for the second straight year,” said Eric S. Yuan, CEO of Zoom. “Zoom is committed to providing frictionless, reliable, and secure technology to empower modern, distributed workforces, and we believe we were recognized due to the convenience and accessibility of our UCaaS solutions, including Zoom Meetings, Zoom Chat, and Zoom Phone. We will continue to work hard to meet current and emerging communication demands and deliver happiness to all of our glo

AMG Advanced Metallurgical Group N.V. Schedule for Third Quarter 2021 Earnings Release20.10.2021 19:00:00 CEST | Press release

Amsterdam, 20October 2021 --- AMG Advanced Metallurgical Group N.V. ("AMG", EURONEXT AMSTERDAM: "AMG") will release its third quarter 2021 financial results on Wednesday, October 27, 2021 at approximately 18:00 CEST. AMG will host a conference call to discuss its financial results for the third quarter 2021 at 15:00 CEST (14:00 BST / 9:00AM EDT) on Thursday, October 28, 2021. Please connect approximately 10 minutes prior to the beginning of the call to ensure participation. The call-in information is as follows: Europe +44 (0)330 027 1846 North America +1 334 777 6978 When prompted, please provide the confirmation code (7571073) and an operator will direct you onto the call. The conference call will be available on the website www.amg-nv.com within twenty-four hours following completion of the call. About AMG AMG is a global critical materials company at the forefront of CO2 reduction trends. AMG produces highly engineered specialty metals and mineral products and provides related vacu

Kitron: Allokering av opsjoner20.10.2021 17:16:02 CEST | Pressemelding

(2021-10-20) Styret i Kitron ASA ("Selskapet" eller "Kitron") vedtok 20. oktober 2021 å utstede 1 440 000 opsjoner, hvoretter 70 000 opsjoner er re-allokert fra Subprogram A (2019-2022), 120 000 opsjoner er re-allokert fra Subprogramn B (2020-2023) og 1 250 000 er allokert fra Subprogram C (2021-2024). Etter allokeringen av opsjoner, vil det være 80 000 opsjoner under Subprogram A (2019-2022) som ikke er allokert og som kan re-allokeres i henhold til beslutning fra styret. Opsjonene blir utstedt i henhold til Kitrons langsiktige insentivprogram for 2019-2022 og styrets retningslinjer for godtgjørelse til ledende ansatte, som vedtatt av ordinær generalforsamling avholdt 21. april 2021. Aksjeopsjonsprogrammet og egenskapene til opsjonene er beskrevet i note 19 og 27 til Kitrons årsregnskap for 2020. Totalt er det allokert 1 120 000 opsjoner til primærinnsidere som følger: * CEO Peter Nilsson mottok 270 000 opsjoner fra Subprogram C. Etter tildelingen har Peter Nilsson 1 030 000 opsjoner

Kitron: Allocation of options20.10.2021 17:16:02 CEST | Press release

(2021-10-20) On 20 October 2021, the board of directors of Kitron ASA (the "Company" or "Kitron") resolved to issue 1,440,000 options, whereof 70,000 options are re-allocated from Subprogram A (2019-2022), 120,000 options are re-allocated from Subprogram B (2020-2023) and 1,250,000 options are allocated from Subprogram C (2021- 2024). Following the allocation of options, there will be 80,000 options under Subprogram A (2019-2022) which are not allocated and that may be re-allocated subject to the decision by the board of directors. The options are issued in accordance with Kitron's long term incentive program 2019-2022 and the board of directors' guidelines for remuneration of senior executives, as approved by Kitron's annual general meeting held 21 April 2021. The share option program and properties of the options are described in note 19 and 27 in Kitron's annual financial statements for 2020. A total of 1,120,000 options are allocated to primary insiders as follows: * CEO and Presid

Invitation to conference call and webcast of Sinch interim report for the third quarter of 202120.10.2021 17:00:00 CEST | Press release

Stockholm, Sweden – October 20, 2021 – Sinch AB (publ), a global leader in cloud communications for mobile customer engagement, will publish its interim report for the third quarter 2021 on Tuesday, November 2, 2021, at 07:30 CET. A conference call and a webcast will take place at 14:00 CET the same day where Oscar Werner, CEO, and Roshan Saldanha, CFO, will present the report. There will be a possibility to ask questions after the presentation. Time for publication of the interim report Tuesday November 2, 2021, at 07:30 CET Time for conference call and webcast Tuesday November 2, 2021, at 14:00 CET Conference call dial-in details Please make sure that you are connected to the conference by calling in to register a few minutes before the call begins. Sweden: +46 (0) 8 506 92 180 UK: +44 (0) 2071 928 000 US: +1 631 510 7495 Access code: 698 7713# Webcast and slide deck The live webcast will be available at investors.sinch.com/webcast The presentation and report will be available at inv