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Basilea reports positive interim results from registrational phase 2 study with oncology drug candidate derazantinib in intrahepatic cholangiocarcinoma (iCCA)

Basilea Pharmaceutica AG /
Basilea reports positive interim results from registrational phase 2 study with
oncology drug candidate derazantinib in intrahepatic cholangiocarcinoma (iCCA)
. Processed and transmitted by West Corporation.
The issuer is solely responsible for the content of this announcement.

* 21% objective response rate with six confirmed partial responses from
29 evaluable patients
* 83% disease control rate
* Safety profile and tolerability of continuous dosing schedule confirmed

Basel, Switzerland, January 09, 2019 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today results from the interim analysis of the registrational phase 2
study with the orally administered pan-fibroblast growth factor receptor (FGFR)
kinase inhibitor derazantinib (BAL087). The analysis showed promising efficacy
in patients with FGFR2 gene fusion-expressing intrahepatic cholangiocarcinoma
(iCCA) and also confirmed the safety profile and tolerability of the drug
candidate observed in previous clinical studies.

The interim analysis in the ongoing registrational phase 2 study was conducted
after 42 patients have been enrolled in the study, with a subset of 29 evaluable
patients who had at least one post-baseline imaging assessment. The objective
response rate (ORR) in these 29 patients was 21%. The disease control rate
(DCR), reflecting the proportion of patients with a partial response or with
stable disease, was 83%. The safety data obtained from all 42 patients enrolled
to date was consistent with the results from previous clinical studies with
derazantinib.

Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: "We are very
pleased to have achieved this important milestone. The response rate and the
safety profile at the time of the interim analysis are promising, especially
considering the poor outcomes with chemotherapy in this group of patients
reported in the literature. We are looking forward to the final data once the
study is completed mid-2020."

He added: "The results of the interim analysis underscore the potential of
derazantinib in the treatment of FGFR-driven tumors. As previously communicated,
we are planning to extend the clinical development program of derazantinib, by
starting a phase 2 study in other types of FGFR-driven solid tumors, mid-2019.
We are also planning to expand the ongoing iCCA study by adding a separate
cohort of patients with FGFR gene mutations to assess the potential expanded
utility of derazantinib in the treatment of iCCA."

The ongoing registrational open-label phase 2 study(1 )is expected to enroll up
to 100 patients with inoperable or advanced iCCA expressing FGFR2 gene fusions.
The patients receive once-daily oral derazantinib, to evaluate its anti-cancer
activity with respect to objective response rate, progression free survival,
overall survival and duration of response, and to further explore the safety and
tolerability of the drug candidate. The additional cohort of iCCA patients whose
tumors express FGFR gene mutations is expected to enroll approximately 50
patients.

About derazantinib
Derazantinib (BAL087, formerly ARQ 087) is an investigational orally
administered small molecule inhibitor of the FGFR family of kinases with strong
activity against FGFR 1, 2, and 3. Therefore, it is called a panFGFR kinase
inhibitor. FGFR kinases are key drivers of cell proliferation, differentiation
and migration. FGFR alterations, e.g. gene fusions, overexpression or mutations,
have been identified as potentially important therapeutic targets for various
cancers, including iCCA, bladder, breast, gastric and lung cancers.(2) Current
scientific literature suggests that FGFR alterations exist in a range of 5% to
30% in these cancers.(3 )In iCCA, FGFR2 gene fusions have been reported in
13-22% of the cases(4, 5) and FGFR gene mutations have been reported in up to
5% of the cases.(3) Basilea in-licensed derazantinib from ArQule Inc. in April
2018. The drug candidate has demonstrated favorable clinical data in previous
clinical studies, including a biomarker-driven Phase 1/2 study in iCCA
patients.(6) Derazantinib has U.S. and EU orphan drug designation for this
disease.

About intrahepatic cholangiocarcinoma (iCCA)
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.(7) 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. There is no proven effective treatment for patients who
progress on first-line chemotherapy, thus there is a high unmet medical need.(8)

About Basilea
Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company,
focused on the development of products that address the medical challenges in
the therapeutic areas of oncology and anti-infectives. With two commercialized
drugs, the company is committed to discovering, developing and commercializing
innovative pharmaceutical products to meet the medical needs of patients with
serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is
headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX:
BSLN). Additional information can be found at Basilea's website www.basilea.com.

Disclaimer
This communication expressly or implicitly contains certain forward-looking
statements concerning Basilea Pharmaceutica Ltd. and its business. 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.

For further information, please contact:
+-------------------------------------------------------+
| Peer Nils Schröder, PhD |
| Head of Corporate Communications & Investor Relations |
| +41 61 606 1102 |
| media_relations@basilea.com |
| investor_relations@basilea.com |
+-------------------------------------------------------+
This press release can be downloaded from www.basilea.com.

References
1     ClinicalTrials.gov identifier: NCT03230318
2     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
3     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
4     R. P. Graham, E. G. Barr Fritcher, E. Pestova et al. Fibroblast growth
factor receptor 2 translocations in intrahepatic cholangiocarcinoma. Human
Pathology 2014 (45), 1630-1638
5     A. Jain, M. J. Borad, R. K. Kelley et al. Cholangiocarcinoma with FGFR
genetic abberations: a unique clinical phenotype. JCO Precision Oncology 2018
(2), 1-12
6     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. Published online on November
13, 2018. https://doi.org/10.1038/s41416-018-0334-0
7     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
8     S. Sahu, W. Sun, Targeted therapy in biliary tract cancers - current
limitations and potentials in the future. Journal of Gastrointestinal Oncology
2017 (8), 324-336


Press release (PDF):
http://hugin.info/134390/R/2230886/876806.pdf



This announcement is distributed by West Corporation on behalf of West Corporation clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Basilea Pharmaceutica AG via GlobeNewswire



 
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