top of page
Marble Surface

Basilea Pharmaceutica

Establishing derazantinib optimum positioning

Dr Brian White

Andrew Keith

Screenshot 2021-05-31 at 11.28.55.png

31 May 2021

Screenshot 2021-05-31 at 11.16.32.png
Screenshot 2021-05-31 at 11.42.10.png

Much of the recent focus at Basilea has involved securing the promise of the FGFR inhibitor derazantinib. The FGFR class has been successfully validated elsewhere through the approvals of Balversa and Pemazyre in bladder and biliary cancer respectively. The key for Basilea in the competitively challenging environment is to identify appropriate positioning once approved and commercialised. As we have highlighted previously, we believe that ultimately the key data will be in combination with the checkpoint inhibitors, particularly in those cancers where the performance of the CKIs has been underwhelming.


Derazantinib delivering on its potential


Basilea has a comprehensive programme ongoing evaluating the potential of derazantinib in both monotherapy and in relevant combinations. The data reported today in iCCA gene fusions is particularly important to the extent that the PFS data is now sitting at 7.8 months which is highly competitive compared with peers. When combined with a more benign tolerability profile (low rates of retinal side effects, stomatitis, hand-foot syndrome, nail toxicity), and its additional potential in gene mutations and amplifications, derazantinib should represent a differentiated and highly attractive addition for physicians and patients in bile duct cancer.


Study modifications should ensure clinically and commercially relevant data


Basilea is progressing derazantinib in other difficult to treat FGFR driven cancers including urothelial (FIDES-02) and gastric cancer (FIDES-03) in monotherapy and combination. The release today suggests a recognition that although data at the initial dose of 300mg may well have proven to be successful clinically, in order to fulfil the true potential of derazantinib in these important patient populations and to maximise commercial relevance, a higher dose of 400mg may be more suitable. As a result, FGFR naïve urothelial cancer patients in 2nd line or later will now receive derazantinib at this higher dose, as will gastric cancer patients. Monotherapy and combination data (FIDES-02) will be available starting in H1 2022 providing an important insight into this dose intensification strategy. FGFR refractory patients will continue to receive 300mg dose in monotherapy and in combination with Tecentriq, with data available later this year providing a helpful insight into the potential utility of this combination approach, albeit in a very challenging patient population. As Basilea seeks to differentiate derazantinib and to maximise its clinical and commercial potential, it is worth remembering that, of the approved FGFR inhibitors, derazantinib appears to have the sole ability to help reverse the immunosuppressive state found in many cancers thanks to its activity against the CSF-1/CSF1R axis. As a result, we believe the combination with the CKIs (Tecentriq for now) offers a unique competitive advantage.


Calvine Partners LLP is authorised and regulated by the Financial Conduct Authority in respect of UK investment advisory and arranging activities.


This publication has been commissioned and paid for by Basilea Pharmaceutica and as defined by the FCA is not independent research. This report is considered to be a marketing communication under FCA rules, and it has not been prepared under the laws and requirements established to promote the independence of investment research, and it is not subject to any prohibition on dealing ahead of the dissemination of investment research. The information provided is widely available to the public.


This report in the United Kingdom is directed at investment professionals, certified high net worth individuals, high net worth entities, self-certified sophisticated investors, eligible counterparties as defined by Financial Services and Markets Act 2000 (Financial Promotion) Order 2000. The report may also be distributed and made available to persons to whom Calvine Partners is lawfully permitted. This publication is not intended for use by any individual or entity in any jurisdiction or country where that use would breach law or regulations, or which would subject Calvine Partners or its affiliates to any registration requirement within such jurisdiction or country.


Calvine Partners may provide, or seek to provide, services to other companies mentioned in this report. Partners, employees, or related parties thereof may hold positions in the companies mentioned in the report subject to Calvine Partners’ personal account dealing rules.


Calvine Partners has only used publicly available information believed to be reliable at the time of this publication and made best efforts to ensure that the facts and opinions stated are fair, accurate, timely and complete at the publication date. However, Calvine Partners provides no guarantee concerning the accuracy or completeness of the report or the information or opinions within. This publication is not intended to be an investment recommendation, personal or otherwise, and it is not intended to be advice and should not be treated in any way as such. Any valuation estimates, such as those derived from a discounted cash flow, price multiple, or peer group comparison, do not represent estimates or forecasts of a future company share price. In no circumstances should the report be relied on or acted upon by non-qualified individuals. Personal or otherwise, it is not intended to be advice and should not be relied on in any way as such. 


Forward-looking statements, information, estimates and assumptions contained in this report are not yet known, and uncertainties may cause the actual results, performance or achievements to be significantly different from expectations.


This report does not constitute an offer, invitation or inducement to engage in a purchase or sale of any securities in the companies mention. The information provided is for educational purposes only and this publication should not be relied upon when making any investment decision or entering any commercial contract. Past performance of any security mentioned is not a reliable indicator of future results and readers should seek appropriate, independent advice before acting on any of the information contained herein. This report should not be considered as investment advice, and Calvine Partners will not be liable for any losses, costs or damages arising from the use of this report. The information provided in this report should not be considered in any circumstances as personalised advice.


Calvine Partners LLP, its affiliates, officers or employees, do not accept any liability or responsibility with regard to the information in this publication. None of the information or opinions in this publication has been independently verified. Information and opinions are subject to change after the publication of this report, possibly rendering them inaccurate and/or incomplete.


Any unauthorised copying, alteration, distribution, transmission, performance, or display, of this report, is prohibited.

bottom of page