appliedradiationoncology.com Open in urlscan Pro
157.56.181.79  Public Scan

Form analysis
1 forms found in the DOM

GET /search-results

<form method="GET" action="/search-results">
  <input type="text" name="q" placeholder="Search the site..."><input type="submit" value="Go">
</form>

Text Content

 * About Us
 * FAQ
 * Advertise
 * Contact
 * Latest Articles

 

 * Journal
   * Issues
   * Subscribe
   * Editorial Policies
   * Submission Guidelines
   * Address Change
   * Advertise
 * News
 * articles
 * Cases
   * Clinical Cases
 * Webinars
   * Upcoming Webinars
   * On Demand
 * CME/CE
 * Resources
   * Subscribe
   * Address Change
   * Editorial Policies
   * Submission Guidelines
   * Forms for Authors
   * Contact Us
   * Email Alert Manager
 * About Us
 * Advertise
 * ARO Blog

 * Clinical Departments
 * Study Confirms Safety, Tolerability of TLX101 Therapy with EBRT


STUDY CONFIRMS SAFETY, TOLERABILITY OF TLX101 THERAPY WITH EBRT

By News Release


 

Telix Pharmaceuticals Limited reported the IPAX-1 Phase I/II study of TLX101
therapy (4-L-[ 131I] iodo-phenylalanine, or 131I-IPA) in combination with
external beam radiation therapy (EBRT) in recurrent glioblastoma multiforme
(GBM) has met its primary endpoint.

The primary objective of the IPAX-1 study was to evaluate the safety and

tolerability profile of intravenous 131I-IPA administered concurrently with
second line EBRT in patients with recurrent GBM. Secondary objectives were to
determine optimal dosing, biodistribution and radiation absorption into the
tumor, as well as assess preliminary efficacy through clinical and imaging-based
assessment of tumor response.

The study also delivered encouraging preliminary efficacy data for further
evaluation, demonstrating a median overall survival (OS) of 13 months from the
initiation of treatment in the recurring setting, or 23 months from initial
diagnosis. Given that GBM has a median survival from initial diagnosis of 12-15
months, the overall survival improvement trend seen in this patient population
clearly warrants further evaluation in a larger patient population.

Recurrent GBM is a highly aggressive cancer that progresses rapidly, and for
which there are few effective treatment options. TLX101 is a systemically
administered targeted radiation therapy that targets L-type amino acid
transporter 1 (LAT-1), which is typically over- expressed in GBM. TLX101 has
been granted orphan drug designation in the United States and Europe.

10 patients were enrolled of whom 9 received the full study treatment dosing of
~2GBq (2000 MBq) of TLX101, either in the form of a single administration or one
of two triple-fractionated regimens. The results demonstrated all dosing
regimens, in combination with EBRT, were well tolerated:

 * Dosimetric analysis demonstrates that radiation exposure to key organs is
   well within acceptable safety limits.
 * The most frequent treatment emergent adverse events (TEAEs) were decreased
   lymphocyte count, fatigue, headache and hiccups, which occurred in three
   patients (30%), followed by decreased platelet count, diarrhea, cerebral
   oedema (swelling), and insomnia, which occurred in two patients (20%).
 * Except for cerebral oedema (swelling), a typical side-effect of radiation to
   the brain, adverse events were of low grade, did not show any trends or
   patterns and were clinically manageable, with a significant proportion deemed
   unrelated to therapy. The therapy was generally well tolerated by patients.
 * Overall survival (OS) was a median of 13 months, from initiation of therapy
   in the recurrent disease setting.
 * Of the nine patients who received conventional imaging, four (44%) exhibited
   stable disease at day 135 and two (22%) at day 180, determined by
   longitudinal imaging.
 * Two patients remain alive at the time of study report.

Dr Colin Hayward, Chief Medical Officer at Telix said, "We are pleased to report
this final outcome, which will be submitted for publication. We can reconfirm
that TLX101 has demonstrated safety and tolerability profile and encouraging
early efficacy data. The median overall survival of 13 months from initial
treatment in the recurrent second line setting reinforces the validity of
further investigation and dose escalation of TLX101 in patients with GBM. Due to
the aggressive nature of this cancer and limited treatment options, we are
experiencing a high level of interest in the follow-on study that Telix is now
undertaking in newly diagnosed patients, as a front-line therapy in combination
with standard of care treatment. In parallel we will continue to study TLX101 in
the recurrent setting."

Dr Josef Pichler, Kepler University Hospital, Austria and Principal Investigator
in the IPAX-1 study said, "When you consider that GBM has a median survival from
initial diagnosis of 12-15 months, the potential benefit demonstrated in
relapsed patients, in a second-line setting is encouraging. We are very
motivated to continue to investigate TLX101 in a larger patient population in
the planned Phase II IPAX-L (Linz) study underway at Kepler University Hospital,
with the goal of collecting additional safety and efficacy data for TLX101 in in
combination with EBRT in patients with relapsed-glioblastoma."

Back To Top

--------------------------------------------------------------------------------


RELATED ARTICLES

 * Last Patient Dosed in Telix’s Phase III ZIRCON Study
   
     In the Phase III pivotal study ZIRCON (Zirconium in Renal...

 * Telix Appoints Kevin Richardson To Lead Americas Division
   
     Telix Pharmaceuticals Limited has appointed Kevin...

 * RefleXion, Telix Expand Prostate Cancer Treatment Partnership
   
     A co-development and commercialization agreement between...



Study Confirms Safety, Tolerability of TLX101 Therapy with EBRT.  Appl Rad
Oncol. 

By News Release| September 23, 2022
Categories:  Clinical Departments|Technologies|Section


ABOUT THE AUTHOR




NEWS RELEASE





--------------------------------------------------------------------------------



Resources
 * Author Guidelines
 * Advertise
 * Contact

Societies
 * ASTRO
 * AAPM
 * ACRO
 * RSNA

Education
 * CME Credits
 * CE Credits
 * CRA Credits

 


 * Contact Us
 * Terms & Conditions
 * Privacy Policy

Copyright © Anderson Publishing, Ltd

 2022
    


ShareThis Copy and Paste


Sign up here to receive our free
bi-weekly ARO e-Newsletter.



Close