Detailed Results from Telix’s ZIRCON Phase III Kidney Cancer Imaging Study Presented at ASCO GU

• Primary endpoint satisfied: Sensitivity of ≥84% and uniqueness of ≥84% in all 3 readers (86% / 87% total)

• Considerably goes beyond confirmatory trial level of sensitivity and uniqueness success targets

• Key secondary endpoints satisfied, accomplishing ≥85% level of sensitivity and ≥89% uniqueness in little kidney masses (cT1a ≤4cm)

  

• Full information set: 93% favorable predictive worth; 75% unfavorable predictive worth; 86% precision (secondary endpoints)

• cT1a masses:  93% favorable predictive worth; 78% unfavorable predictive worth; 87% precision

• Case research study provided on a 1cm mass, showing possible for medical choice making with kidney masses ≤2cm

• Favourable safety and tolerability profile of TLX250-CDx likewise verified

MELBOURNE, Australia, Feb. 19, 2023 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today reveals in-depth favorable arise from its finished essential Phase III ZIRCON trial (ClinicalTrials.gov Identifier: NCT03849118)^[1]. The research study satisfied main and secondary endpoints, with TLX250-CDx showing the capability to dependably characterise and find the clear cell phenotype and offer a non-invasive technique of detecting the existence and spread of ccRCC, providing on an unmet medical requirement in this illness setting.

The outcomes were included in an oral discussion provided by Associate Professor Brian Shuch, MD, Director, Kidney Cancer Program, UCLA Institute of Urologic Oncology (Los Angeles, California) and a Principal Investigator in the Phase III ZIRCON research study, at the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (ASCO GU), on Saturday, 18 February 2023. This marks the very first time that in-depth analyses of the main endpoints and essential secondary endpoints from the ZIRCON research study have actually existed to the medical neighborhood.

An overall of 300 clients were dosed with TLX250-CDx leading to 284 evaluable clients (those clients with main histology reading and evaluable TLX250-CDx animal scan at main evaluation). Each client got a single dosage of TLX250-CDx and a tumour sample from surgical resection (centrally examined) was utilized as the requirement of reality comparator.

The research study provided extremely constant outcomes throughout 3 readers of a typical 86% level of sensitivity and 87% uniqueness (see Figure 1), going beyond the pre-determined limit needed to show the capability of TLX250-CDx to dependably find the clear cell phenotype and offer a precise and non-invasive technique for recognizing the existence and spread of ccRCC. Confidence periods (CIs) surpassed expectations in all 3 readers revealing high precision and consistency of analysis.

The research study likewise satisfied the essential secondary endpoint, accomplishing 85% level of sensitivity and 89% uniqueness in discovering ccRCC in tumours ≤4cm (“T1a” category), presently a substantial medical difficulty in the medical diagnosis of ccRCC. See Figure 2.

Figure 1: Co-main endpoints (complete analysis set)

Sensitivity and uniqueness limits gone beyond by all 3 independent readers^[2]

Figure 2: Key secondary endpoints (little sores, cT1a ≤4cm)

Sensitivity and uniqueness limits were satisfied by all 3 independent readers (complete analysis set)

A medical case research study example existed, showing the capacity for medical choice making and properly recognizing clear cell kidney cancer even in really little kidney masses, smaller sized than 2cm (Figure 3).

Figure 3: ZIRCON medical case in a 1cm mass^[3]

Potential assistance for medical choice making

For such cases the high level of sensitivity and PPV reveals that this client is extremely most likely to have a ccRCC medical diagnosis, verifying that they ought to have this deadly tumour got rid of. The image might help comprehend the phase of the illness in addition to the place, specifying the surgical strategy. In such a client a biopsy would be prevented and they would likely relocate to surgical treatment with self-confidence in the medical diagnosis.

The beneficial safety and tolerability profile of TLX250-CDx was likewise verified, with most of negative occasions (AEs) being post-surgical issues and not research study treatment associated. No unforeseen safety signals were observed and tolerability profile followed experience of girentuximab in previous healing and imaging research studies.

A/Prof Brian Shuch, MD, Director, Kidney Cancer Program, UCLA Institute of Urologic Oncology (Los Angeles, California) said, “On behalf of Telix and all of the private investigators and medical websites that contributed towards the effective ZIRCON research study, it is a benefit to provide at ASCO GU. Since the news of favorable leading line information in November there has actually been incredible interest from peers in the medical neighborhood and it’s fantastic to be able to dig a little much deeper into the medical effect of these exceptional outcomes, consisting of in specific client sub-sets. The high level of sensitivity and uniqueness will permit us to alter client management properly recognizing which clients do or do not have ccRCC.”

Dr Colin Hayward, Chief Medical Officer at Telix said: “We are delighted to share these essential Phase III ZIRCON research study results with the urologic oncology neighborhood for the very first time at ASCO GU, the leading specialised occasion for GU cancer care worldwide. The consistency of outcomes and precision of the test in both bigger and smaller sized kidney masses is specifically motivating. Telix want to thank Dr Shuch for his personal dedication to this research study, in addition to all of the clients and medical groups who took part worldwide.”

Telix is likewise pleased to notify investors that the ZIRCON research study has actually been accepted for discussion at the 38^th Annual European Association of Urology (EAU) Congress occurring in Milan, Italy, from 10 – 13 March 2023. Professor Peter Mulders, Head of Urology at Radboud University Nijmegen Medical Centre and a Principal Investigator in the ZIRCON research study will provide additional analyses in a “game-changing” oral discussion on 11 March. Further information on this and other Telix discussions at EAU to follow.

Investor Briefing

Telix is hosting a financier rundown with A/Prof Brian Shuch and Dr Colin Hayward, Telix Group Chief Medical Officer tomorrow, Tuesday 21 February at 8.30am AEDT (Monday 20 February at 4.30pm EST).

The rundown offers a chance for financiers to hear Dr Shuch’s ASCO GU discussion and a clinician’s point of view on the medical energy of this investigational imaging representative. This will be followed by a Q&A session.

Please register at the following link to access the financier rundown:
https://s1.c-conf.com/diamondpass/10028731-hd94t2.html

Dr Shuch’s discussion can be seen or downloaded from the Telix business website here.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical business concentrated on the advancement and commercialisation of diagnostic and healing radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with worldwide operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is establishing a portfolio of clinical-stage items that intends to attend to substantial unmet medical requirement in oncology and unusual illness. Telix is noted on the Australian Securities Exchange (ASX: TLX). For more details see www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

TLX250-CDx has actually not gotten a marketing authorisation in any jurisdiction. Telix’s lead item, gallium-68 (⁶⁸Ga) gozetotide (likewise called ⁶⁸Ga PSMA-11) injection, has actually been authorized by the U.S. Food and Drug Administration (FDA),^[4] and by the Australian Therapeutic Goods Administration (TGA),^[5] and by Health Canada.^[6]

^[1] Top line information launched to ASX on 7 November 2022.  
^[2] 95% CI needed to be >0.7 for level of sensitivity and >0.68 for uniqueness, for ≥2 independent readers to state the research study favorable.
^[3] Note: representative client reaction just, might not be representative for all clients.
^[4] ASX disclosure 20 December 2021.
^[5] ASX disclosure 2 November 2021.
^[6] ASX disclosure 14 October 2022.

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: [email protected]

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SOURCE Telix Pharmaceuticals Limited