On October 18, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported detailed efficacy and safety results from the PIK3CA wild-type ("WT") cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), PIK3CA WT, advanced breast cancer ("ABC"), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. As previously announced, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in median progression-free survival ("PFS") versus fulvestrant, reducing the risk of disease progression or death by 76%. The gedatolisib doublet reduced the risk of progression or death by 67% versus fulvestrant.

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The detailed study results were presented at a late breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress today, Saturday, October 18 at 4:25 a.m. ET/10:25 a.m. CEST.

In the trial, median PFS with the gedatolisib triplet was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p<0.0001). The objective response rate ("ORR") of the gedatolisib triplet was 31.5% compared to 1% with fulvestrant and the median duration of response ("DOR") was 17.5 months. For the gedatolisib doublet, the median PFS was 7.4 months versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months (HR=0.33; 95% CI: 0.24-0.48; p<0.0001). The ORR of the gedatolisib doublet was 28.3% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response.

The topline efficacy data from the VIKTORIA-1 PIK3CA WT cohort established several new milestones in the history of drug development for HR+/HER2- ABC:

● The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC.

● The 7.3- and 5.4-months incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of an endocrine therapy-based regimen.
● Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR ("PAM") pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA WT ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor.
● The median DOR and incremental ORR improvement relative to control for the gedatolisib triplet and doublet are the highest reported for an endocrine therapy-based regimen in 2L HR+/HER2- ABC.

The median PFS benefit of the gedatolisib triplet and doublet compared to fulvestrant was consistent across subgroups with the gedatolisib triplet showing higher clinical benefit in nearly all subgroups compared to the gedatolisib doublet, particularly for patients who were pre/perimenopausal, endocrine therapy resistant, or had visceral metastases. For patients enrolled in the United States and Canada, median PFS was 19.3 months (HR=0.13; 90% CI: 0.07-0.29) for the gedatolisib triplet and 14.9 months (HR=0.35; 90% CI: 0.17-0.76) for the gedatolisib doublet.

Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Smith Family Endowed Chair in Women’s Health, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial, said: "VIKTORIA-1 is the first study to demonstrate a statistically significant and clinically meaningful improvement in median PFS with inhibition of the PI3K/AKT/mTOR pathway in patients with PIK3CA wild-type disease, all of whom previously received a CDK4/6 inhibitor. With these results, the gedatolisib regimens represent a new potential standard of care for patients with HR+, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor."

The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0%) rash (4.6%, 5.4%, and 0%); and hyperglycemia (2.3%, 2.3%, and 0%). The primary grade 4 TRAEs for the gedatolisib triplet and gedatolisib doublet groups were neutropenia (10.0% and 0.8%, respectively), leukopenia (0.8% in the gedatolisib triplet group) and pneumonitis (0.8% in gedatolisib doublet group). TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group, 3.1% in the gedatolisib doublet group, and 0% in the fulvestrant group.

Overall survival, a key secondary endpoint in VIKTORIA-1, while immature at the time of the analysis, with less than one-half of the required number of events having occurred, showed promising trends for both the gedatolisib triplet and doublet.

Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity, said: "We are very excited that treatment with gedatolisib combined with fulvestrant with or without palbociclib was well-tolerated by the VIKTORIA-1 patients and that only a few patients discontinued treatment due to an adverse event. This safety profile combined with the 7.3 and 5.4-months incremental improvement in median PFS relative to fulvestrant for the gedatolisib regimens, offer potentially paradigm shifting results for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer."

Celcuity initiated a rolling New Drug Application ("NDA") submission in conjunction with the U.S. Food and Drug Administration’s ("FDA") Real-Time Oncology Review program, based on data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. Completion of the NDA submission is targeted for the fourth quarter of 2025. The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled and is expected to report topline data for this cohort in late Q1 2026 or during Q2 2026.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call on Monday, October 20, 2025, at 8:00 a.m. ET to discuss the additional results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast here or register in advance for the teleconference here. A replay of the webcast will be available on the Celcuity website following the live event.

Notes

HR+/HER2- Breast cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (PAM), are primary oncogenic drivers of HR+, HER2- breast cancer.3 Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

VIKTORIA-1

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is fully enrolled. The trial enrolled subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who met eligibility criteria and did not have confirmed PI3KCA mutations (WT) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant, gedatolisib and fulvestrant, or fulvestrant. Subjects who met eligibility criteria and had confirmed PI3KCA mutations (MT) were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet.

Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and wild-type breast tumor cells in nonclinical studies and early clinical data.

(Press release, Celcuity, OCT 18, 2025, View Source [SID1234656812])

On October 18, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported preliminary data from the ongoing ALKOVE-1 Phase 1/2 clinical trial of neladalkib, an investigational ALK-selective inhibitor, in patients with advanced ALK-positive solid tumors outside of non-small cell lung cancer (NSCLC). These data will be presented during a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17-21, 2025, in Berlin, Germany, and are available on Nuvalent’s website at www.nuvalent.com.

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"Neladalkib was designed with the goal of being a best-in-class ALK-selective inhibitor, and initial clinical safety and efficacy data have been reported in TKI pre-treated ALK-positive NSCLC with topline pivotal data expected by the end of this year. Today, we’re excited to share the first report of neladalkib’s encouraging preliminary activity beyond NSCLC, which continue to demonstrate its target characteristics of activity against ALK and ALK resistance mutations, brain penetrance, and avoidance of TRK inhibition associated with off-target CNS adverse events," saidChristopher Turner, M.D., Chief Medical Officer of Nuvalent. "These data highlight the potential for an ALK-selective inhibitor to broadly address medical needs for patients with ALK-positive solid tumors, and the importance of widespread genomic testing. We continue to enroll adult and adolescent TKI naïve and TKI pre-treated patients with advanced ALK-positive solid tumors beyond NSCLC in the global Phase 2 portion of our ALKOVE-1 study, and look forward to providing additional updates as these data mature."

Preliminary data are reported for 34 response-evaluable patients enrolled across 14 solid tumor types outside of NSCLC in the Phase 1 and Phase 2 portions of the ALKOVE-1 clinical trial as of a data cutoff date of August 7, 2025. The majority (32/34) of patients received the recommended Phase 2 dose of 150 mg once daily. Patients were ALK TKI-naïve (38%, 13/34) or ALK TKI pre-treated (62%, 21/34), and 62% (21/34) of patients had received prior chemotherapy.

Among all patients with advanced ALK-positive solid tumors treated with neladalkib, an objective response rate of 44% (15/34) was observed, including 9/13 patients who were ALK TKI-naïve and 6/21 who were ALK TKI pre-treated. 80% (12/15) of responders remained on treatment without disease progression as of the data cutoff date. Three case studies support neladalkib’s potential to induce deep and durable responses in a range of treatment settings:

Treatment ongoing for approximately 12 months with partial response in a TKI-naïve patient with an inflammatory myofibroblastic tumor previously treated with standard of care chemotherapy;
Treatment ongoing for approximately 16 months with partial response in a TKI and chemotherapy pre-treated patient with peritoneal mesothelioma; and,
Treatment ongoing for approximately 10 months with confirmed intracranial complete response in a TKI pre-treated patient with adenocarcinoma of unknown origin with baseline brain metastasis and ALK V1180L resistance mutation.
Among these 34 patients, neladalkib was generally well-tolerated with low rates of dose reduction (8.8%) and no discontinuations due to treatment-related adverse events as of the data cutoff date. The preliminary overall safety profile was consistent with its ALK-selective, TRK-sparing design, and with previously reported data.

Enrollment is ongoing in the global Phase 2 cohort of the ALKOVE-1 trial for adult and adolescent patients with advanced ALK-positive solid tumors other than NSCLC.

The company remains on track to report topline data for patients with TKI pre-treated ALK-positive NSCLC from the ALKOVE-1 trial by the end of 2025. Neladalkib is also being evaluated in ALKAZAR, a global Phase 3 randomized, controlled trial for the treatment of patients with TKI-naïve ALK-positive NSCLC.

About Neladalkib

Neladalkib is an investigational brain-penetrant ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

(Press release, Nuvalent, OCT 18, 2025, View Source [SID1234656748])

On October 18, 2025 Florida Cancer Specialists & Research Institute, LLC (FCS) reported it will be in the spotlight this week in Berlin at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025. Among the 23 studies co-authored by FCS physician investigators selected for presentation to oncology experts worldwide, one has earned the distinction of being featured as an oral presentation and four as poster presentations by FCS first authors.

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23 Florida Cancer Specialists & Research Institute abstracts are being presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin, Germany including one oral presentation by FCS Director of Drug Development Manish R. Patel, MD, and four additional poster presentations by FCS first-authors.
23 Florida Cancer Specialists & Research Institute abstracts are being presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin, Germany including one oral presentation by FCS Director of Drug Development Manish R. Patel, MD, and four additional poster presentations by FCS first-authors.
"FCS is engaged in significant and transformative scientific discoveries that are driving new possibilities and better outcomes for patients everywhere," said Lucio N. Gordan, MD, FCS president & managing physician.

The following physician leader is first author of an oral presentation at the ESMO (Free ESMO Whitepaper) Congress:

Manish R. Patel, MD, FCS director of drug development, will participate in an oral presentation followed by expert discussion and perspectives of initial results of a first-in human study: A tumor-associated Mucin 1 (TA-MUC1)–directed Antibody–drug Conjugate (ADC), in Patients (pts) with Advanced/Metastatic (adv/met) Solid Tumors.
The following physician leaders are first authors of poster presentations at the ESMO (Free ESMO Whitepaper) Congress:

Bradley Monk, MD, FCS medical director of late-phase clinical research, will present the following abstracts:
Post hoc survival outcomes based on initial and subsequent treatment in patients (pts) with mismatch repair proficient/microsatellite stable (MMRp/MSS) primary advanced or recurrent endometrial cancer (pA/R EC) in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial.
Tisotumab Vedotin Plus Carboplatin or Pembrolizumab in Recurrent or Metastatic Cervical Cancer: 5-Year Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study.
Cesar Augusto Perez, MD, FCS, director of drug development, Sarah Cannon Research Institute (SCRI) at FCS, will review and discuss in a poster presentation, Phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with urothelial and non-urothelial solid tumours.
Judy S. Wang, MD, FCS associate director of drug development will present and discuss the findings of the following abstract: Histological biomarker analysis of nonclinical and baseline tumor samples from the phase 1 dose escalation study assessing micvotabart peliodotin (MICVO) in advanced solid tumors.
Dr. Patel, who oversees early phase research at FCS’ three drug development units, said, "Our team is proud to be at the forefront of oncology research, leading first-in-human studies and advancing cutting-edge targeted therapies."

Dr. Monk leads initiatives to expand and deploy late-phase clinical trials. He noted, "By pushing the boundaries of what’s possible, we’re helping bring the next generation of treatments to patients who need them most and are dedicated to increasing clinical trial accessibility to patients worldwide."

FCS researchers have also co-authored numerous abstracts that will also be featured in poster presentations throughout the annual international symposium:

Barry Berman, MD, MS: Clinical and biomarker results from E7386 study 102: Global dose-expansion cohort of E7386 + envatinib in patients with advanced/recurrent endometrial cancer that progressed on platinum-based chemotherapy and an anti−PD-(L)1 immunotherapy
Bradley Monk, MD:
Niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: final overall survival results from the PRIMA/ENGOT-OV26/GOG-3012 trial. (Simultaneous publication in the Annals of Oncology.)
Human papillomavirus integration site mapping in advanced cervical cancer: The NRG Oncology/GOG-0240 NIH Cancer Moonshot.
Second progression-free survival (PFS2) and subsequent treatment in patients (pts) with folate receptor alpha (FR⍺)-positive platinum-resistant ovarian cancer (PROC) treated with mirvetuximab soravtansine (MIRV) vs investigator’s choice chemotherapy (ICC): Phase III MIRASOL trial.
5-year progression-free survival (PFS) with rucaparib (RUCA) maintenance in patients with newly diagnosed advanced ovarian cancer in ATHENA-MONO (GOG-3020/ENGOT-ov45). (Simultaneous publication in the Annals of Oncology.)
The relationship between patient-reported outcomes and clinician-rated toxicity in participants with locally advanced cervix cancer in the OUTBACK trial.
GOG-3119/ENGOT-en29/TroFuse-033: A Phase 3, Randomized Study of Sacituzumab Tirumotecan Plus Pembrolizumab vs Pembrolizumab Alone as First-Line Maintenance Therapy for Mismatch Repair-Proficient Endometrial Cancer.
BELLA: A Phase 2 Study of Relacorilant Plus Nab-Paclitaxel +/- Bevacizumab in Patients with Gynecologic Cancers.
Manish R. Patel, MD:
A phase 1 study of the next-generation farnesyltransferase inhibitor (FTI) KO-2806 as monotherapy in advanced solid tumors.
COM701 in ovarian cancer: A pooled analysis of 3 phase I clinical trials.
Farnesyltransferase inhibitor (FTI) KO-2806 in combination with cabozantinib (cabo) in renal cell carcinoma (RCC): Preliminary results from FIT-001 Phase 1 trial.
Single-agent divarasib experience in patients with KRAS G12C-positive pancreatic adenocarcinoma (panc), cholangiocarcinoma (cholangio), and other solid tumors.
Cesar Augusto Perez, MD:
Tipifarnib (TIP) and alpelisib (ALP) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Phase 1 results from KURRENT-HN.
Phase 1 global study of Iza-Bren (BL-B01D1), an EGFR × HER3 bispecific antibody–drug conjugate (ADC), in patients with metastatic or unresectable NSCLC and other solid tumours.
Judy S. Wang, MD:
First- in- Human Study of the First-in-class Non-cellular Targeting Antibody-Drug Conjugate (ADC), MICVO, in Patients with Select Solid Tumors.
Phase 1 Expansion Study of the First-in-class Non-cellular Targeting Antibody-Drug Conjugate (ADC), Micvotabart Pelidotin (MICVO), in Patients with Select Advanced Solid Tumors.
FCS provides access to advanced clinical trial options across 29 locations in Florida, bringing promising therapies closer to home for cancer patients. Over 110 new early-phase and 40 late-phase studies are launched annually. FCS has played a vital role in the development of numerous cancer drugs approved by the U.S. Food and Drug Administration (FDA).

A longstanding partnership with Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, provides patients with access to a comprehensive listing of clinical trials available in the U.S. Additionally, a partnership with Paradigm Health, Inc. helps streamline and accelerate matching patients to available clinical trials.

Representing more than 45,000 members globally, ESMO (Free ESMO Whitepaper) is a reference for oncology education and information. The ESMO (Free ESMO Whitepaper) Congress is a globally influential oncology platform for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. All of the accepted abstracts will be published online at ESMO (Free ESMO Whitepaper).

(Press release, Florida Cancer Specialists & Research Institute, OCT 18, 2025, View Source;research-institute-shaping-the-future-of-cancer-care-at-global-congress-302587904.html [SID1234656749])

On October 18, 2025 EORTC reported that final results from CATNON trial show that the addition of 12 cycles of chemotherapy to radiotherapy can improve overall survival in a group of patients with a particular type of the rare brain tumour anaplastic glioma. The data will be presented today [Saturday] at the 20th Meeting of the European Association of Neuro-Oncology (EANO) by the study’s principal investigator, Dr Martin van den Bent, from the Erasmus MC Cancer Centre, Rotterdam, The Netherlands.

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The results show that, after a median follow up of nearly 11 years, the addition of 12 cycles of the chemotherapy agent temozolomide (TMZ) to radiotherapy in patients with an anaplastic astrocytoma improved overall survival in the subset of patients with a tumour that had a mutation in the IDH gene (IDHmt). The median overall survival in IDHmt patients who received TMZ after RT was around 12 years.

There was no observable benefit when TMZ chemotherapy was given during radiotherapy, nor in patients in which the tumour did not show an IDH mutation. Several biological markers were associated with outcome in patients with an IDH mutated glioma but, importantly, benefit from the treatment was still observed regardless of those markers.

The study was carried out by researchers from ten countries worldwide, and randomised 751 adult patients with newly diagnosed anaplastic glioma to radiotherapy alone, radiotherapy with concurrent TMZ, radiotherapy with TMZ given after treatment (adjuvant therapy), and radiotherapy with both concurrent and adjuvant TMZ. The patients were enrolled in the trial between 2007 and 2015.

The researchers found that adjuvant (post-radiation) TMZ significantly extended survival. The study confirms the importance of distinguishing between patients with tumours with an IDH mutation and those without. In patients whose tumours had the IDH mutation, the median survival increased to 12.5 years compared with six years in the control group who were initially treated with radiotherapy only. There was no benefit to patients who had concurrent TMZ if they also received an adjuvant treatment, regardless of the IDH status of the tumour.

Methylation profiling, a technique that allows the precise detection of specific regions of DNA, helped predict patient prognosis but did not affect their response to TMZ. This suggests that the chemotherapy benefits most risk groups, the researchers say. The use of methylation profiling to identify DNA modifications showed that more aggressive tumours had significantly worse outcomes, but all patients with IDH-mutant tumours benefited from the standard treatment.

This combined treatment should become the standard of care for patients with anaplastic astrocytoma with an IDH mutation, according to the researchers. This was underlined by the EANO Scientific Committee with its award of the Best Oral Presentation for Clinical Research. Dr van den Bent said: "These results emphasise the importance of long-term follow-up. Thanks to the commitment of patients and the collaboration with partners worldwide, we have been able to identify the optimal treatment strategy that can extend life significantly in this patient population."

EORTC CEO Dr Denis Lacombe said: "Given the rarity of these tumours and the fact that the role of IDH in glioma was only discovered recently, it is a significant achievement to have delivered these results in a short time period, and further underlines the important role of academic clinical research in helping rare disease patients."

Presentation number: OS05.2.A Final clinical and molecular analysis of the EORTC randomized phase III intergroup CATNON trial on concurrent and adjuvant temozolomide in anaplastic glioma without 1p/19q codeletion.

(Press release, EORTC, OCT 18, 2025, View Source [SID1234656764])

On October 18, 2025 SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company developing next-generation immunotherapies for infectious diseases and their associated cancers, reported the presentation of first-in-human clinical data for SCG142 in an investigator-initiated Phase I trial (NCT06544720) in patients with recurrent or metastatic HPV-associated carcinomas. The poster will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin, Germany, on Saturday, 18 October 2025.

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This ongoing first-in-human trial evaluates the safety, tolerability and preliminary efficacy of SCG142, a novel human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T) cell therapy armoured with a TGFβRII-41BB chimeric switch receptor. Eligible patients are HLA-A*02:01-positive with advanced HPV16- or HPV52-positive carcinomas who have progressed on or were intolerant to at least one prior systemic therapy. Key endpoints include safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. As of the data cut-off, tumor shrinkage was observed in all seven treated patients, resulting in a disease control rate (DCR) of 100%. Four of the seven patients (57%) achieved >30% tumor reduction, including two confirmed partial responses (PR) and two unconfirmed PRs. No dose-limiting toxicities or serious adverse events were reported. These preliminary findings support continued clinical development of SCG142.

"SCG142 is a novel and differentiated HPV-specific TCR T cell therapy with promising clinical activity." said Prof. Dr. Yang Li, Director of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University. "We’re excited that tumor shrinkage was observed in all seven treated patients and that SCG142 was well tolerated. These encouraging preliminary findings underscore the potential of SCG142 to provide new solutions for patients in a variety of HPV16 and HPV52 expressing cancers and support further evaluation in larger patient cohorts", she added.

SCG142 was isolated with GianTCRTM, SCG’s proprietary TCR screening platform with the ability to identify fully natural TCRs with high affinity and high avidity properties as well as potent antiviral and anti-tumor effects against infection-related solid tumors accompanied by a lower risk of off-target toxicity. "We are delighted that the excellent preclinical profile of our HPV-E7-specific TCR – including high avidity and dual functionality in both CD8+ and CD4+ T cells – has translated into clinical activity with SCG142" added Dr. Susanne Wilde, VP, Head of Preclinical Research of SCG Cell Therapy.

Besides SCG142, SCG is also advancing SCG101, a hepatitis B virus (HBV)-specific TCR T cell therapy for the treatment of HBV-related hepatocellular carcinoma (HCC).

(Press release, SCG Cell Therapy, OCT 18, 2025, View Source [SID1234656750])