Audio Journal of Oncology Podcast

    An interview with: Trevor Leong MD, Peter McCallum Cancer Centre, Radiation Oncology Department, Melbourne, Australia BARCELONA, Spain—Although pre-operative radiotherapy brought better response rates in patients resected for their gastric or GE-junction adenocarcinomas, there was no improvement in survival. This is the clear finding from a big, long-term study led by an Australian team. The multi-continent, phase-three randomized TOP GEAR trial, headquartered in Sydney Australia, definitively found no benefit for overall or progression-free survival from adding radiation before surgery. This clear finding was announced at the 2024 Annual Meeting of the European Society for Medical Oncology (ESMO), held in Barcelona, Spain First author Trevor Leong MD, from the Radiation Oncology Department of the Peter McCallum Cancer Centre in Melbourne Australia, talked about the results with Peter Goodwin: Trevor Leong MD interview (8mins 37 secs): IN: “Resectable gastric or gastro-esophageal…. OUT: ,,’till next time, Good-bye.” ESMO 2024, Barcelona, ABSTRACT: 03880-8/fulltext “A randomised phase three trial of perioperative chemotherapy (CT) with or without pre-operative chemoradiotherapy (CRT) for resectable gastric cancer (AGITG TOPGEAR). Final results from an intergroup trial of AGITG, TROG, EORTC and CCTG”. NEJM September 13, 2024: https://www.nejm.org/doi/full/10.1056/NEJMoa2405195 TITLE: “Preoperative Chemoradiotherapy for Resectable Gastric Cancer” From: The Australasian Gastro-Intestinal Trials Group, National Health and Medical Research Council Clinical Trials Centre, Trans-Tasman Radiation Oncology Group, European Organisation for Research and Treatment of Cancer, and Canadian Cancer Trials Group. JOURNAL Article: N Engl. J Med.: “The addition of preoperative chemoradiotherapy to perioperative chemotherapy did not improve overall survival as compared with perioperative chemotherapy alone among patients with resectable gastric and gastroesophageal junction adenocarcinoma.” “A randomised phase three trial of perioperative chemotherapy (CT) with or without pre-operative chemoradiotherapy (CRT) for resectable gastric cancer (AGITG TOPGEAR). Final results from an intergroup trial of AGITG, TROG, EORTC and CCTG”. Background In Western countries, the current standard of care for resectable gastric cancer is periop CT. There is much interest in preop CRT, but comparison to periop CT alone is lacking. In TOPGEAR we hypothesized that adding preop CRT to periop CT would improve pathological complete response (pCR) rates and ultimately overall survival (OS) compared to periop CT alone. Methods This international phase 3 trial randomized patients with resectable adenocarcinoma of the stomach and gastro-esophageal junction to periop CT alone, or with preop CRT. The periop CT alone group received 3 cycles of epirubicin/cisplatin/5-fluorouracil (ECF) or 4 cycles of fluorouracil/leucovorin/oxaliplatin/docetaxel (FLOT) both pre- and post-operatively. The preop CRT group received one less cycle of preop chemotherapy followed by chemoradiotherapy (45 Gy in 25 fractions radiation plus infusional 5-FU ), and then the same postop chemotherapy. The primary endpoint was overall survival, and secondary endpoints included progression free survival (PFS), pCR rates, toxicity and quality of life. Results Between September 2009 and May 2021, 574 patients were enrolled from 70 sites across 15 countries in Australasia, Europe, and Canada; 288 to periop CT group and 286 to preop CRT group. Compared to periop CT alone, patients receiving preop CRT achieved a higher pCR rate (16.7% vs 8.0%), a higher rate of major pathological response (0 – <10% residual tumor: 49.5% vs 29.3%), and greater tumor downstaging following resection. After a median follow-up of 66.7 months, there was no significant difference in OS or PFS: median OS periop CT 49.4 months vs preop CRT 46.4 months; median PFS periop CT 31.8 months vs preop CRT 31.4 months. Preop CRT was not associated with increased perioperative treatment toxicity or a higher rate of surgical complications. Conclusions Despite improving pathological outcomes, the addition of preop CRT to periop CT does not improve overall survival compared to periop CT alone in patients with resectable gastric and gastro-esophageal junction adenocarcinoma. Clinical trial identification ACTRN12609000035224. Registered 30 May 2009; NCT01924819. Legal entity responsible for the study Australasian Gastro-Intestinal Trials Group (AGITG). Funding This work was supported by grants from the National Health and Medical Research Council: 1046425 and 2000711, Canadian Institutes of Health Research (CIHR) grant no. 119445, the Canadian Cancer Society Research Institute (CCSRI) grant no. 021039, the Health Research Council of New Zealand (HRC) International Investment Opportunities Fund: Contract no. 09/624, the EORTC Cancer Research Fund, and the Cancer Australia Priority-driven Collaborative Research Sche

An interview with: Domenica Lorusso MD PhD, Director of the Gynaecological Oncology Unit, full Professor of Obstetrics and Gynaecology, Humanitas Hospital San Pio X, Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy. Both overall and progression-free survival were significantly improved when the anti-PD-1 agent pembrolizumab was added to standard chemoradiotherapy as initial treatment for patients with high-risk locally advanced cervical cancer. Results from the randomized, double-blind, phase III KEYNOTE-A18 study of immunotherapy, used together with standard concurrent chemoradiotherapy among 1060 patients, were reported by a multinational team of researchers led from Italy to the 2024 Annual Congress of the European Society for Medical Oncology in Barcelona. The study lead author Domenica Lorusso MD PhD, Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, in Milan, who is a Full Professor of Obstetrics and Gynaecology at Humanitas University, Rozzano, met up with Peter Goodwin to discuss the KEYNOTE-A18 findings. Audio Journal of Onclogy: Domenica Lorusso MD PhD IN: “Immune checkpoint inhibition …..OUT: …….in Barcelona at the ESMO meeting”. Durn: 7:20 secs ESMO Abstract 7090 Lorusso, Gynaecology Oncology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome, Italy “Pembrolizumab plus chemoradiotherapy for high-risk locally advanced cervical cancer: Overall survival results from the randomized, double-blind, phase III ENGOT-cx11/ GOG-3047/KEYNOTE-A18 study” Background At the first interim analysis of the phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study (NCT04221945), pembrolizumab (pembro) + concurrent chemoradiotherapy (CCRT) showed a statistically significant and clinically meaningful improvement in PFS vs placebo (pbo) + CCRT in patients (pts) with high-risk locally advanced cervical cancer (LACC). Based on this study, the US FDA has approved pembro + CCRT for pts with FIGO 2014 Stage III-IVA cervical cancer. We present the OS results from the second interim analysis.Methods Eligible pts with newly diagnosed, previously untreated, high-risk LACC (FIGO 2014 stage IB2-IIB with node-positive disease or stage III-IVA regardless of lymph node status) were randomized 1:1 to 5 cycles of pembro 200 mg or pbo Q3W + CCRT, then 15 cycles of pembro 400 mg or pbo Q6W. CCRT included 5 cycles (optional 6th dose) of cisplatin 40 mg/m2 Q1W + EBRT then brachytherapy. Pts were stratified by planned EBRT type (intensity-modulated radiotherapy [IMRT] or volumetric-modulated arc therapy [VMAT] vs non-IMRT or non-VMAT), stage at screening (IB2-IIB vs III-IVA), and planned total radiotherapy dose (<70 Gy vs ≥70 Gy [EQ2D]). Primary endpoints are PFS per RECIST v1.1 by investigator and OS.Results 1060 pts were randomized to pembro + CCRT (n=529) or pbo + CCRT (n=531). At this analysis (January 8, 2024, data cutoff), median follow-up was 29.9 mo (range, 12.8-43.0). Pembro + CCRT showed a statistically significant improvement in OS compared with pbo + CCRT. The 36-mo OS rate was 82.6% with pembro + CCRT vs 74.8% with pbo + CCRT; median OS was NR in either group (HR=0.67 [95% CI, 0.50-0.90]; P=0.0040). The benefit of pembro + CCRT was generally consistent in all prespecified subgroups, including FIGO stages IB2-IIB (HR=0.89 [95% CI, 0.55-1.44]) and III-IVA (HR=0.57 [95% CI, 0.39-0.83]). Grade ≥3 TRAE incidence was 69.1% in the pembro + CCRT group and 61.3% in the pbo + CCRT group. Conclusions Pembro + CCRT showed a statistically significant and clinically meaningful improvement in OS vs pbo + CCRT in pts with high-risk LACC and had a manageable safety profile. These data provide further support for pembro + CCRT as a new standard of care for this population. Clinical trial identification NCT04221945; EudraCT: 2019-003152-37. Editorial acknowledgement Medical writing assistance was provided by Christine McCrary Sisk of Merck & Co., Inc., Rahway, NJ, USA. This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, Audio Journal of Oncology, October 6, 2025    

An interview with: James Larkin FRCP, PhD, Medical Oncologist, Professor, Royal Marsden Hospital, London Checkpoint inhibitor therapy for advanced melanoma has achieved sustained responses and long-term overall survival, transforming the prognosis for as many as half of all patients. 10-year survival outcomes from the phase Ill CheckMate 067 trial of nivolumab plus ipilimumab in advanced melanoma were reported at the 2024 Annual Meeting of the European Society for Medical Oncology (ESMO) held in Barcelona. Peter Goodwin, talked with study author, James Larkin FRCP PhD, Professor and Medical Oncologist at the Royal Marsden Hospital in London. Audio Journal of Oncology: James Larkin FRCP PhD: IN: “There’s been breath-taking progress ………OUT: join me then, Good-bye!” 14:57secs   SOURCE: Annals of Oncology: https://www.annalsofoncology.org/article/S0923-7534(24)03864-X/fulltext ESMO Abstract LBA43 Larkin, Medicine Department, The Royal Marsden Hospital, London, UK “10-y survival outcomes from the phase Ill CheckMate 067 trial of nivolumab plus ipilimumab in advanced melanoma” Abstract LBA43 Larkin, Medicine Department, The Royal Marsden Hospital, London, UK “10-y survival outcomes from the phase Ill CheckMate 067 trial of nivolumab plus ipilimumab in advanced melanoma” Background In CheckMate 067, improved survival with nivolumab plus ipilimumab (NIVO + IPI) or NIVO alone v IPI has been demonstrated in patients (pts) with advanced melanoma. We now provide the final CheckMate 067 results (minimum f/u 10 y), the longest reported in a phase 3 study of an anti–programmed death (PD)-1–based therapy for any tumor type. Methods Pts with untreated advanced melanoma (N = 945) were randomly assigned 1:1:1 and stratified by PD-ligand (L)1 status, BRAF mutation status, and metastasis stage to receive NIVO (1 mg/kg) + IPI (3 mg/kg) Q3W for 4 doses, followed by NIVO (3 mg/kg) Q2W; NIVO (3 mg/kg) Q2W + placebo; or IPI (3 mg/kg) Q3W for 4 doses + placebo until progression or unacceptable toxicity. Co-primary endpoints were OS and PFS with NIVO + IPI or NIVO v IPI; melanoma-specific survival (MSS) was an exploratory endpoint. Results After a 10-y minimum f/u, median OS was 71.9 mo with NIVO + IPI, 36.9 mo with NIVO, and 19.9 mo with IPI. OS HRs were 0.53 (95% CI, 0.44–0.65) with NIVO + IPI vIPI and 0.63 (0.52–0.76) for NIVO v IPI, and benefit was consistent across subgroups (including PD-L1 expression and BRAF mutation status). Median MSS was not reached (NR) with NIVO + IPI (> 120 mo), 49.4 mo with NIVO, and 21.9 mo with IPI. In pts who had PFS for ≥ 3 y, 10-y MSS rates were 96% with NIVO + IPI, 97% with NIVO, and 88% with IPI. Only 8 pts, 4 in the NIVO + IPI arm and 4 in the NIVO arm, progressed beyond 60-mo of f/u. For pts in the NIVO + IPI arm who discontinued treatment during induction due to a treatment-related adverse event, 10-y OS rates were the same as the ITT group (43%) and MSS rates were similar (50% v 52%). Table: LBA43” MORE: James Larkin is a Medical Oncologist specialising in the treatment of cancers of the kidney and skin including melanoma. Professor Larkin grew up in North Cornwall before taking a first in Natural Sciences from Cambridge University. He undertook clinical training in Oxford, qualifying in 1996. His general medical training was undertaken in London and in 2001 he won a Medical Research Council Research Fellowship for a Clinician, carrying out laboratory research leading to a PhD at the Institute of Cancer Research. His specialist training was completed at The Royal Marsden, where he was appointed as a Consultant in 2008. His research is focussed on trying to understand cancer and its consequences better, as well as developing improved treatments, particularly with targeted therapies and immunotherapies. Globally, he is amongst the most highly cited researchers in both melanoma and kidney cancerThis link is external and opens in a new tab. In 2018, he was elected as a Fellow of the Academy of Medical Sciences and in 2020 as an NIHR Senior Investigator. In 2022, he was appointed to roles as Head of The Royal Marsden Skin Unit, Royal Marsden Joint Training Programme Director for Medical Oncology and Lead of the Cancer Immunotherapy Theme at The Royal Marsden / Institute of Cancer Research NIHR Biomedical Research Centre. Since 2024, he has hosted the educational podcast ‘Melanoma Matters’ with his US colleague Professor Sapna Patel, and in 2026 he will be Scientific Co-Chair of the Annual European Society of Medical Oncology meeting in Madrid. Professor Larkin serves as a medical advisor to the patient advocacy group Melanoma UK, as a trustee of Action Kidney Cancer and sits on the Medical Advisory Board of the International Kidney Cancer Coalition.      

An interview with: Jefferson DeKloe BSc, Department of Otolaryngology, Thomas Jefferson University, Philadelphia, PA CHICAGO, USA—Although the take-up of vaccination for human papilloma virus (HPV) among girls and boys in the USA has been lower than in many other industrial countries, American researchers have now shown clearly that in addition to the prevention of cervical cancer in women, men have also been protected against HPV-related cancers. At the 2024 American Society of Clinical Oncology Annual (ASCO) Meeting in Chicago a new study of HPV vaccination of girls and boys in the United States revealed a real-world reduction of oral, plus head and neck cancers in men, as well confirming the prevention of cervical cancers in women, even though uptake of the vaccine in the US had been sub-optimal. The study looked at HPV-associated cancer incidence in a retrospective cohort analysis of patients from the TriNetX Collaborative Network. At the ASACO meeting Peter Goodwin met up with the lead author of the research, Jefferson DeKloe BSc, from the Department of Otolaryngology at Thomas Jefferson University in Philadelphia USA. Audio Journal of Oncology, with: Jefferson DeKloe BSc IN: “HPV Vaccination …..OUT: ……, I’m Peter Goodwin”. 6:00secs https://meetings.asco.org/abstracts-presentations/231759 “Effects of HPV vaccination on the development of HPV-related cancers: A retrospective analysis of a United States-based cohort.” https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.10507 Effects of HPV vaccination on the development of HPV-related cancers: A retrospective analysis of a United States-based cohort. ALSO: https://www.sciencedirect.com/science/article/pii/S1043661825002762 HPV vaccination and malignancy risks beyond cervical cancer: A retrospective global cohort study Authors: Christian Seebauer, Mohamed Faluogy, Peter Sieg , Henning Olbrich, Ralf Ludwig Department of Oral and Maxillofacial Surgery/Plastic surgery, University Medicine Lübeck, Ratzeburger Allee 160, Lübeck 23538, Germany Department of Dermatology, Allergy, and Venerology, University of Lübeck, Ratzeburger Allee 160, Lübeck 23538, Germany Department of Dermatology, Allergy, and Venerology, Institute of Experimental Dermatology, University of Lübeck, Comprehensive Center for Inflammation Medicine, University-Hospital Schleswig-Holstein, Ratzeburger Allee 160, Lübeck 23538, Germany Received 28 April 2025, Revised 5 July 2025, Accepted 6 July 2025, Available online 11 July 2025, Version of Record 14 July 2025. HPV vaccination significantly reduced hypopharyngeal and laryngeal cancer risk. Vaccination was associated with a marked decrease in leukemia incidence. No significant protection observed for rectal, anal, or oral cavity cancers. HPV vaccination halved all-cause mortality at 8- and 20-year follow-up. Data support possible HPV involvement in hematopoietic and neuronal tissues. Abstract: While HPV vaccination is well established for the prevention of cervical cancer, its broader oncological effects remain insufficiently characterized. Emerging evidence suggests potential protective effects against non-cervical malignancies; however, comprehensive long-term data are limited. We conducted a global, retrospective cohort study utilizing electronic health records from the TriNetX network. Individuals vaccinated against HPV at age 8 years or older were propensity score-matched to unvaccinated controls. Outcomes included the incidence of malignancies in the head-and-neck, gastrointestinal, anogenital, neuronal, and hematologic systems, as well as all-cause mortality, assessed over 8- and 20-year follow-up periods. Kaplan–Meier survival analysis and hazard ratios (HRs) were employed. HPV vaccination was associated with significant reductions in the risk of hypopharyngeal and laryngeal carcinomas (8-year HR: 0.19; 95 % CI: 0.057–0.631; p = 0.0025; 20-year HR: 0.227; 95 % CI: 0.067–0.764; p = 0.0092) and leukemia (8-year HR: 0.461; p = 0.0035; 20-year HR: 0.443; p = 0.0019). No significant protection was observed for rectal, anal, oral cavity, or prostate cancers. All-cause mortality was reduced by nearly half among vaccinated individuals (8-year HR: 0.543; 20-year HR: 0.536; both p < 0.0001). Beyond epithelial malignancies, HPV vaccination may confer systemic cancer protection, particularly in hematologic and potentially neuronal tissues. These findings suggest a broader biological impact of HPV vaccination than previously recognized and underscore the need for mechanistic studies investigating HPV’s oncogenic pathways. If validated, these results could prompt the expansion of vaccination strategies to encompass broader indications and wider population coverage.            

An interview with Rebecca Dent MD, Deputy Chief Executive Officer, National Cancer Centre, Singapore, ESMO 2024 Scientific Chair. ESMO Previous Highlights: Neo-Adjuvant Therapy for Triple Negative Breast Cancer, Checkpoint Inhibition, AI, Cancer Vaccines, and More ……” BARCELONA, Spain—At the last Annual Meeting of the European Society for Medical Oncology (ESMO), medical oncologist Rebecca Dent MD, Deputy Chief Executive Officer at the National Cancer Centre in Singapore, told Peter Goodwin what had, for her, been the key areas of progress in cancer medicine announced at the meeting in which significant advances had been made. Audio Journal of Oncology with Rebecca Dent MD IN: [Goodwin] “With the 2025 meeting of ESMO about to happen …. OUT: ….in Singapore. Thanks very much. 13:13 secs https://www.esmo.org/meeting-calendar/esmo-congress-2024/programme MORE: Professor Rebecca Dent MD MSc is a career-long clinical and translational researcher as well as education-focused, academic clinician with sub-specialist interest in all aspects of triple negative breast cancer (TNBC) and young women with breast cancer. Prof. Dent achieved her MD from McMaster University in Hamilton, Ontario, Canada and then completed her internal medicine and medical oncology residency at the Princess Margaret Hospital and the Sunnybrook Odette Cancer Center in Toronto, Canada. This was followed by a fellowship in breast cancer, supported by a Marion Walker Women’s Health Scholarship, and MSc in Clinical Epidemiology and Statistics at the University of Toronto. During her training Prof Dent was fortunate to have completed electives across Canada, the US (Memorial Sloan Kettering), France (Institut Marie Curie) and the Philippines (Philippine General Hospital). In her North American academic career, Prof Dent served as Chair of the locally advanced breast cancer program and Head, Breast Cancer Clinical Trials Unit at the Sunnybrook Odette Cancer Center from 2008-2011. Her seminal publication whilst in Toronto was a Clinical Cancer Research publication, one of the first to describe what is now known as triple negative with almost 5,500 citations for this individual paper (Dent R et al. Clin Ca Res 2007). She was the PI of one of the first Phase I PARP inhibitor trials in unselected TNBC in combination with taxane chemotherapy and she served as a reviewer for the National Cancer Institute of Canada (NCIC) grants committee. As a consultant at the Sunnybrook Odette Cancer Center, she supervised a number of residents and fellows and was awarded an Outstanding Teaching Award by the University of Toronto. Prof Dent has participated in the ASCO Leadership Development Program and served on a number of ASCO Committees: Education including Chair, Breast Track and Member of the Breast Scientific Committee (ER/HER2 track), as well as on the Editorial Board of the Journal of Clinical Oncology (JCO). In February 2011, Prof Dent moved to Singapore where she is now senior consultant at the National Cancer Center in Singapore (NCCS). Recognizing the need for pan-Asian regional educational interaction Prof Dent co-founded and co-chaired nine Asia Pacific Breast Cancer Summits (https://apbcs.org). Consequently Prof Dent was involved in the establishment of the ESMO Asia meeting subsequently serving as Scientific Chair and Co-Chair Breast Track. Prof Dent has co-chaired the ESMO Breast Preceptorship in Singapore since 2017 and sits on the pan-Asian ESMO adapted guidelines committee as well as the Advanced Breast Cancer ESMO guideline committee. Prof Dent serves as a scientific committee member of the ASCO Breakthrough Asia Meeting. Prof Dent is currently Chair of the ESMO Nomination Committee and a member of the ESMO Council. Prof Rebecca Dent has over 18,000 citations and an h-index over 50. She sits on the Editorial Board of The Lancet Oncology. She has been invited as an oral and plenary discussant at ESMO as well as an invited speaker at numerous meetings for ASCO, ESMO Asia, and other meetings across Asia such as the Japanese Society of Medical Oncology and Korean Society of Medical Oncology. Prof Dent is a steering committee member and PI for a number of large international trials evaluating novel agents in the treatment of TNBC. Funding was secured for a novel investigator initiated global study evaluating the role of PARP inhibition with or without immune checkpoint inhibition in platinum sensitive TNBC which has just completed recruitment in the US, Korea and in Singapore (The DORA study). This is a pivotal Duke NUS Singapore and Duke USA collaboration. As of October 2018, Prof Dent has been Head of the department of Medical Oncology at the National Cancer Center Singapore (NCCS) at SingHealth. NCCS has recently been designated as a comprehensive cancer center and Prof Dent was appointed Chairman of the Division of Medical Oncology in 2021. Prof Dent maintains a busy clinical practice, as well as teaching medical students at Duke-NUS. This has been r

Audio Journal of Oncology interview with: Bart Neyns MD PhD, Vrije Universiteit Brussel, Faculty of Medicine and Pharmacy, Medical Oncology Department, Brussels, Belgium BARCELONA, Spain—Intracranial administration of autologous dendritic cells was combined with combination checkpoint inhibition in a phase 1 study of patients with recurrent glioblastoma that reported marked clinical responses to the European Society for Medical Oncology (ESMO) annual meeting in Barcelona. Cells harvested from each patient were injected directly into the brain tissue resection cavity lining after surgery. Patients also received intra-cranial injections of the checkpoint inhibitor combination: nivolumab plus ipilimumab. At the conference, Peter Goodwin discussed the research with lead author of the study, Bart Neyns MD PhD, Head of Medical Oncology at the Vrije Universiteit, Brussel, in the University Hospital Brussels Faculty of Medicine & Pharmacy, Brussels, Belgium. Audio Journal of Oncology interview with: Bart Neyns MD PhD, Vrije Universiteit Brussel, Faculty of Medicine and Pharmacy, Medical Oncology Department, Brussels, Belgium IN : “Patients with recurrent glioblastoma …. OUT:…from me, Peter Goodwin, goodbye 10:54 secs SOURCE: ESMO 2024 Barcelona ESMO Abstract 441O Neyns , Medical Oncology Department, Vrije Universiteit Brussel – Faculty of Medicine & Pharmacy, Brussels, Belgium “A phase I clinical trial on the intracranial administration of autologous CD1c(BDCA-1)+/CD141(BDCA-3)+ myeloid dendritic cells (myDC) in combination with ipilimumab (IPI) and nivolumab (NIVO) in patients with recurrent high-grade glioma (rHGG)” Reference: CNS tumours Volume 35, Supplement 2S406-S407 September 2024Authors: Neyns1 ∙ I. Dirven1 ∙ L. Lescrauwaet2 ∙ M. Cammaert1 ∙ W. Geens2 ∙ X. Geeraerts1 ∙ L. Stevens1 ∙ S. Brock3 ∙ M. Kockx4 ∙ H. Everaert5 ∙ A-M. Van Binst6 ∙ S. Tuyaerts1 ∙ J. Duerinck7 1. Medical Oncology Department, Vrije Universiteit Brussel – Faculty of Medicine & Pharmacy, Brussels, Belgium 2. Neurosurgery, UZ Brussel – Universitair Ziekenhuis Brussel, Jette, Belgium 3. Pathology, UZ Brussel – Universitair Ziekenhuis Brussel, Jette, Belgium 4. Pathology Department, CellCarta, Antwerpen, Belgium 5. Nuclear Medicine, Vrije Universiteit Brussel – Faculty of Medicine & Pharmacy, Brussels, Belgium 6. Radiology Department, Vrije Universiteit Brussel – Faculty of Medicine & Pharmacy, Brussels, Belgium 7. Neurosurgery Department, Vrije Universiteit Brussel – Faculty of Medicine & Pharmacy, Brussels, Belgium https://www.audiomedica.com/wp-content/2025/09/241011-Bart-Neyns-ESMO-AJO-PRODUCTION-MASTER.mp3Background Intracranial admin of NIVO and IPI following the resection of rHGG is safe and has resulted in encouraging survival (J Duerinck et al. JITC 2021). myDC play a pivotal role in initiating an adaptive anti-tumor immune response and licensing of immune anti-tumor effector cells within the tumor microenvironment. Methods rHGG pts (after prior RT and TMZ, <8 mg methylprednisolone QD), underwent a leukapheresis followed by isolation/cryopreservation of myDC. NIVO (10 mg IV) was administered preoperatively. myDC (5-, 10-, or 20.106 cells) were injected into the brain tissue lining the resection cavity (iCer) following a maximal safe resection (MSR) or intratumorally (iTum) following a stereotactic biopsy (STX). IPI (5 mg) plus NIVO (10 mg) were co-injected iCer or iTum with the myDC. Postoperative NIVO was administered intracavitary (iCav, 10 mg) and intravenously (IV, 10 mg) Q2w (max 11x). Results 21 pts (13 M; med 49 y [range 20 -78]; IDHwt 17 pts, ECOG PS 0 or 1: 18-, 3 pts) underwent procurement of myDC; intraoperative administration of myDC was preceded by MSR in 19 pts, and STx in 2 pts. Respectively 6, 3, and 12 pts were treated at the 3 myDC dose levels. All pts received the peri-op iTum/iCer/IV-admin of IPI and NIVO as planned. The median postop iCav and IV NIVO-admin was 7 (range 0-11) and 8 (0-11). Study treatment was discontinued early for PD in 9- and AE in 3 pts. Most important TRAEs: bacterial colonization of the Ommaya reservoir (n=4), craniotomy wound dehiscence (n=2), and bacterial meningitis (n=1). At DBL (01MAY2024), 6 pts (29%) remain progression-free (incl. 3 pts with >2y PFS). PFS (med. 24w [95% CI 8- 39]) is superior when compared to the pts (n=70) with resectable rHGG treated in 4 other cohorts of the GlITIpNi trial (p=0.003). When including the durable benefit from bevacizumab at first PD in 3 pts, PFS compared favorably to a historical pooled cohort (n=469) of rHGG treated with VEGF(R)-inhibitors (p=0.007). The 1-year OS-rate was 50% [95% CI 24-76]. Conclusions Intracranial administration of myDC combined with IPI/NIVO is feasible, safe and associated with encouraging survival, deserving further investigation.