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HIGHLIGHTS FROM THE 2024 EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY ANNUAL MEETING |
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ARANOTE Study: Transforming Metastatic Hormone-Sensitive Prostate Cancer Treatment
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Fred Saad, MD, FRCS
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| Fred Saad discusses the ARANOTE phase 3 study results, evaluating darolutamide plus ADT in metastatic hormone-sensitive prostate cancer. The trial shows significant improvement in radiographic progression-free survival and secondary endpoints, including time to metastatic CRPC and pain progression.
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| Efficacy and Safety of Darolutamide plus ADT in Patients with mHSPC from the Phase 3 ARANOTE Trial
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| Fred Saad presented results from the phase 3 ARANOTE trial, demonstrating that darolutamide plus ADT significantly improved radiological progression-free survival in patients with mHSPC compared to ADT alone. Darolutamide also showed consistent benefits across secondary endpoints, including time to castration-resistant disease and pain progression, with a favorable safety profile. Based on these findings, darolutamide plus ADT, without the need for docetaxel, could become a new standard of care for mHSPC.
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SPLASH Trial Highlights Radiopharmaceutical Lutetium-177’s Role in Advanced Prostate Cancer Treatment
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Oliver Sartor, MD
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| Oliver Sartor discusses the SPLASH trial results, evaluating Lutetium-177-PNT2002 in metastatic castration-resistant prostate cancer patients who progressed on ARPI therapy. The study shows significant improvement in radiographic progression-free survival for Lutetium-177-PNT2002 compared to alternate ARPI therapy, with a hazard ratio of 0.71.
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| Efficacy of 177Lu-PNT2002 in PSMA-Positive mCRPC Following Progression on an Androgen-Receptor Pathway Inhibitor (SPLASH)
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| Oliver Sartor presents interim results from the phase III SPLASH trial, evaluating 177Lu-PNT2002, a PSMA-targeted radioligand, in patients with PSMA-positive metastatic castrate-resistant prostate cancer following progression on an androgen-receptor pathway inhibitor. 177Lu-PNT2002 significantly reduced the risk of radiographic progression or death and improved key secondary outcomes, with an ongoing need to evaluate OS as data continues to mature.
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| PRINCE Trial Highlights Early Detection of Prostate Cancer Progression with PSMA PET-CT |
| Michael Hofman, MBBS, FRACP, FAANMS, FICIS, GAICD |
| Michael Hofman discusses the development of new criteria for evaluating prostate cancer progression using PSMA PET-CT scans. This work aims to standardize response evaluation and potentially replace the current PCWG3 guidelines that rely on CT and bone scans. |
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| Prostate Cancer Working Group 4 Preliminary Criteria Using Serial PSMA PET/CT for Response Evaluation: Analysis from the PRINCE Trial
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| Michael Hofman presented findings from the Prostate Cancer Working Group 4 (PCWG4) on using serial PSMA PET/CT for response evaluation in prostate cancer. The analysis from the PRINCE trial demonstrated substantial agreement among nuclear medicine specialists using preliminary PCWG4 criteria, detecting progression earlier than conventional PCWG3 criteria.
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| PEACE-1 Trial Reveals Key Genomic Alterations Linked to Survival in Prostate Cancer Patients |
| Cédric Pobel, MD |
| Cédric Pobel discusses an ancillary study of the PEACE-1 trial, focusing on phenotypic and genomic characterization of de novo metastatic prostate cancer. The study analyzes immunohistochemistry and genomic data from patient biopsies. Key findings include the identification of five phenotypes based on androgen receptor and neuroendocrine marker expression. |
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| Phenotypic and Genomic Characterization of De Novo Metastatic Prostate Cancer: An Ancillary Study of the PEACE-1 Phase 3 Trial
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| In this ancillary study from the PEACE-1 trial, phenotypic and genomic profiling of de novo metastatic castration-sensitive prostate cancer (mCSPC) revealed that neuroendocrine marker expression is associated with worse outcomes, including shorter radiographic progression-free survival and overall survival. Patients with alterations in two or more tumor suppressor genes (TP53, PTEN, RB1) had a particularly poor prognosis.
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TiNivo-2 Trial Results: Tivozanib in Advanced Renal Cell Carcinoma Treatment
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Toni Choueiri, MD
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| Toni Choueiri discusses the TiNivo-2 trial results, comparing tivozanib-nivolumab combination to tivozanib monotherapy in advanced clear cell renal cell carcinoma. The study, involving 343 patients, shows no benefit in rechallenging with nivolumab after prior immunotherapy.
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| Tivozanib–Nivolumab vs Tivozanib Monotherapy in Patients with RCC Following 1 or 2 Prior Therapies including an Immune Checkpoint Inhibitor – Results of the Phase III TiNivo-2 Study
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| Toni Choueiri discusses the phase III TiNivo-2 trial comparing tivozanib plus nivolumab to tivozanib monotherapy in metastatic renal cell carcinoma patients previously treated with immune checkpoint inhibitors. The study did not meet its primary endpoint, with no improvement in progression-free survival or overall survival from adding nivolumab to tivozanib.
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| NKT2152: Promising New HIF-2 Alpha Inhibitor for Advanced Renal Cell Carcinoma |
| Eric Jonasch, MD |
| Eric Jonasch discusses data on NKT2152, a novel HIF-2 alpha inhibitor for clear cell renal cell carcinoma. The phase 1/2 study shows promising results in heavily pre-treated patients, with objective response rates around 25% and median progression-free survival of 7.4 months. |
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| NKT2152, a Novel Oral HIF-2α Inhibitor, in Participants with Previously Treated Advanced Clear Cell RCC: Preliminary Results of a Phase 1/2 Study
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| The phase 1/2 study of NKT2152, a novel oral HIF-2α inhibitor, in heavily pretreated advanced clear cell RCC patients demonstrated promising anti-tumor activity. The objective response rate (ORR) was 20%, with a median PFS of 7.4 months, and in patients without prior mTOR inhibitor treatment, the ORR was 35.6% with a PFS of 12.7 months. NKT2152 showed a consistent safety profile, with common adverse events like anemia and fatigue, and is currently being evaluated in dose-expansion cohorts.
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Fecal Microbiota Transplant Boosts Immunotherapy in Metastatic Renal Cell Carcinoma in the TACITO-II Tria
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Chiara Ciccarese, MD
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| Chiara Ciccarese discusses the TACITO-II trial results, evaluating fecal microbiota transplantation (FMT) in patients receiving pembrolizumab plus axitinib for metastatic renal cell carcinoma. The phase II randomized study shows promising results, with FMT increasing the one-year progression-free survival rate from 35% to 66.7%.
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| Fecal Microbiota Transplantation vs Placebo in Patients Receiving Pembrolizumab plus Axitinib for Metastatic Renal Cell Carcinoma. Preliminary Results of the Randomized Phase 2 TACITO Trial
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| The phase 2 TACITO trial explored the use of fecal microbiota transplantation versus placebo in patients receiving pembrolizumab and axitinib for mRCC. Preliminary results show that FMT significantly increased the 1-year PFS rate to 66.7%, compared to 35% in the placebo group, with a median PFS of 14.2 months versus 9.2 months. FMT was well tolerated, with no severe adverse events, and the study supports further investigation into the potential of FMT to enhance the efficacy of ICI and VEGFR-TKI therapies in mRCC.
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COTRIMS Trial Shows High Cure Rates with RPLND in Stage IIA/B Seminoma
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Axel Heidenreich, MD, PhD
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| Axel Heidenreich discusses the final results of the COTRIMS trial, evaluating retroperitoneal lymph node dissection (RPLND) for clinical stage IIA and IIB seminomas. The study demonstrates high oncological efficacy with a 100% overall survival and 88% treatment-free survival after a median follow-up of three years.
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| Prospective COTRIMS (COlogne Trial of Retroperitoneal Lymphadenectomy in Metastatic Seminoma) Trial – 3 Year Update
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| Axel Heidenreich presented a 3-year update from the COTRIMS trial, evaluating primary retroperitoneal lymphadenectomy (RPLND) in clinical stage IIA/B seminomas. The trial demonstrated high cure rates with low surgical complications, with nearly 90% of patients avoiding systemic chemotherapy. Additionally, miR371 was found to be a valid biomarker for predicting lymph node metastases, supporting the inclusion of RPLND as a treatment option for these patients.
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