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BACKGROUND No treatment has surpassed platinum-based chemotherapy in improving overall survival in patients with previously untreated locally advanced or metastatic urothelial carcinoma. METHODS We conducted a phase 3, global, open-label, randomized trial to compare the efficacy and safety of enfortumab vedotin and pembrolizumab with the efficacy and safety of platinum-based chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma. Patients were randomly assigned in a 1:1 ratio to receive 3-week cycles of enfortumab vedotin (at a dose of 1.25 mg per kilogram of body weight intravenously on days 1 and 8) and pembrolizumab (at a dose of 200 mg intravenously on day 1) (enfortumab vedotin-pembrolizumab group) or gemcitabine and either cisplatin or carboplatin (determined on the basis of eligibility to receive cisplatin) (chemotherapy group). The primary end points were progression-free survival as assessed by blinded independent central review and overall survival. RESULTS A total of 886 patients underwent randomization: 442 to the enfortumab vedotin- pembrolizumab group and 444 to the chemotherapy group. As of August 8, 2023, the median duration of follow-up for survival was 17.2 months. Progression-free survival was longer in the enfortumab vedotin-pembrolizumab group than in the chemotherapy group (median, 12.5 months vs. 6.3 months; hazard ratio for disease progression or death, 0.45; 95% confidence interval [CI], 0.38 to 0.54; P<0.001), as was overall survival (median, 31.5 months vs. 16.1 months; hazard ratio for death, 0.47; 95% CI, 0.38 to 0.58; P<0.001). The median number of cycles was 12 (range, 1 to 46) in the enfortumab vedotin-pembrolizumab group and 6 (range, 1 to 6) in the chemotherapy group. Treatment-related adverse events of grade 3 or higher occurred in 55.9% of the patients in the enfortumab vedotin-pembrolizumab group and in 69.5% of those in the chemotherapy group. CONCLUSIONS Treatment with enfortumab vedotin and pembrolizumab resulted in significantly better outcomes than chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma, with a safety profile consistent with that in previous reports. (Funded by Astellas Pharma US and others; EV-302 ClinicalTrials.gov number, NCT04223856.) [ABSTRACT FROM AUTHOR]

Lactiplantibacillus plantarum is a commensal bacterial species often found within the human gut. To expand our knowledge about this human-associated taxon with potential probiotic properties, here we present the draft genome sequence of Lactiplantibacillus plantarum strain APC2688, isolated from a human fecal sample.

Background: The evolving oncology treatment paradigm has created an unmet need for administration options that improve patient experiences and health care efficiencies., Patients and Methods: CheckMate 67T (NCT04810078) was a phase III, open-label, multicenter, noninferiority trial in which patients with advanced/metastatic clear cell renal cell carcinoma were randomized to subcutaneous nivolumab (1200 mg every 4 weeks; coformulated with recombinant human hyaluronidase PH20 20 000 units) or intravenous nivolumab (3 mg/kg every 2 weeks). The primary objective was to assess the noninferiority of subcutaneous versus intravenous nivolumab by coprimary endpoints determined from a population pharmacokinetics analysis [time-averaged serum concentration over the first 28 days (C avgd28 ), and minimum steady-state serum concentration (C minss ); noninferiority threshold: lower boundary of 90% confidence interval (CI) of the geometric mean ratios (GMR) ≥0.8]. Objective response rate (ORR) was a key secondary endpoint powered for noninferiority [noninferiority threshold: lower boundary of 95% CI of relative risk of ORR (subcutaneous versus intravenous nivolumab) ≥0.60]., Results: Overall, 495 patients were randomized. Relative exposure in the subcutaneous versus intravenous arm reported by the GMR of C avgd28 and C minss was 2.098 (90% CI 2.001-2.200) and 1.774 (90% CI 1.633-1.927), respectively. After 8 months of minimum follow-up, ORR was 24.2% with subcutaneous nivolumab (95% CI 19.0%-30.0%) versus 18.2% with intravenous nivolumab [95% CI 13.6%-23.6%; relative risk: 1.33 (95% CI 0.94-1.87)]. Coprimary endpoints and ORR met noninferiority thresholds. Additional efficacy and safety measures were similar., Conclusions: Subcutaneous nivolumab was noninferior to intravenous nivolumab based on pharmacokinetics and ORR. No new safety signals were observed., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Platinum-based chemotherapy (ChT) has been the standard first-line treatment for metastatic urothelial carcinoma (mUC). The purpose of this study was to evaluate the use of induction avelumab followed by avelumab in combination with carboplatin-gemcitabine (carbo/gem) followed by avelumab maintenance. We tested the hypothesis that induction immunotherapy (IO) could enhance the response to ChT and prevent its detrimental effect on immune cells., Materials and Methods: INDUCOMAIN is a multicenter, randomized, investigator-initiated, open-label phase II study evaluating the safety and efficacy of induction avelumab before carboplatin-gemcitabine-avelumab, followed by avelumab maintenance (arm A), compared to carbo/gem (arm B). Eligibility criteria included patients with mUC, no prior systemic therapy, and ineligibility for cisplatin by Galsky criteria. Patients were stratified by the presence/absence of visceral metastasis and Eastern Cooperative Oncology Group performance status 0-1 versus 2. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety., Results: Eighty-five patients were included and randomized to arm A (n = 42) and arm B (n = 43), respectively. ORR was similar between treatment arms: 59.5% in arm A and 53.5% in arm B (P = 0.57). Fourteen patients (33%) in arm A early progressed/died before or at first response assessment, compared to three patients (7%) in arm B. Median OS was 11.1 months in arm A and 13.2 months in arm B [hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.57-1.46, P = 0.69]. Median PFS was 6.9 months in arm A versus 7.4 months in arm B (HR 0.99, 95% CI 0.61-1.60, P = 0.95). Treatment-related adverse events of grade 3-4 occurred in 70.7% of patients in arm A and in 72.1% in arm B. No predictive role of programmed death-ligand 1 expression was found., Conclusions: The hypothesis that induction avelumab could enhance the efficacy of subsequent ChT was not proven. Administering IO alone as induction before ChT is not an adequate strategy., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: This work aimed to determine the role and action points for the involvement of medical societies in the European Health Technology Assessment (EU HTA) Methods: An online pre-convention survey was developed addressing four areas related to the EU HTA: (i) medical societies' role; (ii) role of clinical guidelines; (iii) interface with the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS); and (iv) approaching 'best-available evidence' (BAE). A descriptive analysis of questionnaire outcomes was conducted to inform the European Access Academy (EAA) Fall Convention 2023. Within the working groups (WGs), action points were identified and prioritised., Results: A total of 57 experts from 15 countries responded to the survey. The WGs were attended by (i) 11, (ii) 10, (iii) 12, and (iv) 12 experts, respectively, representing a variety of national backgrounds and stakeholder profiles. The most relevant action points identified were as follows: (i) incorporation of clinical context into population, intervention, comparator, outcomes (PICO) schemes, (ii) timely provision of up-to-date therapeutic guidelines, (iii) ensuring the inclusion of MCBS insights into the EU HTA process, and (iv) considering randomized controlled trials (RCTs) as the gold standard and leveraging regulatory insights if development programs only include single-arm trials., Conclusions: The involvement of medical societies is a critical success factor for the EU HTA. The identified key action points foster the involvement of patient associations and medical societies., Competing Interests: Conflicts of InterestJR and EJ received an unrestricted grant from Abbvie, AstraZeneca, Bayer, Novartis, Roche, Sanofi, and Seagen that partially funded this research. The authors have no further financial or non-financial interests to disclose. BPV has received personal honoraria for advisory boards from Pfizer, Astellas Pharma, Bristol Myers Squibb, Ipsen, EUSA Pharma, MSD, EUSA Pharma, Novartis, AAA, Bayer, and Merck; has been an invited speaker for Astellas Pharma, Janssen, Roche, Pfizer, Bristol Myers Squibb, Roche, Bayer, EUSA Pharma, MSD, AstraZeneca, and Merck; and has received travel support from Merck/Pfizer and Bristol Myers Squibb., (© 2024 by the authors.)

Competing Interests: Disclosure TP reports personal fees for advisory board membership from Astellas, AstraZeneca, Bristol Myers Squibb (BMS), Eisai, Exelixis, Incyte, Ipsen, Johnson & Johnson, Merck, Merck Serono, MSD, Novartis, Pfizer, Roche and Seattle Genetics; personal travel grants from AstraZeneca, Ipsen, MSD, Pfizer and Roche; personal sponsorship for the Uromigos Podcast from Mashup Ltd; institutional honoraria from Gilead; and institutional research grants from Astellas, AstraZeneca, BMS, Eisai, Exelixis, Ipsen, Johnson & Johnson, Merck, Merck Serono, MSD, Novartis, Pfizer, Roche and Seattle Genetics. JB reports personal fees for advisory board membership from AstraZeneca (bladder cancer), BMS (adjuvant study CM 247), Merck (bladder cancer) and Pfizer (global); personal fees as an invited speaker from Merck (lectures in national meetings) and MSD (ESMO Asia Congress 2020); personal stocks/shares in Bicycle; personal royalties as Section Editor for bladder cancer from UpToDate; institutional fees as coordinating principal investigator (PI) of the INDUCOMAIN trial from MSD and of a prostate cancer study of avelumab plus carboplatin from Pfizer, both through the Asia Pacific Regional Office (APRO) Association; and non-renumerated membership of the IMvigor011 study Steering Committee (Genentech) and the American Society of Clinical Oncology (ASCO). EC reports personal fees as an invited speaker from Janssen; and a non-renumerated advisory role as a consulting pathologist for the European Association of Urology (EAU) guidelines for bladder cancer. MDS reports fees from 4D (personal for advisory board membership; personal and institutional for Steering Committee membership and an advisory function), AAA (personal for advisory board and Steering Committee memberships), Amgen (personal for advisory board and Steering Committee memberships and an advisory function), Astellas (personal for advisory board membership, an advisory function and as an invited speaker; personal and institutional for Steering Committee membership and an advisory function), AstraZeneca (personal for advisory board and Steering Committee memberships and as an invited speaker; personal and institutional as coordinating PI and for an advisory function), Basilea (personal for advisory board membership; personal and institutional for Steering Committee membership, an advisory function, clinical trials and as local PI), Bayer (personal for advisory board membership; personal and institutional for Steering Committee membership and an advisory function), Bioclin (personal for advisory board membership, advisory functions and as an invited speaker), BMS (personal for advisory board membership; personal and institutional for Steering Committee membership, an advisory function and travel grants), Calithera (institutional as local PI), Eisai (personal for advisory board membership; personal and institutional as local PI, for an advisory function and clinical trials), Ferring (personal for advisory board membership and an advisory function), Gilead (personal for advisory board membership; personal and institutional for Steering Committee membership), Immunomedics/Gilead (personal for advisory board membership; personal and institutional for Steering Committee membership, an advisory function and as local PI), Ipsen (personal for advisory board membership; personal and institutional for Steering Committee membership and an advisory function), Janssen (personal as an invited speaker; personal and institutional for Steering Committee membership and an advisory function), Merck/Serono (personal for advisory board membership; personal and institutional for Steering Committee membership and an advisory function), MSD (personal for advisory board membership and as an invited speaker; personal and institutional for Steering Committee membership, an advisory function, clinical trials and as local PI), Nektar (institutional for clinical trials and as local PI), Novartis/Sandoz (personal for advisory board membership; personal and institutional for Steering Committee membership and advisory function), Pierre Fabre (personal for advisory board membership and as an invited speaker personal and institutional for Steering Committee membership, an advisory function and as local and coordinating PI), Roche (personal for advisory board membership), Roche/Genentech (personal and institutional for Steering Committee membership and an advisory function), Sandoz (personal for Steering Committee membership and an advisory function), Sanofi (personal for advisory board membership; personal and institutional for Steering Committee membership and an advisory function), Seagen (personal for advisory board membership; personal and institutional for Steering Committee membership, an advisory function and as local PI); and non-renumerated membership of the EAU guidelines group for prostate cancer (writing and discussing guidelines for treatment and diagnostics), the ESMO CPGs author group for bladder cancer and the S3-Leitlinie Blasenkrebs (guidelines for the treatment of bladder cancer). RH reports personal fees for advisory board membership from Astellas, BioNTech, BMS, Merck, MSD, Nektar and Roche; personal fees as an invited speaker from Pfizer and Roche; personal fees for expert testimony from the National Institute of Clinical Excellence; personal and institutional fees for Steering Committee membership from Janssen and Nektar; personal fees for consultancy from Roche; personal fees for a limited liability partnership from the Cancer Centre London; institutional royalties from Janssen; institutional fees as a local PI from Astellas, Basilea, Bicycle, Gilead, Janssen, MSD, Nektar and Roche; institutional fees as a coordinating PI from Cancer Research UK (CRUK); institutional research grants from MSD and Roche; non-renumerated roles as chief investigator or co-investigator on CRUK-funded studies; non-renumerated roles as educational secretary and trustee of the British Uro-oncology group; a non-renumerated role as chair of the NCRI Clinical and Translational Radiotherapy Research Working Group (CTRad); and non-renumerated membership of the consensus guideline group of the Royal College of Radiologists. YL reports personal fees for advisory board membership from Gilead, Merck KGaA, Pfizer, Seattle Genetics and Taiho; personal fees for advisory board membership and lectures from Astellas, AstraZeneca, BMS, Janssen, MSD and Roche; personal fees for Steering Committee membership from Basilea; institutional fees as a local PI from Astellas, AstraZeneca, BMS, Exelixis, Gilead, Incyte, Janssen, Merck KGaA, MSD and Pfizer; institutional fees for Steering Committee membership and as a coordinating PI from Janssen; institutional research grants from Celsius, Janssen, MSD, Roche and Sanofi; Steering Committee membership for Astellas, Gilead/Immunomedics, MSD and Taiho; and non-renumerated memberships of the American Association for Cancer Research (AACR), the Scientific Committee of Fondation ARC, ASCO and ESMO. AN reports personal fees for Steering Committee membership from Astellas, AstraZeneca, Bayer, Clovis Oncology, Janssen, Merck and Roche; institutional research grants from AstraZeneca, BMS, Gilead, Ipsen and Merck; a role as coordinating PI for Incyte; a role as local PI for Pfizer; and a non-renumerated leadership role for the Global Society of Rare Genitourinary Tumors (GSRGT). BPV reports personal fees for advisory board membership from AAA, Astellas Pharma, AstraZeneca, BMS, EUSA Pharma, Ipsen, Merck, MSD, Pfizer and Recordati; personal fees as an invited speaker from AAA, Almirall Pharma, Astellas Pharma, Bayer, BMS, Merck, MSD and Pfizer; and travel grants from BMS and Pfizer. AR reports personal fees for advisory board membership from AstraZeneca, BMS, Ipsen, Merck GA and Pfizer; institutional research grants from Ipsen, Merck GA and Pfizer; institutional fees as local PI from AstraZeneca, BMS, Ipsen, Merck GA and Pfizer; travel grants/accommodation compensation for meetings/conferences from BMS, Ipsen, Merck GA and Pfizer; and a non-renumerated role as affiliate of ASCO. SFS reports personal fees for advisory board membership from Astellas, AstraZeneca, Bayer, BMS, Cepheid, Ferring, Ipsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, Sanochemia, Sanofi, Takeda and UroGen. BS reports personal fees for advisory board membership from Merck KGaA; personal fees as an invited speaker from MSD and Pfizer; personal fees for expert testimony from Ellipses and Ipsen; and personal travel grants from Photocure and Roche/Genentech. MSvdH reports institutional fees for advisory board membership from AstraZeneca, BMS, Janssen, MSD, Pfizer and Seagen; institutional funding for investigator-initiated trials from 4SC, AstraZeneca, BMS and Roche; institutional fees for Steering Committee membership and as local PI from AstraZeneca, BMS, MSD and Seagen; and institutional fees as local and study co-PI from Janssen. SG reports personal fees as an invited speaker for DESO, ESMO, Meister ConCept GmbH and the Swiss Group for Clinical Cancer Research (SAKK); personal travel grants from AstraZeneca, Bayer, Gilead and Intellisphere LLC; a patent for a biomarker of Proteomedix/Onconetix; institutional fees for advisory board membership from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Daiichi Sankyo, Innomedica, Ipsen, Macrogenics, MSD Merck Sharp & Dohme, Myriad Genetics and Orion; institutional fees as an invited speaker for AdMeTech Foundation, ASCO GU, EPG Health, ESMO, Intellisphere LLC, Meister ConCept GmbH, S. Grasso Consulting, SAKK and Silvio Grasso Consulting; institutional funding as a co-investigator from Astellas; other institutional fees from PeerVoice (interview), Pfizer (Scientific Committee Pfizer Forschungspreis), TOLREMO (consulting) and WebMD-Medscape (faculty activity); and a non-remunerated advisory role for ProteoMediX.

Background and Objective: Patients with advanced penile squamous cell carcinoma (PSCC) have poor outcomes and very limited therapeutic options are available. Most PSCC cases have high PD-L1 expression, which is associated with worse prognosis. Immunotherapy targeting PD-L1 could benefit patients with PSCC. Our aim was to evaluate the efficacy and safety of the anti-PD-1 antibody retifanlimab in patients with advanced/metastatic PSCC., Methods: ORPHEUS was a single-arm, multicenter, phase 2 trial in 18 patients with advanced/metastatic PSCC, previously untreated with anti-PD-1/anti-PD-L1 agents. Patients received retifanlimab 500 mg intravenously every 4 wk for up to 2 yr. The primary endpoint was the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included the clinical benefit rate (CBR), disease control rate, duration of response (DoR), time to response, progression-free survival (PFS), overall survival (OS), maximum tumor shrinkage, and safety. The Wilson method was used for the primary endpoint, and the Clopper-Pearson and Kaplan-Meier methods for secondary endpoints., Key Findings and Limitations: Median follow-up was 7.2 mo. The ORR was 16.7% (95% confidence interval [CI] 5.8-39.2); three patients had a partial response. Median DoR was 3.3 mo (range 1.8-8.5). The CBR was 22.2% (95% CI 6.4-47.6%). Median PFS was 2.0 mo (95% CI 1.6-3.3) and median OS was 7.2 mo (95% CI 3.0-9.8). One patient (5.6%) experienced grade 3 treatment-related adverse events (AEs). There were no grade >= 4 treatment-related AEs. The small sample size is the main limitation., Conclusions and Clinical Implications: Single-agent retifanlimab exhibited signals of clinical activity in advanced/metastatic PSCC, with no new safety signals. Further investigation of retifanlimab in this setting is warranted., Patient Summary: Advanced penile cancer of the squamous cell type is a rare tumor with poor prognosis. The aggressiveness of this cancer is usually associated with high levels of a protein called PD-L1. We investigated whether retifanlimab, an immunotherapy drug against PD-1, has activity against this type of penile cancer. Tumor regression or stabilization occurred in one-third of the patients and the side effects were manageable., (Copyright © 2024 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: The gut microbiota has been extensively implicated in health and disease. The functional outputs of the gut microbiota, such as microbial metabolites, are considered particularly important in this regard. Significant associations exist between alterations in the relative abundance of specific microbial taxa and mental health disorders. Dietary fiber has the potential to alter gut microbiota composition and function, modifying bacterial enzymatic function and the production of metabolites. As many taxa of microorganisms have enzymes capable of producing or degrading neurochemicals i.e. neuroactive gut brain modules, new predictive tools can be applied to existing datasets such as those harvested from dietary fiber interventions. We endeavor to perform a systematic review in order to identify studies reporting compositional gut microbiota alterations after interventions with dietary fiber in healthy individuals. We aim to also extract from the selected studies publicly available microbial genomic sequence datasets for reanalysis with a consistent bioinformatics pipeline, with the ultimate intention of identifying altered gut brain modules following dietary fiber interventions., Methods: Interventional trials and randomized controlled studies that are originally published, including cross-over and non-crossover design and involving healthy adult humans will be included. A systematic search of PubMed/MEDLINE and EMBASE, two electronic databases, will be completed., Discussion: Various types of dietary fiber have an impact on the gut microbiota composition, with some promoting the growth of particular taxa while others are reduced in relative abundance. Our search focuses on the impact of this food component on the microbiota of healthy individuals. Compositional gut microbial changes have been reported and our review will compile and update these observations after reanalysis of their datasets with a consistent bioinformatic pipeline. From this it may be possible to predict more detailed functional consequences in terms of neuroactive gut brain modules, of the compositional alterations in gut microbial taxa., Competing Interests: Competing interests: JFC has been an invited speaker at conferences organized by Mead Johnson, Ordesa, and Yakult, and has received research funding from Reckitt, Nutricia, Dupont/IFF, and Nestle. GC has received honoraria from Janssen, Probi, and Apsen as an invited speaker; is in receipt of research funding from Pharmavite, Reckitt, Tate and Lyle, Nestle and Fonterra; and is a paid consultant for Yakult and Zentiva. This support neither influenced nor constrained the contents of this paper. DAL, BV, TB and AL declare no competing interests., (Copyright: © 2024 Lachmansingh DA et al.)

Background: Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor approved to treat locally advanced/metastatic urothelial carcinoma (mUC) in patients with susceptible FGFR3/2 alterations (FGFRalt) who progressed after platinum-containing chemotherapy. FGFR-altered tumours are enriched in luminal 1 subtype and may have limited clinical benefit from anti-programmed death-(ligand) 1 [PD-(L)1] treatment. This cohort in the randomized, open-label phase III THOR study assessed erdafitinib versus pembrolizumab in anti-PD-(L)1-naive patients with mUC., Patients and Methods: Patients ≥18 years with unresectable advanced/mUC, with select FGFRalt, disease progression on one prior treatment, and who were anti-PD-(L)1-naive were randomized 1 : 1 to receive erdafitinib 8 mg once daily with pharmacodynamically guided uptitration to 9 mg or pembrolizumab 200 mg every 3 weeks. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety., Results: The intent-to-treat population (median follow-up 33 months) comprised 175 and 176 patients in the erdafitinib and pembrolizumab arms, respectively. There was no statistically significant difference in OS between erdafitinib and pembrolizumab [median 10.9 versus 11.1 months, respectively; hazard ratio (HR) 1.18; 95% confidence interval (CI) 0.92-1.51; P = 0.18]. Median PFS for erdafitinib and pembrolizumab was 4.4 and 2.7 months, respectively (HR 0.88; 95% CI 0.70-1.10). ORR was 40.0% and 21.6% (relative risk 1.85; 95% CI 1.32-2.59) and median duration of response was 4.3 and 14.4 months for erdafitinib and pembrolizumab, respectively. 64.7% and 50.9% of patients in the erdafitinib and pembrolizumab arms had ≥1 grade 3-4 adverse events (AEs); 5 (2.9%) and 12 (6.9%) patients, respectively, had AEs that led to death., Conclusions: Erdafitinib and pembrolizumab had similar median OS in this anti-PD-(L)1-naive, FGFR-altered mUC population. Outcomes with pembrolizumab were better than assumed and aligned with previous reports in non- FGFR-altered populations. Safety results were consistent with the known profiles for erdafitinib and pembrolizumab in this patient population., Competing Interests: Disclosure AOS has received honoraria from Astellas, AstraZeneca, Bavarina Nordic, Basilea, Bicycle Therapeutics, Bristol Myers Squibb, G1 Therapeutics, Genentech, Gilead, Ideeya Biosciences, Immunomedics, Janssen, Loxo, Merck, Mirati, Nektar, Seattle Genetics, and Taiho and research funding (institutional) from Basilea Pharmaceutica, Bristol Myers Squibb, Janssen, Loxo, Merck, Millennium, and Nektar. NM has received honoraria (personal) from Sanofi; research funding (institutional) from Amgen, Astellas Pharma, AstraZeneca, Bayer, Chugai Pharm, Eisai, Janssen, Lilly, Merck Sharp & Dohme, Pfizer, PRA Health Science, Roche, Seagen, Taiho, and Takeda; and has been reimbursed for travel, accommodations, or expenses (personal) from Pfizer. SHP has received honoraria from Merck, Ono Pharma Korea, and Pfizer; served as a consultant for Janssen Oncology; and received institutional research support from Merck Sharp & Dohme. RAH has received personal fees from Aspen Parkside Hospital, Merck, and Pfizer; consulting fees from Bristol Myers Squibb, Roche, Merck Sharp & Dohme, Janssen Oncology, Nektar, and Bayer; honoraria from Janssen Oncology; has been reimbursed for travel, accommodations, or expenses from Janssen Oncology, Roche/Genentech, MSD Oncology, and Nektar; has other financial or non-financial interests with Merck Sharp & Dohme, Roche, Bristol Myers Squibb, and Janssen; and has a leadership or fiduciary role at Cancer Clinic London Liability Partnership, outside of the submitted work. EFB has received honoraria from Exelixis, Janssen, Merck, Novartis, and Pfizer; research funding (personal) from Astellas and Pfizer; and research funding (institutional) from Astellas, Bristol Myers Squibb, Janssen, Merck, Pfizer, Roche/Genentech, and Seagen. NH has received consulting fees from Astellas, AstraZeneca, Bristol Myers Squibb, Gilead, Janssen, Merck, and Pfizer. MO has served as a consultant for Sanofi, Astellas, and Bayer; has participated in a speaker’s bureau for Regeneron; and has been reimbursed for travel, accommodation, and expenses by Sanofi and Regeneron. BPV has served as a consultant for Astellas Pharma, Astra Zeneca, Bayer, Bristol Myers Squibb, and Novartis; has received honoraria from Astellas, Bristol Myers Squibb, Eusa Pharma, Ipsen, Merck Sharp & Dohme, Pierre Fabre, Pfizer, and Roche; and has been reimbursed for travel, accommodations, or expenses by Bristol Myers Squibb, Janssen-Cilag, Merck, Novartis, and Pfizer. BL has received honoraria from Janssen and has been reimbursed for travel, accommodations, or expenses by Astellas, Jassen, and Pfizer. UB has participated in a speaker’s bureau for and/or received travel and accommodation grants from Astellas, AstraZeneca, Bristol Myers Squibb, Ipsen, Janssen, and Merck Sharp & Dohme and has received research funding (institutional) from Ipsen. YK serves as a functional service provider for Janssen. ST, SA, KD, and SM are employed by Janssen Research & Development and have stock or stock options with Johnson & Johnson. YL has received consulting fees from Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Immunomedics, Janssen (and institutional), MSD Oncology (and institutional), Loxo/Lilly, Pfizer/EMD Serono, Roche, and Taiho Pharmaceutical; has been reimbursed for travel, accommodations, or expenses from Astellas, AstraZeneca, Janssen Oncology, MSD Oncology, and Roche; and has received research funding (institutional) from Astellas Pharma, AstraZeneca, Basilea, Bristol Myers Squibb, Exelixis, Gilead Sciences, Incyte, Janssen Oncology, Merck KGaA, MSD Oncology, Nektar, Pfizer, Roche, Sanofi, and Taiho Pharmaceutical., (Copyright © 2023 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.)