tbuckley/cabot-search huggingface dataset:
Effect of Acupuncture on Neurogenic Claudication Among Patients With Degenerative Lumbar Spinal Stenosis
Authors: Lili Zhu, Yuanjie Sun, Jing Kang, Jun Liang, Tongsheng Su, Wenbin Fu, Wei Zhang, Rongshui Dai, Yan Hou, Hong Zhao, Weina Peng, Weiming Wang, Jing Zhou, Ruimin Jiao, Biyun Sun, Yan Yan, Yan Liu, Zhishun Liu
Journal: Annals of Internal Medicine (2024)

Acupuncture may improve degenerative lumbar spinal stenosis (DLSS), but evidence is insufficient.
Medication-Induced Weight Change Across Common Antidepressant Treatments
Authors: Joshua Petimar, Jessica G. Young, Han Yu, Sheryl L. Rifas-Shiman, Matthew F. Daley, William J. Heerman, David M. Janicke, W. Schuyler Jones, Kristina H. Lewis, Pi-I D. Lin, Carly Prentice, John W. Merriman, Sengwee Toh, Jason P. Block
Journal: Annals of Internal Medicine (2024)

Antidepressants are among the most commonly prescribed medications, but evidence on comparative weight change for specific first-line treatments is limited.
Alcohol-associated liver disease and public health policies
Authors: Shreya Sengupta, Victoria Gill, Jessica L. Mellinger
Journal: Hepatology (2024)

Alcohol-associated liver disease (ALD) rates have increased substantially in the United States and elsewhere around the globe. These increases are largely the result of increases in alcohol use. While there are many levels at which alcohol use interventions can be implemented in order to reduce alcohol use and its negative health consequences, public policy initiatives have emerged as a powerful way to intervene across a population. In this narrative review, we will review major US national as well as worldwide alcohol-associated public health policies with a particular focus on describing how such policies have influenced rates of ALD and its complications and outcomes. We will describe global alcohol public health policy frameworks, review key alcohol policy models, describe existing notable policies and their impacts, and highlight gaps in ALD policy literature where further research and policy interventions could reduce rates of mortality from ALD.
A novel phosphodiesterase inhibitor for the treatment of chronic liver injury and metabolic diseases
Authors: Dalton W. Staller, Sanjali S. Panigrahi, Yahani P. Jayasinghe, Yuxiang Dong, Sohan Mahto, Virender Kumar, Donald R. Ronning, Ram I. Mahato
Journal: Hepatology (2024)

Background and Aims: Chronic liver disease leads to ~2 million deaths annually. Cyclic AMP (cAMP) signaling has long been studied in liver injury, particularly in the regulation of fatty acid (FA) β-oxidation and pro-inflammatory polarization of tissue-resident lymphocytes. Phosphodiesterase 4B inhibition has been explored as a therapeutic modality, but these drugs have had limited success and are known to cause significant adverse effects. The PDE4 inhibitor 2-(4-([2-(5-Chlorothiophen-2-yl)-5-ethyl-6-methylpyrimidin-4-yl]amino)phenyl)acetic acid) (known as A-33) has yet to be explored for the treatment of metabolic diseases. Approach and Results: Herein, we evaluated the efficacy of A-33 in the treatment of animal models of alcohol-associated liver disease and steatotic liver disease. We demonstrated that A-33 effectively ameliorated the signs and symptoms of chronic liver disease, resulting in significant decreases in serum alanine aminotransferase and aspartate aminotransferase levels, decreased overall fat and collagen deposition in the liver, decreased intrahepatic triglyceride concentrations, and normalized expression of genes related to β-oxidation of fatty acids, inflammation, and extracellular matrix deposition. We also designed and synthesized a novel analog of A-33, termed MDL3, which inhibited both phosphodiesterase 4B and PDE5A and was more effective in ameliorating pathophysiological signs and symptoms of liver injury and inflammation. In addition, MDL3 re-sensitized obese mice to glucose and significantly inhibited the pathological remodeling of adipose tissue, which was not observed with A-33 administration. Conclusions: In conclusion, we synthesized and demonstrated that MDL3, a novel phosphodiesterase 4B and PDE5A inhibitor, presents a promising avenue of exploration for treating chronic liver disease.
Angiotensin-Converting Enzyme Inhibitors or Angiotensin-Receptor Blockers for Advanced Chronic Kidney Disease
Authors: Elaine Ku, Lesley A. Inker, Hocine Tighiouart, Charles E. McCulloch, Ogechi M. Adingwupu, Tom Greene, Raymond O. Estacio, Mark Woodward, Dick de Zeeuw, Julia B. Lewis, Thierry Hannedouche, Tazeen H. Jafar, Enyu Imai, Giuseppe Remuzzi, Hiddo J.L. Heerspink, Fan Fan Hou, Robert D. Toto, Philip K. Li, Mark J. Sarnak
Journal: Annals of Internal Medicine (2024)

In patients with advanced chronic kidney disease (CKD), the effects of initiating treatment with an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin-receptor blocker (ARB) on the risk for kidney failure with replacement therapy (KFRT) and death remain unclear.
Randomized Phase II Trial of Immunotherapy-Based Total Neoadjuvant Therapy for Proficient Mismatch Repair or Microsatellite Stable Locally Advanced Rectal Cancer (TORCH)
Authors: Fan Xia, Yaqi Wang, Hui Wang, Lijun Shen, Zuolin Xiang, Yutian Zhao, Huojun Zhang, Juefeng Wan, Hui Zhang, Yan Wang, Ruiyan Wu, Jingwen Wang, Wang Yang, Menglong Zhou, Shujuan Zhou, Yajie Chen, Zhiyuan Zhang, Xian Wu, Yan Xuan, Renjie Wang, Yiqun Sun, Tong Tong, Xun Zhang, Lei Wang, Dan Huang, Weiqi Sheng, Hao Yan, Xu Yang, Yuxin Shen, Yu Xu, Ruping Zhao, Miao Mo, Guoxiang Cai, Sanjun Cai, Ye Xu, Zhen Zhang
Journal: Journal of Clinical Oncology (2024)

PURPOSE To assess whether the integration of PD-1 inhibitor with total neoadjuvant therapy (iTNT) can lead to an improvement in complete responses (CRs) and favors a watch-and-wait (WW) strategy in patients with proficient mismatch repair or microsatellite stable (pMMR/MSS) locally advanced rectal cancer (LARC). PATIENTS AND METHODS We conducted a prospective, multicenter, randomized, open-label, phase II trial using a pick-the-winner design. Eligible patients with clinical T3-4 and/or N+ rectal adenocarcinoma were randomly assigned to group A for short-course radiotherapy (SCRT) followed by six cycles of consolidation immunochemotherapy with capecitabine and oxaliplatin and toripalimab or to group B for two cycles of induction immunochemotherapy followed by SCRT and the rest four doses. Either total mesorectal excision or WW was applied on the basis of tumor response. The primary end point was CR which included pathological CR (pCR) after surgery and clinical CR (cCR) if WW was applicable, with hypothesis of an increased CR of 40% after iTNT compared with historical data of 25% after conventional TNT. RESULTS Of the 130 patients enrolled, 121 pMMR/MSS patients were evaluable (62 in group A and 59 in group B). At a median follow-up of 19 months, CR was achieved at 56.5% in group A and 54.2% in group B. Both groups fulfilled the predefined statistical hypothesis ( P &lt; .001). Both groups reported a pCR rate of 50%. Respectively, 15 patients in each group underwent WW and remained disease free. The most frequent grade 3 to 4 toxicities were thrombocytopenia and neutropenia. Patients in group A had higher rate of cCR (43.5% v 35.6%) at restaging and lower rate of grade 3 to 4 thrombocytopenia (24.2% v 33.9%) during neoadjuvant treatment. CONCLUSION The iTNT regimens remarkably improved CR rates in pMMR/MSS LARC compared with historical benchmark with acceptable toxicity. Up-front SCRT followed by immunochemotherapy was selected for future definitive study.
Dendritic Cell–Based Immunotherapy in Patients With Resected Pancreatic Cancer
Authors: Freek R. van ‘t Land, Marcella Willemsen, Koen Bezemer, Sjoerd H. van der Burg, Thierry P.P. van den Bosch, Michail Doukas, Amine Fellah, P. Martijn Kolijn, Anton W. Langerak, Miranda Moskie, Elise van der Oost, Nina E.M. Rozendaal, Sara J. Baart, Joachim G.J.V. Aerts, Casper H.J. van Eijck
Journal: Journal of Clinical Oncology (2024)

Immunotherapies have shown limited responses in patients with advanced pancreatic cancer. Recently, we reported that dendritic cell (DC)-based immunotherapy induced T-cell responses against pancreatic cancer antigens. The primary objective of this study was to determine the efficacy of DC-based immunotherapy to prevent recurrence of disease.
Impact of Lipoprotein(a) Level on Low-Density Lipoprotein Cholesterol– or Apolipoprotein B–Related Risk of Coronary Heart Disease
Authors: Natalie Arnold, Christopher Blaum, Alina Goßling, Fabian J Brunner, Benjamin Bay, Tanja Zeller, Marco M Ferrario, Paolo Brambilla, Giancarlo Cesana, Valerio Leoni, Luigi Palmieri, Chiara Donfrancesco, Francisco Ojeda, Allan Linneberg, Stefan Söderberg, Licia Iacoviello, Francesco Gianfagna, Simona Costanzo, Susana Sans, Giovanni Veronesi, Barbara Thorand, Annette Peters, Hugh Tunstall-Pedoe, Frank Kee, Veikko Salomaa, Renate B Schnabel, Kari Kuulasmaa, Stefan Blankenberg, Christoph Waldeyer, Wolfgang Koenig
Journal: Journal of the American College of Cardiology (2024)
Comparative Cardiovascular Benefits of Bempedoic Acid and Statin Drugs
Authors: A. Michael Lincoff, Kausik K. Ray, William J. Sasiela, Tariq Haddad, Stephen J. Nicholls, Na Li, Leslie Cho, Denise Mason, Peter Libby, Shaun G. Goodman, Steven E. Nissen
Journal: Journal of the American College of Cardiology (2024)

In the CLEAR (Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen) Outcomes trial, treatment of statin-intolerant patients with bempedoic acid produced a 21% decrease in low-density lipoprotein cholesterol (LDL-C) relative to placebo and a 13% relative reduction in the risk of major adverse cardiovascular events. This study sought to determine whether the relationship between LDL-C lowering and cardiovascular benefit achieved with bempedoic acid resembles that observed with statins when standardized per unit change in LDL-C. To compare the treatment effect of bempedoic acid with statins, the methodology of the Cholesterol Treatment Trialists' Collaboration (CTTC) was applied to outcomes among the 13,970 patients enrolled in the CLEAR Outcomes trial. The CTTC endpoint of "major vascular event" was a composite of coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal stroke, or coronary revascularization. HRs for CTTC-defined endpoints were normalized to 1 mmol/L differences in LDL-C levels between bempedoic acid and placebo groups. A first major vascular event occurred in 703 (10.1%) patients in the bempedoic acid group and 816 (11.7%) patients in the placebo group (HR: 0.85; 95% CI: 0.77-0.94). When normalized per 1 mmol/L reduction in LDL-C, the HR was 0.75 (95% CI: 0.63-0.90), comparable to the rate ratio of 0.78 reported for statins in the CTTC meta-analysis. Normalized risk reductions were similar for bempedoic acid and statins for the endpoints of major coronary events, nonfatal myocardial infarction, and coronary revascularization. Cardiovascular risk reduction with bempedoic acid is similar to that achieved with statins for a given absolute magnitude of LDL-C lowering. (Evaluation of Major Adverse Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated with Bempedoic Acid [ETC-1002] or Placebo [CLEAR Outcomes]; NCT02993406).
Tricuspid Regurgitation in Patients With Heart Failure and Preserved Ejection Fraction
Authors: Rebecca T Hahn, JoAnn Lindenfeld, Michael Böhm, Frank Edelmann, Lars H Lund, Philip Lurz, Marco Metra, Ryan J Tedford, Javed Butler, Barry A Borlaug
Journal: Journal of the American College of Cardiology (2024)
Coronary Artery Bypass Graft Failure in Women
Authors: Sigrid Sandner, Björn Redfors, Kevin R An, Lamia Harik, Rachel Heise, Antonino Di Franco, Stephen E Fremes, David L Hare, Alexander Kulik, Andre Lamy, Joyce Peper, Marc Ruel, Jurrien M Ten Berg, Laura M Willemsen, Qiang Zhao, Yunpeng Zhu, Daniel M Wojdyla, Deepak L Bhatt, John H Alexander, Mario Gaudino
Journal: Journal of the American College of Cardiology (2024)
RE: is it time to reconsider the role of upfront cytoreductive nephrectomy in metastatic renal cell carcinoma?
Authors: Jaleh Fallah, Haley Gittleman, Chana Weinstock, Elaine Chang, Sundeep Agrawal, Shenghui Tang, Richard Pazdur, Paul G Kluetz, Daniel L Suzman, Laleh Amiri-Kordestani
Journal: JNCI Journal of the National Cancer Institute (2024)
RIBAP: a comprehensive bacterial core genome annotation pipeline for pangenome calculation beyond the species level
Authors: Kevin Lamkiewicz, Lisa-Marie Barf, Konrad Sachse, Martin Hölzer
Journal: Genome biology (2024)

Abstract Microbial pangenome analysis identifies present or absent genes in prokaryotic genomes. However, current tools are limited when analyzing species with higher sequence diversity or higher taxonomic orders such as genera or families. The Roary ILP Bacterial core Annotation Pipeline (RIBAP) uses an integer linear programming approach to refine gene clusters predicted by Roary for identifying core genes. RIBAP successfully handles the complexity and diversity of Chlamydia , Klebsiella , Brucella , and Enterococcus genomes, outperforming other established and recent pangenome tools for identifying all-encompassing core genes at the genus level. RIBAP is a freely available Nextflow pipeline at github.com/hoelzer-lab/ribap and zenodo.org/doi/10.5281/zenodo.10890871.
Belzutifan in patients with advanced clear cell renal cellcarcinoma (ccRCC): Subgroup analysis of the phase 2 LITESPARK-013 study.
Authors: Michael B. Atkins, Pooja Ghatalia, Jaime R. Merchan, Saby George, John Haanen, Howard Gurney, Rahul Ravilla, Astrid Aplonia Maria Van Der Veldt, Benoit Beuselinck, Ilya Pokataev, Britt Suelmann, Mark H. Tuthill, Daniel A. Vaena, Flora Zagouri, Jianxin Lin, Rodolfo F. Perini, Yanfang Liu, James Brugarolas, Neeraj Agarwal
Journal: Journal of Clinical Oncology (2024)

4534 Background: In the randomized phase 2 LITESPARK-013 study (NCT04489771), the first-in-class HIF-2α inhibitor belzutifan showed comparable antitumor activity in patients with pretreated advanced ccRCC at 200 mg and 120 mg doses (objective response rate [ORR]: 23.1% vs 23.7%; 1-sided P= 0.5312). We present results of a post hoc analysis of the pooled population (200 mg and 120 mg arms) across patient subgroups based on prior therapy and IMDC risk group. Methods: Patients with advanced ccRCC, measurable disease per RECIST v1.1, a Karnofsky Performance Scale score of ≥70%, ≤3 prior systemic regimens for advanced ccRCC (including an anti–PD-(L)1 regimen), and disease progression during or after an anti–PD-(L)1 regimen were randomly assigned 1:1 to receive belzutifan 200 mg or 120 mg QD. End points in the pooled population and subgroups were ORR and duration of response per RECIST v1.1 by blinded independent central review. Data cutoff was February 10, 2023. Results: A total of 154 patients were enrolled (200 mg, n = 78; 120 mg, n = 76). In the pooled population, the median age was 64.0 years, 127 patients (82.5%) had intermediate/poor risk per IMDC criteria, 110 patients (71.4%) received 1-3 prior tyrosine kinase inhibitor (TKI) regimens, and 81 patients (52.6%) received 2 or 3 prior lines of therapy. As of the data cutoff date, 39 patients (25.3%) in the pooled population remained on treatment. Median follow-up was 20.1 months (range, 14.8-28.4). In the pooled population, ORR was 23.4% (95% CI, 16.9-30.9; 4 complete responses [CRs], 32 partial responses [PRs]) and median duration of response (DOR) was 16.1 months (range, 2.1+ to 23.5+). Additional efficacy analyses for subgroups are presented in the table. Conclusions: This post hoc analysis from the LITESPARK-013 study of patients with pretreated advanced ccRCC suggests that belzutifan has antitumor activity regardless of prior lines of therapies and prognostic risk category. These results further support belzutifan as a treatment option for advanced RCC. Clinical trial information: NCT04489771 . [Table: see text]
Association of baseline inflammatory biomarkers and clinical outcomes in patients with advanced renal cell carcinoma (aRCC) treated with immune checkpoint inhibitors (ICIs).
Authors: Ahmet Yildirim, Mengting Wei, Yuan Liu, Rohit Vivek Goswamy, Yujin Choi, Jacqueline T Brown, Bassel Nazha, Dylan J. Martini, Caitlin Hartman, Greta Russler McClintock, Tony Zhuang, Haydn Kissick, Wayne B. Harris, Bradley Curtis Carthon, Omer Kucuk, Viraj A. Master, Mehmet Asim Bilen
Journal: Journal of Clinical Oncology (2024)

4548 Background: Multiple inflammatory biomarkers such as modified Glasgow Prognostic Score (mGPS), neutrophil to lymphocyte ratio (NLR), monocyte to lymphocyte ratio (MLR), platelet to lymphocyte ratio (PLR), and neutrophil to eosinophil ratio (NER) have been identified in RCC. We analyzed those biomarkers in patients with aRCC treated with ICIs to assess the association with treatment outcomes. Methods: A retrospective analysis was conducted on adult patients with aRCC treated with ICIs at Emory Winship Cancer Institute between 2018 and 2023. Clinical benefit (CB) is determined by stable disease, partial response, and complete response. mGPS (combining albumin and CRP), NLR, MLR, PLR, and NER data were collected from the baseline bloodwork. Multivariate and univariate analyses were conducted on PFS, OS, and CB. MVA was built by controlling the age, gender, race, BMI, smoking status, IMDC risk group, clear cell histology, prior treatment, liver metastases, ECOG performance score, and number of distant metastases, which were subject to backward elimination at the significant level of p &lt; 0.2 Results: Our analysis included a total of 401 patients (118:283 F:M, median age: 66). On univariate analysis, high mGPS, NLR, MLR, PLR, and NER were related to inferior CB; hazard ratios (HR) (95% CI, p value) were 3.03 (1.35-6.77, p=0.005), 1.86 (1.14-3.03, p=0.013), 1.83 (1.10-3.02, p=0.019), 2.37 (1.52-3.71, p &lt;.001), 1.93 (1.22-3.05, p=0.005) respectively. On multivariate analysis, NLR, PLR, NER had statistically significant correlation with CB, HR (95% CI) were 1.75 (1.01-3.04, p=0.047), 2.21 (1.33-3.66, p=0.002), 2.07 (1.24-3.47, p=0.006). Conclusions: The results demonstrated that high systemic inflammatory biomarkers may be related to worse clinical outcomes with ICI treatment. Prospective studies are needed for further validation. [Table: see text]
Health-related quality of life (HRQoL) with nivolumab (NIVO) subcutaneous (SC) or intravenous (IV) in patients (pts) with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior therapy in the phase 3 CheckMate 67T trial.
Authors: Saby George, Maria T. Bourlon, Matthew Dixon, Jennifer Lord-Bessen, Gill Worthy, Katie Frampton, Christine Yip, Rachael Lawrance, Fiona Taylor, Laurence Albiges
Journal: Journal of Clinical Oncology (2024)

4535 Background: NIVO IV has improved outcomes in multiple tumor types. Evolving treatment paradigms have created a need for administration options that address treatment burden and improve efficiencies of healthcare systems. In a phase 1/2 study (CheckMate 8KX), pts were highly satisfied with NIVO SC and preferred it over NIVO IV [Lonardi et al, ESMO 2022; Lonardi et al, SITC 2023]. CheckMate 67T (NCT04810078) is a multicenter, randomized, open-label, phase 3 study that demonstrated pharmacokinetic and objective response rate noninferiority of NIVO SC vs IV in pts with locally advanced or metastatic ccRCC [George et al, ASCO-GU 2024]. This exploratory analysis assessed non-inferiority of HRQoL between pts randomized to NIVO SC (n=248) vs NIVO IV (n=247) in CheckMate 67T. Methods: HRQoL was measured using patient-reported outcomes (PROs), FKSI-19 (kidney cancer-related HRQoL) and the EQ-5D-5L (pt’s health status). FKSI-19 total score (range 0-76, higher score better HRQoL)and EQ-5D-5L visual analogue scale (VAS) (range 0-100, higher score better health HRQoL) scores were evaluated longitudinally on-treatment visits with ≥10 pts per arm included in model [week 57]) using linear mixed models (constrained longitudinal data analysis), with least squares (LS) mean changes from baseline and differences in the LS mean between NIVO SC and NIVO IV assessed; non-inferiority of NIVO SC vs NIVO IV was evaluated by examining overall treatment differences for on-treatment visits relative to prespecified thresholds. Results: PRO data were available for 247 pts (99.6%) for NIVO SC and 245 pts (99.2%) for NIVO IV, with completion rates &gt;87% across instruments up to week 57 for both treatment arms. HRQoL was maintained over time for both NIVO arms for FKSI-19 total score and subscales and EQ-5D-5L VAS. NIVO SC was non-inferior to NIVO IV across FKSI-19 total score and subscales and EQ-5D-5L VAS (Table). Conclusions: These results demonstrate maintenance of HRQoL for pts with advanced or metastatic ccRCC while on treatment with NIVO, regardless of the mode of administration (SC or IV), supporting the use of NIVO SC as a new option to align with patient preferences. Clinical trial information: NCT04810078 . [Table: see text]
Leukocyte immunoglobulin-like receptor (LILRB2)-targeted JTX-8064 plus the anti-PD1 inhibitor JTX-4014 (pimivalimab) in immune-checkpoint inhibitor (ICl) pretreated patients (pts) with advanced or metastatic renal cell cancer (mRCC): Results from the multi-stage phase 1-2 INNATE trial.
Authors: Primo N. Lara, Stew Kroll, Jonathan Alexander Chatzkel, Deanna Gek Koon Teoh, Vincent T Ma, Deepak Kilari, Clara Hwang, Randy F. Sweis, Kiran Yalamanchili, Julio Antonio Peguero, Tianhong Li, Mamta Parikh
Journal: Journal of Clinical Oncology (2024)

4531 Background: Disease progression following treatment of mRCC pts with ICl-based therapy (tx) is nearly universal, warranting evaluation of novel immunotherapeutic approaches. LILRB2 is an immune checkpoint molecule expressed primarily in cells of myeloid origin (e.g., monocytes/macrophages). Inhibition of LILRB2 reprograms macrophages from an immunosuppressive (M2) to an immunostimulatory (M1) phenotype. JTX-8064 is a humanized monoclonal antibody that binds to LILRB2, blocking its interaction with MHC1 molecules. Preclinical studies suggest that JTX-8064 can overcome anti-PD(L)1 resistance mechanisms. Here we report the results of an expansion cohort of previously-treated mRCC pts in INNATE, a multi-stage phase 1-2 trial of JTX-8064 in combination with anti-PD1 agents in solid tumors. Methods: Pts with pathologically-confirmed clear cell mRCC progressing on or after anti-PD(L)1 tx in the most recent prior line, acceptable end-organ function, and ECOG PS 0-1 were treated with JTX-8064 700 mg and JTX-4014 500 mg IV q3 weeks. Primary endpoint was overall response rate (ORR); secondary endpoints were safety, disease control rate (DCR), progression-free survival (PFS), &amp; overall survival (OS). A Simon 2-stage design (n=10+19) was employed where ORR &gt;= 20% was deemed to be of further interest versus null hypothesis of ORR &lt;= 5%, with alpha=0.05. Results: 31 pts were enrolled, with median age of 64 years (range 38-85); 84% males; 16% Hispanic; 93% White; 45% PS=0; 71% one prior tx line. Of 28 pts evaluable for response, 1 CR, 1 PR, 14 SD (6 SD&gt;= 6 months), and 11 PD were seen for an ORR of 7% &amp; DCR of 54%.Median PFS was 4 months (95%CI: 2, 6.8); 12-month OS was 75% (95%CI: 55,88). Tx-related adverse events (AE) of all grades were reported in 11 pts (45%), most commonly fatigue (16%) &amp; diarrhea (10%). Only 4 protocol-related G3-4 AEs were reported: thrombocytopenia (G4); diplopia, diarrhea, &amp; bradycardia (all G3). Three on-study deaths (hypotension; cardiorespiratory arrest; &amp; unknown) were deemed unrelated to protocol tx. Conclusions: While ORR did not meet the protocol-defined efficacy target, evidence of anti tumor activity was seen in ICI pre-treated mRCC pts with combination JTC-8064 + JTX-4014. Treatment was reasonably well-tolerated. Identification &amp; evaluation of clinical and molecular phenotypes most likely to benefit from LILRB2-targeted therapies are warranted. Clinical trial information: NCT04669899 .