Neeraj Agarwal, MD

Neeraj Agarwal, MD

Huntsman Cancer Institute

Salt Lake City, Utah

Neeraj Agarwal, MD, is Professor of Medicine and Presidential Endowed Chair of Cancer Research at the Huntsman Cancer Institute (HCI) at the University of Utah in Salt Lake City. He also directs the Genitourinary Oncology Program, and the Center of Investigational Therapeutics at HCI.

Dr. Agarwal is internationally recognized in the field of genitourinary cancers. He is the study chair of multiple Phase I/II and Phase III trials, and serves as a steering committee member of numerous other trials. He has received the SWOG Young Investigator Award, the William D. Odell Young Investigator Award, and a National Cancer Institute Cancer Clinical Investigator Team Leadership Award. After completing his medical training at the All India Institute of Medical Sciences in New Delhi, he completed a residency in internal medicine and a fellowship in geriatric medicine at the University of Iowa, followed by a hematology-oncology fellowship at HCI.

Dr. Agarwal has authored more than 300 peer-reviewed articles and book chapters. He holds numerous scientific communications leadership roles, including chief editor of the ASCO Daily News, specialty editor for ASCO’s site, and editorial board member of several journals, including the Journal of Clinical Oncology. He also serves as a member of the ASCO Genitourinary Cancers Advisory Panel. Dr. Agarwal was recently appointed as the Senior Director for Clinical Research Innovation at the Huntsman Cancer Institute.


Talks by Neeraj Agarwal, MD

Implications of the FDA Approval of Combination Talazoparib & Enzalutamide Therapy

Dr. E. David Crawford and Dr. Neeraj Argawal, MD, FASCO, discuss the recent FDA approval of Enzalutamide combined with Talazoparib. In this discussion, they examine a Phase 3 trial comparing Enzalutamide and Talazoparib versus Enzalutamide alone on mCRPC patients.

The results of the trial yielded significant differences in the outcomes between the Enzalutamide and Talazoparib combination arm and the Enzalutamide-Only arm. 37% decrease in the risk of progression or death was observed in the combination arm of the trial. In patient populations with tumors containing HRR mutations, the risk of progression or death was decreased by 55%.

Following its recent FDA approval, Dr. Crawford and Dr. Argawal discuss the clinically appropriate populations for Enzalutamide and Talazoparib combination therapy, the process of diagnosis, and the limitations of the therapy. Dr. Argawal emphasizes the necessity of germline testing in identifying predispositions to mCRPC patients and their families.

Dr. Crawford and Dr. Argawal conclude by examining the time to PSA progression in the two trial arms. In the Enzalutamide-Only arm of the trial, average time to progression was 11 months, whereas time to progression in the Combination arm was 28 months. They recognize that the overall survival data is immature at this time, but recognize that short-term benefits of combination therapy for this patient population are significant across the board.

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Real World Utilization of Guideline Based Therapy in mCSPC: Update From the 2021 ASCO Annual Meeting

Neeraj Agarwal, MD, Professor of Medicine and Presidential Endowed Chair of Cancer Research at the Huntsman Cancer Institute at the University of Utah in Salt Lake City, examines the underutilization of effective intensified androgen deprivation therapy (ADT) for patients with metastatic castration-sensitive prostate cancer (mCSPC). He begins by emphasizing the unprecedented efficacy of intensified ADT in improving survival for patients with mCSPC. Dr. Agarwal then asserts that, despite those findings, less than a third of patients are being offered intensified ADT therapies as first-line (1L) treatment for mCSPC, even four to five years after data has become available. Dr. Agarwal supports this argument by citing three studies from the 2021 ASCO Annual Meeting: real-world utilization of advanced therapies and racial disparity among patients with mCSPC, a Medicare database analysis of over 35,000 patients (2009-2018); real-world 1L treatment patterns in patients with mCSPC in a U.S. health insurance database (2014-2019); and real-world treatment patterns among patients diagnosed with mCSPC in community oncology settings (2014-2019). Dr. Agarwal summarized the most salient finding: less than one-third of men received intensified treatment (ADT combined with docetaxel or with a novel hormonal therapy) as their first-line treatment for mCSPC. Additionally, most men received ADT alone or ADT combined with a nonsteroidal antiandrogen as their 1L treatment, even as recently as 2019, with Black and Hispanic men even less likely than White men to receive an intensified treatment. Further, most men whose cancer had spread to soft organs (e.g., liver, lungs) had received ADT alone. Dr. Agarwal concludes by reemphasizing that the vast majority of patients are not receiving intensification therapy which is backed by level-one evidence. Dr. Agarwal points to the importance of education, awareness, and access as critical to developing better science around implementation and leading to more patients being able to receive these transformative treatments.

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TITAN Phase 3 Trial with Apalutamide in Metastatic Castration Sensitive Prostate Cancer

Neeraj Agarwal, MD, Professor of Medicine and Presidential Endowed Chair of Cancer Research at the Huntsman Cancer Institute at the University of Utah in Salt Lake City, summarizes results from the phase 3 TITAN trial of apalutamide in metastatic castration-sensitive prostate cancer (mCSPC), focusing on patient-reported quality of life outcomes. He briefly discusses the design of the study, explaining that it featured a 1:1 randomization of over 1000 patients to apalutamide plus ADT or placebo plus ADT and had dual endpoints of overall survival (OS) and radiographic progression-free survival (rPFS). Dr. Agarwal notes that both primary and final analysis found significant improvements in both OS and rPFS. Surprisingly, adjusting for the approximately 40% crossover from the placebo arm to the apalutamide arm actually led to an even greater reduction in risk of death (48% compared to 35%). Dr. Agarwal notes that this is an unprecedented improvement in survival with mCSPC, and also that rapid and deep PSA decline with apalutamide and ADT was associated with improved OS. He also considers quality of life (QoL) measurements, describing the assessment tools for evaluating pain, fatigue, and health-related QoL, and then highlighting that neither primary nor final analysis saw declines in any of these with apalutamide as compared to placebo. In fact, patients on apalutamide reported experiencing less pain. Dr. Agarwal concludes that in men with mCSPC treatment with apalutamide significantly improved survival outcomes without adversely affecting quality of life and fatigue.

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