(UroToday.com) The 2026 American Society of Clinical Oncology Genitourinary (ASCO) Annual Meeting held in Chicago, IL, will host the Prostate, Testicular, and Penile Cancer – Posters Session. Dr. Neeraj Agarwal will present Abstract 5087: Evaluation of concomitant medications in advanced prostate cancer patients receiving apalutamide: TITAN and SPARTAN post-hoc analysis.
Apalutamide is an androgen receptor pathway inhibitor approved in combination with ADT for patients with metastatic castration-sensitive prostate cancer and nonmetastatic castration-resistant prostate cancer based on the TITAN and SPARTAN trials.1,2 However, because apalutamide induces CYP3A4/2C19 and P-glycoprotein pathways, concerns remain regarding potential drug-drug interactions with commonly prescribed medications frequently used in this patient population.
To better characterize the clinical impact of these interactions, the investigators performed a post-hoc analysis of the TITAN and SPARTAN trials evaluating adverse events associated with commonly used concomitant medications, including antihypertensives, antidiabetics, statins, proton pump inhibitors (PPIs), and corticosteroids, among patients receiving apalutamide plus ADT versus placebo plus ADT.1,2
Concomitant medication use was common across both studies and reflected real-world clinical practice. (1,2) In TITAN, antihypertensives were used by 34.3% of patients receiving apalutamide and 41.9% of these patients experienced treatment-emergent adverse events (TEAEs), with treatment-emergent serious adverse events (TESAEs) occurring in only 1.9%. Similarly, in SPARTAN, 42.8% of patients receiving apalutamide used antihypertensives, with TEAEs observed in 49.4% and TESAEs in only 0.9%.
Among patients receiving antidiabetic medications, TEAEs were reported in 34.4% of TITAN patients and 42.9% of SPARTAN patients receiving apalutamide, while serious adverse events remained infrequent at 1.6% and 3.1%, respectively.
Importantly, rates of adverse events among patients receiving statins, PPIs, and corticosteroids were generally low and comparable to placebo-treated patients. No clinically meaningful increases in serious adverse events or signals suggesting loss of efficacy related to concomitant medication use were observed across either trial.
Key remarks:
- Concomitant medication use was frequent among patients enrolled in the TITAN and SPARTAN trials and reflected routine real-world practice
- Across antihypertensives, antidiabetics, statins, PPIs, and corticosteroids, no clinically meaningful increase in serious adverse events was observed with apalutamide plus ADT
- Rates of treatment-emergent serious adverse events remained low across medication classes
- These findings support the safe and feasible co-administration of apalutamide with commonly prescribed concomitant medications under standard clinical monitoring
- The analysis provides additional reassurance regarding the real-world use of apalutamide in patients with multiple medical comorbidities
Presented by: Neeraj Agarwal, MD, FASCO, Professor, Presidential Endowed Chair of Cancer Research, Director GU Program and the Center of Investigational Therapeutics (CIT), Huntsman Cancer Institute, University of Utah, Salt Lake City, UT
Written by: Julian Chavarriaga, MD, Clinical Assistant Professor, Urologic Oncologist, Department of Urology at Penn State Health @chavarriagaj on X during the American Society of Clinical Oncology Genitourinary (ASCO) Annual Meeting held in Chicago, IL between May 29th and June 1st, 2026
References:- Chi KN, Chowdhury S, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juárez A, Merseburger AS, Özgüroğlu M, Uemura H, Ye D, Brookman-May S, Mundle SD, McCarthy SA, Larsen JS, Sun W, Bevans KB, Zhang K, Bandyopadhyay N, Agarwal N. Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. J Clin Oncol. 2021 Jul 10;39(20):2294-2303. doi: 10.1200/JCO.20.03488. Epub 2021 Apr 29. PMID: 33914595.
- Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, Olmos D, Mainwaring PN, Lee JY, Uemura H, Lopez-Gitlitz A, Trudel GC, Espina BM, Shu Y, Park YC, Rackoff WR, Yu MK, Small EJ; SPARTAN Investigators. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018 Apr 12;378(15):1408-1418. doi: 10.1056/NEJMoa1715546. Epub 2018 Feb 8. PMID: 29420164.