deutenzalutamide (HC-1119) / Hinova Pharma - LARVOL DELTA

A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC). (clinicaltrials.gov) - P3 | N=417 | Recruiting | Sponsor: Hinova Pharmaceuticals Inc. | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Haichuang Pharmaceutical’s core new drug has sparked heated discussion: Deutenenzalutamide and ARPROTAC technology are entering a new clinical stage! [Google translation] (Sohu.com) - "Recently, Haichuang Pharmaceuticals announced that the new drug application for its core product, deutenenzalutamide soft capsules (HC-1119), accepted in November 2023, and has now entered the technical review stage of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This progress has undoubtedly brought expectations to many investors and patients who are concerned about the development of anti-tumor drugs."

China filing • Prostate Cancer

A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC). (clinicaltrials.gov) - P3 | N=417 | Recruiting | Sponsor: Hinova Pharmaceuticals Inc. | N=255 ➔ 417 | Trial primary completion date: Jun 2024 ➔ Dec 2024

Enrollment change • Metastases • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Population Pharmacokinetics Modeling and Simulation of Deutenzalutamide, A Novel Androgen Receptor Antagonist, in Patients With Metastatic Castration-Resistant Prostate Cancer. (PubMed, Clin Pharmacol Drug Dev) - "The final covariate included body weight on peripheral compartment volume. This is the first research developing the population pharmacokinetic model of deutenzalutamide in patients with metastatic castration-resistant prostate cancer, and it is expected to support the future clinical administration of deutenzalutamide."

Journal • Metastases • PK/PD data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Haichuang Pharmaceutical: CDE has completed all professional reviews of deuterated enzalutamide soft capsules and has now entered the comprehensive review stage [Google translation] (Sina Corp) - "On September 19, Haichuang Pharmaceutical (688302.SH) stated on the investor interaction platform that CDE has completed all professional reviews of deuterated enzalutamide soft capsules (project number: HC-1119) and has now entered the comprehensive review stage. The company is continuing to actively communicate with CDE to steadily advance the launch of deuterated enzalutamide."

Launch • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P3 | N=104 | Terminated | Sponsor: Hinova Pharmaceuticals USA, Inc. | Trial completion date: Dec 2024 ➔ Jun 2024 | Active, not recruiting ➔ Terminated; Terminated by Sponsor for various factors including prolonged duration and enrollment challenges

Head-to-Head • Metastases • Trial completion date • Trial termination • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Enzalutamide Gets Added Approval for Prostate Cancer That Hasn’t Spread (National Cancer Institute) - "Other experts believe the approval will have a substantial impact on patient care. One of the trial's lead researchers, Stephen Freedland, M.D., of Cedars-Sinai in Los Angeles, said many patients with these high-risk biochemical recurrences will now be treated with the enzalutamide and leuprolide combination....Dr. Freedland acknowledged that side effects are a concern. 'But there are a lot of benefits' to using both drugs together, he added, including 'delaying metastasis.' The development of metastases not only requires immediate treatment but also can cause significant pain, particularly when the cancer has spread to the bones."

Media quote

HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P3 | N=104 | Active, not recruiting | Sponsor: Hinova Pharmaceuticals USA, Inc. | Trial completion date: May 2024 ➔ Dec 2024 | Trial primary completion date: Nov 2023 ➔ Jul 2024

Head-to-Head • Metastases • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Practice-Changing Results in Prostate Cancer, as Enzalutamide Regimens Show Strong Benefit (Oncology Business Review) - "Lead author Stephen Freedland, MD...speaks with...about how these findings should be applied in practice. Although the data represent a significant advance, Dr. Freedland suggests even more progress ahead, asking 'This is the new standard, but for [patients who are] at really high-risk, how can we do even better?'"

Audio

TALAPRO-2 (Talazoparib + Enzalutamide) in Prostate Cancer: Stephen Freedland and Neeraj Agarwal (Apple Podcasts) - "In this interview, Oncology Data Advisor Editorial Board member Dr. Stephen Freedland...about his recent publication of the TALAPRO-2 study."

Audio • Interview

After prostate cancer treatment, a new standard of care for rising PSA (Harvard Medical School) - "If PSMA findings show just a few metastatic tumors (this is called oligometastatic prostate cancer), then those tumors can be treated surgically or with radiation, and possibly with hormonal therapy. And if PSMA reveals widespread metastatic cancer throughout the body, then 'metastasis-directed therapy is no longer an option, and hormonal therapy with enzalutamide is the best option to delay progression as shown in EMBARK,' Dr. Freedland says."

Media quote

Guideline Revisions Seek to Optimize Detection and Management of Recurrent Prostate Cancer Without Evident Metastasis, Journal Club - Rashid Sayyid & Zachary Klaassen (Urotoday) - "...and Zach Klaassen discuss the amended AUA guidelines on advanced prostate cancer, focusing on biochemically recurrent prostate cancer without metastasis after local treatment. The guidelines emphasize informing patients about the risk of developing metastatic disease and recommend serial PSA measurements and clinical evaluations. High-risk patients, identified by pathologic grade or rapid PSA doubling time, should undergo periodic staging with cross-sectional imaging or PSMA PET imaging."

Video

Triple-Drug Therapies Usher in Sea Change for Men With High-Risk Prostate Cancer, Journal Club - Rashid Sayyid & Zachary Klaassen (Urotoday) - "...and Zach Klaassen discuss the amended AUA guidelines for advanced prostate cancer, focusing on triplet therapy for metastatic hormone-sensitive prostate cancer (mHSPC) and non-metastatic castrate-resistant prostate cancer (M0 CRPC)."

Video

TALAPRO-2 Study of Talazoparib/Enzalutamide in Prostate Cancer: Stephen Freedland and Neeraj Agarwal (YouTube) - "In this interview, Oncology Data Advisor Editorial Board member Dr. Stephen Freedland...speaks with Dr. Neeraj Agarwal...about his recent publication of the TALAPRO-2 study. Dr. Agarwal delves into the results of the trial, which investigated the efficacy of talazoparib plus enzalutamide for first-line metastatic castration-resistant prostate cancer (mCRPC), and their practice-changing significance."

Interview • Video

AUA Guidelines Provide Roadmap for Assessing Disease Burden and Personalizing Systemic Therapies in Metastatic Hormone Sensitive Prostate Cancer, Journal Club - Rashid Sayyid & Zachary Klaassen (Urotoday) - "...and Zach Klaassen discuss the 2023 amended AUA guidelines for advanced prostate cancer, focusing on metastatic hormone-sensitive prostate cancer (mHSPC). They emphasize the importance of assessing metastatic disease extent in newly diagnosed mHSPC patients, as it significantly influences systemic therapy choices. The guidelines recommend using either conventional imaging or PSMA PET for diagnosis, with treatment recommendations based on conventional imaging findings."

Video

Enzalutamide Approved for Prostate Cancer With Biochemical Recurrence: Stephen Freedland, MD (YouTube) - "The FDA recently granted approval to enzalutamide (enza) for the treatment of nonmetastatic castration-sensitive prostate cancer (nmCRPC) with biochemical recurrence, based on the results of the phase 3 EMBARK trial. Following the approval, Oncology Data Advisor Editorial Board member Dr. Stephen Freedland, co-lead investigator of the trial, sat down to share more about its significance for patients with high-risk prostate cancer and biochemical recurrence."

Video

Parsing the Evidence from the EMBARK Trial on a Promising New Drug Regimen in High-Risk Non-Metastatic Hormone-Sensitive Prostate Cancer - Matthew Cooperberg (Urotoday) - "Zach Klaassen converses with Matthew Cooperberg about findings from the EMBARK study, presented at ESMO and published in the New England Journal. The study focuses on the efficacy of enzalutamide (enza) plus leuprolide versus leuprolide alone in treating high-risk non-metastatic hormone-sensitive prostate cancer. Dr. Cooperberg notes the predictability of better efficacy with combination treatment in this patient group."

Video

The struggle is real: Keeping up with the rapidly evolving clinical evidence in urology (Urology Times) - ""Keeping up-to-date is challenging, and rapid progress that is now occurring in our field is truly amazing," writes Michael S. Cookson, MD, MMHC, FACS. Like most of you, I appreciate data-driven approaches to medicine and try, when possible, to adhere to evidence-based medicine. Historically, well-constructed guidelines from trusted, reliable sources have helped provide a good reference for clinical guidance. And in what I will refer to as 'simpler' times, there seemed to be relatively close alignment between the published literature and the updated guidelines."

Online posting

Enzalutamide With or Without Leuprolide and Leuprolide Alone in Biochemically Recurrent Prostate Cancer (THE ASCO POST) - "In the phase III EMBARK trial reported in The New England Journal of Medicine, Stephen J. Freedland, MD, and colleagues found that enzalutamide/leuprolide and enzalutamide alone improved metastasis-free survival vs leuprolide alone in patients with high-risk biochemical recurrence of prostate cancer."

Online posting

Comparative real-world evidence on Darolutamide, Enzalutamide, and Apalutamide for nonmetastatic castration-Resistant prostate cancer patients in the United States (DEAR) (WSAUA 2023) - P=NA | N=870 | "Overall, a lower % of patients discontinued their initial ARI treatment, progressed to mCRPC, or had AEs on darolutamide vs enzalutamide/apalutamide. In analyses adjusting for observed baseline factors, patients on darolutamide had considerably lower risk of DISC and PROG vs enzalutamide/apalutamide. This study confirms the efficacy and favorable tolerability profile for darolutamide in a real-world setting. The observed lower risk of progression to mCRPC with darolutamide vs enzalutamide/apalutamide may be associated with the longer treatment duration."

Retrospective data

A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC). (clinicaltrials.gov) - P3 | N=255 | Recruiting | Sponsor: Hinova Pharmaceuticals Inc. | Trial completion date: May 2022 ➔ Dec 2024 | Trial primary completion date: May 2022 ➔ Jun 2024

Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P3 | N=104 | Active, not recruiting | Sponsor: Hinova Pharmaceuticals USA, Inc. | Recruiting ➔ Active, not recruiting | N=430 ➔ 104

Enrollment change • Enrollment closed • Head-to-Head • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Podcast: ASCO23: Novel Approaches in RCC, mUC, and Prostate Cancer (ASCO Daily News) - "Dr. Neeraj Agarwal and Dr. Jeanny Aragon-Ching discuss the CLEAR study in renal cell carcinoma, a new exploratory analysis combining the TheraP and VISION trials in metastatic urothelial cancer, and compelling advances in prostate cancer and across GU oncology in advance of the 2023 ASCO Annual Meeting."

Audio • Renal Cell Carcinoma

Dr. Morgans on real-world study comparing darolutamide, enzalutamide, and apalutamide in nmCRPC (Urology Times) - "'We found in both unadjusted and adjusted analyses that patients seemed to discontinue enzalutamide and apalutamide at slightly earlier time points than darolutamide,' said Alicia Morgans, MD."

Video

Deutenzalutamide, an oral deuterated androgen receptor inhibitor, vs placebo for patients with mCRPC who have experienced treatment failure with abiraterone and docetaxel: Results of the HC-1119-04 phase 3 trial. (ASCO 2023) - P3 | "Deutenzalutamide demonstrated a statistically significant improvement of PFS vs placebo in a randomized phase 3 study in patients with mCRPC who have failed abiraterone, and who failed or were intolerant to docetaxel. Deutenzalutamide was well tolerated and has the potential as additional treatment option. Clinical trial information: NCT03851640."

Clinical • P3 data • Anemia • Cardiovascular • Dyslipidemia • Hematological Disorders • Hypertension • Metabolic Disorders • Prostate Cancer