Janssen Provides Update on Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA (apalutamide) and ZYTIGA (abiraterone acetate) Plus Prednisone Combination

RARITAN, NJ, USA I April 19, 2021 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that regulatory submissions based on the Phase 3 ACIS study, which evaluated the combination of ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) plus prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), will not be pursued. As presented at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium in February 2021, the ACIS study met its primary endpoint of radiographic progression-free survival (rPFS); however, combination treatment did not show significant benefit over the active control ZYTIGA® plus prednisone in key secondary endpoints, including overall survival (OS).

“Safety results from ACIS were consistent with prior studies of ERLEADA and ZYTIGA plus prednisone, with no new safety signals observed. The study also generated valuable scientific outcomes and insights in subgroups of patients with luminal type in PAM50 test and tumors with average or high androgen receptor activity (molecular signatures of hormone sensitivity), which warrant further investigation,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “These data will be important in informing future programs in our pipeline, as we look to build upon our leadership and commitment in bringing transformational therapies to patients diagnosed with prostate cancer.”

About the ACIS Study
ACIS was a Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of ERLEADA® and ZYTIGA® plus prednisone compared to placebo and ZYTIGA® plus prednisone in 982 patients with chemotherapy-naïve mCRPC who received ADT. The primary endpoint of the study was rPFS. Secondary endpoints of the study included OS, time to chronic opioid use, time to initiation of cytotoxic chemotherapy, and time to pain progression.

About Metastatic Castration-Resistant Prostate Cancer
Metastatic castration-resistant prostate cancer characterizes cancer that no longer responds to ADT and has spread to other parts of the body. The most common metastatic sites are bones, followed by lymph nodes, lungs, and liver.[1] Prostate cancer is the second most common type of cancer in men worldwide. More than one million men around the world are diagnosed with prostate cancer each year.[2]

About ERLEADA® (apalutamide)
ERLEADA® is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).[3]ERLEADA® received U.S. Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. To date, more than 25,000 patients worldwide have been treated with ERLEADA®. ERLEADA® is taken orally, once daily, with or without food.3 The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer include apalutamide (ERLEADA®) with continued androgen deprivation therapy**as a Category 1 Preferred treatment option for patients with non-metastatic (M0) castration-resistant prostate cancer and a PSADT ≤10 months.[4]The NCCN Clinical Practice Guidelines® also include apalutamide (ERLEADA®) with androgen deprivation** as a Category 1 Preferred treatment option for patients with metastatic (M1) castration-naive prostate cancer.‡4 The American Urological Association (AUA) Guidelines for Castration-Resistant Prostate Cancer (CRPC) recommend clinicians offer apalutamide (ERLEADA®) with continued androgen deprivation therapy (ADT) as one of the treatment options for patients with nmCRPC at high risk for developing metastatic disease (Standard; Evidence Level Grade A)***.[5] ERLEADA® is being further studied in two ongoing Phase 3 clinical trials.
For more information about ERLEADA®, visit www.ERLEADA.com.

*© National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed December 11, 2020. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.
**Orchiectomy, LHRH agonist, or LHRH antagonist
Use of an LHRH agonist plus a first-generation antiandrogen is an option for patients receiving ADT alone, but is not an option for patients receiving apalutamide.
The term “castration-naive” is used to define patients who are not on ADT at the time of progression. The NCCN Prostate Cancer Panel uses the term “castration-naive” even when patients have had neoadjuvant, concurrent, or adjuvant ADT as part of radiation therapy provided they have recovered testicular function.
***Standard: Directive statement that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be taken based on Grade A or B evidence.
***Evidence Level: A designation indicating the certainty of the results as high, moderate, or low (A, B, or C, respectively) based on AUA nomenclature and methodology.

About ZYTIGA® (abiraterone acetate)
ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with mCRPC, approved by the U.S. FDA on April 28, 2011 and by the European Commission on September 7, 2011. Additionally, ZYTIGA® was approved for the treatment of high-risk mCSPC by the European Commission on November 20, 2017 and by the U.S. FDA on February 8, 2018.[6] Since its first approval in the U.S. in 2011, ZYTIGA® has been approved in combination with prednisone or prednisolone, in more than 100 countries. More than 500,000 patients worldwide have been prescribed ZYTIGA®.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

[1] Cancer.org. Understanding advanced cancer, metastatic cancer, and bone metastasis. https://www.cancer.org/treatment/understanding-your-diagnosis/advanced-cancer/what-is.html. Accessed April 2021.
[2] World Health Organization. "Globocan 2012: Prostate Cancer: Incidence, Mortality and Prevalence Worldwide, 2012." http://gco.iarc.fr/today/data/pdf/fact-sheets/cancers/cancer-fact-sheets-19.pdf. Accessed April 2021.
[3] ERLEADA® U.S. Prescribing Information, November 2020.
[4] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.3.2020. National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed December 2020.
[5] American Urological Association. Castration-Resistant Prostate Cancer Guidelines. http://www.auanet.org/guidelines/castration-resistant-prostate-cancer-(2013-amended-2018). Accessed April 2021.
[6] ZYTIGA® U.S. Prescribing Information, October 2020.

SOURCE: Janssen

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