Churchill Pharmaceuticals Announces YONSA Clinical Data to be presented at ASCO GU in San Francisco

Data from pivotal STAAR trial published in the February 2018 issue of Urologic Oncology

KING OF PRUSSIA, Pa.--()--Churchill Pharmaceuticals LLC (“Churchill”) today announced that positive data from the STAAR and STAAR-E clinical trials, evaluating YONSA™ (abiraterone acetate) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC), will be presented at the 2018 American Society of Clinical Oncology, Genitourinary Cancers Symposium (ASCO GU), February 8-10, 2018 in San Francisco. The New Drug Application (NDA) for YONSA was based primarily on the results of the STAAR trial – published in the current edition of the journal Urologic Oncology – and was accepted by the U.S. Food and Drug Administration (FDA) for review in July 2017.

"We are delighted with the interest YONSA is receiving from the oncology and urology medical communities as a potential new treatment option for patients with mCRPC,” said Matt Callahan, Chief Executive Officer of Churchill Pharmaceuticals. “We are equally excited about the data emerging from the ongoing STAAR-E study, as we believe the information from this study may be most important when healthcare providers and healthcare systems are considering therapy for patients with mCRPC."

STAAR is a randomized, open-label U.S. trial comparing YONSA (500mg once daily) plus methylprednisolone (4 mg twice daily) to another formulation of abiraterone acetate (Zytiga®*, 1000 mg once daily) plus prednisone (5 mg twice daily). Study investigators evaluated 53 male patients with mCRPC (mean age of 75 years) and a majority of whom had Gleason scores >7. Over 90% of patients treated with YONSA achieved absolute testosterone levels of <1 ng/dL at each time point, while non-detectable testosterone levels (≤0.1 ng/dL) were achieved in a higher percentage of patients treated with YONSA versus patients treated with the comparator.1

The STAAR abstract at ASCO GU reports the 24-hour pharmacokinetic results comparing YONSA to Zytiga®, showing there was no statistical difference between the two agents despite the lower dose of YONSA. The second abstract is the initial release of data from the Phase 3 STAAR-E Study, which concludes that the safety profile of YONSA, in patients treated for up to one year – more than 50% of whom had been previously treated with Zytiga® – is consistent with safety reported in the literature for Zytiga®, and that patients who had been on a Zytiga® regimen can be safely switched to YONSA.

Details regarding these abstracts and presentation of posters are as follows:

            Lead Author:   Chris Dunshee, MD, FACS
Title: Pharmacokinetic (PK) subgroup results from the phase 2 pharmacodynamic and bioequivalence study of abiraterone acetate fine particle formulation (AAFP) in patients with metastatic castration-resistant prostate cancer (mCRPC): The STAAR study
 
Abstract Number: 176
Poster Session A: Prostate Cancer and Trials in Progress
Poster Board Number: H16
Date / Time: Thursday, February 8, 11:30 a.m. – 1 p.m., and 5:15 p.m. – 6:15 p.m. PST
Location: Moscone West Building
 
Lead Author: Richard Levin, MD
Title: Multicenter extension and switch study evaluating the safety of long-term treatment with abiraterone acetate fine particle formulation (AAFP) in patients with metastatic castration-resistant prostate cancer (mCRPC): The STAAR-E study
 
Abstract Number: 181
Poster Session A: Prostate Cancer and Trials in Progress
Poster Board Number: J1
Date / Time: Thursday, February 8, 11:30 a.m. – 1 p.m., and 5:15 p.m. – 6:15 p.m. PST
Location: Moscone West Building
 

About YONSATM (abiraterone acetate)

YONSA is an investigational oral agent, formulated as abiraterone acetate tablets. YONSA is a CYP17 inhibitor being developed for the treatment of metastatic castration-resistant prostate cancer in combination with methylprednisolone. The active ingredient is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, which inhibits 17 α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in testicular, adrenal and prostatic tumor tissues and is required for androgen biosynthesis. YONSA tablets have double the bioavailability of the comparator formulation of abiraterone acetate. YONSA has been formulated using the SoluMatrix Fine Particle Technology™.

The STAAR Study

The STAAR study (CHL-AA-201, A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Evaluate Serum Testosterone Levels in Patients with Metastatic Castration-Resistant Prostate Cancer) was an 84-day study in the U.S. comparing YONSA in combination with methylprednisolone against Zytiga® in combination with prednisone. The primary endpoint was comparative lowering of serum testosterone at pharmacodynamic steady-state. Additional secondary endpoints included safety assessments, prostate-specific antigen (PSA) levels and pharmacokinetic measurements.

The STAAR-E Study

The STAAR-E study (CHL-AA-202, An Open-Label, Single-Arm, Multiple Center Extension Study to Evaluate One Year of Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer) is an open label extension study to evaluate safety of one year of treatment with YONSA in patients with mCRPC who completed three months of treatment with either YONSA in combination with methylprednisolone or Zytiga® in combination with prednisone in the STAAR study and were then transitioned to YONSA. All patients enrolled in the STAAR-E Study completed therapy on YONSA. Secondary objectives include the evaluation of disease progression, evaluation of serum testosterone and PSA levels, and response rate at 6 months and 1 year of treatment with YONSA compared to baseline.

About Churchill Pharmaceuticals, LLC

Churchill is focused on providing value to cancer care by developing quality orally delivered oncology products with optimized clinical profiles. Our commitment to responsibly deliver these products to the patients, payers and healthcare communities we serve is at the core of our business. Churchill has a license from iCeutica to the SoluMatrix Fine Particle Technology™.

For more information, please visit https://www.churchillpharma.com and http://www.iceutica.com

*Zytiga® is a trademark of JOHNSON& JOHNSON.

1.   Stein CA, Levin R, Given R, et al. Randomized phase 2 therapeutic equivalence study of abiraterone acetate fine particle formulation vs. originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer: The STAAR study. Urol Oncol. 2018;36(2):e9-81.e16. doi: 10.1016/j.urolonc.2017.10.018.

Contacts

Media:
Reba Auslander, 917-836-9308
reba@raliancecommunications.com
or
Scott Megaffin
Churchill Pharmaceuticals
info@churchillpharma.com

Release Summary

Churchill Pharma announces YONSA data to be presented at ASCO GU on Feb. 8 in San Francisco, and publication of STAAR data in Urologic Oncology

Contacts

Media:
Reba Auslander, 917-836-9308
reba@raliancecommunications.com
or
Scott Megaffin
Churchill Pharmaceuticals
info@churchillpharma.com