Prostate cancer: New battlefield for global companies

Two new drugs, Erleada and Nubeqa, to follow Xtandi

Mainly targeting non-metastatic castration-resistant prostate cancer

Prostate cancer market is predicted to emerge as another tight battleground for multinational pharmaceutical companies.

 

Pharmaceutical industry sources reported on Jan.

 

20, two new drugs are to compete head-to-head with the world’s first oral option of androgen receptor (AR) inhibitor Xtandi (enzalutamide) supplied by Astellas Pharma Korea.

 

Apparently, both of the new drugs have submitted approval application to Korea’s Ministry of Food and Drug Safety (MFDS), and they are expecting the process to be completed within this year.

 

Janssen’s Erleada (apalutamide) and Bayer’s Nubeqa (darolutamide) are the investigational drugs to be indicated for treating patients with non-metastatic castration-resistant prostate cancer (nmCRPC), a same indication as Xtandi’s.

 

The medical needs for nmCRPC had not been fully met as the specific condition lacks various treatment options and has high risk of death among all prostate cancer conditions.

 

◆ Following the success of Zytiga, Janssen to expand prostate cancer market presence: Already supplying an androgen biosynthesis inhibitor blocking 17α-hydroxylase/C17, 20-lyase (CYP17), Zytiga (abiraterone), Janssen has been predicted to tackle a variety of prostate cancer indications, including nmCRPC, with Erleada.

 

In last September, the U.S.

 

health authority has approved Erleada’s indication to treat metastatic castration-sensitive prostate cancer (mCSPC).

 

During the Phase 3 SPARTAN trial, Erleada confirmed its efficacy.

 

The international study evaluated and compared the safety and efficacy between Erleada plus androgen deprivation therapy (ADT) combination therapy and placebo plus ADT on patients with nmCRPC, who had rapidly rising prostate-specific antigen (PSA) level despite continuous ADT.

 

As a result, the Erleada patient group’s risk of metastasis or death was reduced by 72 percent compared to the placebo group, while the Erleada group’s median metastasis-free survival (MFS) was 40.5 months, or over two years longer than the placebo group.

 

◆ Bayer’s comeback after Xofigo’s staggering performance: Nubeqa has gotten a spotlight as an emerging growth engine for Bayer’s future.

 

Bayer entered the global and Korean prostate cancer treatment market with Xofigo (radium-223 dichloride) in 2013 and 2014, respectively, but the outcome was rather disappointing.

 

Since then the company conducted a trial to confirm Xofigo’s effect as a combination therapy, but the company has failed to turn around.

 

As for Nubeqa, it confirmed its efficacy during the Phase 3 ARAMIS trial.

 

Administering a combination therapy with Nubeqa and ADT, the patient group demonstrated a significant improvement in MFS, a primary efficacy endpoint of the study.

 

The Nubeqa arm’s MFS was 40.4 months, whereas the placebo arm’s was 18.4 months.

 

The investigational drug demonstrating low blood-brain barrier permeability than any other AR inhibitor in every clinical trial phase is its highlighted strength.

 

This could mean patients could expect reduced adverse reaction in central nervous system.

 

Meanwhile, none of treatment options for nmCRPC has been listed for reimbursement.

 

In November 2014, reimbursement on Xtandi was approved with risk sharing agreement (RSA) for treating patients with mCRPC, who has been treated with docetaxel before.

 

The drug renewed the agreement and extended listing in last February to January 2023.