Nubeqa gains flexibility with indication expansion

Will it be able to overcome limitations in access with the expanded indication?

Granted approval for use in combination with ADT for metastatic hormone-sensitive prostate cancer

Enables personalized treatment for patients with various stages of prostate cancer

Accessibility limited due to non-reimbursement... increasing the need to reduce treatment burden

The influence of Nubeqa (darolutamide) is rising in the market with the company expanding its indication as a treatment for metastatic hormone-sensitive prostate cancer (mHSPC).

 

Experts believe that the drug may settle as a flexible treatment option in Korea’s market as it has broadened its path as a personalized treatment.

 

With the approval, overcoming the reimbursement hurdles is expected to serve as the key to competition in the future.

 

Hyun-ho Han, professor of Urology at Severance Hospital

Bayer Korea held a media seminar on the 20th to celebrate the indication expansion for Nubeqa, an oral androgen receptor inhibitor (ARi), and highlighted its clinical significance.

 

In June, Nubeqa was approved by the Ministry of Food and Drug Safety as part of a two-drug regimen in combination with androgen deprivation therapy (ADT) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

 

In South Korea, Nubeqa was previously approved for use in combination with ADT and docetaxel for the treatment of mHSPC patients, as well as in combination with ADT for the treatment of high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).

 

With the expanded indication, Nubeqa can now be used not only as a three-drug regimen in combination with ADT and the chemotherapy agent docetaxel but also as a two-drug regimen in combination with ADT.

 

The approval was based on the results of the global Phase III clinical trial ARANOTE, which evaluated the efficacy and safety of the two-drug regimen of Nubeqa in combination with ADT in 669 patients with mHSPC.

 

The study results showed that the Nubeqa combination group significantly reduced the risk of radiographic progression or death by 46% compared to the placebo group, and this improvement in radiographic progression-free survival (rPFS) was consistently observed across all groups, including high-risk and low-risk mHSPC patients.

 

Also, in the secondary endpoint, overall survival (OS), the Nubeqa combination therapy group demonstrated potential survival benefits compared to the placebo group, showing significant delays in disease progression in terms of PSA level, deterioration in quality of life, and pain progression, thereby proving clinically meaningful improvements in quality of life.

 

The most significant aspect of this expanded indication is that Nubeqa is now the only treatment approved for both three-drug regimens with docetaxel and two-drug regimens with ADT in patients with metastatic hormone-sensitive prostate cancer.

 

The introduction of this new option is expected to offer a more flexible treatment approach tailored to the individual condition and treatment goals of mHSPC, including providing treatment options for elderly patients or those who are not suitable for chemotherapy.

 

Hyun-ho Han, professor of Urology at Severance Hospital, who presented at the media seminar, said, “Most mHSPC patients in Korea are elderly, aged 60 or older, and often have comorbidities.

 

It is necessary to devise personalized treatment strategies based on clinical evidence, taking into account the patient's condition and preferences.” Professor Han added, “With the approval of the two-drug Nubeqa + ADT regimen, it is now possible to tailor treatment according to patient characteristics depending on whether docetaxel is used.

 

Patients who require aggressive initial treatment can consider the three-drug combination therapy of Nubeqa + ADT + docetaxel, while patients with CNS concerns, such as the elderly or those with chronic diseases, or patients who are not suitable for docetaxel treatment, can consider the two-drug combination therapy of Nubeqa + ADT." Currently, Nubeqa is approved in over 85 countries worldwide as a treatment for mHSPC and nmCRPC, and as of 2024, it has surpassed annual sales of approximately KRW 2.4 trillion, establishing itself as a blockbuster drug.

 

However, it is still non-reimbursed in Korea, resulting in high costs and limited access for patients.

 

Currently, treatments such as Xtandi, Zytiga, and Erleada are reimbursed as treatments for mHSPC, so reimbursement is essential for competition with these products..

 

On this, Professor Han emphasized that Korea needs more treatment options when considering the criteria set for reimbursement of the existing drugs in prostate cancer.

 

He said, “There are cases when patients with metastatic prostate cancer or non-metastatic castration-resistant prostate cancer are not eligible for reimbursement coverage.

 

We want to offer cost-effective choices to patients, so any additional covered option that are introduced are welcome on our part.” Considering that existing treatments can only be used in combination with ADT, Professor Han believes that the three-drug regimen of Nubeqa + ADT + docetaxel may offer additional advantages.

 

In addition, MyungKyu Noh, Oncology BU lead at Bayer Korea, said, “Bayer Korea is going through the reimbursement process so that domestic prostate cancer patients can promptly receive our treatment and its reimbursement as soon as possible.

 

We will actively communicate with various stakeholders, including patients, medical staff, and the government, to improve access to treatment for all three indications.