Bayer’s ‘Nubeqa’ can be prescribed at general hospitals

Bayer’s new prostate cancer drug ‘Nubeqa’

Passed DC reviews at SMC·Asan·Gangnam Severance Hospital, etc.

Verified efficacy through Phase III ARAMIS study… improved OS and risk of death

The new prostate cancer drug ‘Nubeqa’’ can now be prescribed at general hospitals in Korea.

 

According to industry sources, Bayer’s oral androgen receptor inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), ‘Nubeqa (larotrectinib)’ has recently passed the review of drug committees (DC) in three major hospitals - the Samsung Medical Center, Asan Medical Center, and Gangnam Severance Hospital.

 

Nubeqa is an androgen receptor inhibitor with a distinct chemical structure that binds to the receptor and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.

 

The drug was approved based on the Phase III ARAMIS study that assessed the safety and efficacy of Nubeqa in combination with androgen deprivation therapy (ADT) compared to ADT alone.

 

Study results demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) in Nubeqa +ADT, with a median of 40.4 months, compared to the 18.4 months for placebo+ADT.

 

Also, Nubeqa+ADT reduced the risk of death by 31%.

 

Also, the full overall survival (OS) results from the pre-specified final OS analysis of the Phase III ARAMIS trial were published in the New England Journal of Medicine (NEJM) on the 9th.

 

Results showed that Nubeqa+ADT showed a statistically significant improvement in OS compared to placebo plus ADT, with a 31% reduction in risk of death.

 

The results hold significance as the OS improvement was achieved despite 55% of patients that taking placebo received subsequent Nubeqa or other life-prolonging therapy after the trial was unblinded at data cut-off for final analysis (November 15, 2019).

 

Meanwhile, Nubeqa has not been added to the insurance benefit list yet.

 

The drug has been determined inappropriate for reimbursement by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in February, and the company has supplemented the data and is again undergoing the listing process.