Bayer Nubeqa for prostate cancer reduces the risk of death by 32.5%!

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Bayer Nubeqa for prostate cancer reduces the risk of death by 32.5%!

Reduce the risk of death by 32.5%! Bayer’s new drug for prostate cancer: Phase III clinical results positive.

In a phase 3 clinical trial in patients with metastatic hormone-sensitive prostate cancer (mHSPC), the combination of androgen deprivation therapy (ADT) ) + chemotherapy (docetaxel), Bayer’s new prostate cancer drug Nubeqa (darolutamide, darolutamide) + ADT + chemotherapy regimen reduced the risk of death by 32.5%.

Bayer Nubeqa for prostate cancer reduces the risk of death by 32.5%!

Based on the data, Bayer is “seeking the fastest possible regulatory timeline” to bring Nubeqa to patients with mHSPC, Robert LaCaze, head of Bayer’s pharmaceutical division’s oncology business, said in a statement.

Robert LaCaze won’t be the one to complete the process, though, and he’s leaving Bayer to hand the baton to former GSK executive Christine Roth, who was previously GSK’s senior vice president of global oncology. , will join Bayer on March 1 this year.

Positive data from Phase 3 ARASENS trial will pit Nubeqa against 2 competing androgen receptor inhibitors – Pfizer/Astellas Xtandi (enzalutamide) and Johnson & Johnson Erleada (apalutamide, Apa other amines) collide. On the surface, the 3 drugs have published some similar patient survival results.

Erleada is the first of 3 drugs to enter the mHSPC (also known as metastatic castration-sensitive prostate cancer [mCSPC]) market. In September 2019, Erleada received U.S. FDA approval based on interim data from the Phase 3 TITAN trial.

Data from the TITAN trial showed that Erleada in combination with ADT reduced the risk of death by 33% compared to ADT.

The final analysis of the trial’s long-term follow-up showed a 35% reduction in the risk of death, according to data presented at last year’s ASCO GU meeting.

Three months later, Xtandi followed Erleada into the mHSPC market. At the time, there were only data showing that the combination of Xtandi and ADT delayed tumor progression or death compared with ADT.

Last year’s final analysis of the Phase 3 ARCHS trial showed that the Xtandi+ADT combination reduced the risk of death by 34% compared to ADT alone.

Although numerically similar, Nubeqa’s Phase 3 ARASENS trial has one key difference from the two trials above.

The Xtandi and Erleada trials used ADT as the control group, while the Nubeqa trial used the ADT + docetaxel combination as the control group, which Bayer says is the standard-of-care regimen recommended by the mHSPC treatment guidelines.

Last February, Bayer and partner Orion launched a Phase 3 ARANOTE trial with their own ADT as a control group.

But it may be because the US FDA has approved Erleada and Xtandi for mHSPC, so the study is being conducted outside the US.

Bayer has high hopes for Nubeqa, which had previously expected peak annual sales of more than 1 billion euros. Based on positive data from the Phase 3 ARASENS trial, the company raised Nubeqa’s peak annual sales, which are expected to exceed 3 billion euros.

However, given that Pfizer/Astellas Xtandi and J&J Erleada have had a multi-year lead, it won’t be easy for Nubeqa to challenge them.

In early 2012, Xtandi was first approved by the US FDA for the treatment of metastatic castration-resistant prostate cancer (mCRPC), and the drug brought Astellas 411.6 billion yen in the nine months ending December 2021 ($3.58 billion) in sales.

Erleada was first approved by the U.S. FDA in February 2018 for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC), and in 2021, the drug will generate $1.29 billion in global sales for J&J.

Nubeqa was approved by the US FDA in July 2019, and the current indication is limited to nmCRPC.

The drug did not have a separate revenue line item in Bayer’s financial reports as of the third quarter of last year.

At an investor meeting in November, Bayer’s pharmaceutical chief executive Stefan Oelrich said Nubeqa is expected to generate sales of 200-250 million euros in 2021.

The company is expected to report fiscal 2021 operating results on March 1 this year.

Reference：

ASCO GU: Bayer tees up another 3-way battle against Pfizer-Astellas, J&J with new Nubeqa prostate cancer data

Bayer Nubeqa for prostate cancer reduces the risk of death by 32.5%!

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