Bayer’s Nubeqa, en route to blockbusterland, clinches 2nd win in prostate cancer subtype

17 Jul 2024
www.fiercepharma.com
Bayer’s Nubeqa, en route to blockbusterland, clinches 2nd win in prostate cancer subtype
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Source: FiercePharma
The ARANOTE readout could help Nubeqa move closer to Bayer’s target of over 3 billion euros in peak sales. (Bayer)
Bayer has claimed a second pivotal trial win for its blockbuster-to-be androgen receptor inhibitor Nubeqa, looking to reach the entire space of metastatic hormone-sensitive prostate cancer (mHSPC).
The positive readout, from the phase 3 ARANOTE trial, showed that Nubeqa’s combination with androgen deprivation therapy (ADT) significantly extended the time before tumor progression or death compared with ADT alone, Bayer said Wednesday.
The German pharma now plans to submit these data for potential approvals around the world.
The ARANOTE readout could help Nubeqa move closer to Bayer’s target of over 3 billion euros in peak sales. With 869 million euros in sales and an 86.5% growth rate in 2023, Nubeqa is on track to cross the blockbuster bar this year.
mHSPC is already contributing to Nubeqa’s sales thanks to an FDA approval in 2022. At that time the phase 3 ARASENS trial showed that the combination of Nubeqa, ADT and the chemotherapy docetaxel lowered the risk of death by 32% versus ADT and chemo.
But not all patients can tolerate chemo. For patients with low-volume metachronous metastases, the current National Comprehensive Cancer Network (NCCN) guidelines only recommend ADT in combination with one of three hormone therapies without chemo as the preferred regimens.
Overall survival is a secondary endpoint in the current ARANOTE trial. Bayer in its Wednesday announcement didn’t touch on what that data point looks like. The safety profiles were comparable between the two treatment arms, the company said.
Besides tumor-slowing or life-extending efficacy, better tolerability has been an important selling point for Nubeqa.
In a real-world study called DEAR based on medical records of 828 patients with non-metastatic castration-resistant prostate cancer—which was Nubeqa’s initial indication gained in 2019—patients who took Nubeqa experienced a lower adverse event rate compared with those who got Pfizer and Astellas’ Xtandi or Johnson & Johnson’s Erleada. Treatment discontinuation or progression to metastatic disease also occurred at a lower rate with Nubeqa compared with the other two second-generation androgen receptor inhibitorsandrogen receptor inhibitors.
In addition to the two existing tumor settings, Bayer is running the phase 3 ARASTEP trial to evaluate whether the addition of Nubeqa could improve on ADT in nonmetastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence. That study could take some time to read out, with an estimated primary completion date in early 2027.
With an FDA go-ahead in November, Pfizer and Astellas’ Xtandi, first approved 12 years ago, has already become the first androgen receptor inhibitor to reach that earlier prostate cancer treatment setting.
On Bayer’s part, Nubeqa and the kidney disease drug Kerendia are considered key growth drivers for the company’s pharma unit. Two of Bayer’s top-selling drugs are facing major headwinds. The J&J-partnered blood thinner Xarelto has lost patent protection in Bayer’s territories outside the U.S., and the Regeneron-partnered eye med Eylea faces tough competition from Roche’s Vabysmo.
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