Bayer hikes Nubeqa's peak sales to more than €3B on prostate cancer data, teeing up new 3-way battle against Pfizer-Astellas, J&J

Bayer is spelling out an even more bullish estimate for Nubeqa’s blockbuster potential, thanks to a trial win in a new prostate cancer frontier for the drug. But the German drugmaker still faces an uphill fight against two formidable incumbent players.

Bayer has significantly dialed up Nubeqa’s peak sales estimate to over 3 billion euros ($3.4 billion) compared with the previous 1 billion euros. The goal is to develop Nubeqa into a “foundational type of drug across the entire spectrum of prostate cancer," Robert LaCaze, head of the oncology business unit at Bayer’s pharma division, said in an interview with Fierce Pharma.

The new number is buoyed by a late-stage study showing that adding Nubeqa to androgen deprivation therapy (ADT) and the chemotherapy docetaxel significantly extended the lives of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Compared with ADT and chemo alone, the Nubeqa regimen slashed the risk of death by 32.5%, according to data released at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU).

Based on the data, Bayer is “pursuing the fastest possible regulatory timelines” to bring Nubeqa to mHSPC patients, LaCaze said in a statement. LaCaze won’t be the one to see that process through; he’s leaving the company, and the baton will be handed to GlaxoSmithKline veteran Christine Roth.

The positive readout, which comes from the phase 3 ARASENS trial, puts Nubeqa on a collision course with two blockbuster rival androgen receptor inhibitors, namely Pfizer and Astellas’ Xtandi and Johnson & Johnson’s Erleada. By the look of it, the three drugs have posted some similar patient survival results.

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Erleada was the first of the three to enter mHSPC, also called metastatic castration-sensitive prostate cancer. The J&J drug got that FDA go-ahead in September 2019 based on interim data from the phase 3 TITAN trial showing its addition to ADT could pare down the risk of death by 33%. The final analysis from the longer follow-up of that trial put the improvement at 35%, according to data from last year’s ASCO GU.

Xtandi followed Erleada into mHSPC three months later. At that time, Xtandi only had data showing its pairing with ADT could stall tumor progression or death over ADT alone. A final analysis of the phase 3 ARCHES trial last year showed the Xtandi-ADT combo reduced the risk of death by 34% versus ADT alone.

Despite the similarities in the numbers, Nubeqa’s ARASENS has one key difference from the other two trials. Unlike Xtandi and Erleada that used ADT as the control arm, Nubeqa was added to the combo of ADT and docetaxel, which Bayer says is a guideline-recommended standard-of-care in mHSPC.

Building on previous knowledge that an androgen receptor inhibitor could work alongside ADT, Bayer started ARASENS hoping to do better with a triplet, LaCaze explained.

Bayer and partner Orion launched their own ADT comparator study, dubbed ARANOTE, last February. Probably because the FDA has already approved Erleada and Xtandi for mHSPC, the study is being conducted outside the U.S.

Physicians select different regimens based on the patient's performance profile, LaCaze explained. “Our goal is to make sure that we generate data across the different spectrum of prostate cancer that will allow doctors to use not just their medical judgment but scientific data as they're choosing the right treatment approach for the patient.”

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Picking on Pfizer/Astellas and J&J wouldn’t be an easy task, given the years of head start the two have gained.  

First approved by the FDA in 2012 as a therapy for metastatic castration-resistant prostate cancer, Xtandi brought in 411.6 billion Japanese yen ($3.58 billion) for Astellas during the nine months ended in December 2021. Erleada, first greenlighted in early 2018 for nonmetastatic castration-resistant disease, got J&J $1.29 billion in global sales for 2021.

Nubeqa now only has a nonmetastatic castration-resistant label from an FDA nod mid-2019. A long path lies ahead for Nubeqa before it could fufill Bayer’s 3-billion-euro aspiration. As of the third quarter of last year, the drug hasn’t earned a separate line item on Bayer’s financial reports. During an investors’ call in November, Bayer’s pharma chief Stefan Oelrich said the company expects Nubeqa’s sales could reach somewhere between 200 million euros and 250 million euros in 2021. The German company is expected to report full-year earnings March 1.

LaCaze touted Nubeqa's safety profile as a “clear differentiation” across the clinical trials. In ARASENS, for example, grade 3/4 treatment-emergent side effects were similar between the two arms, at 66.1% for Nubeqa and 63.5% for the control group.

That allows patients to stay on treatment longer and makes Nubeqa “an ideal agent” to move into even earlier lines of treatment, LaCaze said. Toward that end, Bayer is collaborating on a trial evaluating Nubeqa as a part of an adjuvant treatment for men having radiation therapy for localized prostate cancer with very high risk of recurrence. It's also launching a new trial later this year for patients who have been treated with surgery or radiation and now see a rise in their prostate specific antigen levels, he added.

Editor's Note: The story has been updated with new information on Bayer's peak sales estimate for Nubeqa and additional comments from Robert LaCaze.