Bayer's Nubeqa scores key prostate cancer win in battle with Pfizer, J&J - FiercePharma

Bayer and Orion’s Nubeqa may have been late to the prostate cancer market, but a new gold-standard clinical win could give it a better chance at challenging Pfizer and Astellas’ Xtandi and Johnson & Johnson’s Erleada.

After winning a quick FDA nod in July 2019 based on data showng it could delay tumor metastasis or death in patients with non-metastatic castration-resistant prostate cancer (nmCRPC), Nubeqa has turned up new results showing that when used on top of androgen deprivation therapy (ADT), it can prolong patients’ lives as well.

For Bayer, which is under pressure to ramp up sales from new drugs before its top-selling Xarelto and Eylea fall off the patent cliff, it’s a much-needed win. But how important that win is remains a question.

Detailed data from the phase 3 Aramis trial won't roll out until a future medical meeting, so how long Nubeqa can extend lives isn't yet known. But Bayer says the overall survival improvement is significant—and it’s the first among the three androgen receptor inhibitors to tout such a win in this nmCRPC population. 

At last year’s European Society for Medical Oncology annual meeting, J&J unveiled that its Erleada-ADT pairing cut patients’ risk of death by 25% compared with a combo of ADT plus placebo. However, at that second interim analysis, the benefit wasn’t enough to cross the statistical significance bar.

RELATED: ESMO: J&J's Erleada misses survival mark, but execs see reason to cheer

Meanwhile, Xtandi’s overall survival data were not mature yet, either, according to Pfizer’s most recent update.

On the known marker of delaying time to distant metastasis or death, or metastasis-free survival (MFS), analysts were previously split on Nubeqa’s profile. In the Spartan trial, Erleada showed it could slash risks by 72%, and in the Prosper study, Xtandi demonstrated it could do so by 71%. But for Nubeqa, Jefferies analysts pointed to a hazard ratio of 0.41, which means it only reduced the risk of metastasis or death by 59%—lower than the figures posted by both Xtandi and Erleada.

Nubeqa face several challenges, as GlobalData analysts pointed out back when the drug nabbed its FDA go-ahead last summer. First, nmCRPC is a relatively small market, key opinion leaders have suggested. Plus, reimbursement has so far proven to be a challenge; England's drug cost watchdog, the National Institute for Health and Care Excellence, recently rejected Xtandi in the same setting.

RELATED: Pfizer, Astellas' Xtandi matches J&J's rival Erleada with new prostate cancer nod

But in doing so, the British reviewers cited a lack of evidence that Xtandi could extend lives. Now that Nubeqa has that data, it might be easier for it to win over payers, especially outside of the U.S.

As for the market size limitation, Bayer is also testing Nubeqa in a phase 3 trial dubbed Arasens in metastatic castration-sensitive prostate cancer, though that study's first results won't be out for another couple of years. Both Erleada and Xtandi recently entered that field with FDA approvals.