CHICAGO—Johnson & Johnson may soon be able to move prostate cancer med Zytiga into an earlier disease stage, thanks to game-changing new data that rolled out on Saturday at the American Society of Clinical Oncology (ASCO) annual meeting.
Zytiga, in tandem with prednisone and androgen deprivation therapy, trounced an ADT-plus-placebo duo at improving survival among patients with high-risk metastatic hormone-naïve prostate cancer, cutting the risk of death by 38%, J&J said Saturday. Median overall survival for the Zytiga arm wasn’t reached, while the placebo arm posted an average of 34.7 months.
And that wasn’t all. Zytiga also slashed the risk of progression or death by 53%, more than doubling the average time to one of those events from 14.8 months on ADT alone to 33 months on the J&J med.
“We can consider this a new standard of care for these patients,” Peter De Porre, global clinical leader for J&J’s Janssen, said in an interview.
Right now, Zytiga is approved only for patients with castration-resistant prostate cancer. But the participants in the study, dubbed Latitude, were “not yet castration resistant” and “still sensitive to hormones,” De Porre said. Currently, many patients in that pool have received a combo of ADT and chemo med docetaxel.
But as he pointed out, “there’s a large population of these patients that are either not willing to take chemotherapy, they’re afraid of chemotherapy, or they’re just unfit to get chemotherapy.” The Zytiga cocktail, instead, “offers a new paradigm to patients to be treated at an earlier stage, with a very significant effect on their survival.”
J&J has already kicked off the process of trying to snag a new indication in some countries; it’s submitted applications in Europe, Brazil, Switzerland and Taiwan, and it’s working on a Japanese filing.
If it can win some green lights, it’ll give it a leg up against fierce Pfizer rival Xtandi, which itself has lately run into some trouble expanding its niche. In December, the Pfizer product fell short in a study pairing it with Zytiga that could have supported longer-term treatment.