- Patients with metastatic prostate cancer receiving a combination treatment that included Johnson & Johnson's Zytiga (abiraterone acetate) saw their risk of the death or disease progression decrease by more than half compared to standard of care alone, according recently released trial results.
- The Phase 3 LATITUDE study evaluated a pairing of the big pharma's drug, the immunosuppressent prednisone and androgen deprivation therapy (ADT) — a touchstone for prostate cancer treatment — against ADT and placebo in participants with high-risk metastatic hormone-naïve prostate cancer (mHNPC). In the treatment arm, median overall survival (OS) wasn't reached, while median radiographic progression-free survival (rPFS) was 33 months. In the control arm, median OS was 34.7 months and rPFS was 14.8 months.
- Regarding safety, one in five participants receiving the combination therapy had Grade 3 or 4 hypertension versus one in ten for those getting just ADT. Other serious adverse events, including hypokalemia and increased alanine aminotransferase levels, were seen in both arms, though higher in the treatment arm.
As competition heats up across various plains of the oncology world, combination therapies have become a helpful tool for drugmakers looking to expand product labels and hold onto market share. Big players such as AstraZeneca have exemplified the trend through their clinical aims, while others like Roche and Bristol-Myers Squibb are tapping M&A as a tool.
Differentiation, therefore, will be the primary operative for drugmakers in the space. On Johnson & Johnson's end, the results from LATITUDE showed patients on the combination therapy had a 38% lower risk of death than those taking ADT and placebo.
"Patients with newly diagnosed mHNPC, particularly those with high-risk characteristics, have a poor prognosis. Docetaxel in combination with ADT has shown improved outcomes in these [mHNPC] patients, but many patients are not candidates for docetaxel and may benefit from alternative therapy. Also, while the majority of patients initially start on ADT, it usually becomes less effective over time," Janssen said in an email to BioPharma Dive.
Zytiga has shown its ability to compete. The drug is Johnson & Johnson's highest grossing oncology offering, raking in $2.26 billion in 2016, or roughly 40% of company's total revenue from oncology drugs, according to the company's most recent 10-K filing with the Securities and Exchange Commission.
Johnson & Johnson already filed label expansion submissions for Zytiga to the European Medicines Agency as well as a handful of other countries to include mHNPC patients. As for the U.S., Janssen said that the company is looking into other potential markets to file for the new indication, but did not specify whether the states were on its radar.
“Improvements in the care and treatment of prostate cancer at all stages of its progression are vital. That is especially true for those men who face high-risk metastatic hormone-naïve prostate cancer, a traditionally difficult type of cancer to treat,” Marco Gottardis, Janssen's prostate cancer disease area stronghold leader, said in a June 3 statement.