TITAN trial aims to Erleadain combination with androgen deprivation therapy in patients with mCSPC. Credit: Photo by Paweł Czerwiński on Unsplash.

Janssen Pharmaceutical Companies of Johnson & Johnson has unblinded the Phase III TITAN trial investigating Erleada (apalutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

The development follows recommendation provided by an Independent Data Monitoring Committee (IDMC) and a pre-planned evaluation that showed that the trial achieved its dual primary endpoints of improving radiographic progression-free survival (rPFS) and overall survival (OS).

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

IDMC suggested that patients in the placebo plus ADT group should be allowed to cross over to treatment with Erleada plus ADT. However, the TITAN trial will continue to follow patients for OS and long-term safety results.

Janssen Research & Development Oncology Clinical Development vice-president Margaret Yu said: “The TITAN study was designed to evaluate the efficacy and safety of Erleada in combination with androgen deprivation therapy in patients with newly-diagnosed metastatic castration-sensitive prostate cancer, regardless of the extent of their disease.

“We look to continue to build upon our understanding of Erleada for patients with metastatic prostate cancer.”

“We look to continue to build upon our understanding of Erleada for patients with metastatic prostate cancer as there remains a significant unmet need for additional treatment options.”

Janssen plans to submit applications seeking regulatory approval of Erleada based on results from the TITAN trial within this year.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

TITAN features a randomised, placebo-controlled, double-blind design. It includes more than 1,050 men who were newly diagnosed with metastatic disease, irrespective of prognostic risk, volume of disease, prior treatment with docetaxel or treatment of localised disease.

Patients with mCSPC were randomised to be treated with either Erleada plus ADT or placebo plus ADT as part of the trial.

The trial’s secondary endpoints comprise time to chemotherapy, time to pain progression, time to chronic opioid use, and time to skeletal-related event.