Approximately 1.4 million new cases of prostate cancer are diagnosed worldwide each year, making prostate cancer the second most common cancer in men and the fourth most common cancer overall.¹ It is so common that all men are at risk for developing the cancer, but factors such as age, family history, and obesity increase the odds. Prostate cancer also has one of the widest racial disparities of any cancer, and these disparities are prevalent at every stage of the cancer continuum.

For those diagnosed with prostate cancer, the majority occur in the early stages ², where the disease is considered curable with definitive therapy, such as surgery or radiation therapy. But a proportion of patients will progress after definitive therapy, or worse, be diagnosed at an advanced stage of the disease. It is often then considered incurable. The median overall survival for patients who have increasing levels of the protein prostate-specific antigen (PSA) after localized treatment survive between eight and nine years.³ For those with a certain type of advanced prostate cancer, known as metastatic castration-resistant prostate cancer (mCRPC), the prognosis is dire – survival is only about 13 months.^4,5

Research over the past decade has focused on improving outcomes for men with mCRPC, and while advances have been made with the introduction of therapies known as novel hormonal therapies (NHTs), some patients eventually develop resistance and are left with no other treatment options.

This is where Pfizer is aiming to deliver the next scientific breakthrough.

Pfizer's R&D efforts have led to a robust pipeline allowing us to explore various therapeutic approaches of potential benefit to patients in clinical trials. One such trial is the Phase 3 TALAPRO-2 trial which found that the combination of TALZENNA® (talazoparib), our oral poly ADP-ribose polymerase (PARP) inhibitor, with XTANDI®* (enzalutamide) yielded a statistically significant and clinically meaningful improvement in radiographic progression-free survival compared with placebo plus XTANDI. Benefits in other key endpoints, such as overall survival, prostate-specific antigen (PSA) response, time to PSA progression, and overall response rate, were also observed.

“For men with mCRPC, time is especially important, and we want to give people living with this disease the possibility of more time with their loved ones,” said Chris Boshoff, MD, PhD, Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. “If approved, we believe TALZENNA may offer a new treatment option.”

TALAPRO-2 is a two-part, two-cohort, multicenter, randomized, double-blind, placebo-controlled, Phase 3 study of 1,095 patients with mCRPC. TALZENNA or the combination of TALZENNA plus XTANDI has not been approved by any regulatory agency for the treatment of mCRPC.

“TALAPRO-2 underscores our long-term commitment to men living with advanced prostate cancer,” said Suneet Varma, Global Oncology and U.S. President, Pfizer.“ Based on the compelling combination data from TALAPRO-2, we believe TALZENNA in prostate cancer may become the next potential blockbuster opportunity in our leading Pfizer Oncology portfolio, subject to regulatory approval.”

*Pfizer and Astellas jointly commercialize XTANDI in the United States, and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.