Positive data for Black men
Cases of advanced prostate cancer are on the rise for the first time in 20 years.
What’s more, Black men are 70% more likely to be diagnosed with prostate cancer than White men, and two to four times more likely to die from it than those in any other race/ethnicity — one of the largest disparities in cancer incidence and mortality.
“Age 70 is a factor,” Dr. Aida Habtezion, Pfizer’s chief medicalofficer said. “Men are more likely to develop prostate cancer with advanced age and are more likely to die from prostate cancer. Another factor is having African ancestry. One of six Black men will develop this cancer in their lifetime. Within five to seven years, they can develop cancer that has spread beyond the prostate. Beyond treatment.”
Pfizer recently announced its positive results from the Phase 3 TALAPRO-2 study of TALZENNA ® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI ® (enzalutamide), demonstrating improvements in radiographic, progression-free survival in men with metastatic castration-resistant prostate cancer.
Metastatic castration-resistant prostate cancer (mCRPC) is a cancer that has spread beyond the prostate gland and has progressed despite medical or surgical treatment to lower testosterone. Approximately 10%–20% of prostate cancer patients develop mCRPC within 7 years of diagnosis.
“This is TALAPRO-2 study combines two agents for men with metastatic prostate cancer,” explained Habtezion. “We are excited about this combination, as it has shown meaningful clinical and significant improvements.”
XTANDI is an androgen receptor inhibitor indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC) and mCSPC. Overall survival benefit has been observed in patients treated with XTANDI in mCRPC.
The findings were presented last month during the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium. In the final analysis, TALZENNA plus XTANDI reduced the risk of disease progression or death by 37% versus placebo plus XTANDI.
“Novel hormone therapies dramatically changed outcomes for patients with mCRPC in the last decade, and the results from the TALAPRO-2 study show that the addition of talazoparib to the existing standard of care adds significant clinical benefit,” said Neeraj Agarwal, M.D., FASCO, professor of oncology and presidential endowed chair of cancer research at Huntsman Cancer Institute, University of Utah, and lead investigator for TALAPRO-2.
“In addition to delaying disease progression, this combination delayed prostate-specific antigen progression and time to chemotherapy without adversely impacting patient quality of life,” he said. “The TALAPRO-2 results support the potential for this combination to be practice-changing, with strong, highly consistent efficacy and observations in mCRPC patients both with or without gene mutations, and across clinically relevant sub-populations.”
TALAPRO-2 is the first Phase 3 study to combine TALZENNA with XTANDI in patients unselected for genetic alterations in DNA damage repair pathways.
“Patients with mCRPC need new treatment approaches that can improve outcomes, and the results from TALAPRO-2, which are the longest observed in a randomized trial in this setting, demonstrate the potential of the TALZENNA and XTANDI combination, if approved, to become new standard of care,” said Chris Boshoff, M.D., Ph.D., chief development officer, oncology and rare disease, Pfizer Global Product Development.
“We look forward to working with global regulatory authorities to bring this treatment to men with mCRPC.”
Among patients treated with TALZENNA plus XTANDI, the most common adverse events included anemia (65.8%), decreased neutrophil count (35.7%), fatigue (33.7), decreased platelet count (24.6%), back pain and decreased white blood cell count (22.1% each), and decreased appetite (21.6%).
Pfizer plans to submit detailed results from the trial for peer-reviewed publication. Pfizer has shared these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency, and other regulatory agencies to support regulatory filings.
It is hoped that approval will come this summer.
“It needs the acceptance of the FDA,” said Habtezion, noting the disparity that exists in millions of males who live with this cancer. “It’s important for all men and of course, for Black men.”
For more information visit www.clinicaltrials.gov.