April 1, 2023

Lakeview Gazette

Complete News World

A drug against a type of prostate cancer showed significant improvements against the disease

More than a thousand participants were enrolled to analyze the behavior of this drug.

First results Phase III testing The drug XTANDI ® was given Encouraging results. According to a report from the labs Pfizer and AstellasAfter the first analysis, they were able to determine “Statistically and clinically significant improvement In survival Metastasis is free (MFS)” in patients treated with this drug, leuprolide, versus placebo plus leuprolide.

As such, they explained that these “first-stage positive results from the Phase 3 EMBARK trial” are intended to test XTANDI ® (enzalutamide) in men with hormone-sensitive non-metastatic prostate cancer (nmHSPC; also known as prostate cancer). (NMCSPC) High risk biochemical recurrence (PCR)”.

As indicated, in order to analyze the behavior of this drug, more than a thousand participants were enrolled, who were randomized to one of the three arms of the study. First is “XTANDI plus leuprolide”, next is “Placebo plus leuprolide” and last is “XTANDI monotherapy”.

After initial analysis, they were able to determine a “statistically and clinically significant improvement in metastasis-free survival (MFS),” as described in the SALUD VITHAS MEDIMAR report.

During the evaluation, they noted that “XTANDI plus leuprolide and patients treated with placebo plus leuprolide met its primary endpoint with a statistically and clinically significant improvement in metastasis-free survival (MFS).” It asserts that the combination “significantly improves metastasis-free survival in men with nonmetastatic prostate cancer.”

But that’s not all, as the experts observed “a positive trend in the key secondary endpoint of overall survival (OS)”, although they are still inconclusive, trial participants will be “followed for further analysis endpoints”. They also noted that the trial was able to identify “a key secondary endpoint with a statistically and clinically significant improvement in MFS in patients treated with XTANDI monotherapy and placebo plus leuprolide.”

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Chris Boshoff, Pfizer’s Director of Oncology and Rare Disease Development commented on these results, “XTANDI has impacted the lives of hundreds of thousands of men as the only novel hormone therapy approved in the US for three prostate cancer cases.” We look forward to collaborating with health authorities to bring XTANDI to men with cancer.”

As indicated by the two drug companies, “detailed results will be presented at a future clinical meeting.”

Commenting on this development, Astellas Senior Vice President and Head of Therapeutic Area Development, Ahsan Arozulla, explained: “Although current treatment options for localized prostate cancer are curative, some men are at high risk of biochemical recurrence after primary. treatment, which may lead to metastasis. That’s why, he highlighted, “the EMBARK trial is the first study to demonstrate a statistically significant improvement in MFS using the combination of XTANDI plus leuprolide in men with this disease state.”

As indicated by the two drug companies, “detailed results will be presented at a future clinical meeting,” while “the data will be discussed with regulatory authorities, including the US Food and Drug Administration (FDA), to support a potential regulatory submission” for the drug’s approval.

It was a multinational, randomized, double-blind, placebo-controlled phase III trial, they explained, involving 1,068 patients with metastatic hormone-sensitive prostate cancer (nmHSPC; also called hormone-sensitive prostate cancer). metastatic or nmCSPC) with high-risk biochemical recurrence (BCR). Countries investigated: USA, Canada, Europe, South America and Asia.

The principle of XTANDI ® is enzalutamide, which acts as an inhibitor of androgen receptor signaling. Its administration was carried out through capsules or tablets, which were administered orally once a day with or without food.

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