Higher mortality Bayer or stop prostate cancer combination drug later study
December 04, 2017 Source: Sina Pharmaceutical
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Recently, an independent data monitoring committee (IDMC) warned that Bayer should suspend phase III clinical trials of prostate cancer in order to better take the time to further analyze the causes of increased fractures and deaths.
Bayer is currently undergoing Phase III clinical trials of Radium Ra 223 Dichloro (Radium-223, Xofigo) with Zytiga Acetate and Prednisone/prednisolone for prostate cancer. The subjects were predominantly patients with metastatic castration-resistant prostate cancer (mCRPC) with no or mild symptoms and chemotherapy. This study compared the situation of this population with those who received placebo. The primary endpoint of the trial was survival (SSE-FS) in patients without symptomatic skeletal events.
The trial began recruiting patients in September 2016, and a total of 806 patients were enrolled. The patients in the combined treatment group had not previously received treatment with radium Ra 223 dichloride. In the trial, they received only 6 doses of treatment (every four weeks).
The trial published the results in 2016, showing that the combination of radium-223 and abiraterone can significantly reduce the symptoms of bone pain in patients with prostate cancer.
According to analysts, "Bayer has been pursuing new cancer drugs as a core method of its production line. Xofigo is at the forefront of the market with a peak sales of $1.5 billion, and joint use is an important part of Bayer's strategy to expand Xofigo's market. But Now they should focus on why adding Xofigo to kill cancer cells with targeted alpha rays triggers more patient deaths and fractures."
After the success of AIDS treatments, combination therapy is a new trend in oncology drug development. Although it seems that this still poses a high risk of safety issues, they are often successful in cancer treatment.
Previously, the US FDA partially suspended five clinical trials, including the complete termination of clinical trials of Celgene's FUSION program. The test was performed using AstraZeneri Imfinzi and several Celgene-owned tumor compounds. The combined treatment trials of Merck's Keytruda and Bristol-Myers Squibb were also suspended for similar reasons.
In response, Mike Devoy, a member of the Executive Board and Chief Medical Officer of Bayer Pharmaceuticals, responded in a statement: “Patient safety is our number one priority. Importantly, Xofigo has been acquired based on previous trial data and actual usage. It is still beneficial to approve the indications and the risks and benefits to patients. We are still committed to further exploring the therapeutic potential of radium-223 for many types of tumors, including of course major unmet medical needs such as prostate cancer. ."
Bayer said that more than 18,000 American patients have received Radium-223 since its approval in 2013. The benefit risk profile confirmed by the clinical phase III ALSYMPCA trial is still conducive to Xofigo's final approval.
Prostate cancer cells can spread to areas other than the prostate. The common metastatic sites are adjacent to the bone and nearby tissues or lymph nodes. Castration-resistant prostate cancer is a late-stage type of prostate cancer in which approximately 90% of patients develop bone metastasis. (Sina Pharmaceutical Compilation / Fan Dongdong)
Article, image reference source: Higher Death Rate Forces Bayer to Stop Xofigo/Zytiga Combo Late-Stage Study Early
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