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▎WuXi AppTec Content Team Editor Arvinas announced today that new data have been published showing that bavdegalutamide (also known as ARV-110), a novel PROTAC protein degrader targeting the androgen receptor (AR), targets metastatic castration resistance prostate cancer (mCRPC), continues to provide evidence of antitumor activity and patient benefit
.
These data demonstrate that bavdegalutamide reduced prostate-specific antigen (PSA) levels by ≥50% (PSA50) in 46% of patients with tumors harboring AR T878X/H875Y (T878X=T878A or T878S) mutations
.
Based on this result, Arvinas plans to initiate a pivotal clinical trial by the end of 2022 to evaluate bavdegalutamide in patients with mCRPC
.
These patients had disease progression after receiving innovative hormonal therapy or carried tumors containing AR T878X/H875Y mutations
.
Bavdegalutamide is an AR-targeting PROTAC protein degrader that recruits E3 ubiquitin ligases to the vicinity of ARs, tags ARs with ubiquitin, and guides them for proteasomal degradation
.
The latest data showed that the PSA50 rate of patients with AR T878X/H875Y mutant tumors was 46% (n=26)
.
Of the 7 RECIST-evaluable patients with AR T878X/H875Y-mutated tumors, 2 had confirmed partial responses
.
The PSA50 rate of evaluable patients was 26% (5/19) in the subgroup with less pre-treatment (prior treatment with only one new hormonal drug and no prior chemotherapy)
.
The tolerability of bavdegalutamide was manageable at the recommended dose (RP2D) of 420 mg in a phase 2 clinical trial
.
Most treatment-related adverse events (TRAEs) were grade 1/2, and no grade ≥4 TRAEs occurred in the 113 patients treated with RP2D
.
"These results are very encouraging and reinforce our belief that bavdegalutamide has the potential to provide meaningful benefits for patients with mCRPC who have few treatment options for disease progression following novel hormonal therapy," said Dr.
John Houston, Arvinas President and CEO.
of clinical benefit
.
With particularly robust activity in specific molecularly defined patient populations, we believe there is a clear path to developing this innovative therapy as a precision medicine and plan to initiate a pivotal Trials
.
" Disclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.
.
These data demonstrate that bavdegalutamide reduced prostate-specific antigen (PSA) levels by ≥50% (PSA50) in 46% of patients with tumors harboring AR T878X/H875Y (T878X=T878A or T878S) mutations
.
Based on this result, Arvinas plans to initiate a pivotal clinical trial by the end of 2022 to evaluate bavdegalutamide in patients with mCRPC
.
These patients had disease progression after receiving innovative hormonal therapy or carried tumors containing AR T878X/H875Y mutations
.
Bavdegalutamide is an AR-targeting PROTAC protein degrader that recruits E3 ubiquitin ligases to the vicinity of ARs, tags ARs with ubiquitin, and guides them for proteasomal degradation
.
The latest data showed that the PSA50 rate of patients with AR T878X/H875Y mutant tumors was 46% (n=26)
.
Of the 7 RECIST-evaluable patients with AR T878X/H875Y-mutated tumors, 2 had confirmed partial responses
.
The PSA50 rate of evaluable patients was 26% (5/19) in the subgroup with less pre-treatment (prior treatment with only one new hormonal drug and no prior chemotherapy)
.
The tolerability of bavdegalutamide was manageable at the recommended dose (RP2D) of 420 mg in a phase 2 clinical trial
.
Most treatment-related adverse events (TRAEs) were grade 1/2, and no grade ≥4 TRAEs occurred in the 113 patients treated with RP2D
.
"These results are very encouraging and reinforce our belief that bavdegalutamide has the potential to provide meaningful benefits for patients with mCRPC who have few treatment options for disease progression following novel hormonal therapy," said Dr.
John Houston, Arvinas President and CEO.
of clinical benefit
.
With particularly robust activity in specific molecularly defined patient populations, we believe there is a clear path to developing this innovative therapy as a precision medicine and plan to initiate a pivotal Trials
.
" Disclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.