Avid Bioservices Inc (CDMO)

[biopharm]

If Bavi helps Docetaxel, and Docetaxel helps radiation.

Help me out with this one ...... hmmm, Bavi+Radiation...Go figure, things are about to heat up : )

No, no Biopharm.... you should first connect the dots and notice that Docetaxel is guarded nicely by "Sanofi" and is the most prescribed "Taxane" in the U.S. and "Sunrise" Phase III is highlighting Bavi+Docetaxel already. I think I'll be seeing more shorts covering on Monday.

Adding ADT, Docetaxel to Radiation Improves Survival in Patients With High-Risk Prostate Cancer: Presented at ASTRO

Sept 19, 2014

By Alex Morrisson

SAN FRANCISCO -- September 19, 2014 -- Freedom from progression of prostate cancer in high-risk men was extended from historic numbers by adding androgen deprivation therapy and docetaxel to adjuvant radiation therapy, according to a study presented here at the 56th Annual Meeting of the American Society for Radiation Oncology (ASTRO).

At 3 years follow-up, 73% of the men who underwent the 3-pronged treatment following prostatectomy had achieved freedom from progression, reported Mark Hurwitz, MD, Thomas Jefferson University, Philadelphia, Pennsylvania.

In his oral presentation on September 14, Dr. Hurwitz said that the aim of the single arm trial was to at least improve freedom from progression from its historic 50/5 level in the high-risk population and improve that to at least 70% with freedom from progression of their disease at 3 years.

“The study endpoint was met,” said Dr. Hurwitz. “Addition of androgen deprivation therapy and docetaxel to adjuvant radiation therapy for men at high risk of failure despite adjuvant radiation therapy alone following prostatectomy results in greater than 20% improvement in 3-year freedom from progression as compared with historical controls.”

Dr. Hurwitz said the addition of chemotherapy increased adverse side effects with more than 50 of the 74 patients in the trial experiencing grade 3 or Grade 4 neutropenia and leukopenia. However, “most of these adverse events was anticipated and was manageable without long-term sequelae,” he said.

To be eligible for the study, post-prostatectomy nadir prostate-specific antigen (PSA) had to be greater than 0.2 ng/ml and the tumour Gleason score had to have been 7 or greater. Men were also eligible if their nadir PSA was =0.2 ng/ml and they were diagnosed with Gleason 8 or greater prostate cancer and the patients also were diagnosed with Stage pT3a or greater.

Treatment consisted of androgen suppression for 6 months plus external beam radiation starting 8 weeks after initiation of androgen deprivation at a radiation dose of 66.6 Gray delivered in fractions of 1.8 Gray, followed by docetaxel beginning 3 to 6 weeks after completing the radiation phase of the treatment. Docetaxel was dosed at 75 mg/m2 on day 1 of a 21-day cycle, and was repeated for 6 cycles.

Failure was defined as a PSA value of at least 0.4 ng/ml, the use of non-protocol hormones, clinical failure or death within 3 years. Dr. Hurwitz said 20 events occurred in 3 years, meeting the criteria for a positive trial.

As this was a single arm study using historical controls, “phase 3 trials assessing androgen deprivation therapy and chemotherapy with radiation in this high-risk population is warranted,” said Dr. Hurwitz said.

Funding for this study was provided in part by sanofi-aventis.

[Presentation title: Adjuvant Radiation, Androgen Deprivation and Docetaxel for High-Risk Prostate Cancer Post-Prostatectomy: Results of RTOG 0621. Abstract CT-01]

http://www.firstwordpharma.com/node/1236066?tsid=1#axzz3DvYOA9xE

The most prescribed taxane in the United States

Taxotere® is a chemotherapy agent for which the main indications at present are breast cancer, non-small cell lung cancer and prostate cancer.
Some of the major development possibilities for Taxotere® are cancers of the head and neck and gastric cancer.

http://www.sanofi.com.pk/l/pk/en/layout.jsp?cnt=C604D286-AC41-4435-9588-060FF19BFA82