February 4, 2019
Genentech has closed two large Phase III trials for its once-hyped anti-Alzheimer’s drug crenezumab after an independent data monitoring committee warned the company that crenezumab wasn’t likely to hit its primary endpoint.
The CREAD 1 and CREAD 2 trials had enrolled 1,500 patients worldwide, all of them in the early stages of Alzheimer’s disease, and offered patients doses four times higher than in the Phase II trials that had showed promise in helping patients.
But Genentech, a subsidiary of Roche, announced last week that its IDM committee told them the drug didn’t seem to be improving patients’ scores on individual cognitive tests.
Genentech officials acknowledged the “disappointing” results but said that they’re still studying crenezumab in an ongoing trial of clinically healthy patients in Colombia who carry the genetic mutation associated with heritable Alzheimer’s
J&J Scores on Phase III Metastatic Prostate Cancer Trial
Johnson & Johnson says it has scored another victory for its anti-cancer drug Erleada (apalutamide), this time in patients with metastatic prostate cancer.
The FDA approved Erleada for non-metastatic prostate cancer in February 2018. Last week, Johnson & Johnson subsidiary Janssen Pharmaceutical Companies announced that its Phase III TITAN trial of Erleada and a combination of androgen-depravation therapy had met its two primary endpoints — radiographic, progression-free survival and overall survival.
The specific numbers weren’t released but Johnson officials promised to unveil them “at an upcoming medical congress.”
TITAN was a Phase III, randomized, placebo-controlled, double-blind study in men newly diagnosed with metastatic disease. More than 1,050 men were given either Erleada plus androgen depravation or a placebo with androgen depravation. The men were treated until the disease progressed, until they suffered from drug toxicity, or until they chose to stop treatments.
Erleada is an androgen receptor inhibitor and the first of its kind to win FDA approval for non-metastatic, castration-resistant prostate cancer.
Startup Launches Drug Development Program, Will Donate Rights to Nonprofit
Clinical trial service provider Notable Labs is making its first foray into research with a new investigational leukemia drug and plans to sign over rights to the pediatric treatment to the nonprofit group Cures Within Reach.
Notable has developed its own compound, ND-1000, as a treatment for adult and pediatric leukemia and blood cancers.
Under the FDA’s pediatric priority review voucher program, Notable will be able to donate its commercial rights to price, manufacture and distribute the pediatric form of ND-1000 to the nonprofit, whose mission is to match existing drugs and devices to applications for unsolved diseases.
Baylor Offers New Surrogate Endpoint for Prostate Cancer Survival
Researchers at Baylor University believe they’ve zeroed in on a surrogate endpoint for survival outcomes for prostate cancer patients: the time to biochemical failure in the disease.
The team analyzed data from the Phase III NRG Oncology/Radiation Therapy Oncology Group 9202 trial, which included about 1,500 men with localized, high-risk prostate cancer. The trial tested two treatments treatment — short-term and long-term androgen deprivation therapy.
Biochemical failure — defined as three consecutive rises in a patient’s prostate-specific antigens — seemed to track along four distinct time landmarks — 12 months, 24 months, 36 months and 48 months after the men completed radiation (or two years after the long-term group completed their androgen-deprivation). The trial found long-term androgen deprivation improved the men’s survival rates.
The 24-month biochemical failure status was an accurate predicter of the two different clinical outcomes. The predictive power was even stronger at 36 and 48 months.
Read the team’s findings, published in the Journal of Clinical Oncology, here: https://bit.ly/2DaPzU7.
WCG Acquires MAGI Conference
WCG Clinical has acquired First Clinical Research, organizer of the MAGI conference, in a move the two companies say will help the twice-yearly conference expand its mission of improving communication and sharing best practices among clinical trials professionals.
First Clinical founder and Managing Director Norman M. Goldfarb will remain at MAGI’s helm, “tasked with expanding MAGI’s presence” and “accelerating WCG’s creation of — and participation in — collaborative initiatives that deliver value to the industry,” WCG says.
First Clinical also publishes the Journal of Clinical Research Best Practices, distributed to more than 50,000 subscribers every month.