The efficacy of first-line everolimus/bevacizumab and interferon alfa-2a/bevacizumab appears similar in patients with metastatic renal cell carcinoma, a recent study published online early in the journal Annals of Oncology has shown.

For the open-label, phase II RECORD-2 trial, researchers sought to compare the safety and efficacy of everolimus plus bevacizumab with interferon plus bevacizumab as first-line therapy for patients with metastatic renal cell carcinoma.

Researchers enrolled 365 untreated patients and randomly assigned them 1:1 to bevacizumab 10mg/kg every 2 weeks with either everolimus 10mg/day or interferon 9MIU three times weekly, if tolerated.

Results showed that median progression-free survival was 9.3 months in the everolimus arm and 10.0 months in the interferon arm (P = 0.485). Researchers found that median overall survival was 27.1 months in both treatment arms.

In regard to safety, 23.4% from the everolimus arm and 26.9% from the interferon arm discontinued treatment due to adverse events.

The most common grade 3-4 adverse events in the everolimus/bevacizumab group were proteinuria, stomatitis, and anemia versus fatigue, asthenia, and proteinuria in the interferon/bevacizumab group.

Reference

1. Ravaud A, Barrios CH, Alekseev B, et al. RECORD-2: phase II randomized study of everolimus and bevacizumab versus interferon alfa-2a and bevacizumab as first-line therapy in patients with metastatic renal cell carcinoma. Ann Oncol. 2015. [Epub ahead of print]. doi: 10.1093/annonc/mdv170.

...

Dr. Rex L. Mahnensmith, a former medical director at DaVita's New Haven Dialysis Clinic in Connecticut, who worked as a nephrology professor at Yale University for more than 20 years, is the subject of two federal lawsuits filed in Connecticut that allege sexual misconduct.  The cases were filed on behalf of seven present and former employees of the dialysis center, including nurses, a social worker and a dietitian, The New York Times reported April 13. The DaVita dialysis center is a defendant in the cases, along with Yale and Mahnensmith.

According to the Times, the plaintiffs' complaints include unwanted sexual contact from Mahnensmith, and a lack of action on the part of the university and DaVita, when they reported specific incidents.

"While we can't comment on the specifics of the case, we are confident that when the facts come out, they will show that upon learning of the allegations, DaVita acted swiftly and appropriately," a DaVita spokesperson told NN&I.

DaVita said it had removed the doctor from practice at the clinic in January 2014.

The Times reported that DaVita stressed to its staff its “intent to keep Dr. Mahnensmith happy to protect its contracts with Yale,” the complaints say, because “the Yale contracts afforded DaVita both financial gain and status.” To preserve that connection, court papers say, DaVita failed to act when clinic administrators reported Dr. Mahnensmith’s misbehavior.

“This has been going on for years,” Jennifer Zito, the lawyer for six of the plaintiffs, told the times. “But staff were just told to try and work around him.”

Read more about the cases at The New York Times.

...

The efficacy of first-line everolimus/bevacizumab and interferon alfa-2a/bevacizumab appears similar in patients with metastatic renal cell carcinoma, a recent study published online early in the journal Annals of Oncology has shown.

For the open-label, phase II RECORD-2 trial, researchers sought to compare the safety and efficacy of everolimus plus bevacizumab with interferon plus bevacizumab as first-line therapy for patients with metastatic renal cell carcinoma.

Researchers enrolled 365 untreated patients and randomly assigned them 1:1 to bevacizumab 10mg/kg every 2 weeks with either everolimus 10mg/day or interferon 9MIU three times weekly, if tolerated.

Results showed that median progression-free survival was 9.3 months in the everolimus arm and 10.0 months in the interferon arm (P = 0.485). Researchers found that median overall survival was 27.1 months in both treatment arms.

In regard to safety, 23.4% from the everolimus arm and 26.9% from the interferon arm discontinued treatment due to adverse events.

The most common grade 3-4 adverse events in the everolimus/bevacizumab group were proteinuria, stomatitis, and anemia versus fatigue, asthenia, and proteinuria in the interferon/bevacizumab group.

Reference

1. Ravaud A, Barrios CH, Alekseev B, et al. RECORD-2: phase II randomized study of everolimus and bevacizumab versus interferon alfa-2a and bevacizumab as first-line therapy in patients with metastatic renal cell carcinoma. Ann Oncol. 2015. [Epub ahead of print]. doi: 10.1093/annonc/mdv170.

...

Hydra Biosciences Inc., which specializes in transient receptor potential channel modulation, and Boehringer Ingelheim have started a collaboration and license agreement to identify small-molecule TRP inhibitors, with a primary focus on the treatment of renal diseases and disorders.

The two companies last year began collaborating to research and develop small-molecule TRPC4/5 inhibitors for the treatment of central nervous system diseases and disorders.

Under the terms of the collaboration agreement, the companies will work together to identify and advance candidate inhibitors. Boehringer Ingelheim is responsible for the global development and commercialization of the inhibitors that come from the collaboration. Hydra will receive an undisclosed upfront payment, additional research funding, and the company is eligible to receive milestone payments and tiered royalty payments on future product sales.

...