New Clinical Trials for Kidney Cancer

Two new clinical trials for kidney cancer are available at Lehigh Valley Health Network through its partnership with Memorial Sloan Kettering Cancer Center, giving patients options for experimental treatment and participation in research that advances kidney cancer treatment.

The immunotherapy trials test combinations of drugs that cut off blood supply to tumor cells and help the immune system find and fight cancer cells.

A decade ago, late-stage kidney cancer patients had a small chance of living past a year after diagnosis, said Dr. Suresh Nair, medical director of LVHN Cancer Institute.

“The amount of progress that’s happened in the year is staggering,” he said. “Kidney cancer has probably progressed the most among all the cancer areas in the past year.”

On Thursday, about 30 patients made it to their second annual celebration of advancements in kidney cancer treatment. The event, which was sponsored by the Andy Derr Foundation for Kidney Cancer Research and hosted by LVHN and Memorial Sloan Kettering at Lehigh Country Club, also featured a talk by leading kidney cancer doctor and researcher Dr. Robert Motzer, an oncologist at Memorial Sloan Kettering.

Kidney cancer research had a major breakthrough in 2006, when a Pfizer drug sunitinib won approval from the Food and Drug Administration, Motzer said. The drug cut off blood flow to tumors and prolonged life for late-stage kidney cancer patients.

Since then, survival rates continue to climb due to new generations of sunitinib, including one used by LVHN doctors called cabozantinib, and advancements in immunotherapy, which boosts the immune system to fight cancer.

But there’s a lot more progress to be made.

“That’s why efforts like your own are so important,” Motzer said at LVHN’s event. “That’s what gets the work done.”

Every year, more than 37,000 men and 21,000 women get kidney and renal pelvis cancers, according to the U.S. Centers for Disease Control and Prevention, and more than 13,000 die.

LVHN offers six clinical trials for kidney cancers, including the two newest.

New treatments give patients such as Lackawanna County resident Arlene Townsend a second chance at life. She’s participating in an LVHN immunotherapy trial launched last year.

Before her diagnosis, Townsend, 38, was easily irritated and didn’t have any passion for her job or life.

“It use to be get up, go to work, come home, make dinner,” she said. “It was kind of just going through the motions.”

She had to develop a positive attitude to cope with the physical and emotional toll of her late-stage kidney cancer, which had spread to her bones, lung and the lymph nodes around the heart in 2016, she said. Since her diagnosis, she found a passion for refurbishing furniture, let go of her cynicism and found happiness in life’s small moments.

“If I’m driving — it sounds silly — I notice the clouds,” she said.

“You don’t realize how many great things you have in your life until you think you’re not going to have them anymore.”

The change was so apparent that her husband noticed.

“He thinks I’m much happier,” she said.


CLINICAL TRIALS

Lehigh Valley Health Network and Memorial Sloan Kettering have partnered to bring new cancer treatments to the Lehigh Valley.

What is a clinical trial: A study involving patients who volunteer to receive new medications or treatments under evaluation.

Who may participate: Criteria are unique to each trial but often are based on age, gender, health and medical history. They are designed for participants most like those who will eventually receive the new drugs.

Source: Lehigh Valley Health Network

More information: At lvhn.org, search “clinical trials.”

From http://www.mcall.com/business/healthcare/mc-nws-biz-clinical-trials-kidney-cancer-20180406-story.html

Exelixis’ Kidney Cancer Drug Cabometyx Positive in Phase II

Exelixis, Inc. (EXELAnalyst Report) announced positive top-line data from the phase II trial, CABOSUN, on Cabometyx in patients suffering from previously untreated advanced renal cell carcinoma (RCC).

Results showed that Cabometyx led to significant improvement in progression-free survival in patients with previously untreated advanced RCC, compared with sunitinib. Consequently, the trial met its primary endpoint.

Safety data from the Cabometyx arm of the study were consistent with those observed in previous studies in patients with advanced RCC.

Final results of the trial will be presented at a medical conference shortly.

We remind investors that Cabometyx (the tablet formulation of cabozantinib) was approved by the FDA in Apr 2016 for the treatment of patients with advanced RCC, who have received prior anti-angiogenic therapy.

Meanwhile, the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Cabometyx for review in the same indication. Upon a potential approval, the drug would be marketed in the EU by Exelixis’ partner, Ipsen. The MAA has been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which translates a review period of 150 days instead of the standard 210 days.

Exelixis also plans to submit results of the CABOSUN trial to regulatory authorities in order to discuss further development of Cabometyx and submission strategy for the treatment of first-line advanced RCC.

As per the American Cancer Society, kidney cancer is one of the top 10 most commonly diagnosed forms of cancer in both men and women in the U.S. Hence, approval of Cabometyx in first-line advanced RCC will boost its growth prospects significantly.

Exelixis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Abbott Laboratories (ABT – Analyst Report) , Johnson & Johnson (JNJ – Analyst Report) and Sanofi (SNY – Analyst Report) . All three stocks carry a Zacks Rank #2 (Buy).

From https://www.zacks.com/stock/news/218403/exelixis-kidney-cancer-drug-cabometyx-positive-in-phase-ii

Pipeline Series: Renal Cell Carcinoma – Cancer Therapy Advisor

In the last decade, the U.S. Food and Drug Administration (FDA) has approved a variety of kinase inhibitors, including sorafenib, temsirolimus, everolimus, sunitinib, pazopanib, and axitinib—all angiogenesis inhibitor— for the treatment of patients with advanced renal cell carcinoma (RCC). Two additional immunotherapeutic agents;  bevacizumab, which is another antiangiogenic agent; and nivolumab are also indicated for advanced RCC.

Cabozantinib

Cabozantinib is an oral, small-molecular tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), like the angiogenesis inhibitors, as well as MET and AXL. An open-label, phase 3 trial comparing the efficacy of cabozantinib to that of everolimus in patients with RCC that had progressed after VEGFR-targeted therapy demonstrated a 42% lower rate of progression or death with cabozantinib.1

“Cabozantinib is very interesting. Data published in The New England Journal of Medicine in September 2015 and an update presented at the 2016 Genitourinary Cancers Symposium showed that the drug beat the second-line standard everolimus in terms of progression-free survival,” said Dr Choueiri, who also serves on the National Comprehensive Cancer Network Kidney & Testicular Cancers Panel and is chairman of the Medical and Scientific Steering Committee of the Kidney Cancer Association…

Source: Pipeline Series: Renal Cell Carcinoma – Cancer Therapy Advisor

New drug improves outcome in treatment resistant kidney cancer – ONA

 

A new drug is proven more effective than standard therapies for advanced kidney cancer in patients with demonstrated drug resistance.A study trial, led by researchers from the Dana-Farber Cancer Institute, compared the effectiveness of a new drug, cabozantinib, with the accepted second-line treatment, everolimus (Affinitor).

The trial enrolled 658 patients with clear cell renal carcinoma; all participants had advanced or metastatic renal cell carcinoma and their disease had worsened following first-line therapy.

Initial therapy for these patients had targeted the vascular endothelial growth factor receptor (VEGFR). Cabozantinib proved to be more effective than everolimus in slowing the growth of cancer in these patients and there were early indications that it may have improved their overall survival as well (progression-free survival was a median of 7.4 months vs 3.8 for those using everolimus).

Toni K. Choueiri, MD, clinical director of the Genitourinary Cancer Treatment Center at Dana-Farber Cancer Institute, and first author of the report, feels that cabozantinib may also have potential as a first-line treatment for kidney cancer.Cabozantinib has received breakthrough therapy designation from the Food and Drug Administration. Report data were published online in the New England Journal of Medicine.

Source: New drug improves outcome in treatment resistant kidney cancer – ONA