Kidney (Renal Cell) Cancer

Mental Health State Associated With Higher Death Rates For Prostate And Other Urological Cancers

(EAU 2019) Mar 18, 2019 - Patients with prostate, bladder or kidney cancers are at greater risk of dying if they have had psychiatric care prior to the cancer treatment.

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Infinity To Initiate MARIO-3, A Phase 2 Multi-Arm Study Evaluating IPI-549 In Front-Line Triple Negative Breast Cancer And Renal Cell Cancer

(Yahoo! Finance) Mar 14, 2019 - MARIO-3 will evaluate IPI-549 with Tecentriq and Abraxane® in front-line triple negative breast cancer and IPI-549 with Tecentriq and Avastin® in front-line renal cell cancer.

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New ESMO Guidelines Include FOTIVDA®(tivozanib) Recommendation for Patients with Advanced Renal Cell Carcinoma

(Associated Press) Mar 8, 2019 - EUSA Pharma (EUSA) welcomes the news that FOTIVDA® (tivozanib) has been included in the new European Society of Medical Oncology (ESMO) clinical practice guidelines for renal cell carcinoma (RCC), published on 21st February 2019.

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Scientists Create Tiny Organoid Models Of Kidney Disease From Cells Found In Urine

(Forbes) Mar 4, 2019 - In the study, the researchers show that kidney organoids can be made from a pediatric kidney cancer called Wilms Tumor, which is the most common solid cancer in children.

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Being Overweight in Adolescence May Increase Kidney Cancer Risk Later in Life

(Wiley) Feb 21, 2019 - Being overweight has been linked with a higher risk of developing a form of kidney cancer called renal cell carcinoma (RCC) among adults, but it’s unclear if this risk is present during adolescence.

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KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) Reduced Risk of Death by Nearly Half Compared to Sunitinib as First-Line Treatment for Advanced Renal Cell Carcinoma (RCC)

(Merck) Feb 16, 2019 - Merck, known as MSD outside the United States and Canada, today announced presentation of the full results from the pivotal Phase 3 KEYNOTE-426 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of advanced renal cell carcinoma (RCC) at the 2019 Genitourinary Cancers Symposium (ASCO GU) (Abstract #543). These data were also simultaneously published in the New England Journal of Medicine. This is the first combination regimen to significantly improve overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to sunitinib. Results were consistent across all IMDC subgroups, including favorable, intermediate and poor risk groups, and regardless of PD-L1 expression.

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Pivotal Phase III Data for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) in Advanced Renal Cell Carcinoma

(Pfizer) Feb 16, 2019 - JAVELIN Renal 101 shows significant improvement in progression-free survival with a hazard ratio of 0.69 in patients regardless of PD-L1 expression. US FDA has granted Priority Review to BAVENCIO plus INLYTA for patients with advanced renal cell carcinoma. Data at 2019 Genitourinary Cancers Symposium reinforce consistency of PFS and ORR benefits across broad population of patients with advanced RCC, including all prognostic risk groups, and show increased time to progression on next-line therapy.

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Immunotherapies Could Change Kidney Cancer Care, Studies Suggest

(CNN) Feb 16, 2019 - The way doctors typically approach kidney cancer treatment could be evolving. Two separate studies published Saturday in the New England Journal of Medicine showed that renal cell cancer patients had significantly better outcomes when their treatment combined the targeted therapy drug axitinib, or Inlyta, with an immunotherapy -- one study used pembrolizumab, or Keytruda, and the other used avelumab, or Bavencio. "This is a proof of principle that we can do this if the drugs are in the same class and tolerated when combined," said Dr. Toni Choueiri, director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute/Brigham and Women's Hospital and a professor of medicine at Harvard Medical School in Boston, who was senior author of the avelumab study.

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Merck, Pfizer Drug Combo Extends Kidney Cancer Survival: Study

(Reuters) Feb 16, 2019 - A combination of Merck & Co's immunotherapy Keytruda and Pfizer Inc's Inlyta helped patients with advanced kidney cancer live longer than those receiving and older Pfizer standalone therapy, according to data from a late-stage study presented on Saturday. Nearly 90 percent of patients who received the combination therapy were still alive after 12 months compared with about 78 percent of patients who were alive after a year when treated with the older drug Sutent, data showed. Merck on Monday released interim data from the trial, saying the combination reduced the risk of death by 47 percent compared with Sutent.

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Drug Combination May Become New Standard Treatment For Advanced Kidney Cancer

(Dana-Farber) Feb 16, 2019 - A combination of two drugs -- one of them an immunotherapy agent -- could become a new standard, first-line treatment for patients with metastatic kidney cancer, results from a phase 3 clinical trial suggest. Patients who received the immunotherapy drug avelumab plus axitinib, a VEGF targeted agent, had a significant advantage in progression-free survival compared with those who received sunitinib (Sutent), a VEGF targeted drug that has been a standard treatment for advanced clear cell renal cell carcinoma – the most common form of kidney cancer. “Patients receiving the drug combination also had a higher response rate – meaning their tumors shrank – than the sunitinib-only group,” said Toni K. Choueiri, MD, senior and co-corresponding author of the report on the JAVELIN Renal 101 trial in The New England Journal of Medicine and Director of the Lank Center for Genitourinary Oncology at Dana-Farber.

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No Survival Bump Yet with Tivozanib for RCC

(MedPage Today) Feb 18, 2019 - Patients with refractory renal cell carcinoma (RCC) had statistically significant improvement in progression-free survival (PFS) with the multi-tyrosine kinase inhibitor tivozanib (Fotivda) compared with sorafenib (Nexavar), a randomized trial showed.

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AVEO Oncology Announces Oral Presentation of TIVO-3 Trial Topline Results at the 2019 ASCO Genitourinary Cancers Symposium

(MarketWatch) Feb 16, 2019 - AVEO Oncology today announced the presentation of data from the Phase 3 TIVO-3 study of tivozanib (FOTIVDA®) versus sorafenib in refractory advanced or metastatic renal cell carcinoma (RCC).

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Updated Results from Phase 1 Study of Telaglenastat (CB-839) to be Presented at 2019 ASCO Genitourinary Cancer Symposium

(Yahoo! Finance) Feb 16, 2019 - Clinical study explored Calithera’s lead compound in combination with cabozantinib in patients with advanced renal cell carcinoma.

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National Cancer Centre Singapore and Lucence Diagnostics Announce First Molecular Test that Selects Immunotherapy for Kidney Cancer

(National Cancer Centre Singapore) Feb 15, 2019 - Study was conducted on 36 kidney cancer patients using the CLEARScore™ test that identifies eight genes linked to immunotherapy.

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Pfizer's Forgotten Cancer Pill Is About to Become Its Next Blockbuster

(The Motley Fool) Feb 19, 2019 - A drug that disappointed in 2018 will get an unexpected dance at the big ball.

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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma

(MarketWatch) Feb 15, 2019 - Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This sBLA is based on findings from the Phase 3 KEYNOTE-426 trial, which demonstrated that KEYTRUDA in combination with axitinib, as compared to sunitinib, significantly improved overall survival (OS) and progression-free-survival (PFS) in the first-line treatment of advanced RCC. These data will be presented at the 2019 Genitourinary Cancers Symposium (ASCO GU) in San Francisco on February 16. The sBLA also included supporting data from the Phase 1b KEYNOTE-035 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 20, 2019.

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FDA Grants Priority Review to Keytruda Combo as Frontline Treatment for Kidney Cancer

(Curetoday.com) Feb 15, 2019 - The Food and Drug Administration (FDA) granted a priority review to Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as a frontline treatment for advanced renal cell carcinoma (RCC), according to Merck, the manufacturer of the anti-PD-1 therapy. “Many patients with advanced renal cell carcinoma face a poor prognosis and there remains a need for new and effective treatment options in the first-line setting,” said Roger M. Perlmutter, M.D., Ph.D., president of Merck Research Laboratories, in a press release. The new biologics license application was based on findings from the phase 3 KEYNOTE-426 trial, designed to evaluate Keytruda in combination with Inlyta compared with Sutent (sunitinib) as a frontline treatment in 861 patients with advanced RCC.

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Recurring Infections Could Lead To Delayed Bladder Or Kidney Cancer Diagnosis

(Cancer Research UK) Feb 13, 2019 - Women with bladder or kidney cancer may lose out on a prompt diagnosis if they are already being regularly treated for recurring urinary tract infections (UTIs), according to new research presented at Cancer Research UK’s Early Diagnosis Conference in Birmingham.

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ASCO GU Preview: Merck, Bristol-Myers Squibb, Pfizer and More

(BioSpace) Feb 12, 2019 - The American Society of Clinical Oncology 2019 Genitourinary Cancers Symposium (ASCO GU) is being held in San Francisco from February 14-16. Ahead of the conference, several companies have announced presentations. Here’s a look at just a few. Merck & Company. Merck plans to present survival data from its pivotal Phase III KEYNOTE-426 clinical trial of its checkpoint inhibitor Keytruda in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of advanced or metastatic renal cell carcinoma (RCC). The company had announced in October 2018 that the trial met both primary endpoints of overall survival (OS) and progression-free survival (PFS), as well as the key secondary endpoint of objective response rate (ORR).

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Clinigen Pays Novartis $210M For US Rights To Proleukin

(BioPharma-Reporter.com [UK]) Feb 13, 2019 - Clinigen completes its acquisition of the global rights of Proleukin, after agreeing a $210m fee with Novartis.

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