Kidney (Renal Cell) Cancer

CBT Pharmaceuticals Initiates the APOLLO Oncology Clinical Trials Program

(Morningstar) Sept 18, 2018 - CBT Pharmaceuticals, a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, today announced the initiation of the APOLLO Oncology Clinical Trials Program.

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BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Significantly Improved Progression-Free Survival in Previously Untreated Patients With Advanced Renal Cell Carcinoma in Phase III Study

(Pfizer) Sept 11, 2018 - Merck KGaA, Darmstadt, Germany, and Pfizer Inc. today announced positive top-line results from the pivotal Phase III JAVELIN Renal 101 study evaluating BAVENCIO® (avelumab) in combination with INLYTA® (axitinib), compared with SUTENT® (sunitinib) as initial therapy for patients with advanced renal cell carcinoma (RCC). As part of a planned interim analysis, an independent Data Monitoring Committee confirmed that the trial showed a statistically significant improvement in progression-free survival (PFS) by central review for patients treated with the combination whose tumors had programmed death ligand-1‒positive (PD-L1+) expression greater than 1% (primary objective), as well as in the entire study population regardless of PD-L1 tumor expression (secondary objective). According to the statistical analysis plan, if PFS was statistically significant in the PD-L1+ subgroup, then PFS in the entire study population was to be analyzed for statistical significance. JAVELIN Renal 101 will continue as planned to the final analysis for the other primary endpoint of overall survival (OS). No new safety signals were observed, and adverse events for BAVENCIO, INLYTA and SUTENT in this trial were consistent with the known safety profiles for all three medicines. The alliance intends to pursue a regulatory submission in the US based on these interim results, and these results will be discussed with global health authorities. A detailed analysis will also be submitted for presentation at an upcoming medical congress.

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Study Suggests More People with Kidney Cancer Should Be Screened for Hereditary Cancer Genes

(MSK/On Cancer) Sept 6, 2018 - Researchers have found that more than 20% of people with a type of cancer called advanced non-clear cell renal cell carcinoma have disease that is driven by inherited cancer mutations.

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Exelixis Announces New Recommendations for CABOMETYX® (Cabozantinib) Tablets in Updated National Comprehensive Cancer Network Clinical Practice Guidelines

(Exelixis) Sept 7, 2018 - Exelixis, Inc. today announced that the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines to include new recommendations for CABOMETYX® (cabozantinib) tablets. With the updates, CABOMETYX is recommended by the NCCN for the treatment of advanced renal cell carcinoma (RCC) regardless of patient risk status (favorable-, intermediate-, and poor-risk).

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Roswell Park Approach to Assessing Kidney Tumors May Spare Some Patients Surgery

(RPCI) Aug 28, 2018 - Research team developed algorithm for distinguishing benign tumors from dangerous, look-alike renal cancer.

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NICE U-Turn Recommends Ipsen’s Cabometyx For Kidney Cancer

(PharmaTimes [UK]) Aug 29, 2018 - NHS funding for Ipsen’s Cabometyx is now being recommended by the National Institute for Health and Care Excellence to treat kidney cancer.

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Natera and Fox Chase Cancer Center to Collaborate on Kidney Cancer Study

(Natera) Aug 15, 2018 - Natera, Inc., a global leader in cell-free DNA testing, has partnered with Fox Chase Cancer Center, one of the leading cancer centers in the United States, to assess the company's Signatera™ (Research-Use Only) customized circulating tumor DNA (ctDNA) assay for recurrence monitoring of kidney cancer.

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Five Predictions For AI And Real-World Data In Oncology

(Forbes) Aug 14, 2018 - As progress in oncology care is advancing faster than ever -- especially due to the work of artificial intelligence (AI) and real-world data for clinical decision making -- it can be difficult to distinguish what is hype and what will be realized in the near future.

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Blood Test Could Detect Kidney Cancer Up To 5 Years Earlier

(Cancer Research UK) Aug 13, 2018 - Scientists have discovered that a marker in the blood could help predict the risk that a person will develop kidney cancer, according to research published in the journal Clinical Cancer Research.

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UTSW Scientists Identify New Mechanisms Underlying Pediatric Kidney Cancer

(UT Southwestern) Aug 1, 2018 - Connecting two previously unrelated insights about the formation of pediatric kidney cancer, researchers at UT Southwestern Medical Center have uncovered the means by which the cancer continues to grow, providing potential targets for more effective treatments in the future.

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Bristol-Myers Drops After Cancer Drug Combo Rejected in Europe

(Bloomberg) July 26, 2018 - During a call discussing the company’s second-quarter results, Chief Executive Officer Giovanni Caforio said that Bristol-Myers’s combination cancer treatment had failed to secure additional approval from European regulators for use in a form of kidney cancer. Adding new indications for the drugs has been a key part of their growth. The revelation, which the company said it only learned of on Wednesday, reversed early gains in the shares. They dropped as much as 5 percent, the biggest decline in almost two months, and were down 3 percent to $57.26 at 12:12 p.m. in New York. Chief Scientific Officer Thomas Lynch said Bristol-Myers will ask regulators to re-examine the application after Europe’s Committee for Medicinal Products for Human Use rejected its combination of Opdivo and Yervoy for use in previously untreated patients with kidney cancer.

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Discovery Of Kidney Cancer Driver Could Lead To New Treatment Strategy

(UNC Lineberger CCC) July 19, 2018 - In a study published in the journal Science, researchers led by UNC Lineberger's Qing Zhang, PhD, suggest that ZHX2 is a potential new therapeutic target for clear cell renal cell carcinoma, which is the most common type of kidney cancer.

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AVEO Oncology Issues Statement Regarding Revised TIVO-3 Trial Guidance

(Morningstar) July 19, 2018 - AVEO Oncology today issued the following statement regarding its recently revised guidance on the timing of topline data from the TIVO-3 study, its Phase 3 trial of tivozanib as a third-line treatment for advanced renal cell carcinoma.

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Yale Cancer Researchers Suggest New Treatment For Rare Inherited Cancers

(Yale News) July 16, 2018 - Studying two rare inherited cancer syndromes, Yale Cancer Center (YCC) scientists have found the cancers are driven by a breakdown in how cells repair their DNA.

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Patients With Early Kidney Cancer See Significant Benefits With Robotic Partial Nephrectomy

(Keck School of Medicine of USC) July 10, 2018 - For patients with early kidney cancer, removing part of the kidney instead of the whole kidney is often a preferred treatment because the procedure can effectively remove tumors while preserving kidney function.

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Only Immuno-Oncology Combination Therapy Approved by Health Canada as First-Line Treatment for Advanced or Metastatic Renal Cell Carcinoma

(Markets Insider) July 9, 2018 - Bristol-Myers Squibb Canada Co. today announced that immuno-oncology (I-O) combination therapy OPDIVO (nivolumab) 3mg/kg plus YERVOY (ipilimumab) 1mg/kg for intravenous injections, was approved by Health Canada for the treatment of adult patients with intermediate/poor-risk advanced or metastatic renal cell carcinoma (RCC).

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Priority Changes for Novartis Spell the End for Aveo Pharma Alliance

(Xconomy Boston) July 3, 2018 — When Aveo Pharmaceuticals found itself floundering three years ago in the wake of the FDA’s rejection of its lead cancer drug, Novartis threw out a lifeline: a partnership on another Aveo drug that would finance its development. Now Novartis is pulling that support away.

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FDA to Release List of Surrogate Endpoints in Oncology

(Regulatory Focus) June 25, 2018 - Scott Gottlieb, FDA Commissioner, said Monday at the National Press Club in Washington, DC that his agency will release a list of surrogate endpoints used in cancer drug development soon.

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Real-World Economic Outcomes for Patients Treated for Advanced Renal Cell Carcinoma

(Journal of Clinical Pathways) June 22, 2018 - A new study compared all-cause health care costs and health resource utilization associated with first targeted therapies for advanced renal cell carcinoma.

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SillaJen Announces First Patient Enrolled in Renal Cell Carcinoma Trial with Pexa-Vec in Combination with Regeneron's Cemiplimab

(Morningstar) June 20, 2018 - SillaJen, Inc. announced the first patient has been enrolled in REN026, the Phase 1b clinical trial of Pexa-Vec (pexastimogene devacirepvec) in combination with cemiplimab (REGN2810) for the treatment of renal cell cancer (RCC).

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