Kidney (Renal Cell) Cancer

For Kidney Cancer, the Tumor’s Environment May Hold the Key to Optimizing Treatment

(MSK/OnCancer Blog) Jan 15, 2019 - Scientists at Memorial Sloan Kettering have identified factors in a tumor’s environment that predict how well it will respond to certain cancer therapies.

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Personalized Treatment Benefits Kidney Cancer Patients

(RSNA) Jan 15, 2019 - Personalized treatment plans may extend life expectancy for early-stage kidney cancer patients who have risk factors for worsening kidney disease, according to a new study published in Radiology.

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European Commission Approves Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) for First-Line Treatment of Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma

(PipelineReview.com) Jan 14, 2019 - First I-O/I-O combination regimen to receive European approval for previously untreated patients with advanced renal cell carcinoma; approval based on results from Phase 3 CheckMate -214 trial. Bristol-Myers Squibb Company today announced that the European Commission has approved the combination of Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (“low-dose”) for the first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). This decision represents the first approval of an Immuno-Oncology (I-O) combination therapy for patients with this type of cancer in the European Union.

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European Commission Approves Opdivo For Advanced Renal Cell Carcinoma

(PharmaTimes [UK]) Jan 15, 2019 - The European Commission has approved Bristol-Myers Squibb's Opdivo in combination with low-dose Yervoy for first-line treatment of patients with intermediate and poor risk advanced renal cell carcinoma (RCC).

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Tracon Pharma Says Phase 2 TRAXAR Trial Fails To Meet Primary Endpoint

(Markets Insider/RTTNews.com) Dec 21, 2018 - Tracon Pharmaceuticals said that its Phase 2 TRAXAR trial evaluating TRC105 in combination with Inlyta or axitinib in patients with advanced or metastatic renal cell carcinoma did not meet the primary endpoint of improving progression free survival or PFS in the intent to treat population compared to Inlyta monotherapy.

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Withdrawal of Application for a Change to the EU Marketing Authorisation for Atezolizumab

(ESMO) Dec 10, 2018 - On 22 October 2018, Roche Registration GmbH officially notified the European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for atezolizumab (Tecentriq) to extend its use for treating renal cell carcinoma (RCC).

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Research Review Underscores Progress in Treating Kidney Cancer, Importance of Close Patient Monitoring

(RPCI) Nov 26, 2018 - Checkpoint inhibitors have led to ‘remarkable progress’ as well as need for greater integration of care, authors note.

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Jury Finds Former Aveo CFO Misled Investors

(Boston Globe) Nov 21, 2018 - A federal jury in Boston found the former chief financial officer of Aveo Pharmaceuticals liable for civil securities fraud Tuesday for misleading investors about the Cambridge biotech company’s prospects to win approval of a kidney cancer drug candidate.

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Roche Pulls EU Tecentriq/Avastin Filing In Kidney Cancer

(PMLiVE [UK]) Nov 19, 2018 - Roche has opted to withdraw its filing in Europe for a dual regimen for renal cell carcinoma based on checkpoint inhibitor Tecentriq and Avastin, on the grounds that the data supporting it isn’t strong enough.

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AVEO Oncology Announces Phase 3 TIVO-3 Trial of Tivozanib in Renal Cell Carcinoma Meets Primary Endpoint

(AVEO) Nov 5, 2018 - AVEO Oncology today announced positive topline results from the primary analysis of the TIVO-3 trial, the Company’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib (FOTIVDA®) to sorafenib in 351 subjects with highly refractory advanced or metastatic renal cell carcinoma (RCC). The trial met its primary endpoint of demonstrating a statistically significant benefit in progression-free survival (PFS). Tivozanib demonstrated a 44% improvement in median PFS and 26% reduction in risk of progression or death (Hazard Ratio [HR]=0.74, p=0.02). Median PFS was 5.6 months for tivozanib compared to 3.9 months for sorafenib. The TIVO-3 trial enrolled patients with RCC who have failed at least two prior regimens. Among these, approximately 26% of patients received checkpoint inhibitor therapy in earlier lines of treatment. Tivozanib PFS was longer than sorafenib both in patients who received prior checkpoint inhibitor therapy and those who did not.

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AVEO’s RCC Drug Hits the Mark in Phase III Trial

(BioSpace) Nov 6, 2018 - Cambridge, Mass.-based AVEO Oncology hit the mark in its Phase III study of a treatment for highly refractory advanced or metastatic renal cell carcinoma (RCC). The company said its drug tivozanib met its primary endpoint of demonstrating a statistically significant benefit in progression-free survival (PFS). AVEO’s tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor. In the Phase III TIVO-3 trial, the company compared tivozanib to sorafenib in 351 patients with the RCC indication. AVEO said tivozanib demonstrated a 44 percent improvement in median PFS and 26 percent reduction in risk of progression or death in dosed patients.

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Why You Might Get Kidney Cancer If You Move To Florida

(Forbes) Oct 31, 2018 - How many people diagnosed with kidney cancer have been overdiagnosed with the condition? And what does moving to Florida have to do with your chance of being diagnosed with kidney cancer?

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High-dose, High-Precision Radiation Therapy Safe And Effective For Kidney Cancer Patients With Only One Kidney

(ASTRO 2018) Oct 22, 2018 - Treatment of renal cell carcinoma with stereotactic radiation therapy is as safe and effective for patients with one kidney as it is for those who have two, according to an analysis of the largest-ever, international dataset of solitary kidney patients to receive this emerging treatment.

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Exelixis Announces Results from the Dose-Escalation Stage of the Phase 1b COSMIC-021 Study of Cabozantinib in Combination with Atezolizumab in Previously Untreated Advanced Renal Cell Carcinoma

(Exelixis) Oct 22, 2018 - Combination of cabozantinib and atezolizumab is well tolerated and shows promising anti-tumor activity; safety and efficacy data support 18 expansion cohorts evaluating the combination in 12 different tumor types.

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Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Results in Significantly Longer Treatment-Free Survival in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

(BMS) Oct 22, 2018 - Bristol-Myers Squibb Company today announced the results of a new analysis from the Phase 3 CheckMate -214 study, demonstrating that therapy with Opdivo (nivolumab) plus Yervoy (ipilimumab) in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) was associated with significantly longer treatment-free survival (TFS).

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Positive Data from Randomized Phase III Study Suggests That a Combination of Immunotherapy Drugs Can Help Some People with Advanced Kidney Cancer

(MSK) Oct 21, 2018 - Memorial Sloan Kettering Cancer Center (MSK) researchers presented the results of a randomized phase III trial at today’s press program for the European Society for Medical Oncology’s 2018 Congress in Munich, Germany.

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Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pfizer’s Inlyta® (axitinib) Significantly Improved Overall Survival (OS) and Progression-free Survival (PFS) as First-Line Therapy for Advanced or Metastatic Renal Cell Carcinoma

(Merck) Oct 18, 2018 - Merck, known as MSD outside the United States and Canada, announced today that the pivotal Phase 3 KEYNOTE-426 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Inlyta® (axitinib), Pfizer’s tyrosine kinase inhibitor, met both primary endpoints of overall survival (OS) and progression-free survival (PFS) in the first-line treatment of advanced or metastatic renal cell carcinoma (RCC), the most common type of kidney cancer. Based on the first interim analysis by the independent Data Monitoring Committee (DMC), the KEYTRUDA plus Inlyta combination resulted in statistically significant and clinically meaningful improvements in OS and PFS, compared to sunitinib monotherapy. The study also met the key secondary endpoint of objective response rate (ORR), with significant improvements for the KEYTRUDA and Inlyta combination compared with sunitinib monotherapy.

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A Year Early, Merck Touts Good Kidney Cancer News to Push Rival BMS

(Xconomy New York) Oct 18, 2018 - Merck could soon join rival Bristol-Myers Squibb in making immunotherapy an option for kidney cancer patients who have never had treatment before. Merck reported today that its blockbuster pembrolizumab (Keytruda) has hit its marks much earlier than expected in an 861-person Phase 3 study called Keynote-426. Merck tested a combination of pembrolizumab and axitinib (Inlyta), an approved kidney cancer drug from Pfizer, comparing it with sunitinib (Sutent), another approved drug that works in similar fashion to axitinib.

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Year in Review: Oncology

(MedPage Today) Oct 10, 2018 - Headline-making developments for 2018 included new standards of care, advances in the treatment of several cancers, an update to a key screening guideline, and emerging strategies to balance pain relief without adding to the opioid addiction crisis.

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Hemispherx Biopharma Signs Clinical Trial Agreement with Roswell Park Comprehensive Cancer Center to Study Ampligen in Combination with Checkpoint Inhibitors in a Phase IIa Study in Urothelial Carcinoma, Renal Cell Carcinoma and Melanoma

(P&T Community) Oct 10, 2018 - Hemispherx Biopharma, Inc. announces the signing of a clinical trial agreement with Roswell Park Comprehensive Cancer Center to evaluate Ampligen in combination with checkpoint inhibitors (CPIs).

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