Kidney (Renal Cell) Cancer

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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AVEO Oncology to Present Updated Interim Results from the Phase 2 Portion of the TiNivo Study of Tivozanib and Nivolumab (OPDIVO®) in RCC at the ESMO 2018 Annual Congress

(Morningstar) Oct 9, 2018 - AVEO Oncology today announced that updated interim data from the Phase 2 portion of the TiNivo trial of tivozanib and nivolumab (OPDIVO®) in advanced renal cell carcinoma will be presented at the European Society of Medical Oncology (ESMO) 2018 Annual Congress being held October 19-23, 2018 in Munich, Germany.

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Cabozantinib to Be Featured in 13 Presentations at ESMO 2018 Congress

(MarketWatch) Oct 8, 2018 - Presentations to include results from the dose escalation stage of phase 1b COSMIC-021 study of cabozantinib in combination with atezolizumab in previously untreated advanced renal cell carcinoma.

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Calithera Biosciences Highlights Breadth of Innovative Pipeline at R&D Day

(MarketWatch) Oct 5, 2018 - Updated response rate of 50% in advanced renal carcinoma treated with CB-839 + cabozantinib; CB-839 clinical trial collaboration with Pfizer; Presentation of INCB001158 data expected in 1H2019; R&D day hosted today in New York from 8:00 a.m. -10:15 a.m. ET, live webcast available.

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Stage Four Sarcomatoid Kidney Cancer Patient First To Show Complete Response To Immunotherapy

(Massey Cancer Center) Sept 27, 2018 - Researchers are now recruiting patients with sarcomatoid kidney cancer in clinical trials with checkpoint inhibitors. These trials are expected to show in which group of patients nivolumab and other checkpoint inhibitors are effective against this aggressive subtype of cancer in order to help establish better treatment guidelines.

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AVEO Oncology Announces Initiation of Topline Analysis of Phase 3 TIVO-3 Trial

(AVEO Oncology) Oct 1, 2018 - AVEO Oncology today announced that it has initiated topline analysis of the phase 3 TIVO-3 clinical trial on the unanimous recommendation of the independent TIVO-3 Study Steering Committee, and after notice to the FDA. The TIVO-3 trial is the Company’s randomized, controlled, multi-center, open label study to compare FOTIVDA® (tivozanib) to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC).

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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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