Kidney (Renal Cell) Cancer

Calithera Achieves Positive Topline Results in Randomized Phase 2 ENTRATA Study of Telaglenastat with Everolimus in Renal Cell Carcinoma

(Yahoo! Finance) June 17, 2019 - Doubled median progression-free survival (PFS) in heavily pre-treated patients with advanced renal cell carcinoma. Provides first clinical proof of concept for glutaminase inhibitor telaglenastat.

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FDA Action Alert: Merck, Agios and AMAG Pharma

(BioSpace) June 17, 2019 - June is turning out to be a busy month for approvals for the U.S. Food and Drug Administration (FDA). The agency has a slate of PDUFA dates this week, including two for Merck alone. Here’s a look.

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First Patient Dosed with Gevokizumab in Collaborator Clinical Study in Metastatic Colorectal Cancer, Gastroesophageal Cancer, and Renal Cell Carcinoma

(NASDAQ) June 13, 2019 - XOMA Corporation announced today that gevokizumab, an anti-IL1β monoclonal antibody that XOMA discovered and initially developed, is now actively progressing in a Novartis oncology development program.

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Alkermes Advances ALKS 4230 into Monotherapy Expansion Phase of ARTISTRY-1 in Patients With Renal Cell Carcinoma or Melanoma

(Alkermes) June 12, 2019 - Alkermes plc today announced the initiation of the monotherapy expansion stage of its ARTISTRY-1 clinical trial to evaluate the efficacy, safety and tolerability of ALKS 4230 in treating patients with renal cell carcinoma or melanoma.

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SillaJen Announces First Patient Enrolled in Part 2 of Renal Cell Carcinoma Trial with Pexa-Vec in Combination with Regeneron's Libtayo® (cemiplimab-rwlc)

(Yahoo! Finance) June 6, 2019 - SillaJen, Inc. announced the first patient has been enrolled in Part 2 of JX594-REN026, a Phase 1b clinical trial of Pexa-Vec (pexastimogene devacirepvec) in combination with Libtayo®(cemiplimab-rwlc), for the treatment of renal cell cancer (RCC).

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Team Develops Test To Predict Immunotherapy Response In Kidney Cancer

(UT Southwestern) June 3, 2019 - In a study published today in the Journal for ImmunoTherapy of Cancer, investigators with the UT Southwestern Medical Center Kidney Cancer Program developed a new test to illuminate kidney cancers that may respond to checkpoint inhibitors.

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No Benefit From Pazopanib In Advanced Kidney Cancer After Surgery To Remove Metastases

(ECOG-ACRIN) June 3, 2019 - The results of the ECOG-ACRIN Cancer Research Group’s phase three trial, E2810, show no disease-free survival benefit with the use of one year of pazopanib in patients with metastatic renal cell carcinoma (kidney cancer) who had no evidence of disease following surgery to remove further metastases. There was a trend toward decreased overall survival with pazopanib.

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Xynomic Pharma To Present Long-Term Follow Up Data Showing Abexinostat, Combined with Pazopanib, has Durable Responses in Patients with Pre-Treated Kidney Cancer

(Yahoo! Finance) May 22, 2019 - Xynomic Pharmaceuticals Holdings, Inc. announced today that long-term follow up data of exceptional responders to abexinostat/pazopanib will be presented by Dr. Rahul Aggarwal, a lead investigator at the University of California, San Francisco (“UCSF”).

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Pfizer Oncology to Showcase New Data from Innovative Science That Address Patient Needs at ASCO 2019 Annual Meeting

(Yahoo! Finance) May 15, 2019 - Pfizer will present real-world data on the use of IBRANCE for the treatment of men with metastatic breast cancer (MBC).

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FDA Approves Bavencio® (Avelumab) Plus Inlyta® (Axitinib) Combination For Patients With Advanced Renal Cell Carcinoma

(Pfizer) May 14, 2019 - Bavencio is the first anti-PD-L1 in combination with INLYTA approved by FDA for first-line treatment of patients with advanced renal cell carcinoma (RCC). Phase III study showed combination significantly lowered risk of disease progression or death by 31% and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib. Combination approved based on Phase III data in an overall population that included patients regardless of PD-L1 expression and across favorable, intermediate and poor prognostic groups. Additional regulatory reviews for BAVENCIO plus INLYTA in advanced RCC are underway worldwide, including in the European Union and Japan.

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Novartis Defeats Challenge To Validity Of Afinitor Patent

(Reuters) May 14, 2019 - Novartis scored a win in litigation over one of the patents underlying its cancer treatment Afinitor, as a federal appeals court on Monday rejected arguments by the would-be maker of a generic version that the patent is invalid. The U.S. Court of Appeals for the Federal Circuit upheld claims 1-3 of a Novartis patent on the use of everolimus, the active ingredient in Afinitor, to treat advanced renal cell carcinoma (RCC). The decision affirms a December 2017 ruling against New Jersey-based West-Ward Pharmaceuticals, which has been known as Hikma Pharmaceuticals USA since last June.

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FDA Approves Bavencio-Inlyta Combo for Advanced Renal Cell Carcinoma

(Curetoday.com) May 15, 2019 - The Food and Drug Administration approved the combination use of Bavencio plus Inlyta for the first-line treatment of patients with advanced renal cell carcinoma. Of note, this is the first FDA approval of an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC.

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Infinity Pharmaceuticals Provides Company Update and First Quarter 2019 Financial Results

(Yahoo! Finance) May 7, 2019 - MARIO-3 phase 2 study in front-line triple negative breast cancer and renal cell cancer patients on track to initiate in 3Q19.

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Exelixis Initiating Phase 3 Pivotal Trial (COSMIC-313) of Cabozantinib in Combination with Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Previously Untreated Advanced Renal Cell Carcinoma

(Exelixis) May 1, 2019 - Exelixis, Inc. today announced that it is initiating COSMIC-313, a phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with nivolumab (Opdivo®) and ipilimumab (Yervoy®) versus nivolumab and ipilimumab in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium. The primary endpoint of the trial is progression-free survival, and the secondary endpoints are overall survival and objective response rate. “Clinical observations suggest cabozantinib promotes an immune-permissive environment, which could present an opportunity for additive or synergistic effects with immune checkpoint inhibitors,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis.

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Pfizer Reports First-Quarter 2019 Results

(MarketWatch) Apr 30, 2019 - Merck KGaA and Pfizer announced the discontinuation of the ongoing Phase 3 JAVELIN Ovarian PARP 100 study; the companies also announced that the FDA had accepted for priority review the sBLA for Bavencio with Inlyta (axitinib) for patients with advanced RCC.

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Merck Announces First-Quarter 2019 Financial Results

(Yahoo! Finance) Apr 30, 2019 - Merck announced that the FDA granted priority review for each of the following supplemental Biologics License Applications with Keytruda seeking use in the following indications:

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FDA Approves Merck's KEYTRUDA (pembrolizumab) in Combination With Inlyta (axitinib) as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma (RCC)

(Merck) Apr 22, 2019 - Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved 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). The approval is based on findings from the pivotal Phase 3 KEYNOTE-426 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA in combination with axitinib (KEYTRUDA-axitinib combination) compared to sunitinib.

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Merck's Keytruda Wins FDA Approval As Combination Therapy For Kidney Cancer

(Reuters) Apr 22, 2019 - The U.S. Food and Drug Administration has approved Merck & Co Inc’s cancer therapy, Keytruda, as part of a combination therapy for previously untreated patients with the most common type of kidney cancer, the company said on Monday. The drug was approved in combination with Pfizer Inc’s Inlyta to treat advanced renal cell carcinoma.

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Pazdur Grills PD-1/PD-L1 Companies Over Lack Of Collaboration, Trial Redundancies

(BioCentury) Apr 1, 2019 - FDA's Oncology Center of Excellence Director Richard Pazdur pressed representatives from companies with marketed PD-1/PD-L1 inhibitors to explain why they aren't collaborating more in the clinic while questioning whether there are too many of these drugs on the market. His comments came as he moderated a session at the American Association for Cancer Research (AACR) meeting on Monday titled "PD-1 Pandemonium."

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Study May Explain Why Immunotherapy Not Effective For Some Patients With Metastatic Melanoma And Kidney Cancer

(MD Anderson) Mar 25, 2019 - White blood cells known as B cells have been shown to be effective for predicting which cancer patients will respond to immune checkpoint blockade (ICB) therapy, according to a study at The University of Texas MD Anderson Cancer Center. Study results will be presented April 2 at the AACR Annual Meeting 2019 in Atlanta.

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