ASCO GU Conference Coverage

Darolutamide Delays the Spread of Some Prostate Cancers

(NCI/Cancer Currents Blog) Mar 15, 2019 - The investigational drug darolutamide can help delay the spread of prostate cancer in some men with the disease, a recent clinical trial shows. In addition, the drug caused fewer side effects than similar prostate cancer drugs.

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Phase 3 Randomized Trial Data Shows SBRT has Similar Acute Safety Profile to Conventional Radiation Therapy in Patients with Localized Prostate Cancer

(MarketWatch) Feb 22, 2019 - Accuray Incorporated announced today that data from an international, randomized, 38-center trial (PACE - Prostate Advances in Comparative Evidence) show that treatment with stereotactic body radiation therapy (SBRT) results in a similar safety profile to conventional radiation in men with low- or intermediate-risk prostate cancer.

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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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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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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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Bayer, Janssen and BMS Unveil Promising Data for Prostate Cancer at ASCO GU

(BioSpace) Feb 15, 2019 - As the American Society of Clinical Oncology 2019 Genitourinary Cancers Symposium (ASCO GU) rolls on, companies are showcasing more data in presentations. BioSpace takes a look at some of the latest.

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Bladder Ca Treatment Enters 'Post-Checkpoint' Era

(MedPage Today) Feb 16, 2019 - In two early trials, monoclonal antibody-drug conjugates showed activity in metastatic bladder cancer patients that had failed on checkpoint inhibitors, researchers reported.

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Clinical Data Presented from PIVOT-02 Study of Bempegaldesleukin (NKTR-214) with Nivolumab in Metastatic Urothelial Carcinoma Patients at the 2019 ASCO Genitourinary Cancers Symposium

(NASDAQ) Feb 15, 2019 - Nektar Therapeutics announced today a presentation of new clinical data for bempegaldesleukin1 (NKTR-214) in combination with nivolumab in patients with first-line (1L) advanced or metastatic urothelial carcinoma at the 2019 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (GU) in San Francisco, CA.

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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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Rexahn Presents Updated Interim Data From Phase 2a Trial of RX-3117 in Advanced Bladder Cancer at the 2019 ASCO GU Symposium

(Yahoo! Finance) Feb 19, 2019 - Encouraging preliminary signs of efficacy, including one complete response, observed in patients with advanced bladder cancer who have progressed on multiple prior treatments including immunotherapy and gemcitabine.

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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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MDxHealth Announces Presentation of Positive Data for SelectMDx and ConfirmMDx in Prostate Cancer Diagnosis

(Yahoo! Finance) Feb 15, 2019 - Data to be Presented at the Annual ASCO Genitourinary Cancers Symposium. Data to further support clinical adoption of SelectMDx and ConfirmMDx.

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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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Nektar, Bristol Combo Drug Shows Signs Of Tumor Reduction In Bladder Cancer Patients

(Reuters) Feb 15, 2019 - Nektar Therapeutics said on Friday some patients with advanced bladder cancer treated with a combination of its experimental treatment and Bristol-Myers Squibb Co’s immunotherapy, Opdivo, showed signs of tumor reduction in an early-stage study.

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Opdivo (nivolumab) Plus Yervoy (ipilimumab) Shows Response in Pre-Treated Patients with Metastatic Castration-Resistant Prostate Cancer

(MarketWatch) Feb 14, 2019 - Bristol-Myers Squibb Company today announced data evaluating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) in patients with metastatic castration-resistant prostate cancer (mCRPC). Results from an interim analysis of the Phase 2 CheckMate -650 trial showed that among 32 asymptomatic or minimally symptomatic patients whose disease had progressed after second-generation hormone therapy and who had not received chemotherapy (cohort 1), with a median follow-up of 11.9 months, the objective response rate (ORR) was 25%. Additionally, among 30 patients whose disease progressed after taxane-based chemotherapy (cohort 2), with a median follow-up of 13.5 months, the ORR was 10%.

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Bayer's Investigational Drug Darolutamide Plus Androgen Deprivation Therapy (ADT) Significantly Extends Metastasis-free Survival Compared To Placebo Plus ADT In Non-Metastatic Castration-Resistant Prostate Cancer

(Bayer) Feb 14, 2019 - First results from the Phase III ARAMIS trial with the investigational androgen receptor antagonist darolutamide were presented in an oral presentation at American Society of Clinical Oncology Genitourinary Cancers Symposium and simultaneously published in The New England Journal of Medicine. Statistically significant improvement in metastasis-free survival (MFS), with a median MFS of 40.4 months with darolutamide plus androgen deprivation therapy (ADT) versus 18.4 months with placebo plus ADT.(1) At the time of the first interim analysis, median overall survival (OS) had not yet been reached in either treatment arm; however, these interim results demonstrated a trend in favor of darolutamide plus ADT (HR=0.71, 95% CI 0.50-0.99; P=0.045).(1)

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Bayer/Orion Showcase Results From Prostate Cancer Challenger

(Pharmaphorum.com [UK]) Feb 15, 2019 - Bayer and development partner Orion have released detailed results from the trial that will form the backbone of its filing for their latest prostate cancer drug, as they aim to take on two established blockbusters from Johnson & Johnson and Pfizer/Astellas. J&J and Astellas market androgen receptor antagonists Zytiga (abiraterone) and Xtandi (enzalutamide) respectively – but Bayer hopes to take them on with a drug that may have a safety advantage if approved. Xtandi has been shown to cross the blood-brain barrier and has been linked with neurological side-effects, while evidence gathered so far shows that darolutamide does not penetrate the barrier.

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