ASCO GU Conference Coverage

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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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma

(MarketWatch) Feb 15, 2019 - Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for 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). This sBLA is based on findings from the Phase 3 KEYNOTE-426 trial, which demonstrated that KEYTRUDA in combination with axitinib, as compared to sunitinib, significantly improved overall survival (OS) and progression-free-survival (PFS) in the first-line treatment of advanced RCC. These data will be presented at the 2019 Genitourinary Cancers Symposium (ASCO GU) in San Francisco on February 16. The sBLA also included supporting data from the Phase 1b KEYNOTE-035 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 20, 2019.

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FDA Grants Priority Review to Keytruda Combo as Frontline Treatment for Kidney Cancer

(Curetoday.com) Feb 15, 2019 - The Food and Drug Administration (FDA) granted a priority review to Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as a frontline treatment for advanced renal cell carcinoma (RCC), according to Merck, the manufacturer of the anti-PD-1 therapy. “Many patients with advanced renal cell carcinoma face a poor prognosis and there remains a need for new and effective treatment options in the first-line setting,” said Roger M. Perlmutter, M.D., Ph.D., president of Merck Research Laboratories, in a press release. The new biologics license application was based on findings from the phase 3 KEYNOTE-426 trial, designed to evaluate Keytruda in combination with Inlyta compared with Sutent (sunitinib) as a frontline treatment in 861 patients with advanced RCC.

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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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Immunotherapy Combination Generates Responses Against Castration-Resistant Metastatic Prostate Cancer

(MD Anderson) Feb 14, 2019 - Some patients with metastatic prostate cancer respond to a combination of immune checkpoint inhibitors after hormonal therapy and chemotherapy have failed, according to early results from a clinical trial led by investigators at The University of Texas MD Anderson Cancer Center presented today at the the ASCO GU Symposium in San Francisco.

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Rainier Therapeutics Presents Data on Vofatamab in Patients with Advanced Urothelial Cell Carcinoma (Bladder Cancer) Previously Treated with Chemotherapy at ASCO GU 2019

(Rainier Therapeutics) Feb 15, 2019 - Preliminary data from FIERCE-21 Phase 2 trial highlighted in oral presentation supports advancement to pivotal study. Single agent activity and long-term treatment duration demonstrated.

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New Clinical Data Analysis Shows Survival Benefit Three Years after Treatment with Sipuleucel-T

(Associated Press) Feb 14, 2019 - Dendreon Pharmaceuticals LLC, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, released results of a new retrospective analysis of clinical trial data showing a long-lasting survival benefit three years after treatment with PROVENGE® (sipuleucel-T) in men with metastatic castrate-resistant prostate cancer (mCRPC). (abstract #222).

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Merck Increases Focus on Advanced Prostate Cancer, Expanding Immuno-Oncology Program with Three New Phase 3 Trials

(Merck) Feb 14, 2019 - Research program expanded based on promising data shown with Keytruda® (pembrolizumab) in combination with Lynparza® (olaparib), chemotherapy and anti-hormone agents in patients with metastatic castration-resistant prostate cancer (mCRPC). Data from three cohorts of phase 1b/2 KEYNOTE-365 study to be presented today at the 2019 Genitourinary Cancers Symposium (ASCO GU). Merck, known as MSD outside the United States and Canada, today announced the presentation of interim data from the Phase 1b/2 KEYNOTE-365 umbrella trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with various agents for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

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Merck Eyes Plans Phase III Programs in Prostate Cancer With Keytruda

(BioSpace) Feb 14, 2019 - Merck is increasing its focus on developing therapies for advanced prostate cancer with its powerful checkpoint inhibitor Keytruda. The pharma giant announced plans to expand its immuno-oncology program with three new Phase III trials following promising data from a combination of Keytruda and Lynparza and other agents. During a Thursday presentation during the 2019 Genitourinary Cancers Symposium (ASCO GU) in San Francisco, Merck said interim data from the Phase Ib/II KEYNOTE-365 trial using its vaunted anti-Pd-1 therapy Keytruda in combination with various agents, is showing promise in treating patients with metastatic castration-resistant prostate cancer (mCRPC). Merck said the early findings show anti-tumor activity across three cohorts of the study. The three study cohorts paired Keytruda with Lynparza, docetaxel and prednisone and enzalutamide.

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Janssen Announces Preliminary Results from Phase 2 GALAHAD Study in Adults with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Pathway Defects (DRD)

(Janssen) Feb 14, 2019 - Data showed niraparib demonstrated an objective response rate of approximately 40 percent in patients with metastatic castration-resistant prostate cancer and DNA-repair pathway defects, specifically BRCA1/2.

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TYME Reports Encouraging SM-88 Clinical Results without Typical Hormone-Related Side Effects in Phase II Study of Patients with Biomarker Recurrent Prostate Cancer

(Markets Insider) Feb 14, 2019 - SM-88 therapy did not exhibit typical side effects associated with hormonal castration from androgen-deprivation therapy (ADT). 87% of patients (20/23) remained free of radiographic progression. After 12 weeks, all patients had a decrease in circulating tumor cells (CTCs), a biomarker related to prostate cancer prognosis, with a median decrease of 65%.

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Trovagene Presents Update on Phase 2 Study of Onvansertib in Combination with Zytiga in Patients with mCRPC at ASCO-GU Conference

(Trovagene) Feb 14, 2019 - Trovagene, Inc., a clinical-stage oncology therapeutics company, taking a precision medicine approach to develop drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers, today presented an overview of its ongoing Phase 2 study evaluating Onvansertib in combination with Zytiga® (abiraterone acetate)/prednisone in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) at the Genitourinary Cancers Symposium (ASCO-GU) in San Francisco, CA.

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ASCO GU Preview: Merck, Bristol-Myers Squibb, Pfizer and More

(BioSpace) Feb 12, 2019 - The American Society of Clinical Oncology 2019 Genitourinary Cancers Symposium (ASCO GU) is being held in San Francisco from February 14-16. Ahead of the conference, several companies have announced presentations. Here’s a look at just a few. Merck & Company. Merck plans to present survival data from its pivotal Phase III KEYNOTE-426 clinical trial of its checkpoint inhibitor Keytruda in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of advanced or metastatic renal cell carcinoma (RCC). The company had announced in October 2018 that the trial met both primary endpoints of overall survival (OS) and progression-free survival (PFS), as well as the key secondary endpoint of objective response rate (ORR).

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Pembrolizumab Plus Axitinib Extended Overall Survival and Progression-Free Survival Versus Current Standard Treatment for Advanced Kidney Cancer

(2019 GU Cancers Symposium) Feb 11, 2019 - Results from the randomized, phase III KEYNOTE-426 clinical trial show that first-line therapy with a combination of the PD-1 targeted immunotherapy pembrolizumab (Keytruda) and the VEGF-targeted tyrosine kinase inhibitor axitinib (Inlyta) extended both overall survival and progression-free survival for patients with clear-cell metastatic renal cell carcinoma (mRCC), compared with the current standard of care, sunitinib (Sutent). Findings from this international study will be presented at the upcoming 2019 Genitourinary Cancers Symposium in San Francisco, California. “These results are exciting,” said co-lead study author Thomas Powles, MD, Professor of Urology Oncology at Barts Cancer Institute in London, England. “By adding pembrolizumab to a VEGF-targeted therapy, we are seeing powerful anticancer responses, including improved survival – and importantly, the results are seen across broad subgroups of patients.”

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ASCO-GU – Bristol’s Renal Cancer Lead Looks to be Short-Lived

(Vantage) Feb 11, 2019 - In the Keynote-426 study Merck & Co’s Keytruda looks to have blasted Opdivo out of the water, showing a 47% reduction in risk of death versus Sutent. Bristol-Myers Squibb is probably getting tired of this, but it’s happened again. Another oncology setting in which Opdivo had seized an early foothold, in this case renal cell carcinoma, looks soon to fall to its arch-rival, Merck & Co’s Keytruda. The first-line Keynote-426 study, in which Keytruda was combined with Pfizer's Inlyta, was already known to have hit overall and progression-free survival endpoints, but full data had been kept back until today’s abstract reveal at the Asco-Genitourinary Cancers symposium. The result looks likely also to clip the wings of Pfizer/Merck KGaA’s Bavencio, whose Inlyta combo impressed at Esmo last year.

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Phase II Trial Shows Novel, Radiolabeled PSMA-Targeted Treatment Provides High Response Rates in Men With Metastatic Prostate Cancer

(2019 GU Cancers Symposium) Feb 11, 2019 - A single-arm, phase II trial in men with PSMA-positive metastatic, castration-resistant prostate cancer (mCRPC) that progressed despite standard therapies, found that in the majority of men, the cancers were responsive to treatment with a novel, targeted radiation therapy called Lutetium-177 PSMA-617 (LuPSMA). This is the first prospective study of LuPSMA, part of a potential new class of treatments for men with metastatic prostate cancer. According to the researchers, men receiving the medication lived a median of 13.3 months after treatment, longer than the average 9-month survival time for men with this stage of disease. These findings will be presented at the upcoming 2019 Genitourinary Cancers Symposium in San Francisco, California.

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African-American Men With Advanced Prostate Cancer Live Longer Compared With White Men When Treated With Newer Hormone Therapies

(2019 GU Cancers Symposium) Feb 11, 2019 - A large, retrospective study analyzing five years of data from the Veterans Health Administration (VHA) found that African-American men with metastatic castration-resistant prostate cancer (mCRPC) who were treated with newer prostate cancer drugs abiraterone acetate (Zytiga) or enzalutamide (Xtandi) – and who had not received prior chemotherapy – lived 20% longer compared with white men who received the same treatment. These findings will be presented at the upcoming 2019 Genitourinary Cancers Symposium in San Francisco, California. “We’ve historically seen that prostate cancer is more common, more aggressive, and more lethal in African Americans, compared with men of other racial groups,” said lead study author Megan McNamara, MD, Assistant Professor of Medicine at the Duke University School of Medicine in Durham, North Carolina. “Balancing against other health-related risks, we found that treatment with newer hormonal medicines led to a significantly greater survival for African-American men in this analysis, compared with white men.

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Study Signals Survival Benefit for Black Men on New Prostate Cancer Drugs

(Duke Health) Feb 12, 2019 - It used to be a statistical fact that African-American men fared worse than whites when battling prostate cancer. But recent research led by scientists at the Duke Cancer Institute has been challenging that notion. Added evidence will be presented Feb. 11 at a meeting of the American Society of Clinical Oncology showing better overall survival rates among black men with metastatic disease who are treated with abiraterone acetate or enzalutamide. What’s driving this shifting paradigm appears to be a racial difference in how men respond to new therapies, suggesting a genetic basis for the success of drugs that target hormone production.

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Phase 3 ARCHES Trial Shows XTANDI® (enzalutamide) Significantly Improved Radiographic Progression-Free Survival in Men with Metastatic Hormone-Sensitive Prostate Cancer

(Astellas) Feb 11, 2019 - Pfizer Inc. and Astellas Pharma Inc. announced today results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer (mHSPC).

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