Top News from ASCO GU 2018

All The Most Important News and Updates form ASCO Genitourinary Cancers Symposium 2018

Phase III IMmotion151 study showed Roche’s TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) reduced the risk of disease worsening or death by 26 percent in certain people with advanced kidney cancer

February 8, 2018

Roche has announced results from the positive Phase III IMmotion151 study of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) as a first-line treatment for advanced or metastatic renal cell carcinoma (mRCC). The study met its co-primary endpoint of investigator-assessed progression-free survival (PFS) in people whose disease expressed the PD-L1 (expression ?1%). Those who received TECENTRIQ plus Avastin had a 26-percent reduced risk of disease worsening or death (PFS) compared to people treated with sunitinib (median PFS [mPFS]: 11.2 vs. 7.7 months; HR=0.74; 95% CI 0.57, 0.96; p=0.02). Initial observations from the co-primary endpoint of overall survival (OS) in the overall study population (intention-to-treat, ITT) were encouraging, but are still immature. Safety for the TECENTRIQ and Avastin combination appeared consistent with the known safety profile of the individual medicines and what was previously reported in the Phase II IMmotion150 study.

Bayer showcased latest prostate cancer research on Xofigo® and darolutamide

February 8, 2018

Bayer has announced that new prostate cancer data from the continued research on the long-term efficacy and safety of Xofigo® (radium-223 dichloride) and the ongoing clinical trial program with darolutamide, a novel investigational oral androgen receptor (AR) antagonist, were presented at the 2018 ASCO GU. Bayer presented data from the first interim analysis of REASSURE, a real-world, observational study to evaluate the safety of Xofigo in men with metastatic castration-resistant prostate cancer (mCRPC) in the U.S. In addition, efficacy and safety data from an international, open-label study in mCRPC patients who were re-treated with radium-223 dichloride were presented. Bayer also presented data and provide an update on ongoing studies with darolutamide, including the ARASENS pivotal trial in men with metastatic hormone-sensitive prostate cancer (mHSPC).

Phase 3 PROSPER Trial Shows XTANDI® (enzalutamide) Significantly Reduced the Risk of Metastasis or Death by 71 Percent in Men with Non-Metastatic Castration-Resistant Prostate Cancer

February 8, 2018

Astellas Pharma Inc. and Pfizer Inc. have announced results from the Phase 3 PROSPER trial in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC). The results show that the use of XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastases or death by 71 percent compared to ADT alone. The median for the primary endpoint, metastasis-free survival (MFS), was 36.6 months for men who received XTANDI compared to 14.7 months with ADT alone (n=1401; HR=0.29 [95% CI: 0.24-0.35]; p<0.0001).

ERLEADA™ (apalutamide), a Next-Generation Androgen Receptor Inhibitor, Lowered Risk of Metastasis or Death in Patients with Non-Metastatic Castration-Resistant Prostate Cancer

February 8, 2018

Janssen  announced new findings from the Phase 3 SPARTAN clinical trial that showed treatment with ERLEADA™, an investigational, next-generation androgen receptor inhibitor, decreased risk of metastasis or death by 72 percent and improved median metastasis-free survival (MFS) by more than two years (difference of 24.3 months) in patients with non-metastatic castration-resistant prostate cancer (CRPC) whose prostate specific antigen (PSA) is rapidly rising, compared to placebo.

Blue Earth Diagnostics Announces Presentation at ASCO 2018 on Fluciclovine (18F) PET/CT Impact on Clinical Management of Recurrent Prostate Cancer

February 9, 2018

Blue Earth Diagnostics, a molecular imaging diagnostics company, has announced the presentation of initial results from the FALCON clinical trial (NCT02578940) of fluciclovine (18F) PET/CT, evaluating its impact on patient management in biochemically recurrent prostate cancer patients scheduled for salvage treatment with curative intent.

AVEO Oncology and EUSA Pharma Announce Encouraging Preliminary Results from Phase 2 Portion of the TiNivo Study in Renal Cell Carcinoma

February 10, 2018

AVEO Oncology and EUSA Pharma have announced the presentation of preliminary results from the Phase 2 portion of the TiNivo study, a Phase 1b/2 multicenter trial of oral (PO) tivozanib (FOTIVDA®) in combination with intravenous (IV) nivolumab (OPDIVO®, Bristol-Myers Squibb),  for the treatment of metastatic renal cell carcinoma (mRCC).

Top News from ASCO GU 2018 last edit: 2018-02-12T18:38:08+00:00 da Luca

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