Janssen Provides Update on Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA® (abiraterone acetate) Plus Prednisone Combination
RARITAN, N.J., April 19, 2021 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today that regulatory submissions based on the Phase 3 ACIS study, which evaluated the combination of ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) plus prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), will not be pursued. As presented at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium in February 2021, the ACIS study met its primary endpoint of radiographic progression-free survival (rPFS); however, combination treatment did not show significant benefit over the active control ZYTIGA® plus prednisone in key secondary endpoints, including overall survival (OS). “Safety results from ACIS were consistent with prior studies of ERLEADA and ZYTIGA plus prednisone, with no new safety signals observed. The study also generated valuable scientific outcomes and insights in subgroups of patients with luminal type in PAM50 test and tumors with average or high androgen receptor activity (molecular signatures of hormone sensitivity), which warrant further investigation,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research &Development, LLC. “These data will be important in informing future programs in our pipeline, as we look to build upon our leadership and commitment in bringing transformation...
ConclusionsIn this study, we showed TEW-7197 and ramucirumab considerably decreased invasiveness, thus EMTness in a panel of diffuse-type GC cell lines including GC PDCs. Taken together, we confirmed that combination of TEW-7197 and ramucirumab reduced tumor spheroid and GC PDC-induced blood vessel formation concomitantly in the spheroid-on-a-chip model.
Systematically mapping the mechanical properties of skin and tissue is useful for biomechanics research and disease diagnostics. For example, later stage breast cancer and lymphoma manifest themselves as hard nodes under the skin. Currently, mechanical measurements are done manually, with a sense of touch or a handheld tool. Manual measurements do not provide quantitative information and vary depending on the skill of the practitioner. Research shows that tactile sensors could be more sensitive than a hand. We propose a method that uses our previously developed skin-crawling robots to noninvasively test the mechanical prop...
Conclusion: The proposed model is shown to adequately describe the meal-induced glucose fluctuations in simulated CGM data while validations on clinical CGM data show promising results as well. Significance: The proposed model may lay the grounds for new ways of utilizing available CGM data, including CGM-based parameter estimation and stochastic optimal control.
Conclusion: Mitigation of LVAD sounds from precordial sound recordings of LVAD recipients enables analysis of intrinsic heart sounds. Significance: These findings provide proof-of-concept evidence of the clinical utility of heart sound analysis for bedside and remote monitoring of LVAD recipients.
This study shows that the LVADs can respond appropriately to changing patient states and physiological demands without the need for additional pressure or flow measurements.
Conclusion: The differential characteristics of EDA contributed highly to the accuracy of pain stimulation level detection of the classifiers. The external validity dataset was not considered in the study. Significance: Our approach has the potential for accurate pain quantification using EDA.
Conclusion: Our proposed POPS algorithm provides a general framework for fully automated treatment planning that achieves clinically acceptable dosimetric quality without requiring active planning from human planners. Significance: Our fully automated POPS algorithm addresses many key limitations of other automated planning approaches, and we anticipate that it will substantially improve treatment planning workflow.
Conclusions: The presented CAP algorithm returns increased ablation of the amygdalohippocampal complex, with lower patient risk scores compared to straight-line trajectories. Significance: This is the first clinical application of preoperative planning for steerable needle based LiTT. This study suggests that steerableneedles have the potential to improve - iTT procedure efficacy whilst improving the safety and should thus be investigated further.
David J. BierThe Biden administrationis planning to roll out a new policy in November that denies the right to travel or immigrate to the United States to anyone in the world who is unvaccinated. It will replace various nonsensical travel bans on Europeans, Chinese, Iranians, Brazilians, South Africans, and Indians, but a majority of the world (57 percent) has not received even a single shot of any of the vaccines, andonly 1.9 percent of people in low ‐income countries have received at least one dose. This includes pretty much the entire continent of Africa.Currently, everyone —vaccinated or not...
This study aimed to determine the relationship between domestic violence against women, adaptation to pregnancy, and maternal-fetal antenatal attachment.Design and MethodsThe study consisted of 385 pregnant women who were referred to the antenatal clinics of a public hospital in eastern Turkey. The data were collected using the Domestic Violence against Women Scale (DVAWS), the Maternal-Fetal Antenatal Attachment Scale (MAAS), and the Prenatal Self-Evaluation Questionnaire (PSEQ) to assess adaptation to pregnancy.FindingsPregnant women were exposed to low level of violence (Mean ± SD: 64.42 &p...
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