Shots: The companies reported the positive results from two studies (EV-201 and EV-103) evaluating Padcev as monothx. and in combination with Merck’s Keytruda in patients with LA or mUC who are not able to receive cisplatin CT respectively An updated analysis of EV-201 Cohort 2 showed that 51% achieved confirmed objective response with CR (22%), […]Read More
Shots: The first sBLA is based on the P-III EV-301 trial assessing Padcev vs CT in ~ 600 patients with LA or mUC prior treated with PD-1/L1 inhibitor and platinum-based therapy. The first sBLA seeks to convert PADCEV’s accelerated approval to regular approval The second sBLA is based on cohort 2 of the P-II EV-201 […]Read More
Shots: The MAA is based on the P-III EV-301 trial which involves assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with Pt.-based CT and a PD-1/L1 inhibitor The 1EPs of the trial is OS and 2EPs include PFS, ORR, DoR, DCR as well as the assessment of safety/tolerability and QoL […]Read More
Shots: The submission is based on EV-301 and EV-201 trials in Japan. The P-III EV-301 trial assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with platinum-based CT and PD-1/L1 inhibitor The P-II EV-201 trial assessing Enfortumab Vedotin in ~128 patients with LA/m-UC, prior treated with PD-1/L1 inhibitor, including those who […]Read More
Shots: The first BLA submission is based on P-III EV-301 trial which involves assessing of Padcev vs CT in 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based CT and a PD-1/L1 inhibitor. The 1EP of the study was OS The second BLA submission is based on P-II cohort […]Read More
Shots: The US FDA has granted BTD for disitamab vedotin (RC48) for 2L treatment patients with HER2+ LA/m-UC who had prior received Pt-containing CT treatment Earlier, RemeGen reported the FDA’s clearance of an IND application for a P-II clinical study in the US and the grant of FTD for disitamab vedotin RC48 is a novel […]Read More
The PADCEV was evaluated in P-II EV-201 Trial to evaluate 125 patients locally advanced or metastatic urothelial cancer who received who received prior treatment with a PD-1 or PD-L1 inhibitor and a Pt-based CT The study resulted in ORR 44%, CR 12% leading no cancer detection at time of assessment, PR 32% meaning a decrease […]Read More
Shots: The P-II EV-201 study involves assessing of Enfortumab Vedotin in patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor including those who have also been treated with Pt-CT P-II EV-201 results: ORR 44%; DOR 7.6 mos.; mOS 11.7 mos.; mPFS 5.8 mos.; CR 12%; presented at […]Read More
Shots: Basilea to conduct the P-I/II biomarker-driven clinical trial with its expected initiation in H1’2019 and Roche to provide atezolizumab for the trial The focus of the agreement is for the onset of the trial assessing Basilea’s derazantinib in combination with Roche’s Tecentriq (atezolizumab) in patients with advanced (UC) and FGFR genomic defects Derazantinib (BAL087, formerly ARQ 087) is […]Read More
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