Al Musella 11:34 PM Why do so many phase 3 trials fail after having success in phase 2?
Nghiemphu, Phioanh [Leia] M.D. 11:59 PM There are inherent bias when enrolling in patients in small phase 2 trials, which is why therapies are usually not approved unless show efficacy in phase 3.
Brad Silver 12:30 AM When was chemo changes from 21/7 for 2 years to 5/23 for 1 year?
Nghiemphu, Phioanh [Leia] M.D. 12:40 AM This may have been addressed in part 1 of our conference. We never really used 21/7 dosing.
Brad Silver 12:31 AM Does UCLA suggest clinical trials elsewhere for patients?
Nghiemphu, Phioanh [Leia] M.D. 12:40 AM As best as we can but there are thousands out there and we usually refer patients to clinicaltrials.gov website.
Anonymous Attendee 12:47 AM I have a few questions about this trial at UCLA: Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma This trial with Merck’s Keytruda coupled with DC VAX L has been ongoing for about 14 months. How many patients are enrolled to date? Is there radiation or chemotherapy (temozolomide or avastin to help reduce swelling and prevent tumor growth)? What has UCLA learned from this trial to date? Can someone from the UK participate in this trial? Why is the name of the vaccine “ATL-DC vaccine” and not DCVax-L? Are both generic the same?
Nghiemphu, Phioanh [Leia] M.D. 12:54 AM As long as a patient can come to UCLA to have surgery for tumor resection and come to UCLA every 6 weeks for pembrolizumab or placebo infusion, they can be enrolled into this trial. It is ongoing and we are still enrolling patients. We do not have results as it is still too early. The vaccine names are different but it is the same vaccine.
Anonymous Attendee 12:54 AM Are you aware of changing endpoints over the course of a clinical brain tumour trial here at UCLA? And must the participant be informed about a changed endpoint?
Nghiemphu, Phioanh [Leia] M.D. 12:57 AM Most of our current trials do not always change endpoints. Participants would be informed if there are procedural changes to the trial because of the changed endpoints.
Anonymous Attendee 01:13 AM As part of an industry-wide review, the FDA persuaded PD-1/L1 players Merck & Co., Bristol Myers Squibb, Roche and AstraZeneca to remove four indications on the labels of cancer drugs, after the failure of post-marketing studies. The expert panel will discuss data on three indications for Merck’s Keytruda, two for Roche’s Tecentriq and one for Bristol Myers’ Opdivo.
Is that an issue for the ongoing combo trial keytruda and dcvax-l?
Nghiemphu, Phioanh [Leia] M.D. 01:19 AM these treatments are supported by the clinical trial and not affected by the FDA panel which have to do with FDA provisional approvals. Neither vaccine nor pembrolizumab are indicated for brain cancer.
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