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Evaluating the Phase 2 data on PEGPH20 in Advanced Pancreatic CancerTicker(s): HALO
Name: Dr Joseph Herman - MD
Institution: MD Anderson Cancer Center
- Radiation oncologist who treats several hundred patients with Advanced Pancreas Cancer per year.
- His research has led to new standards in care, and he is the founder of a unique one-day clinic for pancreatic cancer patients who need treatment recommendations from all branches of cancer care.
- Extensively published on both therapeutic and radiological treatments and familiar with the PEGPH20 program as well as FDA's perspective and expectations around Pancreatic Cancer Treatments in development.
Please describe your clinical practice and experience with clinical trials in Pancreatic Cancer.Added By: joe_mccann
What are your overall impressions of the PEGPH20 data?Added By: joe_mccann
What is the likelihood that Progression Free Survival is sufficient for the FDA rather than Overall Survival?Added By: joe_mccann
How will the FDA treat overall response rate (ORR) data?Added By: joe_mccann
Is this too far off the cusp for the current FDA assuming no change at the top (which I expect but cannot depend on)?Added By: joe_mccann
Will the P-value and hazard rate seen in phase II cause pause for the FDA?Added By: joe_mccann
Is the trial design sufficient to allow for a clean progression to Phase III or, as some have claimed, there is too much hair or apparent concern with the exploratory design of the trial to proceed without major reservations from the FDA?Added By: joe_mccann
How familiar are you with HALO’s history vs this specific trial? What is your opinion of the company and management to the extent you have one?Added By: joe_mccann
How do you think about the The protocol amendment in 2014 around Thromboembolic Events (TE). Slide 10 of the company recent presentation showed the TE rates for the 2 arms. How do these numbers for Stage 2 vs. Stage 1 look to you? How concerned about TE are you with PEGPH20?
In your experience is there a clotting risk in pancreatic patients independent of this drug which could have been exacerbated by PEGPH20 in the first trial, that was stopped for clotting issues?Added By: neuman101
How do you look at the PFS vs. OS rates in a study like 202? I ask mainly because the OS HR was .96, while the PFS was only .51. Does the OS HR concern you here? If it does not concern you, why not? (Slide 12)Added By: joe_mccann
Do you think it is best to focus on OS and PFS for Stage 2 only or Stage 1 + 2 combined? The company does an exploratory analysis on the Stage 2 alone and the Hazard ratios look much better.Added By: joe_mccann
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- PEGPH20 Selected For Inclusion In Groundbreaking Clinical Trial Initiative Designed To Transform Outcomes For Pancreatic Cancer Patients HALO Occurred On: Oct 04, 2016
- Halozyme Resumes Patient Enrollment And Dosing In PEGPH20 Clinical Trial With KEYTRUDA HALO Occurred On: Jul 25, 2016
- Halozyme Presents Stage One Efficacy And Safety Analysis Of Phase 2 Clinical Study In Metastatic Pancreatic Cancer Patients Treated With PEGPH20 HALO Occurred On: Jun 04, 2016
- Halozyme Doses First Patient In Phase 3 Clinical Trial Of PEGPH20 In Combination With ABRAXANE And Gemcitabine HALO Occurred On: Mar 16, 2016
- Phase 2 PFS data of PEGPH20 for pancreatic cancer due Q4 2016 HALO Occurred On: Jun 04, 2016