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A Second Opinion: Evaluating the Phase 2 data on HALO's PEGPH20 in combination with ABRAXANE (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer patientsTicker(s): HALO
Name: Dr Andrew Ko - MD
- Professor of Medicine (Hematology/Oncology) and specialist in colorectal and gastrointestinal cancer, with a particular interest in pancreatic cancer.
- Treats 40-50 patients with Advanced Pancreatic Cancer.
- Heads the GI site committee regarding development and oversight of trials focused on pancreatic, colorectal, hepatobiliary, esophagogastric, and neuroendocrine malignancies; and also chairs the Cancer Center scientific Protocol Review Committee.
Please describe your clinical practice and experience with clinical trials in Pancreatic Cancer.Added By: c_admin
What are your overall impressions of the PEGPH20 data?Added By: c_admin
What is the likelihood that Progression Free Survival is sufficient for the FDA rather than Overall Survival?Added By: c_admin
How will the FDA treat overall response rate (ORR) data?Added By: c_admin
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: c_admin
Will the P-value and hazard rate seen in phase II cause pause for the FDA?Added By: c_admin
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: c_admin
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: c_admin
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: c_admin
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: c_admin
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: c_admin
HALO and ADRO put out preclinical data this week at AACR. At least in an murine breast cancer model, PEGPH20 with and without ADRO's LADD and PD-L1 worked synergistically, as measured by both Tumor regression and CD8 infiltration compared to PD-L1 alone. Have you reviewed these data and have any opinion on extrapolation to IO therapy for pancreatic cancers.
In both the recently halted SWOG trial and HALO's pancreatic ph2, PEGPH20 did not provide a significant benefit in the all comers population, but rather only seems to give a benefit in the high HA population. Does this subgroup specific activity concern you, as it seems to have affected the investor/analyst community?
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- Halozyme Therapeutics (HALO) to release HALO-202 study data on combination of PEG PH20 and gemcitabime in treating pancreatic cancer in 2017 HALO Occurred On: Jan 05, 2017
- Halozyme Doses First Patient In Phase 3 Clinical Trial Of PEGPH20 In Combination With ABRAXANE And Gemcitabine HALO Occurred On: Mar 16, 2016