NorthWest Biotherapeutics Inc (NWBO)

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FDA OKs Halozyme's PEGPH20 P3 primary endpoint change in first-line pancreatic cancer

Nov. 26, 2018 4:51 PM ET|About: Halozyme Therapeutics,... (HALO)|By: Douglas W. House, SA News Editor
Halozyme Therapeutics (NASDAQ:HALO) announces that the FDA has agreed to its request to change the efficacy measure in its Phase 3 clinical trial, HALO-301, evaluating PEGPH20 in first-line pancreatic cancer to the single endpoint of overall survival (OS).

The elimination of the former co-primary endpoint of progression-free survival (PFS) means that the planned interim analysis will not be done.

https://seekingalpha.com/news/3412231-fda-signs-primary-endpoint-change-late-stage-study-halozymes-pegph20-first-line-pancreatic?dr=1#email_link

Just seemed close to home. I'm not saying that NWBO is going through the same thing w their trial but it does show flexibility on the FDAs part.

NCT02715804

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : February 25, 2016
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : December 31, 2019