Tuesday, October 25, 2016 8:12:08 AM
PPHM 1501- An open-label, randomized, phase II trial of durvalumab (MEDI4736) with or without bavituximab in patients with previously treated metastatic non-small cell lung cancer (NSCLC): Safety report on first 18 patients.
http://meetinglibrary.asco.org/content/171161-176
Results: Enrollment is ongoing and initially will be limited to no more than 2 patients per arm per week. A safety committee will monitor the occurrence of dose limiting toxicities for the first 18 patients prior to enrolling the remainder of the trial. Conclusions: Analysis of the first 18 patients will be presented.
Author(s):
Ronald B. Natale, David R. Spigel, Rachel E. Sanborn, Alberto Chiappori, Suresh S. Ramalingam, Konstantin H. Dragnev, Joseph Shan, Lisa Stepp, Michael McCleod, David Michael Waterhouse, David E. Gerber; Cedars-Sinai Outpatient Cancer Center, Los Angeles, CA; Sarah Cannon Research Institute, Nashville, TN; Earle A. Chiles Research Institute, Providence Cancer Center, Portland, OR; Moffitt Cancer Center, Tampa, FL; The Winship Cancer Institute of Emory University, Atlanta, GA; Dartmouth Hitchcock Medcl Ctr, Lebanon, NH; Peregrine Pharmaceuticals, Inc., Tustin, CA; Peregrine Pharmaceuticals, Tustin, CA; Florida Cancer Specialists, Cape Coral, FL; Oncology Hematology Care, Cincinnati, OH; The University of Texas Southwestern Medical Center, Dallas, TX
that was with durvalumab, azn's pdl-1 drug. so i think it's safe to say a pdl-1 drug with bavi has been tested in humans....
now the nccn merck trial announced in sept 2016 with a pdl-1 starts as a phase 2, not a phase 1... if there were safety issues w/ bavi and pdl-1, this trial would not be starting as a phase 2 imo.
also Ronald B. Natale has ties to MSK and Spigel was the lead presenter at ESMO...
http://bio.csmc.edu/view/3777/Ronald-B-Natale.aspx
the durvalumab/bavi trial was withdrawn july 28 2016... now the question as to why it was pulled?
https://clinicaltrials.gov/ct2/show/NCT02673814?term=bavituximab&rank=12
and during this time pphm has a pivot to avid in that they basically don't have the resources to run trials and expand avid at the same time without huge dilution...
all the while the "preclinical" stuff keeps getting more promising...
so i think it's safe to say bavi and a pdl-1 drug has been tested in humans... efficacy yet to be determined...
merck seems to have stepped up w/ two trials via nccn and they are testing lag3 with pdl-1 ... and preclinical bavi shows bavi+Pdl-1+lag3 looks promising...
sk confirms they are talking to merck...
they have all the ingredients to get a deal done now or very soon...
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