In the Hyperacute NSCLC PhI/II trial, Significantly longer overall survival (OS) was demonstrated in patients responding with increased IFN-γ secretion by PBMC’s post-vaccination (21.9 vs. 7.2, p=0.044).
Note best supportive care OS is usually 4.6 months, Docetaxel 7.5 months and Pemetrexed 8 months. In the new trial announced today they are tightening their enrollment criteria to bring into the trial patients with healthier immune systems.
"This Phase 2B/3 study will enroll patients having a better baseline immune system status relative to the patient population in the earlier Phase 2 study. In order to be eligible for the study, patients must have Stage IIIB or Stage IV recurrent or treatment refractory non-small cell lung cancer with good performance status (ECOG /= 1000/μL, platelets /= 100,000/μL, hemoglobin 10.0 gm/dL, albumin /= 3.0 gm/dL and acceptable hepatic and renal function are required for enrollment."
Since IFN-γ is secreted by T helper cells (specifically, Th1 cells), cytotoxic T cells (TC cells) and NK cells, patients in the Phase I/II trial that expressed gamma interferon had immune systems that are working well. With this enrollment criteria set, they have a healthy chance of hitting the 21.9 month OS number again. If they get anywhere close to the 21.9 month number they will essentially be blowing the competition out of the water and setting a new paradigm for NSCLC treatment.
Also of note, in their Phase I/II trial NSCLC, all patients received 300 million cells/injection every 2 weeks for up to eight scheduled doses. In the new trial they are trying 2 regimes;
• Tergenpumatucel-L at 300 million cells given by intradermal injection weekly for 11 weeks then every 2 months for 5 additional doses (up to a total of 16 immunizations)
• Tergenpumatucel-L at 300 million cells given by intradermal injection every 2 weeks for 6 doses and then every month for 10 additional doses (up to a total of 16 immunizations).