More info just came up on AACR Abstracts:
PSA;
Results: At entry, PA and PB pts were ~70 yrs with a Gleason score >8 and the majority had received prior abiraterone and/or enzalutamide. PB pts had higher median baseline (BL) PSA (40.6 vs. 20.8 ng/mL), and more prior enzalutamide (53 vs. 26%) and chemotherapy (49 vs. 36%) use vs PA pts. Overall, 2 PA (14%) v 16 PB pts (43%) had a decreased PSA post-BL. Of these, 7 PB (19%) vs. 0 PA pts achieved a confirmed PSA reduction ≥50% from BL. The median OS (months) in PB pts was 23 (17.4 -NR) vs. 8.5 (3.8-20.10) in PA pts. Median OS in PB pts with PSA reduction ≥50% from BL has not been reached as 100% (6/6) of pts are still alive. T cell reactivity, as measured by ELISpot assays, showed that 100% of PA (9/9) pts and 100% of PB (16/16) pts exhibited increases in the frequencies of T cells reactive to at least one prostate cancer antigen other than PSA, which is indicative of antigen spreading.
Conclusions: ADXS-PSA ± pembro elicited a broad antitumor T cell response in all mCRPC pts tested but only ADXS-PSA + pembro reduced PSA ≥50% from BL and prolonged OS in these select pts.
This is the part I like in relation to the PSA -“Median OS in PB pts with PSA reduction ≥50% from BL has not been reached as 100% (6/6) of pts are still alive.”
NEO:
Results. The turnaround time for manufacturing ADXS-NEO has consistently been ≤ 8 weeks from biopsy to first dose. Two pts treated at 1X109 CFU (dose level 1) experienced dose limiting toxicities (i.e., Gr 3 hypoxia ± Gr 3 hypotension) within 4 hours of completing the infusion of the second dose. These acute adverse events correlated with elevation of serum IL-6 and other cytokines, and both cases were manageable and reversible with tocilizumab and/or steroids. A dose de-escalation cohort was initiated at 1X108 CFU, which has been found to be safe and tolerated by one pt. In these pts, ADXS-NEO induced: 1) activation and proliferation of CD4+ / CD8+ T cells; 2) neoantigen-specific T cell responses after 1 week of the initial priming dose and 3) antigen spreading and T cell responses to neoantigens not selected by algorithm.
Conclusions. ADXS-NEO at 1X109 CFU was beyond the maximum tolerated dose but it was effective in eliciting a fast and broad anti-tumor immunity, including T cell responses to neoantigens and antigen spreading. Enrollment continues both in monotherapy and combination therapy arms with anti-PD-1/PD-L1 therapy,
