BMS-936559 / BMS - LARVOL DELTA

Beyond the standard of care: a review of novel immunotherapy trials for the treatment of lung cancer (Cancer Control) - PMID: 23302904; “The monoclonal antibodies ipilimumab, BMS-936558 (anti-PD-1), and BMS936559 (anti-PD-L1) lead to enhanced T-cell-mediated antitumor effects and have produced objective responses in early-phase clinical trials. Studies for SCLC also exist, such as a novel vaccine therapy targeting p53.”

Review • Non Small Cell Lung Cancer • Oncology

Safety, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Severe Sepsis (clinicaltrials.gov) - P1b/2a; N=225; Recruiting; Sponsor: Bristol-Myers Squibb; Trial primary completion date: Sep 2018 ➔ Jun 2018

Trial primary completion date • Biosimilar

PD-1/PD-L1 pathway as a target for cancer immunotherapy: Safety and clinical activity of BMS-936559, an anti-PD-L1 antibody, in patients with solid tumors (ASCO 2012) - Presentation time: Sat, Jun 2; 1:30 PM - 1:45 PM; Anticipated presentation at ASCO 2012

Anticipated data presentation • Melanoma • Oncology

Safety and activity of anti-PD-L1 antibody in patients with advanced cancer (N Engl J Med) - P1, N=207; NCT00729664; Antibody-mediated blockade of PD-L1 induced durable tumor regression (objective response rate of 6 to 17%) and prolonged stabilization of disease (rates of 12 to 41% at 24 weeks) in pts with advanced cancers, including non-small-cell lung cancer, melanoma, and renal-cell cancer

P1 data • Oncology • Renal Cell Carcinoma

PD-1/PD-L1 pathway as a target for cancer immunotherapy: Safety and clinical activity of BMS-936559, an anti-PD-L1 antibody, in patients with solid tumors (ASCO 2012) - Presentation time: Sat, Jun 2; 1:30 PM - 1:45 PM; P1, N=162; Study ID MDX1105-01; Common related rAEs (≥5% pts) included fatigue, diarrhea, infusion reaction, arthralgia, rash, & pruritus; The incidence of G3-4 rAEs was 8.6%; Clinical activity was observed in MEL, RCC, and NSCLC; ORs were observed in heavily pretreated pts; ORs were durable; Among 16 pts with ORs, 7 had responses lasting ≥1 yr; Two other pts had ongoing ORs with durations of 2.3 and 8.5 mos at data lock; In NSCLC, ORs were observed irrespective of histology

P1 data • Melanoma • Oncology

Immune Checkpoint Inhibition in Sepsis: A Phase 1b Randomized, Placebo-Controlled, Single Ascending Dose Study of Antiprogrammed Cell Death-Ligand 1 (BMS-936559). (PubMed, Crit Care Med) - "In this first clinical evaluation of programmed cell death protein-1/programmed cell death-ligand 1 pathway inhibition in sepsis, BMS-936559 was well tolerated, with no evidence of drug-induced hypercytokinemia or cytokine storm, and at higher doses, some indication of restored immune status over 28 days. Further randomized trials on programmed cell death protein-1/programmed cell death-ligand 1 pathway inhibition are needed to evaluate its clinical safety and efficacy in patients with sepsis."

Biomarker • Checkpoint inhibition • Clinical • IO Biomarker • Journal • P1 data

Blockade of the PD-1 axis alone is not sufficient to activate HIV-1 virion production from CD4+ T cells of individuals on suppressive ART. (PubMed, PLoS One) - "We tested the ability of the human anti-PD-L1 mAb BMS-936559 and the human anti-PD-1 mAb nivolumab to increase HIV-1 virion production ex vivo from different peripheral blood mononuclear cell populations obtained from donors on suppressive antiretroviral therapy (ART). Cell surface expression of PD-1 and PD-L1 were not associated with changes in virus production. Ex vivo blockade of the PD-1 axis alone has limited effects on HIV-1 latency."

Clinical • IO Biomarker • Journal • PD(L)-1 Biomarker