April 27, 2017—On Tuesday, Bristol-Myers Squibb Company and Transgene announced a dual collaborative clinical research effort to determine the safety and efficacy of TG4010, a therapeutic vaccine, in combination with nivolumab (OPDIVO) and standard chemotherapy, as a first-line treatment for advances non-squamous non-small cell lung cancer (NSCLC). The trial is set in patients with low levels of PD-L1.
“We are excited to explore the potential benefits of combining OPDIVO with an investigational therapeutic vaccine, TG4010, in NSCLC where the need for new therapies is particularly acute,” said Fouad Namouni, M.D., Head of Oncology Development, Bristol-Myers Squibb, in a press release. “As the science around cancer research continues to rapidly evolve, we are building on our leadership in Immuno-Oncology with potential combinations of therapies that may help advance new therapeutic approaches for patients in need of better options.”
TG4010 is a designed immunotherapy that expresses the coding sequences of human MUC1, a tumor-associated antigen commonly expressed in solid tumors, including NSCLC, and human interleukin-2. TG4010 is a suspension of modified vaccinia virus strain Ankara (MVA) that induces an immune response against MUC1 antigen expressing tumors. In late 2015, it was reported that TG4010 seemingly improved PFS relative to placebo in the phase 2b/3 TIME trial (EudraCT: 2011-001468-23; NCT01383148).
Nivolumab is a PD-1 immune checkpoint inhibitor engineered to help restore the body’s anti-tumor immune response. It was the first inhibitor of its kind to receive regulatory approval. Nivolumab is currently approved in more than 60 countries, including the US, EU, and Japan.
The new phase 2 collaboration will evaluate objective tumor response and disease control. Further, the study will evaluate the safety and tolerability of the combined regimen. Transgene will sponsor the trial, while Bristol-Myers Squibb will provide the nivolumab to be used in the study. Preliminary data is expected in 2018.
Jonathan A. Bell
Published Online: Wednesday, April 27, 2017