Laminar Pharmaceuticals

Anna Bratulic

Published : December 02, 2025

Ref: Imvax

Imvax appears to be putting its strongest emphasis on overall survival (OS), while downplaying a miss on progression-free survival (PFS), in a study of its investigational glioblastoma therapy.

On Tuesday, the company said it is moving ahead anyway to seek a meeting with the FDA to discuss a regulatory path forward for IGV-001 in newly diagnosed glioblastoma (ndGBM) after the Phase IIb trial failed to achieve statistical significance on the primary endpoint PFS, but delivered an improvement of 6.3 months, or 45%, in median OS over placebo.

 IGV-001 is an autologous immunotherapy that combines a patient's own tumour cells with an antisense oligonucleotide (IMV-001) inside temporary biodiffusion chambers implanted shortly after surgical resection of the tumour. In the placebo arm, the chambers contained an inactive solution only. The chambers were removed after roughly 48 hours, and six weeks later all patients began standard therapy with concurrent radiotherapy and temozolomide, followed by maintenance temozolomide.

In the 99-patient trial, IGV-001 led to median OS of 20.3 months versus 14 months in the placebo arm. Patients also saw "measurable patient benefit across multiple metrics" compared to placebo, according to the company. However, the therapy did not significantly move the needle on PFS. There were no drug-related serious adverse events reported.

No sé si es tan mala o llega a ser bueno saber como está en tema competitivo y dificultades compartidas...

J,

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Laminar Pharma's LAM561, a synthetic derivative of oleic acid, has also fallen short of statistical significance on the PFS endpoint of a Phase IIb/III study though the company touted an "improvement trend" earlier this year among first-line MGMT-methylated GBM subgroups, while Northwest Biotherapeutics' DCVax-L personalised immune therapy has reported positive OS data in a Phase III trial in both newly diagnosed and recurrent disease.