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Laminar Pharmaceuticals

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Laminar Pharmaceuticals
Laminar Pharmaceuticals

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#2686

Re: Laminar Pharmaceuticals

Noticia relacionada y con mención: (https://firstwordpharma.com/story/6718700)


Imvax pitches OS advantage for brain cancer therapy after main goal falls short

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,

#2687

Re: Laminar Pharmaceuticals

último párrafo del articulo:

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.

#2688

Re: Laminar Pharmaceuticals

Esos resultados son muy buenos.


Meten +45% en OS en población total.
#2689

Re: Laminar Pharmaceuticals

Manco perdona que estoy jugando con los niños . Los resultado buenos son de laminar o de un competidor ?
#2690

Re: Laminar Pharmaceuticals

Competidor.
#2691

Re: Laminar Pharmaceuticals

Pues vaya mierda entonces. Estamos para que nos meten más presión 
#2692

Re: Laminar Pharmaceuticals

Buenos días 
Como nadie escribe nada . Que consecuencias tiene ese medicamento con el nuestro. Es mejor?
#2698

Re: Laminar Pharmaceuticals

yo entiendo que estamos casi a la par,  a saber de la os que vamos a tener, si en pfs lo superamos puede que la os sea mayor a invax le pasa algo parecido que la muestra es pequeña y le podrián pedir otra fase tres con mas pacientes  en cuanto al tiempo de sacara el farmaco le podemos estar llevando una ventaja de uno a dos años enn caso de ser aprovados toca esperar unos meses y ver nuestra os, nos toca esperar y ser pacientes esto puede hacerse largo.