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Roche says Venetoclax combination improves PFS in phase III CLL trial

PBR Staff Writer Published 19 September 2017

Roche has reported that its cancer drug Venclexta/Venclyxto (venetoclax), developed jointly with AbbVie, has succeeded in a phase 3 study in chronic lymphocytic leukaemia (CLL) patients by meeting its primary endpoint.

The cancer drug was evaluated in the late-stage study dubbed MURANO in combination with MabThera/Rituxan (rituximab) in CLL patients whose disease had relapsed or is in the refractory form. It was pitted against bendamustine plus Mabthera/Rituxan.

Venclexta/Venclyxto was demonstrated to have significantly improved survival of patients while their disease was found to have worsened.

Additionally, Venclexta/Venclyxto did not show any new safety signals or increase in its known toxicities during the treatment combination of Venclexta/Venclyxto plus Mabthera/Rituxan in the MURANO study.

According to Roche, Venclexta/Venclyxto is a small molecule that selectively binds and inhibits the BCL-2 protein, which has a key role in a process called apoptosis or programmed cell death.

Overexpression of the BCL-2 protein in CLL has been linked with resistance to certain treatments. Inhibiting BCL-2 is believed to possibly restore the signaling system that tells cancer cells and other cells to self-destruct.

Venclexta/Venclyxto’s phase 3 study featured 389 patients with relapsed or refractory CLL who were treated with at least one but not more than three lines of therapy in the past.

Roche chief medical officer and global product development head Sandra Horning said: “Chronic lymphocytic leukaemia is considered incurable and becomes harder to treat with each relapse.

“This is the first study to show that Venclexta/Venclyxto plus Mabthera/Rituxan can help people with this type of leukaemia live significantly longer without their disease worsening compared to a standard-of-care regimen.

“We will work with health authorities to bring this potential chemotherapy-free treatment option to the people who need it as quickly as possible.”

Venclexta/Venclyxto is commercialised in the US by AbbVie in collaboration with Roche’s Genentech. Outside of the US, AbbVie holds the commercial rights of the drug.

Image: Site Roche Basel. Photo: courtesy of F. Hoffmann-La Roche Ltd.