News: POLARIX meets Phase III Primary Goals
Roche has just reported that their Polivy combination therapy has reached its primary endpoints during the Phase III POLARIX clinical trial. The drug is being tested in combination with chemotherapy to treat diffuse large B-cell lymphoma (DLBCL.)
Polivy is an anti-CD79b antibody-drug-conjugate (ADC) which works by attaching itself to B cells and delivering an anti-cancer treatment. This is believed to reduce the negative impact of treatment on normal, healthy cells.
The POLARIX trial was a global, randomized placebo-controlled trial testing the efficacy, safety, and tolerability as well as the pharmacokinetics of Polivy in addition to traditional chemotherapy treatments.
The standard of care regimen involved MabThera/Rituxan, cyclophosphamide, doxurubicin, vincristine and prednisone. The trial demonstrated a significant improvement in the rates of progression-free survival for patients taking the Polivy treatment arm -- meeting the trial’s primary goal.
The safety profile is still in line with previous trial stages.
Notably, Polivy in addition to Chemo. Is the first treatment in around twenty years to improve the outcomes in the previously untreated, aggressive form of B cell lymphoma. Under a normal course of treatment, people with this kind of cancer face a 40% relapse rate after their initial treatment, according to the Roche chief medical officer.
Soon, the data from this trial will be submitted to health authorities across the world. Though, the drug is already approved for use alongside the aforementioned combination therapies in many countries including across the EU and in the US.
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