A few years ago, as generics weighed on sales of its three leading cancer drugs, Roche gained early approval for its antibody-drug conjugate Polivy in patients with diffuse large B-cell lymphoma (DLBCL) previously treated. Now the company is looking to position the drug as a first-line treatment – and it says it has the baseline data from a large international study to back it up.
Compared to a placebo, Polivy (polatuzumab vedotin) combined with chemotherapy and a version of Roche’s Rituxan helped patients live longer without making the disease worse, the pharma said Monday morning. Patients in the treatment arm received a combination of cyclophosphamide and doxorubicin chemotherapy with the steroid prednisone (R-CHP), while those in the placebo arm received cyclophosphamide, doxorubicin, vincristine and prednisone (R- CHOP).
The CHOP diet has been in use for over four decades and is now considered the standard of care for patients with newly diagnosed LDGCB. Rituxan was approved with CHOP as a first-line treatment in 2006.
Polivy – developed with ADC technology from SeaGen – targets the CD79b protein, which is expressed in the majority of non-Hodkin B-cell lymphomas, the most common subtype of NHL. After binding to CD79b, Polivy is designed to decimate B cells in a targeted manner, minimizing the effects on healthy cells. ADCs have thus been compared to Trojans, going unnoticed to deliver chemotherapy to cells expressing the target antigen.
A total of 879 patients were included in the Phase III POLARIX study testing Polivy on the first line. Roche has not released specific figures, but the company said it plans to submit the results to health regulators and present them at an upcoming medical meeting.
“Since 40% of people with DLBCL relapse after initial treatment, achieving meaningful first-line therapeutic effects has the potential to be transformative,” said the chief marketing officer and head of global product development, Levi Garraway, in a statement.
When given as a third-line treatment with Rituxan and the chemotherapy drug bendamustine, Polivy had previously achieved a median overall survival of 12.4 months, compared with 4.7 months in the placebo arm.
Several others are competing in the DLBCL space, including Bristol Myers Squibb, which received approval from its CAR-T Breyanzi as a third-line treatment in February. Breyanzi, or lisocabtagene maraleucel, is the third CAR-T on the market for various forms of NHL, alongside Yescarta and Kymriah.
“Up to 40 percent of people with diffuse large B cell lymphoma either do not respond to initial treatment or experience a return of their disease, in which case their treatment options are limited and the prognosis is very poor,” he said. said Sandra Horning, former Roche Marketing Director. Recount Terminal news few years ago.