Positive trials results showing a significant improvement in survival boost Roche’s Polivy

As part of its strategy to explore areas of unmet need for its cancer drug Polivy (polatuzumab vedotin), Roche has announced trial results showing a significant improvement in survival for patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

DLBCL is the most common form of non-Hodgkin lymphoma, accounting for one in three cases. As many as 40% of patients experience relapse or develop refractory disease, at which time salvage therapy options are limited and survival is short, said the company.

“Since 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative,” said Roche chief medical officer and head of global product development, Levi Garraway. “This Polivy regimen is the first in two decades to improve progression-free survival in DLBCL compared to the standard of care.”

Approximately 150,000 people worldwide are estimated to be diagnosed with DLBCL each year.

The pivotal phase 3 POLARIX trial compared Polivy in combination with chemotherapy regimen R-CHP (Riutuxan/rituximab plus cyclophosphamide, doxorubicin and prednisone) with the standard of care R-CHOP (Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone).

Prolonging survival without disease advancement “could be transformative for newly diagnosed DLBCL patients”, said Roche.

Some big predictions are being made for Polivy. Pharma head, Bill Anderson, recently estimated that front-line DLBCL could be worth $2bn for the drug, while Jefferies’ analysts suggested the indication could be worth $3bn for Polivy, “if the POLARIX study results are compelling”.

The company will present the results at an upcoming medical meeting and have submitted it to health regulators.

As part of its Polivy strategy, Roche has ongoing studies investigating combinations of its drug with mosunetuzumab and glofitamab, with Venclexta/Venclyxto (venetoclax) – with AbbVie – and with Rituxan in combination with gemcitabine and oxaliplatin, in the phase 3 POLARGO study.

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). It binds to and kills cancer cells such as CD79b through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells. Polivy is marketed in the US by Genentech.