Roche Aspires for Dominance in DLBCL Market, Unveils Pivotal Trial Data for Polivy

August 9th, 2021 – Earlier today, Roche subsidiary Genentech announced successful outcomes from the much-awaited POLARIX trial. The study evaluated its antibody-drug conjugate (ADC), Polivy, in previously untreated diffuse large B-cell lymphoma (DLBCL) patients. Shares of Roche climbed in light of the news

Results show that the Polivy plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) regimen demonstrated a significant progression free survival compared to R-CHOP, the standard of care. Remarkably, the regimen is the first in 20 years to significantly outperform the standard of care against an aggressive form of lymphoma.

“This Polivy regimen is the first in two decades to improve progression-free survival in DLBCL compared to the standard of care,” said Levi Garraway, M.D., Ph.D., CMO, and Head of Global Product Development. “We look forward to sharing these results with health authorities to bring this important potential new treatment option to patients as soon as possible.”

The company said it would unveil the detailed results at an upcoming medical meeting. 

A Blockbuster Market

Polivy is an anti-CD79b ADC developed using Seattle Genetics ADC technology. Since bagging accelerated approval from the FDA as a third-line treatment for relapsed or refractory (R/R) DLBCL, it scored approvals in over 60 countries, including South Korea and Japan.

Two weeks ago, in an earnings conference call with investors, Roche CEO Bill Anderson stated that the DLBCL indication is a $2 billion worth market, and Polivy is poised to become a dominant player in this area. Currently, the market is dominated by Novartis’ Kymriah, Kite’s Yescarta, and BMS’ Breyanzi—all CAR-T therapies that are time-consuming to manufacture.

“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,” Garraway added.

With a series of newly launched biosimilars hurting the revenue collected by its top drugs, Rituxan, Avastin, and Herceptin, Roche is betting on Polivy to revive the dip in its sales chart.

Presently the drug is used as an off-the-shelf, fixed-duration treatment in the (R/R) DLBCL setting. But, Genetech is evaluating Polivy as a combo regimen in several ongoing studies. They include Polivy plus gemcitabine and oxaliplatin evaluated in the Phase 3 POLARGO study and a combination with Venclexta developed by AbbVie and Genentech. In addition, combinations of Polivy are also tested with the CD20xCD3 T cell-engaging bispecific antibodies, mosunetuzumab, and glofitamab.

Author

Rajaneesh K. Gopinath