Roche snags coveted Polivy win in newly diagnosed lymphoma. But is it enough to change 2 decades of established treatment practices?

After two years of meager sales for Polivy, Roche is trumpeting a much-coveted clinical win that could open up a blockbuster market for the drug. Still, questions remain about the exact size of the opportunity.

In previously untreated diffuse large B-cell lymphoma (DLBCL) patients, a Polivy regimen extended the time to cancer progression or death over the standard-of-care treatment known as R-CHOP, Roche’s Genentech unveiled Monday.

The progression-free survival win from the phase 3 POLARIX trial marks the first time in 20 years a drug has significantly improved on standard therapy in newly diagnosed DLBCL, Roche’s chief medical officer, Levi Garraway, M.D., Ph.D., pointed out.

The win could open a big market opportunity. Recently, Roche's pharma chief Bill Anderson estimated that the front-line DLBCL field could be worth CHF 2 billion for Polivy. In a recent note to investors, Jefferies’ analysts figured the indication could open up a $3 billion market for Polivy “if the Polarix study results are compelling.”

That’s a big if.

R-CHOP, the current standard of care in front-line DLBCL, consists of Roche’s Rituxan, chemotherapies cyclophosphamide, doxorubicin and vincristine, and the corticosteroid prednisone. For the Polivy regimen, Roche replaced vincristine (O) with Polivy, a CD79b-targeted antibody-body drug conjugate.

As industry watchers are well aware, the R-CHOP regimen has set a very high efficacy bar that hasn’t been topped for nearly two decades.

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Now that Polivy has claimed a “significantly improved and clinically meaningful” win in progression-free survival, the remaining question is the exact magnitude of the improvement—and whether it’s transformative enough to shift treatment paradigm.

Plus, writing to clients a month ago, Jefferies analysts said they want to see whether the Polivy regimen carries any safety benefits related to peripheral neuropathy. Roche didn’t add Polivy to R-CHOP for the trial because of concerns over potential compounded neuropathy safety problems with vincristine. The team also pointed to low platelet count as a potential problem for Polivy and R-CHOP based on earlier data.

Roche will present detailed POLARIX results at an upcoming medical meeting and submit them to health authorities, the company said.

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Polivy is currently allowed in third-line DLBCL, vying for share against CAR-T therapies from Novartis, Gilead Sciences’ Kite Pharma and Bristol Myers Squibb, plus a newly approved rival ADC by ADC Therapeutics. Thanks to that limited, late-line use, Polivy’s sales amounted to only 94 million Swiss francs ($103 million) in the first half of the year.

In addition to POLARIX, Roche is also adding Polivy to a combo of its Rituxan, gemcitabine and Sanofi’s Eloxatin in relapsed or refractory DLBCL in the phase 3 POLARGO trial. It’s also trying to pair the ADC with AbbVie-partnered Venclexta or with its CD20xCD3 bispecific antibodies mosunetuzumab and glofitamab in the disease.