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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 $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.

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.

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.