Roche Pharmaceuticals CEO Bill Anderson recently pegged lymphoma drug Polivy’s potential expansion into newly diagnosed patients as a multibillion-dollar opportunity. Now, at least one analyst is backing up that estimate.
Polivy could hit $2.4 billion in peak sales, with $2.1 billion coming from its use in front-line diffuse large B-cell lymphoma (DLBCL), Jefferies analyst Peter Welford said in a Tuesday note to clients.
Welford’s estimate is up from a prior projection of $1.6 billion for the CD79b-directed antibody-drug conjugate. The increase comes after Roche touted a phase 3 win in front-line DLBCL that looks like it may change the standard of care after nearly two decades of stagnant innovation.
While Roche has yet to share detailed results from the phase 3 Polarix study, the company said a regimen of Polivy plus a Rituxan-containing R-CHP combo beat the longtime standard R-CHOP treatment at staving off cancer progression or death in previously untreated DLBCL.
Welford reached his new sales estimate after surveying 50 U.S. oncologists following the Polarix news. The survey results support “significant switching” to Polivy in the front-line use, in as many as 55% of patients, if the drug shows an over 25% reduction in the risk of disease progression or death and if it shows a higher cancer eradication rate than R-CHOP, Welford noted.
Even if Polivy only shows a modest but statistically significant advantage on the progression-free survival marker and a similar complete remission rate, doctors expect to reach for the Roche drug for 39% of front-line DLBCL patients, the analyst wrote.
Over the next five years, even with the possible entrance of new treatments, doctors generally expect to treat 36% of front-line patients with Polivy. Based on that finding, Welford figured Polivy can generate $1.2 billion in peak sales in front-line DLBCL from the U.S. alone.
Thanks to a 2019 FDA approval, Polivy is currently approved to treat relapsed or refractory DLBCL after at least two prior therapies. The drug currently gets some off-label use in the second-line setting.
Among patients who aren’t eligible to undergo stem cell transplant, Polivy is currently used in about 37% of second-line DLBCL patients, Jefferies’ survey suggests. Its use in third and later lines represents about 29% of the market, according to the analysts.
Five years from now, Polivy’s second- and third-line use could decrease to 20% and 17%, respectively. That’s why Welford only projected $300 million in peak sales for its r/r DLBCL indication.
While Polivy may lose share in the second-line-plus market over the long term, Roche has two CD20xCD3 bispecific antibodies, mosunetuzumab and glofitamab, in the pipeline, Welford noted. Given mosunetuzumab’s better safety profile, Welford argued Roche may target the community setting with the drug and leave the more aggressive glofitamab to specialist hospitals.
Overall, Welford put down $2 billion in peak sales for each of the two bispecifics with a 60% chance of success.
