Roche delays Polivy's blockbuster lymphoma filing as FDA asks for more data

Roche is banking on a possible billion-dollar expansion for Polivy in newly diagnosed lymphoma. But the company’s plan to disrupt 20 years of standard treatment is taking longer than expected.

More than eight months after trumpeting a much-coveted clinical win, Roche has yet to file Polivy with the FDA in a combination for previously untreated diffuse large B-cell lymphoma (DLBCL), Roche’s pharma chief Bill Anderson told investors on a conference call Monday.

As Anderson explained, the FDA is asking to see additional data from the ongoing Polarix phase 3 trial. The company has already filed the same indication with authorities in the EU, Japan and China.

“We’ve been in close communication with the FDA about it,” Anderson said. “They were aware of our schedule of additional readouts and just said, hey, in the first-line setting, we just like to see more [progression-free survival] data.”

The agency isn’t looking for data on whether Polivy can extend patients’ lives, the Roche exec said, noting that results on disease progression or death is the standard marker for a regulatory review in frontline DLBCL.

Roche already has 28.2 months of results showing Polivy’s combination with a Rituxan-based R-CHP regimen slashed the risk of disease progression or death by 27% over the longtime standard R-CHOP cocktail. That latter treatment has been the standard of care in the disease setting for 20 years.

With that progression-free survival showing, Roche and industry watchers have predicted that Polivy could trounce an already very powerful treatment and become the new standard of care. Analysts at Jefferies previously estimated the frontline label expansion could mean $2.1 billion in peak sales for Polivy. First approved in 2019, the CD79B-targeted antibody-drug conjugate brought in 247 million Swiss francs ($258 million) of sales in 2021 in relapsed or refractory DLBCL.

Roche is now gathering more data until the next data cut of the Polarix trial. The company plans to file the data with the FDA in the middle of 2022, Anderson said, and it’s aiming to have the approval by the end of the year.

Once approved, the Swiss pharma anticipates a “rapid uptake,” Anderson said. The regimen is quite tolerable and the 27% reduction in the risk of disease progression or recurrence is “very significant” in a curative setting, he added.

Meanwhile, Roche recently got a positive opinion from EU drug reviewers for CD20xCD3 bispecific antibody mosunetuzumab in pretreated follicular lymphoma. Roche recently launched the phase 3 Sunmo study combining Polivy with the drug in second-line DLBCL and is plotting another trial of Polivy with either mosunetuzumab or another CD20xCD3 drug called glofitamab in newly diagnosed DLBCL.