Roche Delays sBLA Submission for Polivy in First-Line DLBCL as FDA Requests Additional PFS Data

Roche Hopes Polivy (CD79b ADC) May Expand by Billions in Newly Diagnosed Lymphoma Indications. But the Company's Plan to Disrupt Two Decades of Standard Treatment Is Taking Longer Than Expected.

Roche's head Bill Anderson told investors on a Monday call that more than eight months after achieving the highly coveted successful clinical trial, Roche has yet to submit a new indication marketing application to the FDA for Polivy combination therapy in previously untreated diffuse large B-cell lymphoma (DLBCL).

FDA Requests More Data from the Ongoing Global Phase III POLARIX Trial. The company has currently submitted marketing applications for this indication to regulatory authorities in the EU, Japan, and China.

Anderson said, "We have been in close communication with the FDA about this." "They are aware of our additional reading plan and just said, hey, in first-line treatment, we just want to see more [progression-free survival] data."

Roche Executives: FDA Did Not Seek Data on Whether Polivy Can Extend Patient Life, Noting That Disease Progression or Death Outcomes Are Standard Metrics for First-Line DLBCL Regulatory Review.

Results from the POLARIX study with a median follow-up of 28.2 months showed that Polivy combined with MabThera, cyclophosphamide, doxorubicin, and prednisone (R-CHP) versus MabThera, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) had 2-year PFS rates of 76.7% vs 70.2%. Polivy + R-CHP reduced the risk of disease progression, recurrence, or death by 27%. This regimen is the first significant improvement in outcomes for such patients compared to standard treatment in 20 years.

As PFS data was disclosed, Roche and industry observers predicted that Polivy could outperform existing treatments and become the new standard of care. Jefferies analysts previously estimated that the expansion into first-line indications might mean Polivy’s peak sales could reach $2.1 billion. Polivy was first approved in 2019 and generated CHF 247 million (USD 258 million) in sales for relapsed or refractory DLBCL in 2021.

Roche is currently collecting more data until the next data cutoff date of the POLARIX trial. Anderson said that the company plans to submit the data to the FDA by the middle of 2022 and aims to gain approval by the end of this year.

Meanwhile, Roche recently received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for mosunetuzumab, a CD20/CD3 bispecific antibody, in pre-treated follicular lymphoma. Roche has recently initiated the Phase III SUNMO study, which combines Polivy with this drug to evaluate its efficacy in second-line DLBCL. Another trial is also being planned to assess the combination of Polivy with either mosunetuzumab or another CD20/CD3 bispecific antibody, glofitamab, for newly diagnosed DLBCL.