FDA Casts Doubts Over Roche's Polivy Label Expansion For Untreated Lymphoma Setting

Today, the FDA Oncologic Drugs Advisory Committee is discussing the supplemental marketing application for Polivy (polatuzumab vedotin-piiq) plus Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for untreated diffuse large B-cell lymphoma (DLBCL).
The agency dropped a briefing document outlining its current concerns about the efficacy and safety of the antibody-drug conjugate.
The drug was first approved in 2019 under the accelerated approval pathway for patients with relapsed or refractory DLBCL who have received at least two prior therapies.
Several concerns related to the Polarix trial include a modest benefit of polatuzumab vedotin (Polivy) plus cancer regimen R-CHP over R-CHOP, another cancer drug regimen, showing a hazard ratio of 0.73.
The point estimates of progression-free survival (PFS) rates at one and two years differed by 4.1% and 6.5%, respectively.
The difference is "questionable whether this rate of difference is clinically meaningful," according to the documents.
The FDA pointed out that the PFS benefit of Pola-R-CHP did not translate into improving overall survival (OS).
The OS rates were numerically lower Pola-R-CHP arm at some early time points but similar at the 2-year time.
The agency added that uncertainty is associated with the point estimates due to low event rates.
The agency said that the difference in complete response rate was not statistically significant in either the drug plus R-CHP arm or the drug plus R-CHOP treatment arm, with a p-value of p=0.1557.
Price Action: RHHBY shares are down 1.07% at $34.99 on the last check Thursday.

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