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

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  • 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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