The Food and Drug Administration has granted approval in April 2023 to the use of polatuzumab vedotin-piiq (Polivy, Genentech, Inc.) in combination with rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL), and an International Prognostic Index (IPI) score of 2 or greater.
The POLARIX study, a randomized, double-blind, placebo-controlled trial involving 879 patients with previously untreated large B-cell lymphoma and an IPI score of 2-5, investigated the superiority of substituting polatuzumab vedotin for vincristine in the R-CHOP regimen. Patients were randomly assigned to either receive polatuzumab vedotin plus R-CHP (pola + R-CHP) or R-CHOP for six 21-day cycles, followed by two additional cycles of rituximab alone in both arms.
The study showed that PFS was significantly longer in the pola + R-CHP arm, with a hazard ratio (HR) of 0.73 (95% CI: 0.57, 0.95; p = 0.0177). The most common adverse reactions with pola + R-CHP (≥20%), not including laboratory abnormalities, were peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. It is essential to acknowledge that there may be other potential side effects or interactions that require consideration. Therefore, patients should have a detailed discussion about any concerns or queries related to the treatment with a qualified physician. The physician can provide further information on the risks and benefits of the treatment and make recommendations based on the patient’s medical history and unique circumstances.
| Trial Name | POLARIX |
|---|---|
| Drug | Polatuzumab vedotin-piiq |
| Brand name | Polivy |
| Manufactured by | Genentech, Inc. |
| FDA Approval | Yes |
| Indication | Previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) with International Prognostic Index (IPI) score of 2 or greater |
| Type of Study | Randomized, double-blind, placebo-controlled trial |
| Number of Participants | 879 |
| Treatment Regimen | polatuzumab vedotin plus R-CHP (pola + R-CHP) vs R-CHOP |
| Duration of Treatment | 6 cycles of 21 days |
| Additional Treatment | Two cycles of rituximab alone in both arms |
| Outcome | PFS was significantly longer in the pola + R-CHP arm with HR of 0.73 |
| Common Side Effects | Peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. There could be other side effects. It is important to discuss any concerns with a physician. |
