Approval Probability
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Adjusted LOA
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Polatuzumab Vedotin · 3 trials · 3 indications
An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants receiving polatuzumab vedotin may develop PN, including peripheral sensory and/or motor neuropathy. Symptoms included hypoesthesia, hyperesthesia, paresthesia, dysesthesia, discomfort, a burning sensation, weakness, gait disturbance, loss of balance, orthostatic hypotension, syncope, or neuropathic pain.
OS was defined as the time from randomization to the death from any cause during the study. Participants who were not reported as having died at the time of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization. Kaplan-Meier (KM) method was used to estimate median OS for each treatment arm.
| Arm | Type | Description |
|---|---|---|
| Pola-R-GemOx (Stage 1) | EXPERIMENTAL | Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) for a maximum dose of 240 mg per cycle (mg/cycle) administered intravenously (IV) and rituximab 375 milligrams per square meter (mg/m\^2) administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\^2 administered IV and oxaliplatin 100 mg/m\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration. |
| Pola-R-GemOx (Stage 2) | EXPERIMENTAL | Participants will receive polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle administered IV and rituximab 375 mg/m\^2 administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\^2 administered IV and oxaliplatin 100 mg/m\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration. |
| R-GemOx (Stage 2) | ACTIVE_COMPARATOR | Participants will receive rituximab 375 mg/m\^2 administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\^2 administered IV and oxaliplatin 100 mg/m\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration. |
| R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin | EXPERIMENTAL | Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV), placebo for vincristine IV, rituximab 375 milligrams per square meter (mg/m\^2) IV, cyclophosphamide 750 mg/m\^2 IV, and doxorubicin 50 mg/m\^2 IV on Day 1 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m\^2 IV will be administered as monotherapy in Cycles 7 and 8. |
| R-CHOP plus Polatuzumab Vedotin Placebo | PLACEBO_COMPARATOR | Participants will receive placebo for polatuzumab vedotin, rituximab 375 mg/m\^2 IV, cyclophosphamide 750 mg/m\^2 IV, doxorubicin 50 mg/m\^2 IV, and vincristine 1.4 mg/m\^2 IV (maximum 2 milligrams per dose \[mg/dose\]) on Day 1 and prednisone 100 mg/day PO on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m\^2 IV will be administered as monotherapy in Cycles 7 and 8. |
| Polatuzumab Vedotin | EXPERIMENTAL | Polatuzumab vedotin will be administered by an IV infusion of escalating doses (starting dose of 0.1 mg/kg, potentially to be followed by 0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, and 4.0 mg/kg doses) every 3 weeks (q3w) (Day 1 of each 21 day cycle). |
| Polatuzumab Vedotin + Rituximab | EXPERIMENTAL | Polatuzumab vedotin will be administered by an IV infusion q3w (Day 1 of each 21 day cycle). Rituximab was administered by an IV infusion at 375 milligrams per square meter (mg/m\^2) body surface area dose q3w. |
| Name | Type | Description |
|---|---|---|
| Polatuzumab Vedotin | DRUG | Polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle IV on Day 1 of each 21-day cycle for up to 8 cycles. |
| Rituximab | DRUG | Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles. |
| Gemcitabine | DRUG | Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles. |
| Oxaliplatin | DRUG | Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle. |
| Cyclophosphamide | DRUG | Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm. |
| Doxorubicin | DRUG | Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm. |
| Vincristine | DRUG | Vincristine IV infusion will be administered as per the schedule specified in the respective arm. |
| Vincristine Placebo | DRUG | Placebo matching to vincristine will be administered as per the schedule specified in the respective arm. |
| Prednisone | DRUG | Prednisone PO will be administered as per the schedule specified in the respective arm. |
| Polatuzumab vedotin Placebo | DRUG | Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm. |
Inclusion Criteria: * Histologically-confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS) or history of transformation of indolent disease to DLBCL * Relapsed disease (disease that has recurred following a response that lasted ≥ 6 months from completion of the last line of therapy...
Polatuzumab Vedotin is an investigational antibody-drug conjugate being studied for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL) and Non-Hodgkin's Lymphoma. It is currently in Phase 3 clinical development for these indications, with completed trials evaluating its safety and efficacy in patients with relapsed or refractory disease.
Polatuzumab Vedotin is a monoclonal antibody (mab) that targets CD79b, a protein expressed on the surface of B-cells. By binding to CD79b, the drug delivers a cytotoxic agent directly to cancer cells, potentially reducing damage to healthy tissues. This targeted approach is being studied in B-cell malignancies like DLBCL.
Polatuzumab Vedotin is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical trials to evaluate the drug's safety and efficacy in patients with B-cell lymphomas, including Diffuse Large B-Cell Lymphoma and Non-Hodgkin's Lymphoma.
Polatuzumab Vedotin is currently in Phase 3 clinical development. It has completed two Phase 3 trials and one Phase 1 trial, with a total enrollment of 1,270 participants across these studies. The drug is investigational and has not yet been approved by regulatory authorities.
Polatuzumab Vedotin has been studied in three completed clinical trials. NCT01290549 was a Phase 1 dose-escalation study in relapsed or refractory B-cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia. NCT03274492 was a Phase 3 trial comparing Polatuzumab Vedotin with R-CHP versus R-CHOP in DLBCL. NCT04182204 was a Phase 3 trial in relapsed or refractory DLBCL.
Polatuzumab Vedotin is also known by its brand name Polivy. It is a distinct antibody-drug conjugate targeting CD79b, and it is not the same as other lymphoma treatments. Its unique mechanism and combination regimens differentiate it from standard chemotherapy options like R-CHOP.