Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. FDA label
Also known as Polatuzumab vedotin (Liquid), Polatuzumab, Polivy, ADC DCDS4501A, Antibody-Drug Conjugate DCDS4501A, DCDS4501A, FCU 2711, polatuzumab vedotin-piiq
Polatuzumab vedotin · 6 trials · 15 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.
Percentage of subjects who achieve CMR/CR on study.
Measure of time from study enrollment until progression.
Will estimate the safety and tolerability of polatuzumab vedotin when added to dose-adjusted-etoposide, prednisone, vincristine (Oncovin), cyclophosphamide, doxorubicin-rituximab (DA-EPCH-R) with or without glofitamab, chemoimmunotherapy.
| 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 plus R-EPCH | EXPERIMENTAL | Polatuzumab vedotin will be given in conjunction with 6 cycles of R-EPCH (rituximab, etoposide, prednisone, cyclophosphamide, hydroxydaunorubicin). The dosing schedule and regimen for R-EPCH will follow established protocols. Polatuzumab vedotin will be administered on Day 1 of each 21-day cycle. |
| Experimental: Polatuzumab Vedotin and R-CHOP | EXPERIMENTAL | The dose of polatuzumab vedotin for each patient will be 1.8 mg/kg (IV for 21 days) |
| Arm A (polatuzumab vedotin, chemotherapy) [CLOSED TO ACCRUAL 05/23/2024] | EXPERIMENTAL | Patients receive rituximab IV on day 1, polatuzumab vedotin IV on day 1, prednisone PO BID on days 1-5, etoposide IV on days 1-4, doxorubicin IV on days 1-4, and cyclophosphamide IV on day 5. Patients also receive filgrastim SC 24-72 hours after the last dose of each treatment cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MUGA scan or echocardiography during screening and FDG PET, CT scan, bone marrow biopsy and aspiration and blood sample collection throughout the study. |
| Arm B (polatuzumab vedotin, glofitamab, chemotherapy) | EXPERIMENTAL | Patients receive rituximab IV on day 1, polatuzumab vedotin IV on day 1, prednisone PO BID on days 1-5, etoposide IV on days 1-4, doxorubicin IV on days 1-4, and cyclophosphamide IV on day 5. Starting with cycle 2, patients also receive glofitamab, over 4 hours, on day 1 and 8 of cycle 2 and day 1 of subsequent cycles. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MUGA scan or echocardiography during screening and FDG PET, CT scan, bone marrow biopsy and aspiration and blood sample collection throughout the study. |
| 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. |
| Etoposide | DRUG | Etoposide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route. |
| Hydroxydaunomycin | DRUG | Hydroxydaunomycin will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route. |
| Glofitamab | BIOLOGICAL | Given IV |
| Multigated Acquisition Scan | PROCEDURE | Undergo MUGA scan |
| Echocardiography Test | PROCEDURE | Undergo echocardiography |
| FDG-Positron Emission Tomography | PROCEDURE | Undergo FDG-PET scan |
| Computed Tomography | PROCEDURE | Undergo CT scan |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspiration | PROCEDURE | Undergo bone marrow aspiration |
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 in B-cell malignancies, including diffuse large B-cell lymphoma, aggressive non-Hodgkin lymphoma, and Richter syndrome. Clinical trials have evaluated it in relapsed or refractory DLBCL, untreated aggressive large B-cell lymphoma, and Richter's transformation, often in combination with chemotherapy or rituximab.
Polatuzumab vedotin targets tubulin, specifically tubulin beta and alpha isoforms including TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. As a tubulin inhibitor, the antibody-drug conjugate delivers a microtubule-disrupting payload to cells, interfering with cell division.
Polatuzumab vedotin is developed by Roche Holding AG, which trades over the counter under the ticker RHHBY. Roche is the sponsor of the clinical trials evaluating the drug in B-cell lymphomas.
Polatuzumab vedotin is in clinical development, with trials ranging from Phase 1 to Phase 3. The drug is not approved; it remains investigational. A Phase 3 trial in relapsed or refractory diffuse large B-cell lymphoma has been completed, while Phase 1 and Phase 2 trials are active but not recruiting.
Polatuzumab vedotin has been studied in several trials, including NCT04182204, a completed Phase 3 trial in relapsed or refractory DLBCL; NCT04231877, a Phase 1 trial in untreated aggressive large B-cell lymphoma; NCT04679012, a Phase 2 trial in Richter's transformation; and NCT04594798, a Phase 2 trial in older patients with DLBCL.
Yes, polatuzumab vedotin is also known as polatuzumab or polatuzumab vedotin (liquid). These names refer to the same antibody-drug conjugate developed by Roche.