Chugai Pharma Obtains Japanese Approval For Polivy To Treat R/r Diffuse Large B-cell Lymphoma

Chugai Pharmaceutical announced that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for the anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion 30mg and 140mg [generic name: polatuzumab vedotin (genetical recombination)] in combination with bendamustine (freeze-dried formulation) and rituximab (BR therapy) for the treatment of relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).“I am very pleased that Polivy in combination with BR therapy now can be offered to patients as a new treatment option for R/R DLBCL, a disease with high unmet medical needs, in the hematologic cancer field following Rituxan and Gazyva,” said Chugai’s president and CEO Dr. Osamu Okuda. “We are preparing to bring this first-in-class anti-CD79b antibody-drug conjugate (ADC) to patients so that we may contribute to realize a better treatment.”The approval is based on data including the results from a multicenter overseas phase Ib/II clinical study (GO29365) that evaluated the efficacy and safety of Polivy in combination with BR therapy compared to BR therapy alone, and a multicenter, single-arm Japanese phase II study (JO40762/P-DRIVE study) that evaluated the efficacy and safety of the combination therapy in R/R DLBCL.The efficacy and safety of Polivy and BR therapy (40 patients) compared with BR therapy alone (40 patients) was studied in the randomized phase II part of the GO29365 study in 80 patients with R/R DLBCL not eligible for autologous stem cell transplantation (ASCT). The primary endpoint of the complete response rate (CRR) at the time point of primary response assessment (PRA; 6 to 8 weeks after last dose of Polivy) as evaluated by an independent assessment committee using positron emission tomography-computed tomography (PET-CT) was 40% (16/40 patients; 95% CI: 24.9-56.7%) in the Polivy + BR therapy group, and 17.5% (7/40 patients; 95% CI: 7.3-32.8%) in the BR therapy group (data cut-off: April 30, 2018). Adverse reactions occurred in 36 (92.3%) patients out of 39 patients who received Polivy. The most common adverse reactions were neutropenia 53.8% (21/39 patients), thrombocytopenia 41.0% (16/39 patients), diarrhea and anemia 33.3% (13/39 patients) each, fatigue and nausea 23.1% (9/39 patients) each, and pyrexia and peripheral neuropathy 20.5% (8/39 patients) each.In the P-DRIVE study, the efficacy and safety of Polivy + BR therapy were studied in 35 patients with R/R DLBCL not eligible for ASCT. The primary endpoint of the CRR at the PRA as assessed by the principal investigator using PET-CT was 34.3% (12/35 patients), (95% CI: 19.1-52.2%) (data cut-off: December 24, 2019). Adverse reactions occurred in 33 (94.3%) patients out of 35 patients who received Polivy. The most common adverse reactions were anemia 37.1% (13/35 patients), nausea 31.4% (11/35 patients), thrombocytopenia and neutropenia 25.7% (9/35 patients) each, constipation, decreased platelet count and decreased neutrophil count 22.9% (8/35 patients) each, and malaise and decreased appetite 20.0% (7/35 patients) each.A double-blind, placebo-controlled global phase III study (GO39942/POLARIX study) is ongoing for untreated DLBCL to compare the efficacy and safety of Polivy in combination with rituximab plus cyclophosphamide, doxorubicin, prednisolone (R-CHP) to rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisolone (R-CHOP).GO29365 is a global, phase Ib/II study evaluating the safety and tolerability of Polivy in combination with bendamustine and rituximab (BR therapy) or obinutuzumab (BG therapy) in R/R follicular lymphoma or DLBCL. In the phase II randomized part of the study with 80 DLBCL patients, the efficacy and safety of Polivy in combination with BR therapy were studied compared to BR therapy alone. The primary endpoint was complete response at the point of primary response assessment as evaluated by an independent assessment committee using PET-CT. Patients received six cycles of treatment, spaced three weeks apart.Polatuzumab vedotin was developed by Roche using Seattle Genetics’ ADC technology. It is a first-in-class anti-CD79b antibody-drug conjugate (ADC), comprising the anti-CD79b humanized monoclonal antibody and a tubulin polymerization inhibitor attached together using a linker. The CD79b protein is expressed specifically in the majority of B-cells, making it a promising target for the development of new therapies.

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