Recalculate sample size based on serious adverse event: CDSCO Panel Tells Roche on Polatuzumab vedotin study

New Delhi: In line with the Phase IV clinical trial protocol of Polatuzumab Vedotin for Injection, 30mg/vial and 140 mg/vial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Roche to recalculate the sample size based on the serious adverse event (SAEs) reported in previous studies and to include more Government study sites.

This came after the drug maker Roche presented the proposal to conduct a Phase IV clinical trial titled “A Phase IV, open-label, study evaluating the safety and efficacy of polatuzumab serotonin combination with Rituximab and CHP(R-CHP) in previously untreated adult patients with diffuse large B-Cell Lymphoma (DLBCL)” vide protocol No: ML45360 version 1 dated 28 Nov 2023.

Polatuzumab vedotin is a CD79b antibody conjugate indicated to treat different types of large B-cell lymphoma.

Polatuzumab vedotin is an antibody-drug conjugate consisting of a CD79b-directed antibody, a microtubule-disrupting agent called monomethyl auristatin E (MMAE), and a cleavable linker that holds the components together.

Polatuzumab vedotin is used in combination with bendamustine and rituximab to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies. In Canada, this indication is approved for patients who are not eligible for autologous stem cell transplant and have received at least one prior therapy.

Polatuzumab vedotin is also used in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) to treat adult patients with previously untreated large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high-grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL.

At the recent SEC meeting for Oncology held on 7th and 8th February 2024, the expert panel reviewed the proposal presented by the drug major Roche to conduct the Phase IV clinical trial titled “A Phase IV, open-label, study evaluating the safety and efficacy of polatuzumab serotonin combination with Rituximab and CHP(R-CHP) in previously untreated adult patients with diffuse large B-Cell Lymphoma (DLBCL)”.

After detailed deliberation, the committee recommended the firm to recalculate the sample size based on the SAEs reported in previous studies and to include more Government study sites.

Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO for further evaluation by the committee.

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