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On 14 May 2019, Professor Hervé Tilly from the University of Rouen, Rouen, FR, and colleagues, published in The Lancet Oncology1 results from a phase Ib-II trial investigating the efficacy and safety of polatuzumab vedotin in combination with immnunochemotherapy in patients with naïve diffuse large B-cell lymphoma (DLBCL).
The current standard of care for DLBCL involves treatment with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).2 However, in high-risk DLBCL patients, R-CHOP does not always lead to successful outcomes and the prognosis of patients not responding to R-CHOP is poor.2 The investigators of this trial assessed the tolerability and preliminary activity of polatuzumab vedotin together with cyclophosphamide, doxorubicin, prednisone (CHP) chemotherapy, as well as rituximab or obinutuzumab (anti-CD20 therapy), as first-line treatment for naïve DLBCL.
The primary objective of this ongoing, multicenter, open-label, non-randomized, phase Ib-II trial (NCT01992653) was treatment safety and tolerability, as well as the determination of the maximum tolerated dose of polatuzumab vedotin. Secondary endpoints included, overall response rate (ORR), complete response (CR), progression-free survival (PFS), event-free survival (EFS), and overall survival (OS).
|
Naïve DLBCL phase II cohort (n = 66) |
95% CI |
---|---|---|
ORR |
89% (n = 59) |
|
CR |
77% (n = 55 |
|
12-month PFS |
91% |
84–98 |
24-month PFS |
83% |
73–93 |
12-month OS |
94% |
88–100 |
12-month EFS |
80% |
71–90 |
Proportion of ongoing responses at 12 months |
95% |
89–100 |
The results of this phase Ib-II trial indicate that pola in combination with G-CHP or R-CHP has a manageable toxicity profile and leads to promising response outcomes in previously untreated patients with DLBCL
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