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On Tuesday 4th June an oral abstract session took place at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. During that session, Abstract 7505 was presented by Catherine Diefenbach, NYU Langome Health, New York, NY, USA, on a phase Ib/II clinical trial involving polatuzumab vedotin combination therapy.
Polatuzumab vedotin is a first-in-class antibody-drug conjugate that targets CD76b, a protein expressed in follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Polatuzumab vedotin in combination with rituximab, and bendamustine was approved by the FDA on June 11, 2019 for the treatment of relapsed or refractory (R/R) DLBCL.2
This open-label, single-arm, phase Ib/II study assessed the safety and preliminary efficacy of polatuzumab vedotin in combination with obinutuzumab and lenalidomide (Pola-G-Len), in patients with R/R FL. The primary efficacy endpoint of the trial was complete response (CR) at the end of induction treatment, as assessed by an independent review committee (IRC) based on PET-CT scans. Here the speaker presented the results of the pre-planned interim analysis of the trial.
Baseline characteristic |
Efficacy population |
Safety population |
---|---|---|
Median age (range) |
58 (53–68) |
62 (32–87) |
ECOG PS 0–1 |
94% |
98% |
Ann Arbor stage III–IV |
94% |
88% |
FL International Prognostic Index (FLIPI)≥ 3 |
44% |
58% |
Number of prior lines: 1 2 ≥3 |
17% 22% 61% |
21% 21% 58% |
Median number of prior lines (range) |
3 (1–5) |
3 (1–7) |
Refractory to last line |
50% |
50% |
Pre-planned interim analysis data
Response at end of induction (n= 18), % (n) |
Modified Lugano 2014 criteria by IRC |
---|---|
Objective response |
89% (16) |
CR |
67% (12) |
PR |
22% (4) |
SD |
6% (1) |
Disease progression (PD) |
0 (0) |
Missing/not evaluable/not available |
6% (1) |
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