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FDA approval granted to polatuzumab vedotin in combination with bendamustine and rituximab for R/R DLBCL
The United States (US) Food & Drug Administration (FDA) have granted accelerated approval to polatuzumab vedotin (Pola) in combination with bendamustine (B) and rituximab (R) (BR) for the treatment of patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not eligible for transplant. This is the first chemoimmunotherapy to be approved in this setting.1,2
Background: Pola
Pola is an antibody-drug conjugate which binds to CD79b on B-cells, specifically delivering a cytotoxic dose of monomethyl auristatin E (MMAE), which is a microtubule inhibitor.2,3 CD79b is a viable target in DLBCL as it is ubiquitously expressed in mature B-cell lymphomas.3
Founding trial information: GO29365 (NCT02257567)
The phase Ib/II randomized trial compared Pola + BR to BR. Another arm of this trial investigated Pola + B + obinutuzumab (Pola + BG) to BG. The FDA approval is based on the results of the randomized phase Ib/II results presented at ASCO 20184 and ASH 20182 which are summarized below.
Results given as Pola + BR versus BR
Study design, phase II:2
- N = 80
- Randomization (1:1):
- Pola + BR (n = 40)
- BR (n = 40)
- Dosing as below, every 21 days for up to 6 cycles:
- Pola: 1.8mg/kg
- B: 90mg/m2/day x 2 days
- R: 375mg/m2
- Follow-up (phase II): 22.3 months
Efficacy: phase II:1,2
Table 1: Efficacy results for Pola + BR compared to BR in phase II portion of the study as assessed by independent review committee at the end of treatment
Pola + BR
(n = 40)
BR
(n = 40)
Hazard ratio (HR)
P value
Complete response rate
40%
18%
-
0.026
Median duration of response (DoR)
10.3 months
(5.6–not reached [NR])
4.1 months
(2.6–12.7)
0.44
0.032
Median progression-free survival (PFS)
7.6 months
(6.0–17.0)
2.0 months
(1.5–3.7)
0.34
<0.0001
Median overall survival (OS)
12.4 months
(9.0–NR)
4.7 months
(3.7–8.3)
0.42
0.0023
- Of patients who partially or completely responded (n = 25)
- Duration of response (DOR) ≥6 months: 16 (64%)
- DOR ≥12 months: 12 (48%)
Safety, phase II:4
- Manageable toxicity
- Most common adverse events (AEs): neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, fever, decreased appetite and pneumonia1
- Most common grade 3–5 AEs higher in pola + BR vs BR
- Cytopenias
- Febrile neutropenia
- Infections
References