The lym Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the lym Hub cannot guarantee the accuracy of translated content. The lym and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Lymphoma & CLL Hub is an independent medical education platform, sponsored by Beigene, Johnson & Johnson and Roche, and supported through educational grants from Bristol Myers Squibb, Incyte, Lilly, and Pfizer. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out moreCreate an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View lym content recommended for you
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
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
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
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
References