Polatuzumab

Unassigned

New Medicines

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) - in combination with rituximab and bendamustine

Information

New molecular entity
Roche
Roche

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Pre-registration (Filed)

Feb 19: Filed in EU, under accelerated assessment programme [8,9].


Feb 19: BLA submitted to FDA for use in combination with rituximab and bendamustine, the FDA is expected to make a decision on approval by August 19, 2019 [8].


Dec 18: Granted orphan drug status in EU & US [6].


Apr 18: Filings for relapsed or refractory DLBCL now planned for 2018, and in 2021 for first-line use [5].


Oct 17: EU & US filings will be 2020 at the earliest [4].


Oct 17: Granted breakthrough therapy status in US [2].


Jun 17: Granted PRIME status In EU for use in combination with rituximab and bendamustine for the treatment of people with relapsed or refractory DLBCL [2].


Category

Anti-CD79B antibody–drug conjugate
The two most common types of NHL are DLBCL and follicular lymphomas. The overall annual incidence of DLBCL in Europe is 3.8/100,000 but the incidence increases with age and varies considerably across Europe [1].
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) - in combination with rituximab and bendamustine
Intravenous infusion

Further information

Yes
To be confirmed

Trial or other data

Dec 18: Roche announces longer-term data from the PIb/II GO29365 study showing that polatuzumab vedotin, in combination with rituximab plus bendamustine (BR), demonstrated a median overall survival (OS) of over one year compared to the BR arm (12.4 vs. 4.7 months, HR 0.42; 95% CI 0.24, 0.75), in people with R/R DLBCL not eligible for a haematopoietic stem cell transplant. OS was an exploratory endpoint. Adverse events (AEs) were consistent with those seen in previous studies of polatuzumab vedotin, and of BR, with no new safety signals observed. Treatment with polatuzumab vedotin plus BR resulted in a 66% reduction in risk of disease progression or death (as measured by investigator-assessed progression free survival; PFS; HR=0.34; 95% CI 0.2-0.570; p<0.0001), with 40% achieving a complete response (CR) compared to 18% in the BR arm (primary endpoint, as measured by positron emission tomography (PET); CR rates assessed by independent review committee; p=0.026). Furthermore, patients treated with polatuzumab vedotin plus BR achieved higher CR rates and longer PFS and OS compared with BR in all subgroups tested, including patients from cell-of-origin groups, germinal centre B-cell-like and activated B-cell-like, which are associated with a worse prognosis in DLBCL [7].


Dec 17: Genentech reports that the PII part of a PI/II trial met its primary endpoint (GO29365; NCT02257567). In the trial, the combination of polatuzumab vedotin and bendamustine, compared with bendamustine alone, significantly increased complete response rates in 225 patients with relapsed or refractory DLBCL in the US, Australia, Canada, Czech Republic, Germany, Hungary, South Korea, Spain and the UK [2].


Evidence based evaluations

Diffuse large B-cell lymphoma (DLBCL) - first-line with chemotherapy

Information

Licence extension / variation
Roche
Roche

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Anti-CD79B antibody–drug conjugate
The two most common types of NHL are DLBCL and follicular lymphomas. The overall annual incidence of DLBCL in Europe is 3.8/100,000 but the incidence increases with age and varies considerably across Europe [1].
Diffuse large B-cell lymphoma (DLBCL) - first-line with chemotherapy
Intravenous infusion