By Sahana Shankar
In another step towards fighting relapsed Diffuse Large B-Cell Lymphoma (DLBCL), a type of blood cancer, Roche scores EU approval for its novel combination therapy.
Roche announces that its antibody-drug conjugate, Polivy (polatuzumab vedotin) has received conditional marketing authorization from the European Commission, benefiting relapse patients. In June 2019, the US FDA had given accelerated approval for Polivy, to be used as a combination therapy with bendamustine and Rituxan (BR), for patients with relapsed DLBCL who have undergone 2 rounds of therapy.
Polivy was designated as Breakthrough Therapy by FDA and PRIME (PRIority MEdicines) by the European Medicines Agency (EMA) in 2017 to expedite its development and clinical trials to provide preliminary evidence and improve current therapies substantially. With approvals for its conditional use in the US and EU, Roche continues to investigate Polivy’s efficacy in Non-Hodgkin’s Lymphoma (NHL).
Diffuse Large B-Cell Lymphoma (DLBCL)
DLBCL is an aggressive Non-Hodgkin’s Lymphoma that affects B- lymphocytes, the blood cells which produce antibodies to protect against infections. The GLOBOCAN survey estimates 18,000 annual cases in the US and around 150,000 people are affected worldwide every year, making it the most prevalent NHL. It initiates in the lymph nodes but could spread to any organ. With the current combination regimen, DLBCL is considered potentially curable, despite its aggressiveness. However, reports indicate that the first 24 month period in remission is crucial and up to 40% of patients relapse with a more robust malignancy and limited survival, partly due to limited treatment options.
Clinical Trial Evaluation
The combination therapy of Polivy with BR benefits adults with relapsed DLBCL who are not suitable candidates for a stem cell transplant. Polivy’s claim to fame comes from a global, phase Ib/II clinical study that evaluated its safety, tolerability, and activity. A randomized trial with 80 relapsed patients resulted in:
- A complete response (no detectable cancer at the time of assessment) in 40% of people treated as opposed to 17.5% with BR treatment only
- Patients treated with Polivy + BR had better survival with a median of 12.4 months versus 4.7 months with BR only
- Polivy + BR resulted in a longer time (10.3 months) between first response to treatment and deterioration as compared to BR treatment (4.1 months)
Polivy performed better than BR treatment across the board with better progression-free survival, event-free survival, and overall survival.
Polivy – Mode of Action
CD79 is an antigen receptor complex associated protein. Polivy acts by recognizing the B-cell specific membrane marker CD79b and selectively eliminates B-cells by delivering an anti-cancer agent. This minimizes damage to healthy cells and improves efficacy, making Polivy a first-in-class anti-CD79b antibody-drug conjugate.
This brings Roche’s count of approved drugs for hematologic diseases to 5 and their investigation pipeline includes candidates to broaden the portfolio and offer combinatory solutions to most blood disorders.
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