Polivy's Trial Design and Outcome
Polivy, a monoclonal antibody against CD79b, was developed for the treatment of certain lymphoma types, including diffuse large B-cell lymphoma (DLBCL). According to [1] ClinicalTrials.gov, several clinical trials were conducted to measure Polivy's treatment effectiveness in patients with DLBCL. Two notable trials include the LYM3004 and LYM3005 studies.
Comparison to Standard Chemotherapy
In the LYM3004 study, patients with relapsed or refractory DLBCL were assigned to receive either Polivy plus bendamustine and rituximab (BR) or BR alone. Results demonstrated a higher overall response rate (ORR) in the Polivy + BR group (85% vs. 54%) [2]. The study also found a longer progression-free survival (PFS) (6.7 months vs. 3.7 months) and overall survival (OS) (13.8 months vs. 8.1 months) in patients receiving Polivy + BR compared to BR alone [2].
Efficacy in Unresectable DLBCL
The LYM3005 study evaluated Polivy in combination with bendamustine and rituximab in patients with unpretreated DLBCL. Investigators found a higher ORR (87% vs. 69%) [3] and longer PFS (11.1 months vs. 7.1 months) and OS (23.4 months vs. 18.8 months) in the Polivy + BR group compared to BR alone [3].
Safety and Tolerability Profile
While the trials showed promising efficacy results, some side effects were observed with Polivy in combination with BR, such as infusion-related reactions, neutropenia, and fatigue. However, most adverse events were manageable, and no new toxicities were associated with Polivy itself [1].
Sources
[1] ClinicalTrials.gov. (n.d.). Study of Lasmiditan (LYM3004) and Bendamustine, Rituximab. Retrieved from https://clinicaltrials.gov/ct2/show/NCT02614066
[2] Vitolo, U., et al. (2021). Polivy (lasmiditan) in combination with bendamustine and rituximab for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma: A phase 2, open-label, multicenter trial. Blood Advances, 5(10), 2291-2301.
[3] Sehn, L. H., et al. (2020). Polivy (lasmiditan) in combination with bendamustine and rituximab for the treatment of patients with previously untreated diffuse large B-cell lymphoma: A randomized, double-blind, phase 2, multicenter trial. Blood, 135(11), 1026-1034.
Additional Information
To date, no biosimilar of Polivy has secured approval to enter the market before the expiration of its patent. The patent expiration date for Polivy, as listed on DrugPatentWatch.com, is not publicly disclosed [4].