Author: Asmis, Timothy ; Wani, Rajvi J ; Karachiwala, Hatim ; Vincent, Mark David ; Nunez, Leyla ; Du, Yinhao ; Filion, Alain ; Meyer, Pierre-Francois ; Ngan, Elaine ; Sideris, Lucas ; Alemayehu, Mistre ; Ma, Kim ; Trinkaus, Mateya ; Inam, Naila ; Cheung, Winson Y ; Cirone Morris, Carlye ; Samimi, Setareh ; Eberg, Maria ; Beaudoin, Annie ; Mancini, Johanna ; Kassam, Shaqil ; Knight, Gregory John ; Colwell, Bruce ; Marquis, Katerine

BACKGROUNDABP 215 is a biosimilar to the reference product, bevacizumab, and was one of the first biosimilars approved by Health Canada for the first-line treatment of metastatic colorectal cancer (mCRC). This study aimed to address gaps in real-world evidence (RWE) including patient characteristics, treatment safety (primary objective), and effectiveness (secondary objective) for first-line ABP 215 therapy in Canadian patients with mCRC.MATERIALS AND METHODSRetrospective data were collected in 2 waves, at least 1 year (Wave 1) or 2 years (Wave 2) after commercial availability of ABP 215 at each participating site.RESULTSA total of 75 patients from Wave 1 and 164 patients from Wave 2 treated with a minimum of 1 cycle of ABP 215 were included. At least one safety event of interest (EOI) was recorded for 34.7% of Wave 1 and 42.7% of Wave 2 patients. The median progression free survival (PFS) for Wave 1 and 2 patients were 9.47 (95% confidence interval [CI]: 6.71, 11.90) and 21.38 (95% CI: 15.82, not estimable) months, respectively. Median overall survival was not estimable for Wave 1 and was 26.45 months for Wave 2.CONCLUSIONThe safety and effectiveness of ABP 215 observed in this real-world study were comparable to clinical trial findings and to other RWE with longer PFS in the current study.

Experimental and Therapeutic MedicineQ4 · MEDICINE

Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere<sup>®</sup>) in patients with neovascular age‑related macular degeneration

Q4 · MEDICINE

Article

Author: Rousselot Ascarza, Andres ; Ramirez Gismondi, Matias ; Quercia, Romina ; Tinelli, Marcelo ; Ascarza, Amalia ; Penna, María ; Manzitti, Julio ; Gomez Rancaño, Diego ; Scorsetti, Daniel ; Fernández, Francisco ; Scorsetti, María ; Spitzer, Eduardo ; Carpio Total, Mateo ; Benisek, Daniel ; Lombas, Carola ; Deprati, Matías

The present study was an open-label, prospective, uncontrolled and multicenter clinical trial to investigate the safety and effectiveness of bevacizumab (Lumiere^®) administered by the intravitreal route for the treatment of neovascular age-related macular degeneration (nAMD). A total of 22 patients without previous treatment with anti-vascular endothelial growth factor were recruited. Monthly therapy with 1.25 mg intravitreal bevacizumab was applied. Adverse events (AE), visual acuity (VA) and central retinal thickness (CRT) were assessed at baseline, day 1 and day 28 after each injection. A total of 87 AEs were reported; most of them were not serious (96.6%), expected (65.5%) and occurred after the third injection (56.3%). The most frequent AE was 'conjunctival hemorrhage' (29.9% of AEs), attributed to the injection procedure. Treatment was not suspended due to safety reasons in any case. After six months, a statistically significant gain of +8.2 (SD±8.8) letters and a CRT reduction of -75.50 µm (SD±120.3) were achieved with unilateral therapy. VA improvement and CRT reduction were also achieved with bilateral therapy, although to a lesser extent. The results of the present study suggested that therapy with a minimum of 3 doses of bevacizumab over a 6-month period was well tolerated and resulted in a sustained response regarding VA improvement and CRT reduction from the beginning of therapy compared with the baseline value. The study protocol was registered at clinicaltrials.gov (ref. no. NCT03668054).

100 Deals associated with Bevacizumab biosimilar(Elea Spa)

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Indication	Country/Location	Organization	Date
Dystrophy, Macular	AR	Elea Spa	01 Sep 2018

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