Stivant (bevacizumab biosimilar) / AryoGen Pharmed - LARVOL DELTA

Effect of panretinal photocoagulation versus intravitreal bevacizumab injection on optic disc microcirculation in patients with diabetic retinopathy. (PubMed, Int J Retina Vitreous) - "This study demonstrated that IVB and PRP treatments produced distinct short-term microvascular changes in the optic nerve of diabetic retinopathy patients. PRP treatment significantly reduced vascular density in the optic disc and peripapillary region over 3 months, with an initial increase in RNFL thickness followed by a decrease by month 3. In contrast, IVB treatment led to a slight increase in optic disc vascular density while significantly reducing RNFL thickness. No significant correlation was found between changes in RNFL thickness and peripapillary vascular density within either treatment group."

Journal • Diabetes • Diabetic Retinopathy • Metabolic Disorders • Retinal Disorders

Spigel Looks at Using Different Regimens Depending on PD-L1 Status in NSCLC (Targeted Oncology) - KEYNOTE-189 (NCT02578680); KEYNOTE-042 (NCT02220894); KEYNOTE-024 (NCT02142738); IMpower150 (NCT02366143); CheckMate 227 (NCT02477826); "SPIGEL: Right now, the NCCN [National Comprehensive Cancer Network] guidelines [for patients with non–small cell lung cancer (NSCLC) positive for PD-L1 expression (≥ 1%-49%) are quite complicated].1 There are a lot of options, but the preferred combination is carboplatin or cisplatin/pemetrexed [Alimta]/pembrolizumab [Keytruda]."

Media quote

PARP Inhibitors in Advanced Ovarian Cancer (PracticeUpdate) - "Dr. Westin: PARP inhibitors are here to stay for the treatment of ovarian cancer, and we have a number of different potential places where we can utilize them. I think that the majority of us now are looking to see where they fit best. So we have indications to use PARP inhibitors, both alone as well as in combination, with antiangiogenic agents in frontline maintenance. It's clear that the biggest benefit to PARP inhibitors as a maintenance is in those patients that have a biomarker, whether that's a BRCA mutation, germline or somatic, or in patients who have been identified as having homologous or combination deficient disease. There still appears to be some benefit to patients that have homologous or combination proficient disease, but it's quite short lived."

Interview • Video

Dr. Ahn on the Utility of Atezolizumab/Bevacizumab in HCC (OncLive) - "Daniel H. Ahn, DO...discusses the utility of atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) in hepatocellular carcinoma (HCC)....Patients receiving atezolizumab/bevacizumab should be screened and appropriately treated for esophageal varices to reduce the risk of bleeding associated with the combination, says Ahn."

Video

Intraocular Injection of StivantⓇ (A Biosimilar to Bevacizumab): A Case Series. (PubMed, J Ophthalmic Vis Res) - "Although the results of this case series showed relative improvement in CMT one month after the last injection of StivantⓇ, BCVA improvement was statistically significant only in the RVO group. This would be essential to design a randomized clinical trial to evaluate the non-inferiority of StivantⓇ in comparison to bevacizumab."

Clinical • Journal • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Richard S. Finn, MD, tells us about the safety profile of atezolizumab & bevacizumab from IMbrave150 (YouTube) - "Dr. Finn...tells us about the safety profile of atezolizumab and bevacizumab in the Phase 3 IMbrave150 trial investigating combination atezolizumab and bevacizumab compared with sorafenib in previously untreated patients with advanced hepatocellular carcinoma (HCC)."

Video

Episode 10: HCC Treatment After Previous I/O Therapy (Targeted Oncology) - "Richard S. Finn, MD: Michael, we have other TKIs [tyrosine kinase inhibitors] in liver cancer, specifically in the second-line setting-regorafenib and cabozantinib-that were approved based on randomized data vs placebo....Michael A. Morse, MD, FACP, MHS: Thank you for picking on me. The simple answer is, we don’t know. We have to do something for those people. For somebody who has maintained their performance status and we are able to manage the toxicities of these drugs, it’s fair to say we should start them on something and, if they progress, move on to the next drug....Catherine Frenette, MD: It’s tough, and you’re right. There are no data, and it’s really anybody’s best guess at this point."

Video

Safety of Intravitreal Injection of Stivant, a Biosimilar to Bevacizumab, in Rabbit Eyes. (PubMed, J Ophthalmic Vis Res) - "These results suggest that this drug could be a safe and inexpensive alternative to intravitreal bevacizumab. The efficacy of these injections was not investigated in this study and needs to be evaluated in future studies."

Clinical • Journal • Review

Efficacy and safety of proposed bevacizumab biosimilar BE1040V in patients with metastatic colorectal cancer: A phase III, randomized, double-blind, noninferiority clinical trial. (PubMed, Clin Ther) - P3 | "The proposed biosimilar BE1040V was noninferior to the reference product in terms of efficacy in the treatment of mCRC, and tolerability was comparable between the 2 drugs. ClinicalTrials.gov identifier: NCT03288987."

Clinical • Head-to-Head • Journal • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

AryoGen’s bevacizumab biosimilar BE1040V found noninferior to Avastin in phase III study (JD Supra) - "...AryoGen Pharmed’s proposed bevacizumab biosimilar, BE1040V (STIVANT), was found to be noninferior to the reference product (AVASTIN) in a Phase III clinical trial in patients with metastatic colorectal cancer."

P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

AryoGen notches an advance with its bevacizumab candidate (Center for Biosimilars) - "A biosimilar bevacizumab such as BE1040V can play an important role in making these advanced therapeutic combinations available to patients, the authors note. Biosimilars are highly similar to innovator brands and have no clinically significant differences with regard to tolerability and efficacy. The chief advantage of a biosimilar over an innovator product is its presumed greater affordability for patients and health care systems."

Clinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Big Ten cancer clinical trial tests combining immunotherapy, antiangiogenic therapy, and chemotherapy in advanced non-squamous non-small cell lung cancer - "The multicenter, single-arm, phase II clinical trial, BTCRC-LUN17-139, led by Nasser H. Hanna, MD, at Indiana University Melvin and Bren Simon Cancer Center, will build on the foundation of chemotherapy and immunotherapy, and add antiangiogenic therapy, which is intended to block the formation of new blood vessels, to stop the growth of tumors."

A Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab (AryoGen Pharmed) Compared With Bevacizumab (Avastin®) in Metastatic Colorectal Cancer (clinicaltrials.gov) - P3; N=126; Completed; Sponsor: AryoGen Pharmed Co.; Active, not recruiting ➔ Completed; Trial primary completion date: Mar 2018 ➔ Jul 2018

Clinical • Head-to-Head • Trial completion • Trial primary completion date