Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie - LARVOL DELTA

Safety of an Intravitreal Bevacizumab Biosimilar (MVASI). (PubMed, Clin Exp Ophthalmol) - "Intravitreal MVASI had a similar ophthalmic safety profile and may be used as an alternative to Avastin."

Journal • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Macular Edema • Ocular Infections • Ocular Inflammation • Oncology • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Uveitis • Vasculitis • Wet Age-related Macular Degeneration

Cost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare. (PubMed, J Med Econ) - "The objective of this study is to explore the cost-efficiency and budget-neutral expanded access of bevacizumab-bvzr in mCRC and mNSCLC in Medicare.Methods We developed a Medicare payer perspective simulation model of patients treated for mCRC and mNSCLC to estimate cost-savings from converting bevacizumab (originator) to bevacizumab-bvzr or alternative biosimilars such as bevacizumab-awwb, -maly, and -abcd...At 100% conversion, monthly savings from biosimilar conversion could fund up to 13,887 additional mCRC patient-months of treatment with bevacizumab-bvzr + FOLFOX, and up to 8,959 additional mNSCLC patient-months of treatment with bevacizumab-bvzr + paclitaxel + carboplatin...The biosimilar NNC from other biosimilars ranged from 60-4,564 and 55-4,422 for mCRC and NSCLC, respectively.Conclusion In the first cost-efficiency and expanded access study of biosimilar bevacizumab in mCRC and mNSCLC, we find that bevacizumab-bvzr-based regimens can result in substantial cost..."

Journal • Medicare • Reimbursement • US reimbursement • Colorectal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety Outcomes of Mobile Laminar Airflow Device To Perform Intravitreal Injections: A Three-Year Retrospective Study. (PubMed, J Hosp Infect) - "Using a portable LAF device, such as the Operio mobile, for IVIs in a non-OR setting is a safe and effective alternative to traditional ORs."

Journal • Retrospective data • Anesthesia • Cardiovascular • Glaucoma • Ocular Infections • Ocular Inflammation • Ophthalmology

CodeBreaK 301: Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Amgen | Trial completion date: Apr 2031 ➔ Aug 2031 | Trial primary completion date: Sep 2027 ➔ Jan 2028

Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor

A phase 3 study of first-line sotorasib, panitumumab, and FOLFIRI versus FOLFIRI with or without bevacizumab-awwb for patients with KRAS G12C–mutated metastatic colorectal cancer (CodeBreaK 301). (ASCO-GI 2025) - P1, P3 | "Clinical Trial Registration Number: NCT06252649 Background: CodeBreaK 300 (NCT05198934) evaluated sotorasib, a selective inhibitor that irreversibly binds to the Kirsten rat sarcoma (KRAS) G12C mutant protein, in combination with panitumumab, an anti–epidermal growth factor receptor inhibitor, and showed that 960 mg sotorasib + panitumumab provided a statistically and clinically significant improvement in progression-free survival compared with trifluridine/tipiracil or regorafenib in patients with chemorefractory metastatic colorectal cancer (mCRC) (1). In CodeBreaK 101 (NCT04185883) subprotocol H expansion cohort 2F, the addition of folinic acid, fluorouracil, and irinotecan (FOLFIRI) to this combination in the first-line setting demonstrated a manageable safety profile and promising response rate of 78% in patients with KRAS G12C–mutated mCRC (2)...2. Siena, ESMO 2024."

Clinical • Metastases • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • EGFR • KRAS

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS (PRNewswire) - "IMDELLTRA (tarlatamab-dlle) generated $67 million of sales in the fourth quarter. Sales increased 86% quarter-over-quarter, driven by volume growth and inventory levels...MVASI (bevacizumab-awwb) sales decreased 8% year-over-year to $173 million in the fourth quarter and 9% for the full year."

Sales • Cervical Cancer • Colorectal Cancer • Fallopian Tube Cancer • Glioblastoma • Non Small Cell Lung Cancer • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer

Systemic anti-VEGF biosimilar therapy associated with improved macular anatomy and duration of effect in a patient with nearly recalcitrant neovascular age-related macular degeneration. (PubMed, Retin Cases Brief Rep) - "When systemic anti-VEGF biosimilar therapy was administered, there was improved anatomy and prolonged duration of effect compared to the intravitreal therapy alone. Adverse systemic effects limit the routine use of systemic anti-VEGF therapy for retinal disease. However if a patient requires systemic anti-VEGF or anti-VEGF biosimilar therapy for malignancy, it may also benefit retinal disease leading to benefits in quality of life and fewer office visits."

Journal • Age-related Macular Degeneration • Macular Degeneration • Oncology • Ophthalmology • Ovarian Cancer • Retinal Disorders • Solid Tumor • Wet Age-related Macular Degeneration

Drugs for age-related macular degeneration. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Comparison of Efficacy, Safety, and Economic Outcomes Between Biosimilar ABP 215 and Originator Bevacizumab in Japanese Patients With Colorectal Cancer. (PubMed, Cureus) - "Economic outcomes indicated a potential savings of approximately 800,000 Japanese yen per patient with biosimilar ABP 215 use. Conclusions Although this is a single-center, retrospective, observational study with limitations in terms of the number of cases and background factors, the use of the bevacizumab biosimilar ABP 215 product is recommended in Japan from the perspective of reducing medical costs, given the findings of no differences in efficacy and safety."

HEOR • Journal • Colorectal Cancer • Oncology • Solid Tumor

AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS (PRNewswire) - "Nplate (romiplostim) sales increased 9% year-over-year to $456 million in the third quarter. U.S. government orders were $128 million in Q3'24 compared to $142 million in Q3'23. Excluding these U.S. government orders, Nplate sales grew 18% year-over-year in the third quarter, driven by 14% volume growth and higher net selling price; IMDELLTRA (tarlatamab-dlle) generated $36 million of sales in the third quarter. Sales increased 200% quarter-over-quarter, driven by volume growth. IMDELLTRA is the first and only FDA-approved bispecific T-cell engager (BiTE) therapy for the treatment of extensive-stage small cell lung cancer (ES-SCLC); MVASI (bevacizumab-awwb) sales decreased 8% year-over-year to $195 million in the third quarter. Going forward, we expect continued sales erosion driven by competition."

Sales • Brain Cancer • Cervical Cancer • Gynecologic Cancers • Kidney Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

CodeBreaK 301: Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Amgen | Trial completion date: Jan 2031 ➔ Apr 2031 | Trial primary completion date: Jun 2027 ➔ Sep 2027

Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=347; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting; N=439 ➔ 347

Clinical • Enrollment change • Enrollment open • IO biomarker • Mismatch repair • Monotherapy • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=200; Recruiting; Sponsor: National Cancer Institute (NCI); N=347 ➔ 200

Clinical • Enrollment change • IO biomarker • Mismatch repair • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=231; Recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Recruiting

Clinical • Enrollment open • IO biomarker • Mismatch repair • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=200; Suspended; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Suspended

Clinical • IO biomarker • Mismatch repair • Trial suspension • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

Treatment Outcomes in Patients who Received Bevacizumab Therapy for Radiation Induced Brain Necrosis (IASLC-WCLC 2024) - "The secondary outcomes were to assess the safety of bevacizumab for the treatment of RBN in adults, evaluate whether clinical benefit varied based on bevacizumab dosing strategy, and determine if there are differences in outcomes with bevacizumab and biosimilar product, bevacizumab-awwb...Bevacizumab possessed a manageable safety profile and was well-tolerated. Additionally, our study demonstrated that clinical benefits were similar across dosing strategies including dosage, frequency, and biological product."

Clinical • Brain Cancer • Breast Cancer • Cardiovascular • Fatigue • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bevacizumab biosimilar (bevacizumab-awwb) is safe in the treatment of retinopathy of prematurity. (PubMed, Clin Exp Ophthalmol) - No abstract available

Journal • Retinal Disorders • Retinopathy of Prematurity

Cost-effectiveness analysis of bevacizumab biosimilars versus originator bevacizumab for metastatic colorectal cancer: a comparative study using real-world data. (PubMed, Value Health) - "Bevacizumab biosimilars demonstrated real-world cost-savings while providing similar survival benefit as originator bevacizumab, confirming the initial expectations of their implementation and supporting health system sustainability."

Cost effectiveness • HEOR • Journal • Metastases • Real-world • Real-world evidence • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

CodeBreaK 301: Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Real-World Use of Off-Label MVASI in the Treatment of Patients With Neovascular AMD and DME. (PubMed, Transl Vis Sci Technol) - "In our cohort of patients with n-AMD and DME in the maintenance phase, bevacizumab-awwb seems to represent a viable and cost-effective intravitreal therapy with comparable efficacy and safety to the originator. This study provides a preliminary assessment of the efficacy and safety of intravitreal bevacizumab-awwb, which is widely used off-label in retinal vascular diseases."

Journal • Real-world • Real-world evidence • Retrospective data • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Liver cancer in ovo models for preclinical testing (EASL-ILC 2024) - "Treatments with atezolizumab (anti-PD-L1, TECENTRIQ®) and bevacizumab (anti-VEGF, MVASI®) were tested. This study provides complete information, with detailed characterization and rational arguments that could lead to the partial replacement of conventional laboratory animals with a more ethical model, better suited to the current needs of preclinical research of new immunotherapies for liver cancer."

IO biomarker • Preclinical • Gastrointestinal Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Transplant Rejection

Safety of marketed biosimilar monoclonal antibody cancer treatments in the US: a disproportionality analysis using the food and drug administration adverse event reporting system (FAERS) database. (PubMed, Expert Opin Drug Saf) - "Significant AE reporting signals were identified: 1) death for biological rituximab, pruritus for biosimilar rituximab-pvvr, and infusion related reaction for biological rituximab and biosimilar rituximab-pvvr (significantly higher ROR for rituximab-pvvr than biological rituximab, p < .0001); 2) death for biological bevacizumab and biosimilar bevacizumab-bvzr (significantly higher ROR for bevacizumab-bvzr than biological bevacizumab, p < .0001), hypertension, platelet count decreased (PCD), and proteinuria for biological bevacizumab and biosimilar bevacizumab-awwb (significantly higher ROR of PCD for bevacizumab-awwb than originator bevacizumab, p = .001); and 3) rash for biosimilar trastuzumab-anns. Findings call for large, longitudinal studies to examine causality of certain AEs with rituximab-pvvr and bevacizumab biosimilars."

Adverse events • Journal • Cardiovascular • Dermatology • Hypertension • Oncology • Pruritus • Renal Disease

AMGEN REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS (PRNewswire) - "Product Sales Performance:...(i) Nplate (romiplostim) generated $317 million of sales in the first quarter. Sales decreased 12% year-over-year, primarily driven by volume decline in comparison to the first quarter of 2023, which included a U.S. government order of $82 million. Excluding the U.S. government order from this comparison, Nplate sales grew 13% year-over-year, primarily driven by volume growth; (ii) MVASI (bevacizumab-awwb) generated $202 million of sales in the first quarter. Sales were flat year-over-year for the first quarter. Volume growth was largely offset by lower net selling price and unfavorable changes to estimated sales deductions. Going forward we expect continued net selling price erosion driven by competition."

Sales • Cervical Cancer • Colorectal Cancer • Fallopian Tube Cancer • Glioblastoma • Non Small Cell Lung Cancer • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Thrombocytopenia

ONE BATTLE AFTER ANOTHER: BEVACIZUMAB CARDIOMYOPATHY AFTER HIGH-GRADE ENDOMETRIAL CARCINOMA (ACC 2024) - "We present a case of a 69-year-old female with hypertension, type II diabetes, and prior breast cancer, who developed cardiac dysfunction with bevacizumab-awwb treatment.Case: A 69 year old female with history of hypertension, type II diabetes mellitus, and right breast cancer status post radiation therapy and adjuvant hormonal therapy with letrozole presents with new high-grade endometrial carcinoma...She subsequently had total laparoscopic abdominal hysterectomy and salpingo oophorectomy, chemotherapy with carboplatin/paclitaxel and bevacizumab, and maintenance therapy with bevacizumab-awwb. At the 3-month follow-up, her LVEF decreased to 45-50%, leading to a referral to the cardio-oncology clinic.Decision-making: Patient was started on guideline-directed medical therapy (carvedilol and lisinopril)...Lisinopril was replaced with sacubitril/valsartan, dapagliflozin and spironolactone... Bevacizumab, an anti-VEGF monoclonal antibody, plays a role in developmental..."

Breast Cancer • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Diabetes • Endometrial Cancer • Gynecology • Heart Failure • Hypertension • Metabolic Disorders • Oncology • Solid Tumor • Type 2 Diabetes Mellitus

CodeBreaK 301: Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Amgen

Metastases • New P3 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor