Boyounuo (bevacizumab biosimilar) / Luye Group, AstraZeneca - LARVOL DELTA

Economic evaluation of three domestic bevacizumab biosimilars and the original bevacizumab for treating nonsquamous non-small cell lung cancer in china: a cost-effectiveness analysis. (PubMed, Cost Eff Resour Alloc) - "Domestic bevacizumab biosimilars are cost-effective alternatives to first-line treatment for nonsquamous NSCLC in China. IBI305 exhibited the most significant cost-effective advantage among the domestic biosimilars."

HEOR • Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung 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

Boan Biotech's Biologics License Application for Boyounuo (Bevacizumab Injection) Accepted in Brazil (PRNewswire-Asia) - "Boan Biotech today announced that Brazil's Agência Nacional de Vigilância Sanitária (ANVISA) has accepted the company's Biologics License Application (BLA) for Boyounuo® (Bevacizumab Injection)....Boyounuo was launched in China in 2021 for treating multiple types of cancer including advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) and metastatic colorectal cancer."

Non-US regulatory • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

AZD9291 (Osimertinib) With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer (clinicaltrials.gov) - P3; N=300; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Non-clinical pharmacology and toxicology studies of bevacizumab biosimilar LY01008. (PubMed, Eur J Pharmacol) - "In the one-month multiple-dose toxicity study in cynomolgus monkeys, the toxicokinetics profiles of LY01008 was similar with Avastin, the characteristics of the toxic reactions were the same and the extent was similar between LY01008 and Avastin, and no new toxic reactions were observed on LY01008. In conclusion, LY01008 had a good safety profile, and was biosimilar with Avastin in the comparative studies of pharmacodynamics, pharmacokinetics, toxicokinetics and toxicology, which supported the clinical trial and marketing application of LY01008 as a biosimilar of Avastin."

Journal • Cardiovascular • Oncology

Cost-Effectiveness of Bevacizumab Biosimilar LY01008 Combined With Chemotherapy as First-Line Treatment for Chinese Patients With Advanced or Recurrent Nonsquamous Non-Small Cell Lung Cancer. (PubMed, Front Pharmacol) - "The parameters that determine the cost of LY01008 have the greatest impact on the cost-effectiveness results. From the perspective of the Chinese healthcare system, first-line LY01008 at a real-world dosage combined with chemotherapy is likely to represent a cost-effective strategy compared with first-line chemotherapy alone for Chinese advanced or recurrent nonsquamous NSCLC patients."

HEOR • Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Randomized, Double-blind, Parallel-group Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of LY01008, a Candidate Bevacizumab Biosimilar, with its Reference Product Avastin® in Healthy Chinese Male Subjects. (PubMed, Expert Opin Biol Ther) - P1 | "This study demonstrated equivalent PK, comparable safety, and similar immunogenicity of LY01008 to Avastin® in healthy subjects, thus paved the way for further clinical evaluation. The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT05110118)."

Clinical • Journal • P1 data • PK/PD data • Oncology

Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1; N=112; Completed; Sponsor: Shandong Boan Biotechnology Co., Ltd

Clinical • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: OHSU Knight Cancer Institute; Trial completion date: Feb 2021 ➔ Feb 2025; Trial primary completion date: Feb 2021 ➔ Feb 2022

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Anemia • Breast Cancer • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Small Lymphocytic Lymphoma • Solid Tumor • T Acute Lymphoblastic Leukemia • Thrombocytosis

Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non-small-cell lung cancer: A multicenter, randomized, double-blinded, phase III trial. (PubMed, Cancer Commun (Lond)) - P3 | "LY01008 demonstrated similarity to Avastin in terms of efficacy and safety in Chinese patients with advanced or recurrent non-squamous NSCLC. LY01008 combined with paclitaxel/carboplatin is expected to become a new treatment option for unresectable, metastatic, or recurrent non-squamous NSCLC patients in the first-line setting."

Clinical • Journal • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer (clinicaltrials.gov) - P2; N=66; Recruiting; Sponsor: Mayo Clinic; Trial completion date: Feb 2028 ➔ Mar 2024; Trial primary completion date: Mar 2027 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Endometrial Adenocarcinoma • Endometrial Cancer • Fallopian Tube Cancer • Infectious Disease • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Sarcoma • Solid Tumor

Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor (clinicaltrials.gov) - P3; N=400; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Carcinoid Tumor • Colorectal Cancer • Endocrine Cancer • Gastric Cancer • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma • MRI

Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2/3; N=488; Recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Jul 2027 ➔ Jun 2023; Trial primary completion date: Jul 2027 ➔ Jun 2023

Clinical • IO biomarker • Trial completion date • Trial primary completion date • Endometrial Adenocarcinoma • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor • PD-L1

Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2/3; N=488; Recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Recruiting

Clinical • Enrollment open • IO biomarker • Endometrial Adenocarcinoma • Endometrial Cancer • Fallopian Tube Cancer • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • PD-L1

Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2/3; N=488; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

Clinical • IO biomarker • New P2/3 trial • Endometrial Adenocarcinoma • Endometrial Cancer • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • PD-L1

Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2/3; N=488; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • IO biomarker • Endometrial Adenocarcinoma • Endometrial Cancer • Fallopian Tube Cancer • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • PD-L1

Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2/3; N=488; Suspended; Sponsor: National Cancer Institute (NCI); Trial completion date: Jun 2023 ➔ Jul 2027; Recruiting ➔ Suspended

Clinical • IO biomarker • Trial completion date • Trial suspension • Endometrial Adenocarcinoma • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor • PD-L1

AZD9291 (Osimertinib) With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer (clinicaltrials.gov) - P3; N=300; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

Clinical • New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Thoracic Cancer • EGFR

Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2/3; N=488; Recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Jun 2023 ➔ Jul 2027; Trial primary completion date: Jun 2023 ➔ Jul 2027; Suspended ➔ Recruiting

Clinical • Enrollment open • IO biomarker • Trial completion date • Trial primary completion date • Endometrial Adenocarcinoma • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor • PD-L1

Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2/3; N=488; Suspended; Sponsor: National Cancer Institute (NCI); Trial completion date: Jul 2027 ➔ Jun 2023

Clinical • IO biomarker • Trial completion date • Endometrial Adenocarcinoma • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor • PD-L1

Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2/3; N=444; Recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Recruiting

Enrollment open • Endometrial Adenocarcinoma • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor • PD-L1

Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2/3; N=488; Suspended; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Suspended

Clinical • IO biomarker • Trial suspension • Endometrial Adenocarcinoma • Endometrial Cancer • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • PD-L1