Beianting (bevacizumab biosimilar) / Betta Pharma, Chinese PLA General Hospital, Beijing Mabworks Biotech - LARVOL DELTA

Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial. (PubMed, Signal Transduct Target Ther) - P2/3 | "We aimed to assess the tolerability and efficacy of finotonlimab (an anti-programmed cell death protein-1 antibody) in combination with SCT510, a bevacizumab biosimilar, versus sorafenib in unresectable advanced HCC. Median OS was also significantly longer in patients receiving finotonlimab plus SCT510 (22.1 months [18.6, not available]) than in those receiving sorafenib (14.2 months [95% CI: 10.2, 15.8]; HR: 0.60 [95% CI: 0.44, 0.81], p < 0.0008). Finotonlimab in combination with bevacizumab demonstrated favorable efficacy, in comparison to sorafenib, as a first-line treatment for unresectable HCC, with a manageable safety profile."

Clinical • Journal • P2/3 data • Hepatocellular 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

SCT-I10A combined with a bevacizumab biosimilar (SCT510) versus sorafenib in the first-line treatment of advanced hepatocellular carcinoma: A randomized phase 3 trial. (ASCO 2024) - P2/3 | "The combination of SCT-I10A and SCT510 showed substantial clinical advantages and an acceptable safety profile in patients with advanced HCC, thereby supporting its suitability as a first-line treatment option for HCC."

Clinical • Metastases • P3 data • Cardiovascular • Cerebral Hemorrhage • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Hepatocellular Cancer • Hypertension • Oncology • Solid Tumor • AFP

Sintilimab plus bevacizumab biosimilar IBI305 and chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): first interim results from a randomised, double-blind, multicentre, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "In this interim analysis, sintilimab plus IBI305 plus cisplatin and pemetrexed was generally efficacious and well tolerated in patients with EGFR-mutated NSCLC who progressed after receiving EGFR tyrosine-kinase inhibitor therapy."

IO biomarker • Journal • P3 data • P3 data: top line • Gastrointestinal Disorder • Hematological Disorders • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

mil60 Versus Bevacizumab in Patients With Treatment-naïve Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=517 | Completed | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Unknown status ➔ Completed

Metastases • Trial completion • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

[VIRTUAL] Efficacy and safety of MIL60, a bevacizumab biosimilar, in combination with paclitaxel/carboplatin in patients with advanced or recurrent non-squamous non-small cell lung cancer: A randomized, double-blind, multicenter phase III study (ESMO 2021) - P3 | "MIL60 and BEV are equivalent in clinical efficacy in non-squamous non-small cell lung cancer patients, and the safety, Pop PK and immunogenicity of MIL60 was similar with BEV."

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

Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial. (PubMed, BioDrugs) - P3 | "Equivalent efficacy and similar pharmacokinetics, safety, and immunogenicity support bioequivalence of CT-P16 and EU-bevacizumab in patients with nsNSCLC."

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

A randomized, double-blind, single-dose, parallel phase I clinical trial to compare the bioequivalence, immunogenicity and safety of bevacizumab biosimilar and bevacizumab in healthy Chinese subjects. (PubMed, Expert Opin Drug Metab Toxicol) - P1 | "This study showed that bevacizumab biosimilar and Bevacizumab had similar pharmacokinetics (PK) parameters and safety in healthy Chinese subjects. This trial was registered in ClinicalTrials.gov (Number: NCT05476341, date registered: 25, Jul 2022) and Drug Clinical Trial Registration and Information Disclosure Platform (Number: CTR20171308, date registered: 16, Nov 2017)."

Clinical • Journal • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Retrospective Indication-Matched Cohort Study of Reference Product and Biosimilar: Bevacizumab Versus Bevacizumab-Awwb. (PubMed, Hosp Pharm) - "Median drug cost per dose and per milligram for bevacizumab-awwb was less than bevacizumab, representing a 15.8% and 12.1% discount, respectively. Utilization and safety outcomes were similar for this indication-matched cohort of 68 patients receiving bevacizumab or bevacizumab-awwb across a wide range of disease states."

Journal • Retrospective data • Brain Cancer • Cardiovascular • Cerebral Hemorrhage • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Glioblastoma • Gynecologic Cancers • Hematological Disorders • Hepatocellular Cancer • Hypertension • Lung Cancer • Oncology • Renal Disease • Solid Tumor • Venous Thromboembolism

Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study. (PubMed, EClinicalMedicine) - P3 | "Patients with untreated advanced or recurrent NSCLC were randomized (1:1 ratio) to receive either MIL60 or bevacizumab in combination with paclitaxel/carboplatin. The efficacy, safety and immunogenicity of MIL60 were similar with bevacizumab, providing an alternative treatment option for advanced or recurrent non-squamous NSCLC. This study was sponsored by Betta Pharmaceutical Co., Ltd."

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

MIL60 Bevacizumab Biosimilar Candidate Demonstrates Equivalence in NSCLC (Center for Biosimilars) - P3, N=436; NCT03196986; "The IRC-assessed FAS ORRs for the biosimilar and reference cohorts were 48.6% (95% CI, 42.6%-57.8%) and 43.1% (95% CI, 37.4%-52.1%), respectively. Investigators noted the ORR finding of 48.6% for the Chinese patient population was significantly higher than in Western patients previously studied (38%). Investigators observed no significant differences in median DoR, PFS, or OS. Median OS was 19.3 months and was comparable to previous study findings...The partial response rate was 48.6% and 43.1% in the biosimilar and reference groups, respectively."

P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Cediranib Maleate and Olaparib Compared to Bevacizumab in Treating Patients With Recurrent Glioblastoma (clinicaltrials.gov) - P2; N=70; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: May 2021 ➔ May 2022; Trial primary completion date: May 2021 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • 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

BACCI: Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer (clinicaltrials.gov) - P2; N=133; Active, not recruiting; Sponsor: Academic and Community Cancer Research United; Trial completion date: Mar 2021 ➔ Mar 2023

Clinical • Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • 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