Vasforda (bevacizumab biosimilar) / Hanwha Solutions, Prestige BioPharma, Huons, Intas - LARVOL DELTA

A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients (clinicaltrials.gov) - P3 | N=650 | Active, not recruiting | Sponsor: Prestige Biopharma Limited | Trial completion date: Apr 2025 ➔ Dec 2025

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

A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients (clinicaltrials.gov) - P3 | N=650 | Active, not recruiting | Sponsor: Prestige Biopharma Limited | Trial completion date: Jul 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2023 ➔ Jul 2024

Metastases • Trial completion date • Trial primary completion date • 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

A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients (clinicaltrials.gov) - P3 | N=650 | Active, not recruiting | Sponsor: Prestige Biopharma Limited | Recruiting ➔ Active, not recruiting | N=500 ➔ 650

Enrollment change • Enrollment closed • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Prestige Biopharma Limited | Trial completion date: Dec 2023 ➔ Jul 2024 | Trial primary completion date: Sep 2023 ➔ Dec 2023

Metastases • Trial completion date • Trial primary completion date • 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

"Prestige Biopharma and Intas Pharmaceuticals Announce Partnership to Commercialize Bevacizumab Biosimilar in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, CIS and the SEA countries https://t.co/rNDb5Qsnql" (@NewsFromBW)

Licensing / partnership

Prestige Biopharma and Intas Pharmaceuticals Announce Partnership to Commercialize Bevacizumab Biosimilar in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, CIS and the SEA countries (Businesswire) - "Prestige Biopharma Limited...and Intas Pharmaceuticals Limited...announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige Biopharma’s bevacizumab biosimilar, in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan....HD204 is currently in Phase III clinical development (SAMSON-II) and the US and EU filing is planned next year....The partnership arrangement includes the exclusive rights for Intas and its affiliate Accord Healthcare that will commercialize the bevacizumab biosimilar in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan, leveraging their strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market."

European regulatory • Licensing / partnership • sBLA • Cervical Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology

A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenecity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Prestige Biopharma Limited | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: May 2022 ➔ Sep 2023

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

A randomized phase I study comparing the pharmacokinetics of a bevacizumab (HD204) biosimilar to European Union- and United States of America-sourced bevacizumab. (PubMed, PLoS One) - P1 | "HD204 demonstrates equivalent pharmacokinetic profiles compared to those of both US-sourced and EU-sourced bevacizumab. (NCT03390673)."

Clinical • Journal • P1 data • PK/PD data

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

A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenecity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients (clinicaltrials.gov) - P3; N=500; Recruiting; Sponsor: Prestige Biopharma Pte Ltd; Trial completion date: Nov 2021 ➔ Dec 2022; Trial primary completion date: Aug 2021 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung 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

Prestige Biopharma and Pharmapark Announce License and Supply Agreement to Commercialize Prestige's Bevacizumab Biosimilar in the Russian Federation (Businesswire) - "Prestige BioPharma and Pharmapark LLC today announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma's Bevacizumab biosimilar in the Russian Federation."

Licensing / partnership • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology

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