PMID- 37313371 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230615 IS - 1176-9351 (Print) IS - 1176-9351 (Electronic) IS - 1176-9351 (Linking) VI - 22 DP - 2023 TI - A Real-World Study of Safety, Immunogenicity and Efficacy of Bevacizumab in Patients With Solid Malignancies: A Phase IV, Post-Marketing Study in India. PG - 11769351231177277 LID - 10.1177/11769351231177277 [doi] LID - 11769351231177277 AB - OBJECTIVE: The aim of this study was to evaluate the post-marketing safety, tolerability, immunogenicity and efficacy of Bevacizumab (manufactured by Hetero Biopharma) in a broader population of patients with solid tumors. PATIENTS AND METHODS: This phase IV, prospective, multi-centric clinical study was carried out in Indian patients with solid malignancies (metastatic colorectal cancer, non-squamous non-small-cell lung cancer, metastatic renal cell carcinoma) treated with Bevacizumab between April 2018 and July 2019. This study included 203 patients from 16 tertiary care oncology centers across India for safety assessment, of which a subset of 115 patients who have consented were also evaluated for efficacy and immunogenicity. This study was prospectively registered in the Clinical Trial Registry of India (CTRI), and was commenced only after receiving approval from the competent authority (Central Drugs Standard Control Organization, CDSCO). RESULTS: Out of the 203 enrolled patients, 121 (59.6%) patients reported 338 adverse events (AEs) during this study. Of 338 reported AEs, 14 serious adverse events (SAEs) were reported by 13 patients including 6 fatal SAEs, assessed as unrelated to the study medication and 7 non-fatal SAEs, 5 assessed as related, and 3 unrelated to Bevacizumab. Most AEs reported in this study (33.9%) were general disorders and administration site conditions, followed by gastrointestinal disorders (29.1%). The most frequently reported AEs were diarrhea (11.3%), asthenia (10.3%), headache (8.9%), pain (7.4%), vomiting (7.9%), and neutropenia (5.9%). At the end of the study, 2 (1.75%) of 69 patients reported antibodies to Bevacizumab without affecting safety and efficacy. However, at the end of 12 months, no patient had reported antibodies to Bevacizumab. Complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) were reported in 18.3%, 22.6%, 9.6%, and 8.7% of patients, respectively. The overall response rate (CR + PR) was reported in 40.9% of patients at the end of the study. Disease control rate (DCR), also known as the clinical benefit rate (CBR) was reported in 50.4% of patients. CONCLUSIONS: Bevacizumab (Cizumab, Hetero Biopharma) was observed to be safe, well tolerated, lacking immunogenicity, and efficacious in the treatment of solid tumors. The findings of this phase IV study of Bevacizumab, primarily as a combination therapy regimen suggest its suitability and rationality for usage in multiple solid malignancies. CLINICAL TRIAL REGISTRY NUMBER: CTRI/2018/4/13371 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/advsearch.php : 19/04/2018]; Trial Registered Prospectively. CI - (c) The Author(s) 2023. FAU - Sinha, Shubhadeep D AU - Sinha SD AD - Department of Clinical Development & Medical Affairs, Hetero, Hyderabad, Telangana, India. FAU - Biswas, Ghanashyam AU - Biswas G AD - Department of Medical Oncology, Sparsh Hospital & Critical Care, Bhubaneshwar, Odisha, India. FAU - Bheemareddy, Bala Reddy AU - Bheemareddy BR AD - Hetero Drugs, Hyderabad, Telangana, India. FAU - Chary, Sreenivasa AU - Chary S AD - Department of Clinical Development & Medical Affairs, Hetero, Hyderabad, Telangana, India. FAU - Thakur, Pankaj AU - Thakur P AD - Department of Clinical Development & Medical Affairs, Hetero, Hyderabad, Telangana, India. FAU - Jain, Minish AU - Jain M AD - Department of Medical Oncology, Noble Hospital, Pune, Maharashtra, India. FAU - Maksud, Tanveer AU - Maksud T AD - Department of Medical Oncology, Unique Hospital, Surat, Gujarat, India. FAU - Pawar, Suraj AU - Pawar S AD - Department of Surgical Oncology, Kolhapur Cancer Centre, Kolhapur, Maharashtra, India. FAU - Chatterjee, Koushik AU - Chatterjee K AD - Department of Radiation Oncology, Institute of Post Graduate Medical Education & Research Hospital, Kolkata, West Bengal, India. FAU - Voonna, Murali Krishna AU - Voonna MK AD - Department of Surgical Oncology, Mahatma Gandhi Cancer Hospital, Vizag, Andhra Pradesh, India. FAU - Goel, Anil AU - Goel A AD - Department of Radiation Oncology, Sir Sayaji General Hospital, Vadodara, Gujarat, India. FAU - Puligundla, Krishna Chaitanya AU - Puligundla KC AD - Department of Medical Oncology, MNJ Cancer Hospital, Hyderabad, Telangana, India. FAU - Lakshmaiah, Kuntegowdanahalli Chinnagiriyappa AU - Lakshmaiah KC AD - Department of Medical Oncology, Srinivasam Cancer Care & Multi-Specialty Hospital, Bangalore, Karnataka, India. FAU - Talluri, Leela AU - Talluri L AD - Department of Clinical Development & Medical Affairs, Hetero, Hyderabad, Telangana, India. FAU - Vattipalli, Ramya AU - Vattipalli R AD - Department of Clinical Development & Medical Affairs, Hetero, Hyderabad, Telangana, India. FAU - Kakkunnath, Sheejith AU - Kakkunnath S AD - Department of Clinical Development & Medical Affairs, Hetero, Hyderabad, Telangana, India. LA - eng PT - Journal Article DEP - 20230601 PL - United States TA - Cancer Inform JT - Cancer informatics JID - 101258149 PMC - PMC10259146 OTO - NOTNLM OT - Bevacizumab OT - Solid tumors OT - metastatic carcinoma of the cervix OT - non-squamous non-small cell lung cancer OT - phase IV study OT - vascular endothelial growth factor COIS- The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. EDAT- 2023/06/14 06:42 MHDA- 2023/06/14 06:43 PMCR- 2023/06/01 CRDT- 2023/06/14 03:56 PHST- 2023/01/18 00:00 [received] PHST- 2023/05/03 00:00 [accepted] PHST- 2023/06/14 06:43 [medline] PHST- 2023/06/14 06:42 [pubmed] PHST- 2023/06/14 03:56 [entrez] PHST- 2023/06/01 00:00 [pmc-release] AID - 10.1177_11769351231177277 [pii] AID - 10.1177/11769351231177277 [doi] PST - epublish SO - Cancer Inform. 2023 Jun 1;22:11769351231177277. doi: 10.1177/11769351231177277. eCollection 2023.