Pembroria (pembrolizumab biosimilar) / Biocad - LARVOL DELTA

Việt Nam’s Ministry of Health has granted market authorisation to Pembroria, a Russian-made anti-cancer drug containing the active ingredient pembrolizumab, along with 13 other vaccines and biological products. (Tin Tuc - Vietnam News Agency) - "Under Decision No. 628/QĐ-QLD, signed on October 31 by DAV Director Vũ Tuấn Cường, 14 vaccines and biologicals were approved for three-year circulation in Việt Nam as part of the ministry’s 57th registration round....Pembroria (with the main active pharmaceutical ingredient being Pembrolizumab, at dosage 100mg/4ml packaged into one bottle), produced by the Russian company Limited Liability 'PK-137' and registered through a firm based in the United Arab Emirates, is formulated as a concentrated solution for intravenous infusion. It has a shelf life of 24 months from the date of manufacture."

Approval • Breast Cancer • Cervical Cancer • Lung Cancer • Melanoma • Renal Cell Carcinoma

The Drug Administration of Vietnam confirmed on November 11 that Pembroria, containing the active ingredient Pembrolizumab at 100 mg/4 ml, has been granted a three-year marketing authorisation. (DTiNews) - "Pembroria is formulated as a concentrated solution for infusion, with a shelf life of 24 months from its manufacturing date."

Approval • Breast Cancer • Cervical Cancer • Colorectal Cancer • Melanoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma

Real-world effectiveness and safety of pembrolizumab biosimilar BCD-201 in metastatic or unresectable melanoma (ESMO 2025) - "Conclusions BCD-201 demonstrated promising real-world efficacy and tolerability, supporting its use as an alternative to reference pembrolizumab in advanced melanoma. Legal entity responsible for the study Institute of Oncology and Radiobiology."

Clinical • Metastases • Real-world • Real-world effectiveness • Real-world evidence • Melanoma • Oncology • Solid Tumor • BRAF • PROCR

RESULTS OF PROSPECTIVE OBSERVATIONAL STUDY OF PEMBOLIZUMAB BIOSIMILAR BCD-201 IN PATIENTS WITH REFRACTORY CLASSICAL HODGKIN'S LYMPHOMA (ICML 2025) - "Fifty percent of patients had received four or more lines of therapy; none of the patients met criteria to undergo high doses chemotherapy followed by autologous stem cell transplantation; one patient was refractory to brentuximab vedotin. BCD-201 pembrolizumab biosimilar demonstrated high ORR, overall survival and safety profiles."

Clinical • Observational data • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • PROCR

Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma (clinicaltrials.gov) - P3 | N=366 | Active, not recruiting | Sponsor: Biocad | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2023 ➔ Dec 2023

Enrollment closed • Metastases • Trial primary completion date • Melanoma • Oncology • Solid Tumor • PROCR

A Trial Comparing Chemotherapy Versus Novel Immune Checkpoint Inhibitor (Pembrolizumab) Plus Chemotherapy in Treating Relapsed/Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: National Cancer Institute (NCI) | N=334 ➔ 0 | Initiation date: Apr 2023 ➔ Aug 2023 | Not yet recruiting ➔ Withdrawn

Checkpoint inhibition • Enrollment change • Trial initiation date • Trial withdrawal • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemcitabine) and to Pembrolizumab for Patients With Advanced Squamous Cell Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=106 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Aug 2023 ➔ Aug 2024 | Trial primary completion date: Aug 2023 ➔ Aug 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • ATM

Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=188 | Recruiting | Sponsor: National Cancer Institute (NCI) | N=282 ➔ 188

Enrollment change • IO biomarker • Surgery • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Aug 2023 ➔ Nov 2023

Metastases • Trial initiation date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PD-L1 • PGR

Dr Aggarwal on the Activity of BXCL701 Plus Pembrolizumab in SCNC mCRPC (OncLive) - "Rahul Aggarwal, MD, discusses key findings from a phase 2a trial evaluating the combination of BXCL701 and pembrolizumab in patients with metastatic castration-resistant prostate cancer with the small cell neuroendocrine cancer phenotype."

Video

Double-Blind, Randomized Clinical Trial to Evaluate the PK and Safety of BCD-201 and Keytruda® in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=131 | Active, not recruiting | Sponsor: Biocad

Metastases • New P1 trial • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • PROCR

Updates in Renal Cell Carcinoma From ESMO 2022 (Medscape) - "Dr Eric Jonasch...discusses the most notable renal cell carcinoma (RCC) data presented at the 2022 European Society for Medical Oncology Congress. He begins with COSMIC-313, which added cabozantinib to nivolumab plus ipilimumab in intermediate-and poor-risk advanced RCC. The triplet achieved significant improvements in progression-free survival over the standard of care, nivolumab plus ipilimumab...None of the trials were able to replicate the recent positive results with pembrolizumab, raising questions over the future of immunotherapy in this indication....Dr Jonasch then discusses the negative PIVOT-09 trial of bempegaldesleukin plus nivolumab, before ending with KEYNOTE-B61. This phase 2 trial suggests that pembrolizumab plus lenvatinib could be a promising combination in non-clear cell RCC."

Video • Renal Cell Carcinoma

Expert Point of View: Daniel M. Geynisman, MD (THE ASCO POST) - "Dr. Geynisman...'Following nephrectomy, the goal of adjuvant treatment is to ideally cure or at least significantly delay disease progression. The disease-free survival curves in the updated analysis separate even further with an additional 6 months of follow-up, which is promising for adjuvant pembrolizumab. There was particular benefit in patients with very high-risk disease, those with sarcomatoid features, and those who already had metastatic disease. We still need be very mindful of potential toxicity, and thus a personalized discussion based on individual risk is necessary for each patient.'"

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