BA1104 (nivolumab biosimilar) / Luye Group, Shandong Boan Biotechnology - LARVOL DELTA

Shandong Boan Biotechnology announced that China’s Center for Drug Evaluation has accepted its application for a Phase II clinical trial of its anti-CD25 antibody BA1106 combined with PD-1 inhibitor BA1104 as first- or second-line therapy for driver gene-negative non-small cell lung cancer. (TipRanks) - "The multicenter, single-arm, open-label study will assess efficacy, safety, and pharmacokinetics in a patient population with limited options after developing resistance to existing immune checkpoint inhibitors."

New P2 trial • Non Small Cell Lung Cancer

Pharmacokinetics, Safety, and Immunogenicity of a Biosimilar of Nivolumab (LY01015): A Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Trial in Healthy Chinese Male Subjects. (PubMed, BioDrugs) - "LY01015 demonstrated highly similar pharmacokinetics to nivolumab in healthy Chinese male subjects. Both drugs exhibited comparable safety and immunogenicity profiles."

Clinical • Journal • P1 data • PK/PD data

A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P3 | N=510 | Recruiting | Sponsor: Shandong Boan Biotechnology Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

First Patient Enrolled in Phase III Clinical Trial of Boan Biotech's Nivolumab Injection (PRNewswire-Asia) - "Boan Biotech...announced today that the first patient in Phase III clinical trial of its Nivolumab Injection (BA1104) in China has been enrolled. BA1104 is the first biosimilar to Opdivo to undergo a Phase III study in China....The Phase III clinical trial is a randomized, double-blind, multicenter study designed to compare the efficacy, safety, and immunogenicity of BA1104 and Opdivo combined respectively with chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma."

Trial status • Esophageal Squamous Cell Carcinoma • Squamous Cell Carcinoma

A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P3 | N=510 | Not yet recruiting | Sponsor: Shandong Boan Biotechnology Co., Ltd

Metastases • New P3 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

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

Rethinking I-O in PROC: A Potential Answer in Two vs. One (OncLive) - "In recent years, advances in our understanding of ovarian cancer biology and new treatment approaches have improved patient outcomes, but additional therapeutic options are needed. While initial response rates to chemotherapy could be high, I've seen many people with ovarian cancer relapse and eventually develop resistance to platinum-based chemotherapy, leading to a poor prognosis....Furthermore, while the immuno-oncology (I-O) treatments known as anti-PD-1/L1 therapies have been successful in a wide range of solid tumors, the benefit for patients with ovarian cancer has been limited,4 and there are currently no FDA-approved I-O treatments specifically for this disease."

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