FDA clears IND application for Ph 3 MarsLight-11 trial of IBI363 in Squamous NSCLC
“U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to initiate a global Phase 3 clinical trial (MarsLight-11) of IBI363 in immunotherapy(IO)-resistant squamous non-small cell lung cancer (NSCLC). IBI363 is Innovent’s self-discovered novel PD-1/IL-2α-bias bispecific antibody fusion protein. The upcoming study will be the first global Phase 3 trial of IBI363 and represents a significant milestone in advancing a first-in-class, dual-immune activation immunotherapy for this large patient population. Besides, the pivotal trial of IBI363 head-to-head against pembrolizumab (Keytruda®) in the treatment of melanoma is underway in China.”
Share:
More News
“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy
“Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of
“Whitehawk has established strong expertise in ADC technology and oncology drug development,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development. We look forward to supporting the efficient advancement of multiple programs by contributing high-quality
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data