Primary endpoint met in Ph 2 study, FOURLIGHT-1, showing a 40% reduction in the risk of disease progression or death with manageable safety profile
“These results are especially encouraging given that the FOURLIGHT‑1 study enrolled patients whose disease had progressed soon after prior CDK4/6 inhibitor therapy, a difficult-to-treat population,” said Jeff Legos, Chief Oncology Officer, Pfizer. “The strength of these data reinforces our confidence that atirmociclib may meaningfully differentiate from the CDK4/6 inhibitor class, the standard-of-care backbone in HR-positive breast cancer, with the potential for improved efficacy and tolerability. We are continuing to accelerate development of this next-generation cell cycle inhibitor in earlier lines of therapy where it may offer even greater benefit for patients.”
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“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