FDA Approves KEYTRUDA and KEYTRUDA QLEX each with Trodelvy as 1L Treatment of PD-L1+ (CPS ≥10) Advanced TNBC
“Patients with PD-L1+ unresectable locally advanced or metastatic TNBC have limited treatment options in the first-line setting, as this aggressive disease often advances quickly,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “We now have new first-line treatment options that combine, for the first time, a PD-1 inhibitor with a Trop-2-directed ADC, and significantly reduce disease progression or death compared to KEYTRUDA plus chemotherapy. Today’s approvals of KEYTRUDA and KEYTRUDA QLEX each in combination with Trodelvy represent a meaningful milestone for those living with advanced TNBC.”
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