#Checkmate 9la publication update#

LITESPARK-004 (MK-6482-004) phase 2 study of belzutifan, an oral hypoxia-inducible factor 2α inhibitor (HIF-2α), for von Hippel-Lindau (VHL) disease: Update with more than two years of follow-up data (Abstract 4546)ĭata from the phase 2 LITESPARK-004 trial (NCT03401788) supported the approval of belzutifan patients with von Hippel-Lindau (VHL) disease who require therapy for associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors not requiring immediate surgery in 2021.

“The journey of discovery that has led to the development of is quite amazing from the discovery of the VHL gene at the in 1993 to the work of and being awarded the Nobel Prize in 2019, to understanding how VHL regulates the HIF and other factors to the development of this drug by the group at UT Southwestern…This is an amazing example of science that is properly motivated that led to highly effective therapy for this disease.” 3 Investigators will present data with more than 3 years of follow-up during the meeting. The median progression-free survival was 14.5 months. Phase 1 LITESPARK-001 (MK-6482-001) study of belzutifan in advanced solid tumors: Update of the clear cell renal cell carcinoma (ccRCC) cohort with more than 3 years of total follow-up (Abstract 4509)Īmong heavily pretreated patients with clear cell RCC (n = 55), previously reported data from the phase 1/2 LITESPARK-001 trial (NCT02974738) showed that the small molecule inhibitor of HIF-2α elicited an objective response rate of 25%. Long-term follow-up data from 2 trials of belzutifan (Welireg) in patients with renal cell carcinoma (RCC) will contextualize the clinical benefit of the agent across variant histologies. Potentially, in this pretreated population we might have different ADCs available, and we might need to decide which ones to prioritize.” GENITOURINARY CANCERSĮric Jonasch, MD, professor in the Department of Genitourinary Medical Oncology, The University of Texas MD Anderson “Other big news we had recently was the that TROPiCS-02 trial were positive meaning that sacituzumab govitecan, an anti-TROP2 antibody-drug conjugate, after being approved in triple-negative disease is also more active than chemotherapy in the hormone receptor–positive disease. 2 The data potentially add an additional agent to the treatment landscape for this patient population. In March 2022, Gilead, the developer of sacituzumab govitecan (Trodelvy) announced that the phase 3 TROPiCS-02 trial met its primary end point of demonstrated PFS improvement among patients with hormone receptor–positive/HER2-negative advanced breast cancer vs chemotherapy. Primary results from TROPiCS-02: A randomized phase 3 study of sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) in patients (Pts) with hormone receptor–positive/HER2-negative (HR+/HER2-) advanced breast cancer (Abstract LBA1001) “DESTINY-Breast04 was the first phase 3 trial launched to confirm the paradigm of HER2-low and it was a trial which included patients with pretreated HER2-low tumors both with hormone receptor–positive and triple-negative disease…not only PFS, which was the primary end point, but also OS was improved with trastuzumab deruxtecan therapy and these might change the way we treat these patients who are pretreated with chemotherapy with or without endocrine therapy.” 1 Patients treated with the antibody-drug conjugate achieved statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor (HR) status vs physician’s choice of chemotherapy. The primary end point of the pivotal phase 3 DESTINY-Breast04 (NCT were met after fam-trastuzumab deruxtecan-nxki (Enhertu) according to a news release ahead of the 2022 ASCO meeting. Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Results of DESTINY-Breast04, a randomized, phase 3 study (Abstract LBA3) Paolo Tarantino, MD, clinical research fellow at Dana-Farber Cancer Institute in Boston, Massachusetts

Checkmate 9la publication