Opdivo® IV Infusion Approved in Taiwan in Combination with Yervoy® for Unresectable or Metastatic 1L HCC
This approval is based on the results from the CheckMate -9DW study, a global multi-center Phase 3 clinical study (CA209-9DW: ONO-4538-92), evaluating Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib monotherapy for patients with unresectable HCC who have not received prior systemic anti-cancer therapy. In this study, in which 85% of patients in the comparator arm were treated with lenvatinib and 15% were treated with sorafenib, Opdivo plus Yervoy met its primary endpoint of overall survival (OS), demonstrating a statistically significant and clinically meaningful improvement in OS compared to lenvatinib or sorafenib monotherapy. The median OS with Opdivo plus Yervoy (n=335) was 23.7 months (95% CI: 18.8-29.4) vs. 20.6 months (95% CI: 17.5-22.5) with lenvatinib or sorafenib (n=333; HR=0.79; 95% CI: 0.65-0.96 P=0.018), reducing the risk of death by 21%.1) The safety profile of Opdivo plus Yervoy was consistent with previously reported data, with no new safety signals identified.
Share:
More News
“Pancreatic cancer has historically been one of the most difficult-to-treat cancers and people whose tumors harbor a KRAS G12C mutation face limited options once their disease progresses,” said Jacob Van Naarden, executive vice president, and president of Lilly Oncology. “This Breakthrough Therapy designation reflects the early potential we’re seeing with
“This financing reflects the confidence our investors and strategic partners have in the progress we have made to date and the opportunities that lie ahead,” said Dr. Jack Hoppin, Chief Executive Officer of Ratio Therapeutics. “As we march the ATLAS trial forward and prepare for our 5th IND filing, these
“We are excited to initiate monotherapy expansion evaluating IDE892 in MTAP-deleted PDAC and NSCLC. We designed IDE892 to be a potential best-in-class PRMT5 inhibitor, including approximately 1,400-fold selective MTA-PRMT5 cooperative binding versus SAM-PRMT5 cooperative binding, lack of brain penetrance, and favorable drug-like properties intended to maximize its therapeutic window as
“The data presented at ASCO provided important insight into the potential clinical path for CRB-701 in 2L oropharyngeal cancer, a distinct tumor-type that is on the rise due to HPV infections,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “Unfortunately, current treatment options have shown limited efficacy underscoring the