European Commission approves Opdualag (nivolumab + relatlimab) for the Treatment of Unresectable or Metastatic Melanoma with Tumor Cell PD-L1 Expression < 1%
“Opdualag is now the first approved LAG-3-blocking antibody combination for advanced melanoma in the European Union. The RELATIVITY-047 study demonstrated the important benefit of inhibiting both LAG-3 and PD-L1 with our novel immunotherapy combination,” said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. “This is a continuation of our work in bringing innovative medicines to adults and adolescents living with melanoma. Thank you to all of the patients, researchers and physicians who contributed to these advancements and made today’s approval possible.”
Share:
More News
“Antengene announced it has entered into a global clinical collaboration with MSD to evaluate the combination of ATG-022, a CLDN18.2-targeting antibody-drug conjugate (ADC), and MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors. At the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2025), Antengene
“Advanced esophageal squamous cell carcinoma is a difficult-to-treat disease, and unfortunately overall survival remains low,” said Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “The initiation of the pivotal Phase 3 IDeate-Esophageal01 clinical trial demonstrates our shared commitment with Daiichi Sankyo to
“Overall response rate (ORR) was 97% (114/117) with a complete response/stringent complete response (CR/sCR) rate of 68% (79/117) and a very good partial response or higher (>VGPR) rate of 85% (100/117), per International Myeloma Working Group (IMWG) criteria as investigator-assessed. Of those evaluable for minimal residual disease (MRD) testing at
“EMA approval of the MIRACLE trial protocol is a huge milestone for us. Although we’re already seeing recruitment in our first non-EU country, we believe that this expansion into the EU really supercharges our recruitment potential,” said Walter Klemp, Chairman and CEO of Moleculin. “Importantly, when combined with the sites
