Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Adjuvant Treatment of CSCC with a High Risk of Recurrence After Surgery and Radiation
The positive opinion is supported by results from the global Phase 3 C-POST trial investigating adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence following surgery and radiation. In the trial, Libtayo reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio [HR]: 0.32; 95% confidence interval [CI]: 0.20-0.51; p<0.0001). Fewer patients treated with Libtayo had locoregional or distant recurrence compared with those who received placebo (4% vs. 17% and 5% vs. 13%, respectively). Detailed data were published in the New England Journal of Medicine (NEJM) in May 2025.
Share:
More News
“FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “By combining cell-selective delivery with targeted protein degradation in a single molecule,
“We are excited to expand our clinical collaboration with Roche to evaluate a second KRAS combination with potential best-in-class MTA-cooperative PRMT5 inhibitor IDE892 for pancreatic cancer patients, where there remains a high unmet medical need. IDEAYA is advancing multiple rational combination strategies for the IDE892 program, including with MAT2A inhibitor
“These encouraging initial safety observations represent an important first step in the clinical evaluation of ZI-MA4-1 and our TCR-NK platform” said Namir Hassan, Chief Executive Officer of Zelluna. “The first patient received all three planned doses, and the independent committee’s recommendation enables us to continue recruitment at the first dose
“Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us