REGN at ESMO: cslide.ctimeetingtech.com
CSCC: " The median duration of response has not been reached, and as of the data cut-off date, for pts with CR or PR, the observed duration of response exceeded 6 months in 9 pts and 12 months in 5 pts."
aNSCLC...< a combination regimen of cemiplimab plus RT in advanced NSCLC (NCT02383212).>..."As of 1 Sept, 2017, 33 pts (22 M/ 11 F; median age 67.0 years [range, 47–82]) were enrolled; 66.7% and 30.3% had an ECOG performance status of 1 and 0, respectively; the status of one pt was unknown. Overall response rate (ORR; complete response [CR] + partial response [PR]) was 18.2% (0 CR and 6 PRs) with a median duration of response of 14.9 months (95% CI: 5.5–14.9). Disease control rate (ORR + stable disease [SD]) was 72.7% (6 PRs + 18 SDs). "
registrational P2 aBCC: "
We are conducting a phase 2, non-randomised, 2-group, multi-centre study of cemiplimab in patients with advanced BCC who experienced disease progression or are intolerant to HHI therapy (NCT03132636). Group 1 will enrol patients with both nodal and distant metastatic BCC. Group 2 will enrol patients with locally advanced BCC who are not candidates for surgery. Cemiplimab will be administered intravenously every 3 weeks in all patients. The primary objective of the study is to evaluate overall response rate (ORR) as determined by central review. The ORR will be assessed separately for patients in Group 1 or Group 2 (by RECIST 1.1 for radiology, and modified WHO for photography). Up to 137 patients will be enrolled. For Group 1, 50 patients are required to provide at least 85% power to reject a null hypothesis of an ORR of 15% at a 2-sided significance level of 5% if the true ORR is 34%. For Group 2, 80 patients are required to provide at least 85% power to reject a null hypothesis of an ORR of 20% at a 2-sided significance level of 5% if the true ORR is 35%. An additional 5% in sample size will account for patient withdrawals. This study is ongoing."
2L rHCC (expansion cohort): "As of 1 Sept, 2017, 26 pts were enrolled (25 M/1 F), median (range) age was 65 (40–78) years; 24 pts (92.3%) had =1 prior systemic therapy; ECOG performance status was 1 in 19 pts (73.1%), 0 in 6 (23.1%) and missing in 1. Median duration of follow-up was 7.2 (range: 1.8–15.5) months. By investigator assessment, 5 pts (19.2%) had partial response, 14 (53.8%) had stable disease, 6 (23.1%) had progressive disease and 1 was not evaluable. Median progression-free survival was 3.7 months (95% CI: 2.3–9.1). Five pts (19.2%) completed the planned 48-week treatment, and 21 (80.8%) discontinued prematurely, mainly due to disease progression (65.4%). Three of the 5 pts who completed planned treatment remained without disease progression at the last response assessment. The most common treatment-emergent adverse events (TEAEs) of any grade were fatigue (26.9%), decreased appetite, increased aspartate aminotransferase (AST), abdominal pain, pruritus, and dyspnoea (each 23.1%). Grade =3 TEAEs occurring in?=?2 pts were hyponatraemia (3 pts), autoimmune hepatitis (2 pts) and increased AST (2 pts). Two pts (7.7%) had a TEAE resulting in death: 1 with pulmonary embolism that was considered unrelated to treatment and another with hepatic failure considered possibly related to treatment."
HCC: 20% is large number, but trial subjects # is too small. It may be prudent to go for 1L, but they need to rush here if competitor do not eat them alive. |
