Efficacy
In the KEYNOTE-629 trial locally advanced cohort, 27 of 54 patients achieved a confirmed response, with an ORR (complete or partial response) of 50.0% (95% CI: 36.1%-63.9%), including 9 complete responses (CR) (16.7%) and 18 partial responses (PR) (33.3%).r Stable disease was observed in 13 patients, including 8 with stable disease for at least 12 weeks. DCR was 64.8% (n = 35; 95% CI: 50.6%-77.3%). Median time to response was 2.6 (IQR, 1.4-3.6) months. Median DoR was not reached (NR) (95% CI: NR-NR).
In the recurrent/metastatic cohort, 37 of 105 patients achieved a response, with an ORR of 35.2% (95% CI: 26.2%-45.2%), including 11 with CR (10.5%) and 26 with PR (24.8%). Stable disease was observed in 30 patients, including 18 who achieved stable disease for at least 12 weeks. DCR was 52.4% (n = 55; 95% CI: 42.4%-62.2%). Median time to response was 1.6 (IQR, 1.4-3.1) months. Median DoR was NR (95% CI: 22.4 months-NR).
In the total population, 64 of 159 patients achieved a response, with an ORR of 40.3% (95% CI: 32.6%-48.3%), including 20 with CR and 44 with PR. Stable disease was observed in 43 patients, including 26 patients who achieved stable disease for at least 12 weeks. DCR was 56.6% (n= 90; 95% CI:48.5%-64.4%).
Best overall response as per RECIST v1.1r
© Ann Oncol 2021
In the locally advanced cohort, 24 of 54 patients (44.4%) had experienced disease progression or died. Median PFS was NR (95% CI: 5.5 months-NR), and estimated PFS rates at 6 and 12 months were 60.9% (95% CI: 46.2%-72.8%) and 54.4% (95% CI: 39.6%-67.0%), respectively. Of the 54 patients, 14 (25.9%) had died. Median OS was NR (95% CI: NR-NR), and the estimated OS rate at both 12 and 18 months was 73.6% (95% CI: 59.5%-83.4%).
In the recurrent/metastatic cohort, 69 of 105 patients (65.7%) had experienced disease progression or died. Median PFS was 5.7 (95% CI: 3.1-8.5) months, and estimated PFS rates at 6 and 12 months were 49.4% (95% CI: 39.3%-58.7%) and 36.4% (95% CI: 27.0%-45.9%), respectively. Of the 105 patients, 59 patients (56.2%) had died. Median OS was 23.8 (95% CI:13.4-29.8) months, and the OS rates at 12 and 24 months were 61.0% (95% CI: 50.9%-69.5%) and 48.4% (95% CI: 38.5%-57.6%), respectively.
In the total population, 93 of 159 patients (58.5%) had experienced disease progression or died. Median PFS was 7.8 (95% CI: 5.3-12.3) months and estimated PFS rates at 6 and 12 months were 53.3% (95% CI: 45.0%-60.9%) and 42.4% (95% CI: 34.3%-50.2%), respectively. Of the 159 patients, 73 patients (45.9%) had died. Median OS was 26.4 months (95% CI: 19.5 months-NR), and the OS rates at 12 and 24 months were 65.1% (95% CI: 57.1%-72.0%) and 52.7% (95% CI: 43.8%-60.9%), respectively.
Kaplan-Meier curves for PFS and OS in the locally advanced and recurrent/metastatic cohortr
© Ann Oncol 2021
The CARSKIN study enrolled 39 patients with unresectable cSCC. The primary cohort’s ORR at week 15 was 41% (95% CI: 26%-58%), including 13 partial and 3 complete responses.r Best responses were 8 partial and 8 complete responses. At a median follow-up of 22.4 months, median PFS was 6.7 months, DoR was not reached, and OS was 25.3 months. In the expansion cohort, the ORR was higher amongst those with PD-L1-positive disease (55%) versus PD-L1-negative disease (17%) (P=0.02).