Nektar Therapeutics med nye data pÄ SITC-
18.6 Month Median Follow-Up for First-Line Stage IV Melanoma Cohort in PIVOT-02: (Response measured by RECIST v1.1 by blinded independent central radiology (BICR) review for 38 efficacy-evaluable patients per protocol, which were treated at the recommended Phase 2 dose in PIVOT-02 and with >1 on treatment scan. Data cut as ofSeptember 25, 2019):
- At a median time of follow-up of 18.6 months, confirmed objective response rate (ORR) was 53% (20/38) in efficacy-evaluable patients, with 34% (13/38) of patients achieving confirmed complete responses (CR). 42% (16/38) of patients achieved a maximum reduction of 100% in target lesions. DCR, also known as disease control rate (CR+ Partial Response + Stable Disease), was 74% (28/38).
- Median time to response was 2.0 months and median time to complete response was 7.9 months.
- Median percent reduction of target lesions from baseline was 61.5%.
- At a median time of follow-up of 18.6 months, median duration of response has not been reached and 85% (17/20) of patients with responses had ongoing responses.
- Among the 35 patients with known baseline PD-L1 status, ORR in PD-L1 negative patients was 5/13 (39%) and in PD-L1 positive patients was 14/22 (64%).
- At a median time of follow-up of 18.6 months, the Kaplan-Meier estimate of median progression-free survival (PFS) was not reached (95% CI: 5.3, NE).
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