- The company said Saturday that data from the Pivot-02 phase 1/2 study, designed to evaluate the combination of Bristol-Myers Squibb Co.'s (BMY) Opdivo with its investigational medicine NKTR-214, demonstrated "important" response rates across the three types of tumors tested. The company said it and Bristol-Myers are now actively enrolling patients in the phase 2 expansion part of the study in five tumor types.
Nektar Therapeutics reports first data for NKTR-214 in combination with OPDIVO
- Nektar Therapeutics (NKTR) and Bristol-Myers Squibb (BMY) announced the first presentation of data from the PIVOT-02 Phase 1/2 Study, which is designed to evaluate the combination of Bristol-Myers Squibb's Opdivo (nivolumab) with Nektar's investigational medicine, NKTR-214.
- Highlights from the oral presentation include:
- Advanced Treatment-Nave 1L Melanoma Patients (Stage IV): Responses were observed in 7/11 (63%) efficacy-evaluable patients (2 CR and 5 PR) ?. Median time to response was 1.7 months. DCR, also known as disease control rate (CR + PR + 3 SD), was 91%. All 7 patients with responses continue on treatment in the trial.
- Advanced Treatment-Nave 1L Renal Cell Carcinoma Patients (Stage IV): For patients with one or more baseline scans, responses were observed in 6/13 patients (46%) (1 CR+ and 5 PR). DCR (CR + PR + 5 SD) was 85%. Median time to response in these patients was 1.9 months. For patients with two or more scans available, responses were observed in 6/10 patients (60%) (1 CR, 5 PR, 2 SD). All 11 patients with disease control (CR, PR or SD) continue on treatment in the trial.
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