Not seen since February of 2001, shares of Nektar Therapeutics (NKTR 37.91, +5.41 +16.7%) trade to better than 15-year highs in light of data out Saturday from the company’s NKTR-214 in combination with Bristol-Myers’ (BMY 60.76, -0.10 -0.2%) Opdivo (nivolumab).
As a bit of background, NKTR-214 is the company’s cancer treatment currently being tested in melanoma, renal cell carcinoma, non-small cell lung cancer, bladder, and triple-negative breast cancers; NKTR-214 preferentially binds to the CD122 receptor on the surface of cancer-fighting immune cells in order to stimulate their proliferation. In clinical and preclinical studies, treatment with NKTR-214 resulted in expansion of these cells and mobilization into the tumor micro-environment. NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines. Nektar and Bristol-Myers Squibb entered into a clinical collaboration in September of 2016 to evaluate the potential for the combination of Opdivo and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care. Bristol-Myers Squibb and Nektar are equally sharing costs of the combined therapy trials, but Nektar maintains its global commercial rights to NKTR-214.
The study was detailed at the 2017 Society for Immunotherapy of Cancer (SITC) Annual Meeting held over the weekend. There, NKTR and BMY announced initial results from the PIVOT-02 Phase 1/2 Study, which as mentioned was designed to evaluate the combination of BMY’s Opdivo (nivolumab) with Nektar's investigational medicine, NKTR-214.
Management noted the initial findings underscore the benefits of Opdivo with NKTR-214 across several tumor types. Namely, in patients with Naïve 1L Melanoma (stage IV) responses were observed in 7/11 (63%) efficacy-evaluable patients (2 CR and 5 PR). The median time to response was 1.7 months. Disease control rate (CR + PR + 3 SD), was 91% and all 7 patients with responses continue on treatment in the trial.
In patients with Renal Cell Carcinoma Patients (stage IV), those 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% and tha 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.
For patients with Renal Cell Carcinoma (stage IV, I-O Naïve) with one or more baseline scans, responses were observed in 1/7 patients (14%) (1 PR). DCR (CR + PR + 6 SD) was 100% and the median time to response was 3.5 months. All 7 patients with disease control (PR or SD) continue on treatment in the trial.
As for safety, the most common grade 1-2 adverse events were fatigue (74%), flu-like symptoms (68%), rash (60%) and pruritus (42%). There were no treatment discontinuations due to adverse events (AEs) or study deaths.
Importantly, NKTR observed responses in 3 of 4 Stage IV non-small cell lung cancer patients whose tumors did not express PD-L1 and who had progressed on prior chemotherapy, including one patient who experienced a complete response. In the combination treatment, there were no Grade 3 or higher immune-mediated adverse events at the recommended Phase 2 dose or below. As such, Nektar and Bristol are now actively enrolling patients in the Phase 2 expansion part of the PIVOT study in 5 different tumor types.