Saturday evening Nektar Therapeutics (NKTR 53.70, -36.65,
-40.6%) released preliminary data from the ongoing PIVOT Phase 1/2 Study, which
is evaluating the combination of Bristol-Myers Squibb's (BMY
50.26, -2.87, -5.4%) Opdivo (nivolumab) with Nektar's investigational medicine,
Investors have been on edge since mid-May when the company released its American Society of Clinical Oncology (ASCO) abstract which highlighted preliminary phase 1/2 results from the company’s PIVOT (NKTR-214 plus nivolumab in patients with advanced solid tumors). The results showed the objective response rate (ORR) against melanoma was 52% vs. 63% response in the company’s November data release, while the ORR in renal cell carcinoma was 54% vs. the 71% rate disclosed on the company’s Q4 earnings call.
This weekend’s data failed to calm investor angst likely due to the drop-off in ORR in both melanoma and renal cell carcinoma. Specifically, responses were seen in 14 out of 28 patients with melanoma – or 50% -- vs. the mid-May response from the ASCO abstract of 52%. Renal cell carcinoma responses were seen in 12 out of 26 patients – or 42% -- vs. the mid-May response from the ASCO abstract of 54%. Median study time for these groups was 4.6 and 5.6 months, respectively, a time frame some on the Street are criticizing as too early for treatment to develop.
NKTR management noted that the Phase 1 dose-escalation and Phase 2 expansion stages of the PIVOT trial to-date, NKTR has observed important responses, including activity in PD-L1 negative patients. BMY’s Opdivo is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression. NKTR-214 is an investigational immuno-stimulatory therapy designed to expand and activate specific cancer-fighting T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of cell-surface PD-1 on these immune cells.
The whole point of BMY partnering with NKTR was to hopefully expand response rates to Opdivo by putting NKTR-214’s CD122 receptor to work. The hope was that there would be a higher response rate in those who were PD-L1 negative.
Looking ahead, management noted that the study is still expanding, and that enrollment is ongoing in the Phase 2 stage of the PIVOT study in over 400 patients with melanoma, renal cell, urothelial, non-small cell lung, and triple negative breast cancers.
Overall, the preliminary results from the ongoing PIVOT study presented showed that pre-specified efficacy criteria were achieved in three tumor types: first-line melanoma, first-line renal cell carcinoma, and first-line urothelial cancer. As a result, NKTR and BMY will initiate a Phase 3 registrational trial in first-line advanced melanoma patients in Q3 2018, and pivotal studies are also being designed in renal cell carcinoma and urothelial cancer.
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