Nektar Therapeutics (NKTR and Bristol-Myers Squibb BMY announced preliminary data from the ongoing PIVOT phase I/II study at the American Society of Clinical Oncology (ASCO) annual meeting. The study is evaluating the combination of Nektar's lead immuno-oncology candidate, NKTR-214 with Bristol-Myers Squibb's Opdivo (nivolumab). The company presented data for patients enrolled in the phase I dose-escalation stage of the study and for the first patients consecutively enrolled in select dose expansion cohorts in phase II.
The PIVOT study showed that pre-specified efficacy criteria were achieved in three tumor types: first-line melanoma, first-line renal cell carcinoma (a type of kidney cancer) and first-line urothelial cancer. Both the companies plan to commence a phase III registrational study in first-line advanced melanoma patients in the third quarter of 2018, and pivotal studies are also being designed in renal cell carcinoma and urothelial cancer. If the efficacy criteria at the recommended phase II dose (RP2D) is met in the first stage (N1) of patients consecutively enrolled or in the second stage (N1 + N2) of patients consecutively enrolled, the combination regimen would be advanced to registrational trials in that tumor type.
Results in treatment-naïve patients with Stage IV metastatic melanoma showed that the objective response rate (ORR) in the first part of the study was 85% in 13 treated subjects, while responses were observed in 50% of 28 patients in stage two of the study.
Further, data showed that in treatment-naïve patients with Stage IV metastatic renal cell carcinoma-, the ORR in stage one of the study was 64% in 11 patients, while responses were seen in 46% of 26 patients in the second phase of the study.
Finally, results in treatment-naïve patients with Stage IV metastatic urothelial carcinoma showed that the ORR in the first part of the study was 60% in 10 patients, with the same response rate in both PD-L1 negative patients and in those with PD-L1 positive tumours.
The companies added that enrolment is also continuing in the second stage of the PIVOT trial with over 400 patients with melanoma, renal cell, urothelial, non-small-cell lung and triple negative breast cancers.
The companies added that overall in the study, at week three, 53% of 17 patients with a PD-L1 negative status at baseline were converted to PD-L1 positive status. Results showed that of these subjects, 78% achieved either stable disease, partial response or a complete response.
Shares of the company were down by more than 40% as the response rates in melanoma and kindney cancer studies were below market expectations.
The companies believe that NKTR-214 in combination with Opdivo can potentially expand the treatment benefits we can bring to patients with cancer. The companies added that enrolment is also continuing in the second stage of the PIVOT trial with over 400 patients with melanoma, renal cell, urothelial, non-small-cell lung and triple negative breast cancers.
Shares of Nektar have decreased 33.3% year to date, compared with the industry’s gain of 3%.
We note that, Opdivo, became the first PD-1 immune checkpoint inhibitor to gain regulatory approval in July 2014. It is currently approved in several countries including the United States, the EU and Japan for several cancer indications. Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy — classical Hodgkin lymphoma in both the United States (May 2016) and the EU (November 2016).
In November 2016, Opdivo gained FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
We also note that in February 2018, Nektar inked an agreement with Bristol-Myers Squibb to jointly develop and commercialize NKTR-214 in combination with the Bristol-Myers Squibb's Opdivo and Opdivo plus Yervoy (ipilimumab) in more than 20 indications across 9 tumor types.
Nektar is also conducting a phase I/II PROPEL study to evaluate the efficacy and safety of NKTR-214 in combination with Roche's RHHBY Tecentriq (atezolizumab) and Merck's MRK Keytruda (pembrolizumab). Notably, this PROPEL study complements the company’s ongoing PIVOT trial.
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Nektar carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
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