Nektar Therapeutics (NKTR - Free Report) updated preliminary data from one cohort of the phase I/II PIVOT-02 study, evaluating its immuno-oncology candidate, bempegaldesleukin, in combination with Bristol-Myers’ (BMY - Free Report) PD-1 inhibitor, Opdivo (nivoumab) in patients with advanced or metastatic triple-negative breast cancer (“TNBC”), came in below market expectations. The data was presented at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference held in France.
Preliminary data showed that 13% of the patients achieved a confirmed overall objective response rate (“ORR”). All the patients achieving a confirmed overall ORR received at least one prior chemotherapy regimen.
Meanwhile, the company stated that the updated data supports potential future development of bempegaldesleukin plus Opdivo in combination with chemotherapy for TNBC patients. We expect the company to provide more details from the PIVOT-02 study on its third-quarter earnings call anticipated in November.
In response to the disappointing data, Nektar’s shares fell 6.6% on Sep 26. In fact, shares of the company have declined 71.2% in the past year compared with the industry’s decrease of 22.2%.
We remind investors that Nektar was added to the S&P 500 Index in March 2018. However, following the major fall in shares prices of Nektar in the past year, S&P Dow Jones Indices announced that the company will no longer be a constituent of the S&P 500 Index. The market capitalization of the company now represents that of mid-cap market space. Las Vegas Sands Corp. (LVS - Free Report) will replace Nektar in the S&P 500 Index and the latter will be placed in the S&P MidCap 400 Index. These changes will be effective from Oct 3, before market open.
We note that Nektar has faced two setbacks in 2019 so far. In July, Nektar informed that sub-optimal lots of bempegaldesleukin resulted in reduced response rate in cancer patients evaluated in clinical studies under PIVOT program. The company is enrolling new patients for consistent results, which may lead to delay in completion of the study. In the meantime, the company is developing bempegaldesleukin in combination with Takeda’s TAK-659 and Pfizer’s (PFE - Free Report) Bavencio among others.
In the same month, the FDA informed the company about rescheduling of advisory committee meetings for the discussion of the new drug application seeking approval for Nektar’s opioid analgesic, NKTR-181. The delay was due to a number of scientific and policy issues relating to opioid analgesics.
Nektar currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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