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Biotech / Medical : biotech firesales

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From: Julius Wong6/4/2018 9:43:26 AM
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Nektar down 24% premarket on Opdivo + NKTR-214 data

Nektar Therapeutics (NASDAQ: NKTR) slumps 24% premarket on light volume in apparent response to its announcement of preliminary data from a Phase 1/2 clinical trial, PIVOT, assessing the combination of NKTR-214 and Bristol-Myers Squibb's (NYSE: BMY) Opdivo (nivolumab) in a range of cancers. The results were presented at ASCO in Chicago.
The company says the combination achieved the pre-specified efficacy criteria (historical objective response rate (ORR) for a single-agent checkpoint inhibitor) in first-line melanoma, first-line renal cell carcinoma (RCC) and first-line urothelial cancer.Investors appear disappointed with the drop the response rate in melanoma and RCC.In 13 treatment-naive Stage IV metastatic patients in Stage 1 of the trial, the ORR was 84.6% (n=11/13) but it dropped to 50.0% (n=14/28) in Stage 2.
The ORR in PD-L1-negative participants was 41.7% (n=5/12) and 61.5% (n=8/13) in PD-L1-positive patients.
ORR in advanced treatment-naive RCC patients was 63.6% (n=7/11) in Stage 1 and 46.2% (n=12/26) in Stage 2.
ORR in PD-L1-negative and PD-L1-positive patients was 52.9% (n=9/17) and 28.6% (n-2/7), respectively.
ORR in advanced treatment-naive urothelial cancer was 60.0% (n=6/10).
ORR in PD-L1-negative and PD-L1-positive patients was 60.0% (n=3/5) and 60.0% (n=3/5), respectively.
The companies plan to launch a Phase 3 study in first-line melanoma next quarter. Pivotal trials in first-line renal cell carcinoma and first-line urothelial cancer are being designed.
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