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Monday, June 4, 2018

====Nektar Therapeutics (NKTR) : plummets on 'underwhelming' cancer trial data


  • Data released Saturday suggested that patients diagnosed with melanoma aren't reacting to the company's experimental treatment as well as earlier samples did. The prior data, released last year, was in part responsible for the company's rally to all-time highs in the first half of 2018.
  • Bristol-Myers Squibb, Nektar's partner on the skin cancer treatment, fell more than 3 percent Monday.




Nektar Therapeutics reports preliminary data for NKTR-214 in combination with Opdivo for patients with stage 4 metastatic melanoma, renal cell carcinoma, and urothelial cancers presented at ASCO 2018; showed that pre-specified efficacy criteria were achieved in three tumor types  
  • Preliminary results from the ongoing PIVOT study presented today 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, Nektar and Bristol-Myers Squibb (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.

Nektar Therapeutics (NKTR) shares dropped 29% in premarket trade Monday after the company released early data from a phase 1/2 clinical trial testing the company's NKTR-214 in combination with Bristol-Myers Squibb's (BMY) cancer drug Opdivo.

Bristol-Myers shares declined nearly 1% premarket. The trial, which tested the safety and efficacy of the combination in patients with stage IV metastatic melanoma, renal cell carcinoma and urothelial cancers, had "underwhelming" results, said EvercoreISI analyst Josh Schimmer. "We remain unconvinced that '214 adds benefit to Opdivo," he said. Noting that the companies did not separately present results for "stage 2" patients in the trial, he said, "if new cohort (N2) [overall response rate] doesn't improve substantially with follow up, we expect investors to broadly lose confidence (if they haven't already)." Drugmakers have been working to combine various cancer treatments in clinical trial to see if the combinations work better than one treatment on its own, and Bristol-Myers' Opdivo is already a blockbuster cancer drug on its own accord. Not all analysts were so gloomy about Nektar's NKTR-214, which is the company's lead immuno-oncology drug candidate and is also being tested on its own and in combination with other drugs, though the Bristol-Myers collaboration is furthest along. The latest results, presented at the American Society of Clinical Oncology's annual meeting, are "supportive of the long-term potential for NKTR-214 to enhance the efficacy of PD-1 in a number of tumor types," said J.P. Morgan analyst Jessica Fye, "but expect near-term volatility based on immature response rate data (not entirely unexpected) that came in on the low end of Street expectations" and without an update on lung cancer patients. Nektar shares have dropped 12.2% over the last three months, and Bristol-Myers shares have dropped 19.7%, compared with a 1.6% rise in the S&P 500 (SPX).

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