UNITED STATES
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FORM
CURRENT REPORT
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Item 8.01 Other Events.
On March 14, 2022, Nektar Therapeutics (“Nektar”) and Bristol-Myers Squibb Company (“BMS”) announced that an independent Data Monitoring Committee (the “DMC”) review of the first analysis of the Phase 3 PIVOT IO-001 clinical trial (the “PIVOT IO-001 Trial”) evaluating the doublet therapy bempegaldesleukin, Nektar’s investigational CD122-preferential IL-2 pathway agonist drug, in combination with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated unresectable or metastatic melanoma, had determined that the PIVOT IO-001 Trial did not meet the primary endpoints of progression-free survival and objective response rate for the trial. The DMC also notified Nektar and BMS that the third primary endpoint of overall survival did not meet statistical significance at the first interim analysis. Based on data reviewed by the DMC and as further described in the press release, Nektar and BMS have decided to unblind the trial and to perform no additional analyses for the overall survival endpoint. Additionally, based on the results from the PIVOT IO-001 Trial, Nektar and BMS have also made the decision to stop enrollment for and unblind the ongoing PIVOT-12 study in adjuvant melanoma, which is evaluating the doublet therapy of bempegaldesleukin in combination with Opdivo compared to Opdivo monotherapy in patients at high risk for recurrence after complete resection of melanoma. A copy of the press release issued in connection with the announcement is attached hereto as Exhibit 99.1, and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press release titled “Bristol Myers Squibb and Nektar Announce Update on Phase 3 PIVOT IO-001 Trial Evaluating Bempegaldesleukin (BEMPEG) in Combination with Opdivo (nivolumab) in Previously Untreated Unresectable or Metastatic Melanoma.” | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NEKTAR THERAPEUTICS | ||
| Date: March 14, 2022 | By: | /s/ Mark A. Wilson |
| Mark A. Wilson | ||
| General Counsel and Secretary | ||
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