DewDiligence
3 years ago
NKTR’s Bempeg fails as addend to Opdivo in first-line melanoma:
https://finance.yahoo.com/news/bristol-myers-squibb-nektar-announce-105900961.html Bristol Myers Squibb and Nektar Therapeutics today announced an update following the first analysis of the Phase 3 PIVOT IO-001 study evaluating the doublet therapy of bempegaldesleukin in combination with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated unresectable or metastatic melanoma. Following a review of the study for efficacy and safety by an independent Data Monitoring Committee (DMC), Bristol Myers Squibb and Nektar were informed that the study did not meet the primary endpoints of progression-free survival (PFS) and objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR). The DMC notified the companies that the third primary endpoint of overall survival (OS) did not meet statistical significance at the first interim analysis.
Given there was no additional clinical benefit in the doublet therapy arm compared to the monotherapy arm for the primary endpoints of PFS and ORR, and based on the data reviewed by the DMC, the companies have decided to unblind the trial and to perform no additional analyses for the OS endpoint.
Additionally, based on the results from PIVOT IO-001, the companies have also made the decision to discontinue enrollment 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.
DewDiligence
4 years ago
NKTR +18% on clinical-trial_collaboration_testing Bempeg+Keytruda in_H&N_cancer:
https://finance.yahoo.com/news/nektar-announces-agreement-phase-2-130000352.html
NKTR is receiving no cash from MRK—only free drug for use in the trial. Rather, unding for the trial is being provided by NKTR’s financing deal with SJC Pharma (https://finance.yahoo.com/news/nektar-announces-collaboration-sfj-pharmaceuticals-125900283.html ).
Note that the 3-year PD-(L)1 exclusivity period of the BMY/NKTR collaboration, which was announced on 2/14/18, has now expired, enabling NKTR to test Bempeg with any PD-(L)1 agent of its choosing.
p.s. Even after today’s pop, NKTR’s share price is down about 70% from the day of the BMY announcement three years ago.