Bristol-Myers Squibb Provides Update on Part 2 of CheckMate -227
- Study Did Not Meet Its Primary Endpoint of Overall Survival with Opdivo??(nivolumab) Plus Chemotherapy vs. Chemotherapy in First-Line Non-Squamous Non-Small Cell Lung Cancer
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company?(NYSE: BMY) today announced that Part 2 of the Phase 3 CheckMate -227 trial did not meet the primary endpoint of overall survival (OS) with?Opdivo??(nivolumab) plus chemotherapy versus chemotherapy in patients with first-line non-squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 status (HR 0.86; 95% CI 0.69-1.08). The median OS for patients treated with?Opdivo?plus chemotherapy was 18.83 months vs. 15.57 months for chemotherapy, and the landmark one-year OS was 67.3 percent vs. 59.2 percent, respectively. In an exploratory analysis of patients with first-line squamous NSCLC, the median OS was 18.27 months for?Opdivo?plus chemotherapy vs. 11.96 months for chemotherapy (HR 0.69; 95% CI 0.50-0.97). No new safety signals were observed. The company will share complete findings from this trial at an upcoming medical meeting.
?While this is not the outcome we had hoped for, the?Opdivo?plus chemotherapy one-year landmark overall survival in the non-squamous population was consistent with the experimental arms in previously-reported trials of IO/chemotherapy combination regimens,? said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb. ?We thank the patients and investigators who participated in this trial.?
Bristol-Myers Squibb also announced that Part 1a of the CheckMate -227 trial met the co-primary endpoint of OS, demonstrating a statistically significant benefit for?Opdivo?plus low-dose?Yervoy??(ipilimumab) versus chemotherapy in patients whose tumors express PD-L1 =1%. Additional information can be found at?www.bms.com.
Time Change for Q2 Earnings Results Conference Call
Bristol-Myers Squibb Company announced today that its second quarter 2019 earnings call has been rescheduled to 8:30 a.m. ET tomorrow, Thursday, July 25, 2019. The dial-in information remains the same and is listed below. During the conference call, company executives will review financial information and will address inquiries from investors and analysts.
Investors and the general public are invited to listen to a live webcast of the call at?http://investor.bms.com?or by dialing in the U.S. toll free 888-254-3590 or international 323-994-2093, confirmation code: 9333832. A replay of the call will be available beginning at 11:45 a.m. ET on July 25 through 11:45 a.m. ET on August 8, 2019. The replay will also be available through?http://investor.bms.com?or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 9333832.
About CheckMate -227
CheckMate -227 is a multi-part open-label Phase 3 trial evaluating?Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced non-small cell lung cancer across non-squamous and squamous tumor histologies:
- Part 1:
- Part 1a:?Opdivo?plus low-dose?Yervoy?or?Opdivo?monotherapy versus chemotherapy in patients whose tumors express PD-L1
- Part 1b:?Opdivo?plus low-dose?Yervoy?or?Opdivo?plus chemotherapy versus chemotherapy in patients whose tumors do not express PD-L1
- Part 2:?Opdivo?plus chemotherapy versus chemotherapy, regardless of PD-L1
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