Bristol-Myers Squibb Announces CheckMate -227 Part 1a Meets Co-Primary Endpoint of Overall Survival
- Study Met Its Co-Primary Endpoint of Overall Survival with Opdivo??(nivolumab) Plus Low Dose Yervoy?(ipilimumab) vs. Chemotherapy in First-Line Non-Small Cell Lung Cancer Patients Whose Tumors Express PD-L1 =1%
- Third Tumor Type in Which Opdivo Plus Yervoy Demonstrates Overall Survival Benefit in a Phase 3 Trial
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company?(NYSE: BMY) today announced that Part 1a of the Phase 3 CheckMate -227 trial evaluating?Opdivo???(nivolumab) plus low-dose?Yervoy???(ipilimumab) met the co-primary endpoint of overall survival (OS), demonstrating a superior benefit versus chemotherapy in first-line non-small cell lung cancer (NSCLC) patients whose tumors express PD-L1 =1%. The safety profile was consistent with previously reported findings in first-line NSCLC for the?Opdivo?3 mg/kg every two weeks and low-dose?Yervoy?(1 mg/kg) every six weeks combination schedule. The company will share data from this trial with regulatory authorities.
In an exploratory analysis of patients in Part 1b whose tumors do not express PD-L1, a survival benefit was also observed with?Opdivoplus low-dose?Yervoy. The company looks forward to the complete findings from CheckMate -227 Part 1 being presented at an upcoming medical meeting.
?CheckMate-227 is the first Phase 3 trial to demonstrate that patients with lung cancer can achieve superior overall survival with a dual immunotherapy combination versus chemotherapy,? said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb. ?Lung cancer is the third tumor type where the?Opdivo?plus?Yervoy?regimen has shown a significant overall survival benefit in a randomized Phase 3 trial, reinforcing the importance of?Yervoy?in the treatment of cancer. We thank the patients and investigators who participated in this trial.?
?The nivolumab plus ipilimumab results from Part 1a of CheckMate-227 offers the potential for a chemo-sparing regimen that demonstrates an OS benefit to first-line lung cancer patients,? said Martin Reck, CheckMate 227 study investigator, from Lung Clinic Grosshansdorf, German Center of Lung Research. ?I am also encouraged to see activity in PD-L1 expressors and non-expressors, and look forward to seeing the full data presented in the future.?
Bristol-Myers Squibb also announced today that Part 2 of the CheckMate -227 trial, evaluating?Opdivo?plus chemotherapy, did not meet the pre-specified primary endpoint of OS versus chemotherapy in patients with non-squamous histology, regardless of PD-L1 status. Additional information can be found at?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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