Bristol-Myers Squibb (BMS) has announced the mixed results from the phase 3 CheckMate -227 trial of the lung cancer drug Opdivo (nivolumab).
The part one of the phase 3 CheckMate -227 trial assessing Opdivo plus low-dose Yervoy (ipilimumab) achieved the co-primary endpoint of overall survival (OS).
According to the company, the part one showed a superior benefit versus chemotherapy in first-line non-small cell lung cancer (NSCLC) patients whose tumours express PD-L1 ≥1%.
A survival benefit was also observed with the lung cancer drug plus low-dose Yervoy in an exploratory analysis of patients in Part 1b whose tumours do not express PD-L1.
Bristol-Myers Squibb oncology development head Dr Fouad Namouni said: “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.
“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 part two of the CheckMate -227 trial has failed to meet the primary endpoint of OS with Opdivo plus chemotherapy versus chemotherapy in patients with first-line non-squamous NSCLC, regardless of PD-L1 status.
The median OS for patients treated with Opdivo plus chemotherapy was 18.83 months compared to 15.57 months for chemotherapy, while the landmark one-year OS was 67.3% versus 59.2%.
BMS said that the median OS was 18.27 months for Opdivo plus chemotherapy compared to 11.96 months for chemotherapy in an exploratory analysis of patients with first-line squamous NSCLC.
Namouni added: “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.
CheckMate -227 is a multi-part open-label phase 3 trial designed to assess Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced NSCLC cross non-squamous and squamous tumour histologies.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to exploit the body’s own immune system to help restore anti-tumour immune response.