Bristol-Myers Squibb announced Monday that the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) reduced the risk of progression or death by 42 percent versus chemotherapy in first-line advanced non-small-cell lung cancer (NSCLC) patients whose tumours have high tumour mutation burden (TMB). The company noted that the benefit was observed regardless of PD-L1 expression levels and in both squamous and non-squamous tumour histology.
In February, Bristol-Myers Squibb said that the Phase III CheckMate -227 trial investigating the combination of Opdivo plus Yervoy versus chemotherapy in first-line advanced NSCLC patients whose tumours have high TMB, regardless of PD-L1 expression, met its co-primary endpoint of progression-free survival (PFS).
In the study, more than 2500 patients have been randomised across non-squamous and squamous histologies, evaluating Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced NSCLC. According to Bristol-Myers Squibb, Part 1a of the trial is evaluating Opdivo plus Yervoy and Opdivo monotherapy versus chemotherapy in patients whose tumours express PD-L1.
Meanwhile, Part 1b investigated Opdivo plus Yervoy and Opdivo plus chemotherapy versus chemotherapy in patients whose tumours do not express PD-L1. Further, Part 2 of the study is evaluating Opdivo plus chemotherapy versus chemotherapy in a broad population with a primary endpoint of overall survival (OS).
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Results presented Monday at the American Association for Cancer Research (AACR) annual meeting also showed that PFS was significantly improved with the combination versus chemotherapy in patients with PD-L1 of at least 1 percent and PD-L1 less than 1 percent. Bristol-Myers Squibb added that "encouraging" OS was observed with Opdivo plus Yervoy versus chemotherapy in patients with high TMB of at least 10 mut/Mb.
According to the drugmaker, in the combination arm, PFS was 43 percent in patients with high TMB versus 13 percent in the chemotherapy group. Meanwhile, the overall response rate was 45.3 percent in the Opdivo plus Yervoy group compared to 26.9 percent in the chemotherapy arm. Bristol-Myers Squibb further noted that among patients who responded to the drug combination, 68 percent had "ongoing responses at one year" versus 25 percent for patients in the chemotherapy group.
However, shares in Bristol-Myers Squibb were down as much as 8.5 percent on the study results. Gabelli & Co. analyst Jeff Jonas remarked "it's definitely narrowed their base of patients, and they'll hope their combination therapies work out." Analysts recently predicted that the results could be disappointing based on the company's decision to focus the study on a narrow group of patients.
Separately on Monday, Merck & Co. reported that Keytruda (pembrolizumab) in combination with chemotherapy for the first-line treatment of patients with metastatic non-squamous NSCLC significantly improved OS, reducing the risk of death by 51 percent compared with chemotherapy alone. The data from the KEYNOTE-189 trial were presented at the AACR annual meeting.
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