BMS reports mixed results for Opdivo in lung cancer trial

25th July 2019 (Last Updated August 9th, 2019 15:17)

Bristol-Myers Squibb (BMS) has reported mixed results from the Phase III CheckMate -227 study of Opdivo (nivolumab) in combination with chemotherapy or its other drug, Yervoy (ipilimumab)

BMS reports mixed results for Opdivo in lung cancer trial
BMS’ Opdivo combination yields mixed results in patients with advanced NSCLC. Credit: Rept0n1x.

Bristol-Myers Squibb (BMS) has reported mixed results from the Phase III CheckMate -227 study of Opdivo (nivolumab) in combination with chemotherapy or its other drug, Yervoy (ipilimumab).

CheckMate -227 is a multi-part, open-label clinical trial that compared Opdivo combination to chemotherapy alone in first-line advanced non-small cell lung cancer (NSCLC) patients.

The study’s co-primary endpoints are overall survival (OS) and progression-free survival (PFS).

In Part Ia of the trial, a combination of Opdivo and low-dose Yervoy met the OS endpoint with a superior benefit, compared to chemotherapy, in subjects whose tumours express PD-L1 >1%.

Exploratory analysis of Part Ib, involving patients without PD-L1-expressing tumours, also revealed a survival benefit with the combination.

Findings also showed a safety profile consistent with previous data from first-line NSCLC patients who received a combination of 3mg/kg Opdivo every two weeks and 1mg/kg Yervoy every six weeks.

However, Part II of the CheckMate -227 trial failed to meet the OS endpoint when treated with Opdivo plus chemotherapy, compared to chemotherapy alone, irrespective of the patients’ PD-L1 status.

The median OS was 18.83 months with the combination and 15.57 months in the chemotherapy group. The landmark one-year OS was 67.3% versus 59.2%, respectively.

Exploratory analysis observed the median OS to be 18.27 months for Opdivo plus chemotherapy and 11.96 months for chemotherapy alone.

Investigators did not report any new safety signals.

Bristol-Myers Squibb Oncology Development head Fouad Namouni said: “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.”

Merck last month announced positive five-year results from a Phase Ib study of its Keytruda as a single agent in advanced NSCLC.

Over five years, Keytruda demonstrated a 23.2% overall survival (OS) rate in treatment-naïve patients and 15.5% in previously treated subjects.