NEW YORK – Bristol Myers Squibb said on Wednesday that the three-year follow-up data from the Phase III CheckMate-227 trial showed that non-small cell lung cancer patients with PD-L1 expression levels greater than 1 percent who received the combination of its PD-1 inhibitor nivolumab (Opdivo) and CTLA-4 inhibitor ipilimumab (Yervoy) experienced better outcomes than those who received chemotherapy.
For PD-L1-expressing patients, the three-year overall survival rate was 33 percent for those on the nivolumab and ipilimumab combination, and 22 percent for those who only received chemotherapy. Patients treated with the combination regimen had a three-year progression-free survival rate of 18 percent compared to 4 percent in those treated with chemotherapy alone.
In the PD-L1-positive group who saw their tumors shrink on the nivolumab and ipilimumab combination, 38 percent continued to respond to the drug for three years. Comparatively, 4 percent of responders in the chemotherapy-only arm remained in response three years later.
Further, investigators found that 70 percent of patients whose tumors expressed PD-L1 and had a complete or partial response by six months on the drug combination were alive three years later compared to 39 percent of patients in the chemotherapy arm.
In an exploratory analysis, researchers found that patients whose tumors expressed less than 1 percent of PD-L1 had a three-year overall survival rate of 34 percent on the nivolumab and ipilimumab combination compared to 15 percent on chemotherapy.
"The three-year outcomes from CheckMate-227 show evidence of sustained survival gains with nivolumab plus ipilimumab in the first-line treatment of non-small cell lung cancer; the data reaffirm the established scientific rationale that dual inhibition of PD-1 and CTLA-4 has the potential to deliver deep and durable responses for certain patients," Suresh Ramalingam, an investigator on the CheckMate-227 study, said in a statement
Nick Botwood, VP of oncology clinical development at Bristol Myers-Squibb, said in a statement that based on the results from the PD-L1-expressing population, the company will potentially seek approval with the US Food and Drug Administration for nivolumab and ipilimumab as a first-line treatment for NSCLC. If successful, this will be the fifth indication for the combination.