clinical trials of advanced and earlier treated lung cancer, with survival rates about double those seen with the older treatment after three years.
The presentation, “Three-year follow-up from CheckMate 017/057: Nivolumab versus docetaxel in patients with previously treated advanced non-small cell lung cancer (NSCLC),” was given on Sept. 10.
The two treatment approaches were compared in two Phase 3 clinical trials. One, called CheckMate -017 (NCT01642004), included 272 patients with squamous non-small cell lung cancer (NSCLC). The other, CheckMate -057 (NCT01673867) focused on non-squamous NSCLC and included 582 patients. All patients received the treatment as a second line, following one failed platinum-based chemotherapy regimen.
The study looked at the outcomes after a minimum of 36.6 months and noted that overall survival was clearly improved with Opdivo treatment. At three years, 16% of squamous NSCLC patients treated with Opdivo were still alive. Among those who had been treated with Taxotere, that number was 6%.
Similar rates were achieved in patients with non-squamous disease, in which 18% of Opdivo-treated and 9% of Taxotere-treated patients were still alive at three years.
“Opdivo is already a standard of care in previously treated non-small cell lung cancer across histologies, demonstrating durable, long-term survival in two pivotal Phase 3 studies. Data from CheckMate -017 and CheckMate -057 continue to reinforce the compelling and sustained survival benefit demonstrated with Opdivo for these patients even after three years,” Enriqueta Felip, MD, head of the Thoracic Tumors Group at Vall d’Hebron Institute of Oncology, said.
“These results are important for the clinical community and represent the longest follow-up data reported for a PD-1 inhibitor versus chemotherapy in second-line NSCLC,” she added.
Opdivo is a checkpoint inhibitor targeting the PD-1 molecule. The trials had recruited patients irrespective of their levels of the PD-L1 molecule, which earlier studies argued would be predicting of response to PD-1 blockers.
The studies showed that patients who had PD-L1 levels of less than 1% also benefitted from the treatment. Among patients with squamous cancer, survival rates were nearly identical in patients with higher and lower levels of the factor — 13% and 14%, respectively.
Non-squamous lung cancer patients with high levels of PD-L1 had a somewhat better survival rate than those with low levels — 26% compared with 11%.
Of the 427 patients who received Opdivo in the two studies, 17% survived for three years or longer.
Researchers also reported that the safety and side effects profile of Opdivo was similar to that observed in earlier studies.
“Our utmost priority at BMS [Bristol-Myers Squibb] is to bring forth transformational medicines to deliver what matters most to patients fighting cancer: long-term survival,” said Nick Botwood, MD, development lead, thoracic cancers at Bristol-Myers Squibb.
“The long-term survival benefit seen with Opdivo in the pivotal CheckMate -017 and -057 studies demonstrates our commitment to this vision. These data also increase our understanding of the value Opdivo may bring to patients with previously treated metastatic NSCLC, as we continue to explore Opdivo alone and in combination with other agents across a range of thoracic cancers.”