Bristol-Myers Squibb has been looking to preserve Opdivo’s share of the non-small cell lung cancer market with long-term survival data. And Tuesday, it came out with immuno-oncology’s longest-term data yet.
At the five-year mark, use of Opdivo in previously treated NSCLC patients delivered survival rates more than five timesas high as docetaxel chemotherapy did, BMS said at the World Conference on Lung Cancer in Barcelona. More than 13% of those treated with Opdivo were still alive five years after treatment began, versus just 2.6% of docetaxel patients.
And among patients who responded to Opdivo, 32.2% were still responding at that point. Opdivo-treated patients responded for a median 19.9 months, compared with 5.6 months for those in the docetaxel arm.
In other words, “one out of three patients who responds” to Opdivo is “still responding at five years,” Sabine Maier, M.D., the company’s development lead for thoracic cancers, noted. Those results sit in stark contrast with the “very transient benefit” that chemo offers.
“What’s exciting is if you make it to two or three years, you actually have a very high chance of also making it progression-free to five years,” she said. And that stat “gives us hope that by using I-O in different settings, we could be seeing similar plateaus.”
The analysis pooled results from two of the New Jersey drugmaker’s phase 3 trials, known as CheckMate-017 and CheckMate-057. Between those two studies, BMS started with a hefty sample size of more than 850 patients, so “we can very well characterize” Opdivo’s impact, Maier said.
The pooling also allowed BMS to examine Opdivo’s effects on subgroups, and Maier flagged a “substantial increase in survival” even in those patients whose tumors tested negative for biomarker PD-L1.
Bristol is hoping the new results will help it hold onto share in a market that’s steadily shrinking, thanks in no small part to rival Merck & Co. Ever since the Big Pharma’s Keytruda-chemo combo showed it could cut death risks by half in previously untreated NSCLC patients, use of the drug in the front-line setting has skyrocketed—reducing the number of patients eligible to receive Opdivo and Yervoy.
And given that BMS still doesn’t have its own I-O regimen approved for newly diagnosed patients, it needs those second-line lung cancer sales. New competition is pressuring Opdivo in other key areas such as kidney cancer, and a recent spate of trial failures hasn’t helped sales prospects, either.
Originally published on fiercepharma.com