Bristol-Myers Squibb released the pooled efficacy and safety results from its Phase III CheckMate -017 and CheckMate -057 trials in patients with previously treated advanced non-small cell lung cancer (NSCLC).

The results of the two long-term trials showed that patients receiving the company’s checkpoint inhibitor, Opdivo (nivolumab), had a long-term overall survival (OS) improvement compared to docetaxel chemotherapy alone. For the Opdivo group, OS rates at five years were 13.4% compared to 2.6% for docetaxel. The benefit was seen in all subgroups of patients.

“Since the U.S. Food and Drug Administration approval in second-line non-small cell lung cancer in 2015, Opdivo has become an important treatment option for this population of patients, who historically face five-year survival rates of less than 5% when treated with standard chemotherapy,” said Sabine Maier, development lead, Thoracic Cancers, Bristol-Myers Squibb.

Maier added, “The long-term survival outcomes from these two studies in a large patient population add to the body of evidence supporting the durability of Opdivo-based regimens, which has now been demonstrated across multiple tumor types and lines of therapy.”

The pooled five-year analysis was the longest follow-up from randomized Phase III trials of an immuno-oncology therapy in this setting. In both trials, patients experienced disease progression during or after first-line platinum-based chemotherapy. They were randomized 1:1 to receive Opdivo once every two weeks or docetaxel once every three weeks until disease progression or unacceptable toxicity.

Once the primary analysis was wrapped, patients in the docetaxel cohort who were no longer benefiting from the chemotherapy could switch over to receive Opdivo.

The safety profile was consistent with earlier reports in second-line NSCLC. Of the patients still participating, only 2 of 70 had new treatment-related select adverse events between years three and four. No new treatment-related adverse events were reported between the fourth and fifth years in the 55 patients remaining in the trial.

In patients who had an objective response to Opdivo, a third, 32.2%, continued to see a response at five years. None of the patients with an objective response to docetaxel continued to have a response at the five-year mark. Median duration of response for the Opdivo cohort was 19.9 months compared to 5.6 months for the docetaxel group.

“The five-year CheckMate -017 and 057 data underscores the durable efficacy for Opdivo in this patient population compared to traditional chemotherapy,” said Scott Gettinger, professor, Medical Oncology at Yale Cancer Center.

Last week, the company announced that its Phase III CheckMate -548 study of Opdivo (nivoumab) added to current standard of care to treat brain cancer, newly diagnosed glioblastoma multiforme (GBM), didn’t meet one of its primary endpoints, progression-free survival (PFS). The trial will continue to evaluate the other primary endpoint, overall survival (OS).

CheckMate -548 is evaluating Opdivo and temozolomide and radiation compared to temozolomide and radiation alone. The patients have newly diagnosed GBM that is 06-methylguanine-DNA methyltransferase (MGMT)-methylated. GBM is the most common central nervous system tumor and is the most aggressive. Standard treatment can include surgery followed by radiation and chemotherapy. However, treatment options are limited. The five-year survival rate of patients with GBM is less than five percent.

MGMT methylation status is a biomarker used to guide treatment.

The data monitoring committee recommended the trial continue as planned, with an estimated primary completion date in February 2022. Secondary endpoints are PFS as assessed by the investigator, and OS rate up to two years.

“Though CheckMate -548 did not show statistically significant improvement in progression-free survival, we are continuing to evaluate the benefit the addition of Opdivo to the standard of care treatment regimen may bring to patients suffering from GBM, an extremely aggressive and difficult disease to treat,” said Fouad Namouni, head, Oncology Development, for Bristol-Myers Squibb.



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