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Neoadjuvant Opdivo with platinum-doublet chemo had a statistically significant and clinically meaningful improvement versus chemo alone in resectable NSCLC.
Neoadjuvant Opdivo with chemo significantly improved overall survival in resectable NSCLC per final CheckMate-816 results, reinforcing prior efficacy data.
Among adult patients with resectable (tumors 4 centimeters or larger or node positive) non-small cell lung cancer (NSCLC), neoadjuvant treatment with Opdivo (nivolumab) in combination with platinum-doublet chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with neoadjuvant chemotherapy alone
These data were garnered from the final OS analysis from the phase 3 CheckMate-816 study which were shared in a press release from Bristol Myers Squibb. Notably, these data have built on previously reported event-free survival (EFS) and pathological complete response (pCR) findings — both of which were primary end points of the study — which also met statistical significance.
“The final analysis of overall survival in the CheckMate-816 study underscores the potential of Opdivo in combination with chemotherapy to provide a meaningful survival benefit for patients with resectable NSCLC,” said Dr. Dana Walker, vice president and global program lead of Late Development, Oncology, at Bristol Myers Squibb, in the press release. “This is the first and only phase 3 study of a neoadjuvant-only immuno-oncology therapy to show a statistically significant benefit in patients with resectable NSCLC. Opdivo-based therapies have shown improved efficacy in the neoadjuvant and perioperative treatment of patients with resectable NSCLC.”
Overall survival (OS): the average length of time that patients are alive after being diagnosed with or starting treatment for a disease.
Event-free survival (EFS): measurement of how long a patient is free of disease progression or other complications after treatment for cancer.
Pathological complete response (pCR): the absence of cancer in tissue samples after treatment.
Furthermore, the safety profile of the Opdivo combination with chemotherapy showed consistent results with what was previously reported studies and no new safety signals were observed.
An analysis of the updated data will be conducted, according to the company, who also plans to provide a comprehensive update on the data in a future peer-reviewed setting.
CheckMate-816 is a randomized, open-label, multi-center trial which is evaluating the efficacy of Opdivo in combination with chemotherapy versus chemotherapy alone as a neoadjuvant treatment for patients with resectable stage 1B to 3A NSCLC. The trial enrolled 358 patients, who were randomly assigned to receive either 360 milligrams (mg) of Opdivo plus histology-based platinum doublet chemotherapy every three weeks for three cycles or platinum doublet chemotherapy alone on the same schedule, followed by surgical resection.
The study’s primary end points are EFS and pCR; secondary end points include OS, major pathologic response and time to death or distant metastases.
Opdivo is a PD-1 immune checkpoint inhibitor designed to leverage the body’s immune system to restore anti-tumor activity. By reinvigorating the immune response against cancer cells, Opdivo has is now a key treatment option across multiple malignancies. Moreover, in July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. The agent is now approved in over 65 countries.
Furthermore, in October 2015, the combination of Opdivo with Yervoy (ipilimumab) became the first immuno-oncology regimen to gain regulatory approval for metastatic melanoma treatment. This combination is now approved in more than 50 countries.
Some, but not all, of the current indications of Opdivo in the cancer care space include:
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