Neoadjuvant Opdivo (nivolumab) Plus Chemotherapy Significantly Improves Event-Free Survival in Patients with Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial

Bristol Myers Squibb moment blazoned the Phase 3 CheckMate-816 trial met the primary endpoint of bettered event-free survival (EFS) in cases with resectable stage IB to IIIAnon-small cell lung cancer (NSCLC). In a prespecified interim analysis, Opdivo (nivolumab) plus chemotherapy showed a statistically significant and clinically meaningful enhancement in EFS compared to chemotherapy alone when given before surgery. This combination preliminarily showed a significant enhancement of pathologic complete response (pCR), the trial’s other primary endpoint. The safety profile of Opdivo plus chemotherapy was harmonious with preliminarily reported studies in NSCLC.

“ CheckMate-816 is the first Phase 3 trial with an immunotherapy- grounded combination to demonstrate a statistically significant and clinically meaningful benefit as a neoadjuvant treatment for cases withnon-metastaticnon-small cell lung cancer. The combination of Opdivo plus chemotherapy first showed a statistically significant enhancement in pathologic complete response rate without impacting surgical issues and has now extended the time cases live free of complaint progression, rush or death,” said Abderrahim Oukessou,M.D., vice chairman, thoracic cancers development lead, Bristol Myers Squibb. “ The event-free survival data from CheckMate-816 strengthen the substantiation for the eventuality of Opdivo- grounded curatives to ameliorate long- term clinical issues when used in the earlier stages ofnon-metastatic cancers.”

Innon-metastatic NSCLC, Bristol Myers Squibb and collaborators are exploring the use of immunotherapy in the neoadjuvant, adjuvant andperi-operative settings, as well as in association with chemoradiation. The scientific explanation for using immunotherapy in the neoadjuvant setting is twofold the presence of a excrescence during immunotherapy treatment may enable a stronger vulnerable response, potentially making the treatment more effective against a primary excrescence, while offering an occasion to target covertmicro-metastasis.

Bristol Myers Squibb thanks the cases and investigators who were involved in the CheckMate-816 clinical trial.

About CheckMate-816

CheckMate-816 is a Phase 3 randomized, open marker,multi-center trial assessing Opdivo plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in cases with resectablenon-small cell lung cancer, anyhow of PD-L1 expression. For the primary analysis, 358 cases were randomized to admit either Opdivo 360 mg plus histology- grounded platinum fellow chemotherapy every three weeks for three boluses, or platinum fellow chemotherapy every three weeks for three boluses, followed by surgery. The primary endpoints of the trial are pathologic complete response (pCR) and event-free survival (EFS). Secondary endpoints include overall survival ( Zilches), major pathologic response (MPR), and time to death or distant metastases.

About Lung Cancer

Lung cancer is the leading cause of cancer deaths encyclopedically. The two main types of lung cancer arenon-small cell and small cell. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84 of judgments. Non-metastatic cases regard for the maturity of NSCLC judgments ( roughly 60). While numerousnon-metastatic NSCLC cases are cured by surgery, 30 to 55 develop rush and bones of their complaint despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/ or after surgery (adjuvant) to ameliorate long- term issues.

Bristol Myers Squibb Creating a More Unborn for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transubstantiating cases’lives through wisdom. The thing of the company’s cancer exploration is to deliver drugs that offer each case a better, healthier life and to make cure a possibility. Structure on a heritage across a broad range of cancers that have changed survival prospects for numerous, Bristol Myers Squibb experimenters are exploring new borders in individualized drug, and through innovative digital platforms, are turning data into perceptivity that edge their focus. Deep scientific moxie, slice- edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a grim grasp on numerous corridor of a case’s life, and Bristol Myers Squibb is committed to taking conduct to address all aspects of care, from opinion to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Opdivo

Opdivo is a programmed death-1 (PD-1) vulnerable checkpoint asset that’s designed to uniquely harness the body’s own vulnerable system to help restoreanti-tumor vulnerable response. By employing the body’s own vulnerable system to fight cancer, Opdivo has come an important treatment option across multiple cancers.

Opdivo’s leading global development program is grounded on Bristol Myers Squibb’s scientific moxie in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of excrescence types. To date, the Opdivo clinical development program has treated further than cases. The Opdivo trials have contributed to gaining a deeper understanding of the implicit part of biomarkers in patient care, particularly regarding how cases may profit from Opdivo across the continuum of PD-L1 expression.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose charge is to discover, develop and deliver innovative drugs that help cases prevail over serious conditions. For further information about Bristol Myers Squibb, visit us atBMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Rectifiers are wholly possessed accessories of Bristol-Myers Squibb Company. In certain countries outside theU.S., due to original laws, Celgene and Juno Rectifiers are appertained to as, Celgene, a Bristol Myers Squibb company and Juno Rectifiers, a Bristol Myers Squibb company.

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