Bristol Myers Cancer Drug Opdivo In Combination With Chemo Shows Improved Overall Survival In Certain Patients With Lung Cancer

Zinger Key Points

Opdivo plus chemotherapy showed a significant overall survival benefit in resectable NSCLC, per final Phase 3 CheckMate -816 study results.
In October, the FDA approved Opdivo for resectable NSCLC.
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On Wednesday, Bristol Myers Squibb & Co BMY announced the final analysis of overall survival (OS) from the Phase 3 CheckMate -816 study, which evaluated Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC).

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The results showed a statistically significant and clinically meaningful improvement in overall survival, a key secondary endpoint, compared to neoadjuvant chemotherapy alone.

The results build on the previously reported primary endpoints of event-free survival (EFS) and pathological complete response (pCR), which also met statistical significance.

The safety profile of Opdivo in combination with chemotherapy was consistent with previously reported studies, with no new safety signals observed.

“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 Dana Walker, vice president, global program lead, late development, oncology, Bristol Myers Squibb. “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.”

In October, the FDA approved Bristol Myers’ Opdivo for resectable NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery.

Last week, Bristol Myers released topline data from its Phase 2 TRANSCEND FL trial of Breyanzi (lisocabtagene maraleucel) for relapsed or refractory indolent B-cell non-Hodgkin lymphoma.

The study met its primary endpoint in the marginal zone lymphoma (MZL) cohort and Breyanzi demonstrated a statistically significant and clinically meaningful overall response rate (ORR) in these patients. It also met the key secondary endpoint of complete response rate (CRR).

Price Action: BMY stock closed higher by 1.01% to $54.98 on Wednesday.

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