Bristol Myers Squibb & Co BMY announced the first disclosure of data from the Phase 3 CheckMate -77T trial of the perioperative regimen of neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC).
With a median follow-up of 25.4 months, in patients treated with the Opdivo regime, the risk of disease recurrence, progression or death was reduced by 42%, compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.
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Additionally, neoadjuvant Opdivo and chemotherapy showed improvements in the secondary efficacy endpoints of pathologic complete response (pCR; 25.3% vs. 4.7%) and major pathologic response (MPR; 35.4% vs 12.1%).
The study is ongoing to assess its other secondary endpoint of overall survival (OS).
Definitive surgery rates were 78% with the Opdivo-based regimen vs. 77% with chemotherapy and placebo, with complete resection achieved in 89% vs. 90% of patients, respectively.
In an exploratory analysis of the second BMS study, dubbed CheckMate-816, three cycles of neoadjuvant Opdivo with chemotherapy achieved a three-year event-free survival rate of 72%, compared with 47% in comparators who received chemotherapy alone.
Opdivo with chemotherapy reduced the risk of death by 63%. Three-year OS rates favored neoadjuvant Opdivo with chemotherapy over chemotherapy alone at 85% vs. 66%, respectively.
The PD-1 blocker also showed "promising" overall survival benefits and reduced the risk of death by 85% at three years, as opposed to 66% with chemotherapy alone. However, OS data from CheckMate-816 is still immature.
Price Action: BMY shares are down 0.17% at $57.28 on the last check Wednesday.
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