Bristol Myers Squibb...the U.S. Food and Drug Administration (FDA) approved Opdivo ® (nivolumab) for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC)...

Ono Pharmaceutical...and Bristol-Myers Squibb...announced that ONO has received a supplemental approval of Opdivo® (generic name: nivolumab) Intravenous Infusion (“Opdivo”), a human anti-human PD-1 monoclonal antibody in Japan for the neoadjuvant treatment of non-small cell lung cancer in combination with chemotherapy, for a partial change in approved items of the manufacturing and marketing approval.

...the Ministry of Food and Drug Safety approved the combined administration of platinum-based chemotherapy and Opdivo as neoadjuvant therapy before surgery in NSCLC patients with tumors that can be resected (tumor size greater than four centimeters or benign lymph node.

Bristol Myers Squibb Canada (BMS) announced Health Canada’s approval of OPDIVO® (nivolumab) 360 mg (injection for intravenous use) in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) in the neoadjuvant setting.

OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of:...adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy.

OPDIVO as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults.

The National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending nivolumab in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable (tumours ≥ 4 cm or node-positive) non-small cell lung cancer (NSCLC) in adults.

Non-Small Cell Lung Cancer: Adjuvant Systemic Therapy…Nivolumab 360 mg and platinum-doublet chemotherapy every 3 weeks for 3 cycles…Platinum-doublet chemotherapy options include: Carboplatin…paclitaxel...

Nivolumab or atezolizumab is recommended (category 1; preferred) as a subsequent monotherapy option for select patients with metastatic NSCLC regardless of PD-L1 levels

Neoadjuvant nivolumab plus chemotherapy resulted in longer EFS and a higher pCR rate versus chemotherapy alone in Japanese patients, consistent with findings in the global population.

Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -77T trial met its primary endpoint of improved event-free survival (EFS) as assessed by Blinded Independent Central Review (BICR) in patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). In a prespecified interim analysis, the perioperative regimen of neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo showed a statistically significant and clinically meaningful improvement in EFS compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.

In this open-label, phase 3 trial, we randomly assigned patients with stage IB to IIIA resectable NSCLC to receive nivolumab plus platinum-based chemotherapy or platinum-based chemotherapy alone, followed by resection….In patients with resectable NSCLC, neoadjuvant nivolumab plus chemotherapy resulted in significantly longer event-free survival and a higher percentage of patients with a pathological complete response than chemotherapy alone.

Bristol Myers Squibb (NYSE: BMY) today announced results from the Phase 3 CheckMate -816 trial, which showed that neoadjuvant treatment with three cycles of Opdivo (nivolumab) in combination with chemotherapy significantly improved event-free survival (EFS), a primary endpoint, compared to chemotherapy alone in patients with resectable non-small cell lung cancer (NSCLC). With a minimum follow-up of 21.0 months, Opdivo with chemotherapy reduced the risk of disease recurrence, progression or death by 37% (Hazard Ratio [HR] 0.63; 97.38% Confidence Interval [CI]: 0.43 to 0.91; p=0.0052) across randomized patients when administered before surgery. In patients receiving the combination, median EFS was 31.6 months, compared to 20.8 months for patients treated with chemotherapy alone.

Bristol Myers Squibb...today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC), based on results from the CheckMate -816 trial. The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 13, 2022.

In the study, 24% of patients treated with Opdivo plus chemotherapy prior to surgery achieved pCR, compared to 2.2% of patients treated with chemotherapy alone (Odds Ratio [OR] 13.94, 99% Confidence Interval [CI]: 3.49–55.75; p<0.0001), with pCR defined as no evidence of cancer cells in their resected tissue as assessed by a blinded independent pathology review. Additionally, Opdivo plus chemotherapy was well tolerated and showed consistent improvements in pCR regardless of PD-L1 expression levels, histologies or stages of disease.

Bristol Myers Squibb (NYSE: BMY) today announced that the Phase 3 CheckMate -816 trial met a primary endpoint of pathologic complete response (pCR) in resectable non-small cell lung cancer (NSCLC). In the trial, significantly more patients treated with Opdivo (nivolumab) plus chemotherapy before surgery showed no evidence of cancer cells in their resected tissue compared to those treated with chemotherapy alone. CheckMate -816 is the first and only Phase 3 trial to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC.

...PFS was significantly longer in the nivolumab arm compared to the placebo arm with the median PFS of 12.12 vs 8.11 months... and 12-month PFS rate of 50.1% vs 30.2%... OS, while not mature, tended to be longer in the nivolumab arm compared to the placebo arm....ONO-4538-52/TASUKI-52 met the primary endpoint; nivolumab in combination with carboplatin, paclitaxel, and bevacizumab significantly prolonged PFS with a manageable safety profile.