opdivo

NICE has rejected the routine use of Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) on the NHS in England and Wales for the treatment of melanoma in patients post-surgery, it has been announced.

Bristol Myers Squibb’s therapy regimen of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) has secured FDA approval for the first-line treatment of unresectable malignant pleural mesothelioma, a potentially life-threatening lung cancer caused by asbestos fibre insulation, and one that sees around 20,000 new diagnoses a year in the US.

The combo was tested in 605 participants, with each receiving fortnightly intravenous infusions of Opdivo alongside intravenous infusions of Yervoy every six weeks for up to two years, or until disease progression or unacceptable toxicity wa

NICE has announced its recommendation of Bristol-Myers Squibb’s blockbuster immunotherapy drug Opdivo (nivolumab) for the treatment of two non-small cell lung cancer (NSCLC) indications in the second-line, it has emerged.

Currently, chemotherapy or a PD-1/PDL-L1 inhibitor is used as standard first-line treatment of locally advanced NSCLC, with Opdivo recommended only as a treatment for patients who have received chemotherapy.

Bristol-Myers Squibb has announced updated results from trialing Opdivo (nivolumab) plus Yervoy (ipilimumab) versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).

The results came from the Phase 3 CheckMate-214 study. With a follow-up of 42 months, the combination of Opdivo plus Yervoy yielded superior overall survival (OS), objective response rates, duration of response and complete response (CR) rates for intermediate/poor-risk (IP) patients compared to patients treated with sunitinib alone.

Five Prime Therapeutics and Bristol-Myers Squibb have confirmed that their randomised Phase 2 trial investigating the efficacy of the former’s cabiralizumab combined with the latter’s blockbuster immunotherapy Opdivo (nivolumab) in the treatment of advanced pancreatic cancer failed to meet its primary endpoint.

The combo fell short both with and without chemotherapy in a study of around 160 enrolled participants with locally advanced or metastatic or locally advanced or metastatic pancreatic cancer that had progressed despite having received one line of chemotherapy.  

Bristol-Myers Squibb has confirmed it has withdrawn its application with the European Commission for its combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of advanced non-small cell lung cancer (NSCLC).

The decision was made after the EMA’s Committee for Medicinal Products for Human Use (CHMP) informed the company that the data had submitted was not valid due to a number of “protocol changes” that had been made during the execution of the clinical study which generated them.

MSD’s Keytruda (pembrolizumab) overtook Bristol-Myers Squibb’s (BMS) blockbuster drug Opdivo (nivolumab) in total sales in the third quarter of 2019 to emerge as leader in the global immune checkpoint inhibitor market, according to a new report from GlobalData.

According to the findings, MSD’s drug saw a 62% growth in revenue compared to Q3 2018 to reach $3.1 million. Over the same period, Opdivo experienced sales growth of just 1%, generating $1.8 million

Bristol Myers Squibb has lifted the curtain on new Phase 3 data for its blockbuster immunotherapy Opdivo (nivolumab), showing that the drug, when combined with Yervoy (ipilimumab) and two cycles of chemotherapy, met its primary endpoint for the first-line treatment of advanced non-small cell lung cancer (NSCLC).

At a pre-specified analysis, the results illustrated that the combo showed superior overall survival benefit in relation to its comparator, chemotherapy monotherapy for up to four cycles followed by optional maintenance therapy.

Bristol-Myers Squibb took the opportunity at the European Society for Medical Oncology (ESMO) 2019 Annual Congress to present new Phase 3 data on its blockbuster immunotherapy Opdivo (nivolumab) in the treatment of unresectable advanced or recurrent oesophageal squamous cell carcinoma (ESCC) refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs.

Opdivo was shown to extend overall survival by 23% compared to docetaxel or paclitaxel chemotherapy, meeting the trial’s primary endpoint.

Bristol-Myers Squibb has revealed that its blockbuster immunotherapy drug Opdivo (nivolumab) has secured recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for a new dosing schedule in the adjuvant treatment of specific patients with melanoma.

The recommendation concerns adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.