View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
October 23, 2019updated 12 Jul 2022 12:23pm

BMS’ CheckMate -9LA lung cancer study meets primary goal

Bristol-Myers Squibb (BMS) has reported that its Phase III CheckMate -9LA clinical trial of Opdivo (nivolumab) and low-dose Yervoy (ipilimumab) combination met the primary endpoint in non-small cell lung cancer (NSCLC) patients.

Bristol-Myers Squibb (BMS) has reported that its Phase III CheckMate -9LA clinical trial of Opdivo (nivolumab) and low-dose Yervoy (ipilimumab) combination met the primary endpoint in non-small cell lung cancer (NSCLC) patients.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

Opdivo is the company’s programmed death-1 (PD-1) immune checkpoint inhibitor that leverages the body’s immune system to restore anti-tumour response.

BMS designed Yervoy, which is a recombinant, human monoclonal antibody, to bind to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) and potentially induce T-cell activation and proliferation.

The open-label, multi-centre, randomised Phase III CheckMate -9LA trial compared 360mg Opdivo plus 1mg/kg Yervoy in combination with chemotherapy to chemotherapy alone as first-line therapy in patients with advanced NSCLC.

Participants received either two cycles of the combination or up to four cycles of only chemotherapy followed by optional maintenance therapy.

The primary endpoint was overall survival (OS), while secondary endpoints included progression-free survival (PFS), overall response rate (ORR) and efficacy measures based on biomarkers.

Data from a pre-specified interim analysis showed that the combination achieved the primary endpoint, demonstrating superiority in overall survival (OS) versus chemotherapy alone.

The safety profile of the combination was observed to be similar to the known safety profiles of the individual components in first-line NSCLC.

Bristol-Myers Squibb Oncology Development head Fouad Namouni said: “We are excited by the CheckMate -9LA results, which demonstrate the potential of Opdivo plus low-dose Yervoy to provide a survival benefit to patients with non-small cell lung cancer in the first-line setting when administered concomitantly with a limited course of chemotherapy.

“These results build on the benefit the combination of Opdivo plus Yervoy has previously shown in first-line melanoma, renal cell carcinoma and most recently lung cancer, and may provide a new therapeutic option for patients.”

The Opdivo and Yervoy combination has approval in more than 50 countries to treat patients with metastatic melanoma.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena