View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. Comment
March 1, 2021updated 22 Jul 2022 11:30am

LoA Update: BeyondSpring’s plinabulin jumps 8 points after Phase III trial endpoints met in febrile neutropenia

The Likelihood of Approval (LoA) of BeyondSpring’s Phase III plinabulin in febrile neutropenia rose by 8 points as of 22 February, according to GlobalData’s LoA data.

By Sean Rai-Roche

The Likelihood of Approval (LoA) of BeyondSpring ’s Phase III plinabulin in febrile neutropenia rose by 8 points as of 22 February, according to GlobalData’s LoA data. The increase comes on the back of the Phase III trial reaching completion and achieving its primary endpoint. Interim results showed that plinabulin reached noninferior duration of severe neutropenia (DSN) and a faster onset compared with Amgen ’s Neulasta (pegfilgrastim).

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.

Interim analysis was released by BeyondSpring on 30 April 2020. The 105-patient, placebo-controlled Phase III (NCT03102606) trial assessed duration of severe neutropenia (DSN) in the first treatment cycle of taxotere in patients with advanced or metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer (NSCLC), and previously treated metastatic prostate cancer. The primary endpoint was DNS at the end of cycle one, which was 21 days, according the ClinicalTrials.gov.

The non–granulocyte colony-stimulating factor small molecule plinabulin previously had an LoA of 39%. Based on GlobalData’s analysis using a combination of machine learning and a proprietary algorithm, the LoA has risen to 47%. Plinabulin activates guanine nucleotide exchange factor (GEF-H1), resulting in dendritic cell maturation and other effects that prevent neutropenia by limiting neutrophil breakdown. BeyondSpring reported that plinabulin protects against chemotherapy-induced neutropenia (CIN) during the first week of chemotherapy, suggesting a rapid MoA, while it took Neulasta until week two to offer neutrophil protection, according to BeyondSpring media release.

Sean Rai-Roche is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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